Pharmaceuticals, Biotechnology & Life Sciences

The science side of health care — companies that discover and make medicines, plus the tools and equipment other researchers use to develop them.

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Pharmaceuticals, Biotechnology & Life Sciences

Chugai Regains Emugrobart Rights as Roche Halts Obesity Development

Chugai Pharmaceutical has regained full rights to emugrobart after Roche discontinued development of the anti-latent myostatin antibody for obesity, following interim Phase II data that suggested clinically meaningful weight loss targets were unlikely to be met despite a favorable safety profile. With the rights back in-house, Chugai is preparing to restart development of emugrobart for spinal muscular atrophy and is exploring out-licensing, reshaping how the asset fits into its broader pipeline plans. The company's narrative projects revenue of ¥1,723.1 billion and earnings of ¥695.2 billion by 2029, implying 8.7% yearly revenue growth and a ¥223.8 billion earnings increase from ¥471.4 billion today. The most pessimistic analysts assumed revenue near ¥1,609.4 billion and earnings of about ¥608.3 billion by 2029, and while consensus views the emugrobart spinal muscular atrophy reboot as incremental, the news could still shift how investors weigh competing views on pipeline risk. Chugai's forecasts yield a fair value of ¥8870, a 46% upside to its current price.
4519.JP · Technology · Positive Chugai regains full rights to emugrobart and will restart development for spinal muscular atrophy after Roche halted obesity work.
ROP.SW · Technology · Negative Roche discontinued development of emugrobart for obesity after interim Phase II data suggested weight-loss targets were unlikely to be met.
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Capricor Falls 10% as Deramiocel OLE Data Fails to Ease FDA Concerns

Capricor Therapeutics shares fell about 10% in Monday trading despite positive data from an open-label extension study of deramiocel for Duchenne muscular dystrophy, as investors remained doubtful the candidate will win US FDA approval. A 24-month crossover analysis of HOPE-3 found that patients who began deramiocel after 12 months on placebo slowed upper limb decline by 76% compared to the first year, while patients always on deramiocel showed a similar reduction in rate of decline at both 12 and 24 months. H.C. Wainwright's Joseph Pantginis, who rates Capricor at neutral, said he expects a Complete Response Letter from the FDA for deramiocel, writing that the OLE data strengthens the efficacy story but does not resolve the regulatory uncertainty tied to what occurred during the randomized portion of HOPE-3. Cantor Fitzgerald's Kristen Kluska, who rates Capricor at overweight, was more optimistic, saying the 24-month OLE data reinforce the durability and consistency of the treatment effect and that she leans more toward a potential approval with an attractive risk/reward setup of plus 300% to minus 70%. The OLE analysis was included in a major amendment to the company's BLA, and deramiocel faces a Nov. 22 FDA action date after a late July FDA advisory panel failed to endorse the candidate following briefing documents from agency scientists that called HOPE-3 data into question.
CAPR · Regulation · Negative Deramiocel OLE data fails to resolve FDA regulatory uncertainty ahead of the Nov. 22 action date, with analysts expecting a Complete Response Letter.
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AstraZeneca Opens $1 Billion Kendall Square R&D Center in Cambridge, Massachusetts

AstraZeneca has opened its newest global strategic research and development center in Kendall Square, Cambridge, Massachusetts, part of a more than $1 billion investment in the state that will expand its Massachusetts workforce by over 50 percent in the coming years. The 570,000 square foot, 18 story site at 290 Binney Street will house nearly 2,000 researchers and scientists alongside the company's genomic medicine site at 100 Binney Street, and includes ten floors of interconnecting laboratories integrating robotics, continuous automation and agentic AI. The scientists will work on AstraZeneca's oncology, cell therapy, chronic disease and rare disease pipeline, targeting conditions such as COPD, obesity and metabolic disease, breast cancer and rare diseases, while pursuing future innovation in cell therapy and biologics to fuel growth beyond 2030. The Massachusetts investment sits within AstraZeneca's broader $50 billion US investment, and the new site joins its other US-based global strategic research center in Gaithersburg, Maryland, as part of a coast-to-coast footprint of 24 R&D, manufacturing, commercial and corporate sites. Chief Executive Officer Pascal Soriot said Kendall Square is a leading innovation ecosystem and one of the key locations where AstraZeneca will discover the next generation of scientific breakthroughs, while Massachusetts Governor Maura Healey called the investment a major vote of confidence in the state.
AZN.LSE · Capital · Positive AstraZeneca opens a $1B+ Kendall Square R&D center, part of its broader $50B US investment, expanding its Massachusetts workforce by over 50%.
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Novartis Signs $7.8B RNA Therapeutics Deal With Abogen Biosciences

Novartis entered a licensing and option agreement with China-based Abogen Biosciences, giving the Swiss pharma giant exclusive worldwide rights to Abogen's lead candidate ABO2203 and options to license additional programs built on Abogen's proprietary RNA platform. Under the agreement, Abogen will receive an upfront payment of $575 million and is eligible to receive up to approximately $7.2 billion in potential milestone payments if all options covering additional programs are exercised and the specified development, regulatory and commercial milestones are achieved, plus royalties on future product sales. ABO2203 is an investigational messenger RNA-encoded CD19xCD3 T-cell engager being developed for autoimmune diseases, designed to reset B cells by directing endogenous production of T-cell engagers in vivo. The transaction remains subject to customary closing conditions, including required regulatory clearances. The deal comes as Novartis faces generic competition for Entresto and Promacta and back-to-back pipeline setbacks, including the late-stage failure of pelacarsen and the HARBOR study of del-desiran in myotonic dystrophy type 1.
NOVN.SW · Capital · Positive Novartis signs $7.8B licensing/option deal with Abogen for RNA therapeutics, adding pipeline assets amid generic competition and pipeline setbacks
Abogen Biosciences · Capital · Positive Abogen receives $575M upfront and up to ~$7.2B in milestones plus royalties under the Novartis licensing and option agreement
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Insmed CFO Sara Bonstein to Step Down October 30; Shares Fall 8%

Insmed Inc announced that Chief Financial Officer Sara Bonstein will step down on October 30, sending shares down 8% Monday. Bonstein will continue as CFO through the company's reporting of its third-quarter 2026 financial results and will participate in the earnings call on October 29, while Insmed has begun a search for her successor. She served as CFO for nearly seven years, during which Insmed raised more than $4.2 billion in capital, and the company said her transition is not related to any disagreement over accounting practices, financial statements, internal controls, or operations. Chair and Chief Executive Officer Will Lewis said Insmed is well positioned to reach cash flow positivity next year with a clear path toward sustained top-line growth and bottom-line profitability. The company reaffirmed its full-year 2026 guidance of revenue in the range of $1.25 billion to $1.40 billion for BRINSUPRI and $450 million to $470 million for ARIKAYCE, and will release third-quarter 2026 results on October 29.
INSM · Capital · Negative CFO Sara Bonstein is stepping down on October 30, a leadership change that sent shares down 8%.
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Investing.com·21hRead more →
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Vaxcyte Surges 32% on Positive Phase 3 Data for VAX-31 Pneumonia Vaccine

Vaxcyte shares jumped about 32% in Monday morning trading after the company reported positive phase 3 topline data for VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. The OPUS-1 trial tested non-inferiority and immunogenicity of VAX-31 against Merck's Capvaxive and Pfizer's Prevnar 20 in patients aged 50 and over. For the 11 serotypes shared by the three shots, VAX-31 met all primary noninferiority assessments, and three serotypes unique to VAX-31 plus cross-reactive serotype 20B met the OPA GMR superiority criterion. Vaxcyte plans to release results from two other phase 3 trials, OPUS-2 and OPUS-3, in the first half of 2027, with a BLA eyed for the first half of 2028. Approved vaccines cover significantly fewer pneumonia strains than VAX-31: Capvaxive covers 21 strains and Prevnar 20 covers 20.
PCVX · Technology · Positive Positive phase 3 topline data for VAX-31 met non-inferiority and superiority criteria, advancing its lead vaccine candidate.
MRK · Competition · Negative Vaxcyte's VAX-31 beat Merck's Capvaxive on shared serotypes and covers more strains, a competitive threat to Capvaxive.
PFE · Competition · Negative VAX-31 matched Pfizer's Prevnar 20 on shared serotypes while covering more strains, a competitive threat to Prevnar 20.
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Pharmaceuticals, Biotechnology & Life Sciences

Precigen Shares Surge 52.5% as Papzimeos Sales Reach $74.6 Million

Precigen shares have climbed 52.5% over the past three months, outpacing a 0.2% decline for the industry, on the strength of its sole marketed drug, Papzimeos. Papzimeos, the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis, generated $74.6 million in revenue in the first six months of 2026, with second-quarter product sales more than doubling sequentially. A marketing authorization application for Papzimeos in adults with recurrent respiratory papillomatosis is under review in Europe, and the drug holds seven years of FDA market exclusivity through Aug. 14, 2032. Inovio Pharmaceuticals is developing INO-3107 as a competing treatment for recurrent respiratory papillomatosis, with an FDA decision expected on Oct. 30, 2026. Beyond Papzimeos, Precigen is developing PRGN-2009 through its AdenoVerse platform, which recently received FDA platform technology designation, and a phase II study is testing PRGN-2009 with Merck's Keytruda in recurrent or metastatic cervical cancer, with a portfolio update planned by the end of 2026.
PGEN · Demand · Positive Papzimeos generated $74.6 million in first-half 2026 revenue with Q2 sales more than doubling sequentially.
INO · Competition · Negative Inovio's competing RRP treatment INO-3107 faces an FDA decision Oct 30, 2026, while Precigen's Papzimeos already holds approval and seven years of exclusivity.
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FDA Delays Novo's Denecimig BLA Review Over Facility Remediation

The FDA has extended its review of Novo's denecimig biologics license application for haemophilia A, citing facility remediation activities, with no new regulatory action date provided. Novo said the agency has not identified any deficiencies related to the clinical efficacy or safety data in the application. Denecimig is an investigational FVIIIa-mimetic bispecific antibody developed as a subcutaneous prophylactic treatment for adults and children with haemophilia A, including patients with inhibitors, and is being studied for once-monthly, every-two-weeks and weekly dosing. Novo submitted the BLA in September 2025 and had anticipated a decision in the third quarter of 2026; the delay stems from a pre-license inspection of the manufacturing facility and subsequent remediation requirements, which Novo said do not affect its other marketed products or its 2026 financial outlook. The company continues to target a U.S. launch of denecimig in the first half of 2027, with the submission supported by data from the FRONTIER development program, including the pivotal phase III FRONTIER2 and FRONTIER3 studies and the FRONTIER4 open-label extension.
NVO · Regulation · Negative FDA extended review of denecimig BLA due to facility remediation, delaying the haemophilia A treatment's approval timeline
Novo · Regulation · Negative FDA delayed the denecimig BLA review over manufacturing facility remediation, pushing the anticipated decision past Q3 2026
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Tempus AI Wins FDA Clearance for Two AI-ECG Cardiac Products

Tempus AI has received 510(k) clearance from the Food and Drug Administration for two next-generation AI cardiovascular products, Tempus ECG-MR and Tempus ECG-PH. Tempus ECG-MR analyzes standard 12-lead resting electrocardiograms to detect signs associated with undiagnosed moderate or severe mitral regurgitation, while Tempus ECG-PH is an AI-enabled software device that analyzes standard 12-lead ECG data and provides a binary output for signs associated with pulmonary hypertension. The clearances come as the AI-ECG analysis market is expected to grow from $2.01 billion in 2025 to $2.40 billion in 2026, a compound annual growth rate of 19.3%, according to the Business Research report. Among peers, GE HealthCare's Advanced Imaging Solutions segment, which combines the former Imaging and AVS businesses, generated $3.77 billion in revenues in the second quarter of 2026, up 5.0% organically, with segment EBIT margin rising 90 basis points to 13.9%. iRhythm Holdings, whose platform is supported by more than 3 billion hours of curated ECG data and more than 12 million patient reports, expanded work with Desert Oasis Healthcare and signed two commercial agreements through Luum during the second quarter of 2026. Tempus shares have declined 17.7% over the past year, and the stock currently trades at a forward 12-month price-to-sales ratio of 7.30X versus an industry average of 4.82X.
TEM · Regulation · Positive Tempus AI received FDA 510(k) clearance for two next-generation AI-ECG cardiac products, ECG-MR and ECG-PH.
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Summit Therapeutics, AstraZeneca and Daiichi Sankyo to Study Ivonescimab Plus Datroway Combos

Summit Therapeutics has signed a clinical collaboration with AstraZeneca and its Japan-based partner Daiichi Sankyo to evaluate ivonescimab in combination with the antibody-drug conjugate Datroway, also known as datopotamab deruxtecan, across multiple solid tumors including breast and lung cancers. The collaboration is expected to initially focus on a phase III study in first-line triple-negative breast cancer, expanding ivonescimab's development into a new tumor type. Under the agreement, each company will supply its respective drug, AstraZeneca or Daiichi will sponsor the planned studies, and the companies will share study costs while retaining development and commercial rights to their own therapies. The Datroway collaboration builds on the larger deal between AstraZeneca and Summit announced in the last week, under which AstraZeneca agreed to invest $2 billion in Summit to accelerate development of ivonescimab, with the companies also set to evaluate ivonescimab alongside AstraZeneca's investigational Claudin-18.2-targeted ADC sonesitatug vedotin, or Sone-Ve, in gastrointestinal cancers. An FDA filing is under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a final decision expected by Nov. 14, 2026.
4568.JP · Technology · Positive Daiichi Sankyo's Datroway (datopotamab deruxtecan) will be evaluated in combination with ivonescimab across multiple solid tumors, including a phase III triple-negative breast cancer study
AZN.LSE · Technology · Positive AstraZeneca will co-sponsor and supply its Datroway ADC in a new phase III combination study with ivonescimab, expanding its oncology pipeline
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CellCarta and Waters Form Strategic Partnership for Companion Diagnostics

CellCarta has established a strategic partnership with Waters Corporation to jointly pursue companion diagnostic and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies. The collaboration will initially emphasize flow cytometry-based programs, aiming to give sponsors a coordinated path from biomarker strategy through clinical development, regulatory submission and global commercialization. Waters will provide underlying technology capabilities including instrumentation, reagents, standardized panels, assay development, software analysis, and where appropriate custom reagent and IVD commercialization, while CellCarta will integrate and deploy assays across its global CDx Lab Network, supporting Phase I-III clinical trial testing, analytical and clinical evidence generation, regulatory and logistics support, and commercial laboratory services. The companies cited existing platform alignment between CellCarta's CAP-accredited laboratory in Jining, China and BD flow cytometry platforms as a practical foundation for global sponsors seeking to include China in future multinational CDx and biomarker programs. Todd Chermak, President of CellCarta, said the partnership offers sponsors a more connected path from biomarker strategy through global clinical development and, where appropriate, commercialization, and that the companies are already engaging pharmaceutical and biotechnology companies on near-term opportunities.
WAT · Demand · Positive Waters forms strategic partnership with CellCarta to pursue companion diagnostic and next-gen flow cytometry opportunities with pharma/biotech sponsors.
CellCarta · Demand · Positive CellCarta partners with Waters to jointly pursue CDx and flow cytometry programs, integrating assays across its global CDx Lab Network for sponsors.
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Vaxcyte's VAX-31 Meets Phase 3 Endpoints, Stock Hits 52-Week High

Vaxcyte Inc. reported positive topline results from its pivotal Phase 3 OPUS-1 trial of VAX-31, an investigational 31-valent pneumococcal conjugate vaccine, sending its shares up 56.91% to $88.62 in premarket trading on Monday to a new 52-week high. In the trial, VAX-31 met all prespecified co-primary immunogenicity endpoints in participants aged 50 and older, achieving noninferiority across all 28 serotypes shared with Pfizer Inc.'s Prevnar 20 and/or Merck & Co Inc.'s Capvaxive. Specifically, the candidate matched noninferiority standards for 11 serotypes common to both PCV20 and PCV21, nine serotypes shared exclusively with PCV20, and eight serotypes shared solely with PCV21, while demonstrating superiority for three unique serotypes plus the cross-reactive serotype 20B. The trial also met noninferiority criteria across all 321 serotype comparisons in immunobridging between adults aged 18 to 49 and those aged 50 to 64, and safety evaluations showed a tolerability profile comparable to PCV20 and PCV21 with no vaccine-related serious adverse events or discontinuations. The findings will form the foundation for an upcoming Biologics License Application submission to the U.S. Food and Drug Administration, and the company plans to report data from the OPUS-2 and OPUS-3 adult Phase 3 trials in the first half of 2027, with Phase 2 infant results expected by the end of that same period.
PCVX · Technology · Positive VAX-31 met all Phase 3 OPUS-1 co-primary immunogenicity endpoints with a comparable safety profile, paving the way for a BLA submission.
MRK · Competition · Negative Vaxcyte's VAX-31 met noninferiority vs Merck's Capvaxive (PCV21) across shared serotypes, a competitive threat to Capvaxive.
PFE · Competition · Negative VAX-31 achieved noninferiority vs Pfizer's Prevnar 20 across shared serotypes, challenging Prevnar 20's franchise.
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Benzinga·23hRead more →
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Novo Nordisk Targets Over $23 Billion in Pipeline Sales by 2035 as GLP-1 Competition Bites

Novo Nordisk is diversifying beyond its GLP-1 obesity and diabetes franchise, aiming to launch more than five potential blockbuster drugs by 2030 and generate over $23 billion in pipeline-related sales by 2035. The company, whose Ozempic and Wegovy have driven recent growth, has begun exploring the hair-loss market, which its Chief Scientific Officer says can leverage Novo's scientific knowledge, and plans to advance multiple Phase 3 programs across obesity, diabetes and other therapeutic areas. Chief Executive Mike Doustdar acknowledged the loss of confidence, saying it takes time and hard work to build back, after the company's post-Wegovy strategy presentation sent hair-loss drug developers Veradermics and Absci higher. Novo has lost ground to rival Lilly in the injectable GLP-1 market and faces key semaglutide patent expirations in major markets in the early 2030s, prompting Morgan Stanley to downgrade the stock to Sell on medium-term growth concerns. Novo trades at around 10.2x forward GAAP earnings, below its five-year average of 30.0x and the sector median of 23.3x, while its forward price-to-sales ratio of 3.8x is below its five-year average of 9.6x and broadly in line with the sector median of 3.7x.
NVO · Competition · Negative Novo Nordisk has lost ground to rival Lilly in the injectable GLP-1 market and faces semaglutide patent expirations, prompting a Morgan Stanley downgrade.
LLY · Competition · Positive Novo Nordisk acknowledged losing ground to rival Lilly in the injectable GLP-1 market, a competitive gain for Lilly.
ABSI · Demand · Positive Absci shares rose after Novo Nordisk's strategy presentation highlighted the hair-loss market, signaling potential demand for hair-loss drug developers.
MANE · Demand · Positive Veradermics shares rose after Novo Nordisk's strategy presentation signaled interest in the hair-loss market, a potential demand driver for hair-loss drug developers.
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FDA Expands Eli Lilly's Jaypirca to First-Line CLL/SLL Treatment

Eli Lilly announced that the FDA has expanded the label of its oral cancer drug Jaypirca, also known as pirtobrutinib, to include a new indication in chronic lymphocytic leukemia or small lymphocytic lymphoma. Jaypirca has been approved to treat adults with previously untreated CLL/SLL who do not have a known 17p deletion, allowing the drug to be used as a first-line treatment for eligible patients. The approval is supported by data from the phase III BRUIN CLL-313 study, which showed that Jaypirca reduced the risk of disease progression or death by 80% compared to chemoimmunotherapy. Before this latest approval, Jaypirca was already approved for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor, and for adults with relapsed or refractory mantle cell lymphoma following two lines of systemic therapy including a BTK inhibitor. Jaypirca is already generating meaningful sales for Lilly, with revenues rising 66% year over year to $357 million in the first half of 2026, though its sales remain relatively small compared with Lilly's much larger obesity and diabetes portfolio.
LLY · Regulation · Positive FDA expanded Jaypirca's label to first-line CLL/SLL, broadening the eligible patient population for Lilly's drug
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Pacira signs Molteni to commercialize EXPAREL across EU and U.K.

Pacira BioSciences signed an exclusive agreement with Molteni Farmaceutici to distribute and commercialize EXPAREL in the European Union and U.K. Under the deal, Pacira will receive an undisclosed upfront payment, a supply price, and royalties on future commercial sales in the licensed territories. Pacira will continue to manufacture EXPAREL, while Molteni will oversee regulatory, market access, and commercialization activities. Molteni plans to launch EXPAREL sequentially in Italy, Germany, Austria, and Poland, with plans to seek approval in Switzerland. The first commercial sale is expected in 2027.
PCRX · Demand · Positive Pacira signs exclusive deal with Molteni to commercialize EXPAREL across the EU and U.K., expanding commercial reach for its product.
Molteni Farmaceutici · Demand · Positive Molteni gains exclusive rights to distribute and commercialize EXPAREL in the EU and U.K., adding a product to its commercial portfolio.
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Shionogi to Acquire IntraBio for USD 2.0 Billion, Adding AQNEURSA to Rare Disease Portfolio

Shionogi & Co., Ltd. announced that its Board of Directors approved an agreement to acquire IntraBio Inc., a biopharmaceutical company developing and commercializing therapies for neurodegenerative diseases, for an upfront consideration of USD 2.0 billion payable to IntraBio shareholders. Under the agreement signed on October 5, 2026, IntraBio would become a wholly owned subsidiary of New Jersey-based Shionogi Inc., with the transaction scheduled to close between November 2026 and December 2026, subject to competition-law waiting periods and other customary conditions. The deal would add AQNEURSA (levacetylleucine) to Shionogi's rare disease portfolio; the drug was approved by the FDA in September 2024 for neurological manifestations of Niemann-Pick disease type C and by the European Medicines Agency in January 2026, and on September 18, 2026 it became the first and only FDA-approved treatment for Ataxia in patients with Ataxia-Telangiectasia, for which it is also under EMA review. Shionogi said the acquisition builds on the rare disease foundation it established through its April 2026 acquisition of global rights to edaravone, known as RADICAVA in the U.S. and RADICUT in Japan, and would strengthen its pipeline across Pompe disease, Fragile X syndrome, Jordan's syndrome and early-stage rare neurodegenerative programs. The impact on Shionogi's consolidated financial results for the fiscal year ending March 2027 is currently under review.
4507.JP · Capital · Positive Shionogi's board approved a USD 2.0 billion acquisition of IntraBio, adding AQNEURSA and rare-disease pipeline assets to its portfolio.
IntraBio Inc. · Capital · Positive IntraBio is being acquired by Shionogi for USD 2.0 billion upfront, delivering consideration to its shareholders.
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TMAN targets 4 billion baht in revenue within 3-5 years, pursuing a New S-Curve in longevity supplements

T. Man Pharmaceutical Public Company Limited, or TMAN, has announced the creation of a New S-Curve, moving into the longevity and wellness hub megatrend, with a target of driving revenue growth to 4 billion baht within the next 3-5 years, up from 2.5 billion baht in 2025. Prapol Thanachotiphan, Chief Executive Officer of TMAN, told InfoQuest that in the first 1-3 years the company will continue to grow from its core business by expanding hospital channels to raise their revenue share to 15-20% from 10% previously, while pushing the Propolis brand to become a full regional and international brand, from its current exports to more than 7 countries, and more than 10 countries across all products. Meanwhile, its OEM contract manufacturing business has grown by more than 100%, and it recently secured a major customer, Berham, in the distribution business for other brands. For the creation of the New S-Curve, the company will launch a new supplement brand at the end of this year, focusing on dietary supplements, vitamins and biotechnology under its own brand, targeting growth of 5-10% per year for this group over the next 5 years, and has assigned its subsidiary Nova Health to accelerate collaboration with leading research institutes to develop health innovations that address longevity, together with external partners.
TMAN.BK · Demand · Positive TMAN targets revenue growth to 4 billion baht via hospital channel expansion, Propolis international brand push, and a new supplement brand, driving product demand.
Nova Health · Technology · Positive Subsidiary Nova Health is assigned to collaborate with research institutes to develop longevity health innovations.
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AstraZeneca Closes $2 Billion Equity Investment in Summit Therapeutics

Summit Therapeutics announced the closing of AstraZeneca's $2.0 billion strategic equity investment in the company. Under the Securities Purchase Agreement, AstraZeneca purchased approximately 108,955 shares of preferred stock convertible into Summit common stock at a 1:1,000 ratio, representing a common stock price of $18.36, a premium over the closing trading price on the day the investment was announced. The proceeds will support accelerated development of ivonescimab, a potential first-in-class investigational PD-1 / VEGF bispecific antibody, across solid tumor settings including combinations with antibody drug conjugates such as sonesitatug vedotin and Datroway. Summit Chairman and Co-Chief Executive Officer Robert W. Duggan said the investment reflects AstraZeneca's confidence in Summit and in ivonescimab's potential to redefine cancer treatment. Baker Hostetler LLP is serving as legal advisor to Summit.
AZN.LSE · Capital · Positive AstraZeneca closed a $2.0 billion strategic equity investment in Summit Therapeutics, a major financing/M&A event for AstraZeneca.
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Shionogi to acquire US-based IntraBio for 316 billion yen, strengthening rare disease drugs

Shionogi announced on the 5th that it will acquire US biopharmaceutical venture IntraBio. It will acquire all shares for 2 billion dollars, or about 316 billion yen, making it a wholly owned subsidiary. IntraBio was founded in 2015 and has strengths in the research and development of rare neurological disease drugs, with sales of 67.86 million dollars for the fiscal year ending December 2025. Shionogi is working to strengthen its rare disease drug business as a priority area outside of infectious diseases, and since April of this year it has begun global sales of a treatment for amyotrophic lateral sclerosis (ALS).
4507.JP · Capital · Positive Shionogi will acquire IntraBio for ~$2B/316B yen, an M&A deal expanding its rare disease pipeline.
IntraBio Inc. · Capital · Positive IntraBio is being acquired in full for $2B, making it a wholly owned Shionogi subsidiary.
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AnnJi Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for SBMA

AnnJi Pharmaceutical announced it is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201, also known as rosolutamide, in patients with spinal and bulbar muscular atrophy, or SBMA, also called Kennedy's disease. The company said it submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now activate U.S. sites for the global trial. The ROMA-KD study is a global, multicenter, randomized, double-blind, placebo-controlled trial expected to enroll approximately 200 ambulatory patients with symptomatic SBMA worldwide, with the United States as a key region, and is intended to support potential global regulatory submissions. AJ201, an investigational oral small molecule and a potential first-in-class treatment for SBMA, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the United States and the European Union. AnnJi said the Phase 3 program builds on encouraging results from its completed Phase 2 study announced in May 2025, and the company also noted its SBMA Patient and Care Partner Advisory Council, first announced in collaboration with the Kennedy's Disease Association at the 2026 KDA International Patient and Scientific Conference.
7754.TWO · Technology · Positive AnnJi advances AJ201 into pivotal Phase 3 ROMA-KD trial for SBMA after encouraging Phase 2 results
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AnnJi Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for SBMA

AnnJi Pharmaceutical is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201, also known as rosolutamide, in patients with spinal and bulbar muscular atrophy, or SBMA, also called Kennedy's disease. The company said it submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now activate U.S. sites for the global trial. ROMA-KD is a global, multicenter, randomized, double-blind, placebo-controlled study expected to enroll approximately 200 ambulatory patients with symptomatic SBMA worldwide, with the United States as a key region, and is intended to support potential global regulatory submissions. AJ201, an investigational oral small molecule and a potential first-in-class treatment for SBMA, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the United States and the European Union. The Phase 3 program builds on encouraging results from the completed Phase 2 study announced in May 2025, and AnnJi said it has also established an SBMA Patient and Care Partner Advisory Council in collaboration with the Kennedy's Disease Association.
7754.TWO · Technology · Positive AnnJi advances AJ201 into pivotal Phase 3 ROMA-KD trial for SBMA after encouraging Phase 2 results
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Moderna Jumps 175% in Q3 on Cancer Therapy Trial Win, Nasdaq 100 Entry

Moderna Inc. ranked as the second top-performing stock in the US market in the third quarter, with shares surging 174.98 percent over the three months ending September. The rally was driven by news that its Intismeran Autogene combined with Merck's Keytruda achieved the primary endpoint of recurrence-free survival and the secondary target of distant metastasis-free survival in a late-stage clinical trial, marking the first positive readout from a phase 3 trial combining an mRNA-based cancer treatment with individualized neoantigen therapy and the first late-stage phase to show a clinically meaningful improvement over Keytruda alone. Melanoma, the target indication, is expected to increase by 112,000 cases by the end of the year, including an estimated 8,500 deaths, after some 330,000 cases were diagnosed globally in 2022. In August, Moderna received FDA approval of its biologics license application for the 2026 to 2027 formulas of its Spikevax and mNEXSPIKE COVID-19 vaccines. The vaccine maker is set to join the Nasdaq 100 index on Friday, October 9, replacing Warner Bros. Discovery Inc., which is set to merge with Paramount Skydance Corp. on Tuesday, October 6.
MRNA · Technology · Positive Its mRNA cancer therapy Intismeran Autogene with Keytruda achieved the primary endpoint in a phase 3 trial, driving the stock's 175% Q3 surge.
MRNA · Regulation · Positive Moderna received FDA approval of its biologics license application for the 2026-2027 Spikevax and mNEXSPIKE COVID-19 vaccine formulas.
MRK · Technology · Positive Moderna's Intismeran Autogene combined with Merck's Keytruda hit the primary endpoint of recurrence-free survival in a late-stage cancer trial, a positive readout for Keytruda's use in combination therapy.
WBD · · Neutral Named only as the company being replaced in the Nasdaq 100 by Moderna ahead of its merger with Paramount Skydance; no substantive development affecting it.
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Arcus Biosciences to Present New Casdatifan ARC-20 Kidney Cancer Data

Arcus Biosciences announced it will host an in-person investor event on October 20, 2026, in New York City to present new ARC-20 platform data on its investigational HIF-2a inhibitor casdatifan across first-, second-, and late-line clear cell renal cell carcinoma treatment settings. The data package spans TKI-free first-line combinations, long-follow-up second-line cabozantinib combinations, and translational HIF-2a pharmacodynamic correlations with overall survival. Arcus also plans to complete enrollment in the PEAK-1 Phase 3 trial and start PEAK-20 by year end 2026, with the ARC-20 datasets feeding into how credible those registrational bets look. The company's narrative projects $290.3 million revenue and $50.1 million earnings by 2029, yielding a $39.91 fair value and a 63% upside to its current price, while some of the lowest ranked analysts assume revenue could fall to about US$120.2 million by 2028.
RCUS · Technology · Positive Arcus will present new ARC-20 casdatifan HIF-2a kidney cancer data and advance PEAK-1/PEAK-20 registrational trials.
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Dashenlin's H1 revenue hits 13.99 billion yuan; 1.405 billion yuan convertible bonds due in October

Dashenlin held an online briefing on its 2026 interim results on September 30, addressing investor questions about negative investing and financing cash flows, convertible bond conversion, and logistics and distribution. The company said the negative investing cash flow mainly stemmed from capital expenditure on new store openings, digitalisation and logistics system construction, as well as consideration paid for pharmacy acquisitions, while the negative financing cash flow was mainly due to continued cash dividends. Operating cash flow remained a net inflow. The 1.405 billion yuan convertible bonds issued by the company will mature on October 21, 2026, and have not yet been converted. The company said its cash reserves are sufficient, and it will assist holders willing to convert, while repaying principal and interest in full and on time to holders who hold to maturity, with controllable redemption risk. On logistics, the company has built a three-tier warehouse network of group warehouses, regional warehouses and district warehouses. As of the end of the reporting period, it had 35 warehouses nationwide, including in Inner Mongolia and Xinjiang, with total warehousing area of 420,000 square metres. Self-operated delivery accounted for more than 85% of total delivery volume, warehouse shipment fulfilment rate reached 99%, and shipment error rate was below 0.008%. The interim report showed revenue of 13.99 billion yuan, up 3.46% year on year; net profit attributable to the parent of 927 million yuan, up 16.10%; non-GAAP net profit attributable to the parent of 931 million yuan, up 18.05%; net operating cash flow of 1.289 billion yuan, down 55.70%; and a proposed cash dividend of 0.41 yuan per share before tax.
603233.CG · Capital · Positive H1 revenue rose 3.46% to 13.99bn yuan and net profit attributable to parent rose 16.10% to 927m yuan, with a proposed dividend of 0.41 yuan per share.
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Jim Cramer Says GRAIL Could Rise Like Moderna After FDA Panel Backs Galleri

Jim Cramer said GRAIL, Inc. could climb much higher after an FDA advisory panel backed its Galleri multi-cancer early detection test, comparing the stock to Moderna when it traded around $120. The panel voted 7-2 with one abstention that Galleri's benefits outweighed its risks, 6-4 on effectiveness and unanimously on safety, though the recommendation is not binding and final approval had not been granted as of October 2, with Reuters reporting a decision is expected in the coming months. GRAIL generated $44.7 million of revenue in the second quarter, up 26% year over year, as Galleri revenue rose 24% to $42.6 million and test volume increased 35% to more than 61,000, while the company posted a $110.2 million net loss and a $90.3 million adjusted EBITDA loss with $861.6 million in cash, cash equivalents and short-term marketable securities at June 30. Moderna, Inc. reported $145 million of revenue in the second quarter against $142 million a year earlier and a $782 million net loss, ending June with $6.9 billion in cash, cash equivalents and investments, and its Phase 3 INTerpath-001 trial of intismeran autogene with Merck's Keytruda met its recurrence-free-survival and distant-metastasis-free-survival endpoints in resected melanoma. Citi analyst Geoff Meacham said on September 30 that Moderna's roughly $80 billion market capitalization was approaching Regeneron's despite materially lower expected revenue and earnings, while GRAIL's bear case rests on adoption and reimbursement, with Galleri costing about $700 out of pocket and generally not covered by Medicare or private insurers.
GRAL · Regulation · Positive FDA advisory panel voted 7-2 that Galleri's benefits outweigh risks, advancing it toward approval.
MRNA · Capital · Neutral Cramer compared GRAIL to Moderna at $120, while Citi noted Moderna's ~$80B market cap approaches Regeneron's despite lower expected revenue and earnings.
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Vor Biopharma's Telitacicept Shows Durable Responses in Phase 3 Myasthenia Gravis Analysis

Vor Biopharma reported a post hoc analysis from a China-based Phase 3 trial showing that telitacicept produced deep, durable clinical responses and was generally well tolerated over 48 weeks in adults with generalized myasthenia gravis. The analysis highlighted that most patients who reached minimal symptom expression maintained it and spent much of their remaining follow-up in this state. The new data reinforce the depth and durability of response but do not materially change the key near-term catalyst, the UPSTREAM global Phase 3 topline readout in 2027, or the central risk that global data might not match prior China experience. The results sit beside Vor's completion of enrollment in the global UPSTREAM Phase 3 gMG trial in early September 2026. Vor Biopharma's narrative projects $111.0 million revenue and $19.1 million earnings by 2029, implying an earnings decrease of $608.7 million from $627.8 million today, and forecasts a $39.00 fair value, a 109% upside to its current price.
VOR · Technology · Positive Post hoc Phase 3 analysis shows telitacicept produced deep, durable responses over 48 weeks in generalized myasthenia gravis, reinforcing the drug's clinical profile.
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Sanofi, Novartis and Novo Nordisk Lead Week of Multi-Billion-Dollar Healthcare Deals

A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech and Moderna to dismiss lawsuits filed by Bayer's Monsanto unit over their use of US Patent No. 7,741,118, a patent related to mRNA technology, with Judge William Bryson saying the companies failed to prove the patent was invalid or not infringed by their COVID-19 vaccines. Sanofi agreed to a deal worth up to $8B, including $1B upfront, with Regeneron to jointly develop four long-acting immunology therapies, led by the clinical-stage IL-13 monoclonal antibody REGN20423. China's Abogen Biosciences signed a licensing and option agreement with Novartis worth up to $7.8B, comprising a $575 million upfront payment and up to approximately $7.2 billion in potential milestone payments if all options on all programs are exercised, covering an exclusive worldwide license to Abogen's lead asset ABO2203. Jiangsu Hengrui Pharmaceuticals agreed to license global rights to its experimental obesity drug HRS-1596 to Novo Nordisk in a deal worth up to $2.6B, with $300M upfront and the transaction expected to close in Q4 2026. Meanwhile, the S&P 500 Health Care Sector Index slipped 2.66% for the week, with Incyte down 6.93% and Regeneron down 6.71% among the top decliners, while McKesson rose 4.11% and Cardinal Health gained 3.67%.
NOVN.SW · Demand · Positive Novartis signed a licensing and option agreement with Abogen worth up to $7.8B covering ABO2203.
SAN.PA · Demand · Positive Sanofi agreed to an up-to-$8B deal with Regeneron to jointly develop four long-acting immunology therapies.
Abogen Biosciences · Demand · Positive Abogen Biosciences licensed its lead asset ABO2203 to Novartis in a deal worth up to $7.8B.
22UA.XETRA · Regulation · Negative Delaware judge rejected BioNTech's motion to dismiss Monsanto's mRNA patent lawsuits over its COVID-19 vaccine.
600276.CG · Demand · Positive Hengrui licensed global rights to its obesity drug HRS-1596 to Novo Nordisk for up to $2.6B, with $300M upfront.
MRNA · Regulation · Negative Delaware judge rejected Moderna's motion to dismiss Monsanto's mRNA patent infringement lawsuits over its COVID-19 vaccine.
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CanSino issues urgent announcement after hitting daily limit up: mRNA cancer vaccine development still in early stage

CanSino surged to the daily limit up on the last trading day before the National Day holiday, with its share price breaking through the previous consolidation range and reaching a new stage high since April 2023, while its H shares also moved higher in tandem. On October 1, CanSino issued a stock movement announcement stating that the company had noted recent market developments regarding mRNA technology, as well as the release or planned disclosure of overseas clinical stage data for mRNA cancer vaccines. CanSino made clear that the mRNA platform is one of the technology platforms in its portfolio, and that the company is developing preventive mRNA vaccines and therapeutic biologics, as well as related delivery systems. In the therapeutic area, it is advancing research and development of mRNA vaccines for indications including glioblastoma, rhabdomyosarcoma, and cervical cancer, as well as the development of In Vivo CAR-related therapies, all of which are currently in early stages. In August this year, Merck and Moderna jointly announced that their personalized messenger RNA cancer vaccine met its primary endpoint in a Phase III trial, making it the first therapeutic vaccine proven effective in a large-scale Phase III clinical trial globally. On August 25, CanSino's official WeChat account announced that its subsidiary CanSino Shanghai Biologics had formally signed a strategic cooperation framework agreement with Depush Hangzhou Biotechnology for the joint development of personalized therapeutic mRNA cancer vaccines. The two parties will jointly advance the research, development, and commercialization of personalized therapeutic mRNA cancer vaccines, with a global focus on gastrointestinal solid tumors and rare tumor treatment areas. It should be noted that CanSino's entire mRNA product line has not yet moved beyond the early research and development stage, and innovative drug development carries multiple uncertainties including technical failure, clinical results falling short of expectations, and approval delays, while competition in the domestic mRNA vaccine sector is also becoming increasingly intense.
688185.CG · Technology · Neutral CanSino clarified its mRNA cancer vaccine programs (glioblastoma, rhabdomyosarcoma, cervical cancer, In Vivo CAR) remain in early stages despite the stock's limit-up.
德普世(杭州)生物科技有限责任公司 · Demand · Positive Depush Hangzhou signed a strategic cooperation framework agreement with CanSino Shanghai Biologics to jointly develop personalized therapeutic mRNA cancer vaccines.
MRK · Technology · Positive Merck's partnered personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial, the first such therapeutic vaccine success.
MRNA · Technology · Positive Moderna's jointly announced personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial.
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Amoytop Biotech appoints Zeng Honglin as board secretary; first-half net profit rises 11.37% to 477 million yuan

Amoytop Biotech announced the appointment of Zeng Honglin as board secretary. Former board secretary Yang Yiling stepped down from the role to comply with the regulatory requirement that the board secretary must not concurrently serve as chief financial officer, and will continue to serve as deputy general manager and chief financial officer. Zeng Honglin was born in September 1988 and graduated from Xiamen University with a degree in accounting. He holds a certified public accountant certificate and a legal professional qualification certificate. From November 2015 to November 2025, he worked in investment banking at the Shanghai securities underwriting and sponsorship branch of Sinolink Securities, serving successively as project assistant, project manager, senior manager, business director, and executive general manager. From November 2025 to September 2026, he served as executive director of the company's finance center. Amoytop Biotech was founded in 1996 and listed on the Shanghai Stock Exchange in 2020. It focuses on the research, development, production, and sale of recombinant proteins and their long-acting modified drugs. In the first half of 2026, the company achieved operating revenue of 1.837 billion yuan, up 21.58% year on year, and net profit attributable to shareholders of the listed company of 477 million yuan, up 11.37% year on year, mainly driven by continued volume growth for Pegbin as evidence-based medical evidence strengthened, and initial volume growth for the new product Yipeisheng after it was included in medical insurance. As of the close on September 30, Amoytop Biotech rose 3.30% to 52.89 yuan per share, giving the company a total market value of 21.59 billion yuan.
688278.CG · Capital · Positive First-half net profit rose 11.37% to 477 million yuan on 21.58% revenue growth, an earnings event for the company.
688278.CG · Demand · Positive Revenue growth was driven by continued volume growth for Pegbin and initial volume growth for new product Yipeisheng after medical-insurance inclusion.
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Iovance Biotherapeutics Fair Value Raised to US$12.80 on Amtagvi Demand

The fair value estimate for Iovance Biotherapeutics has been raised to US$12.80 per share from US$10.00, according to Simply Wall St. The revision reflects stronger expectations for the Amtagvi launch, margin trends and upcoming data, with the revenue growth assumption shifting from 43.38% to 45.57% and the net profit margin assumption moving from 9.50% to 12.09%. H.C. Wainwright lifted its price target to US$20 from US$9, citing FY26 total revenue guidance of US$410m to US$420m tied to U.S. demand for Amtagvi and Proleukin, while Wells Fargo moved to US$18 from US$14 and Goldman Sachs pointed to an inflection in the Amtagvi launch and easing logistical challenges. Barclays flagged durability in second line lung cancer for lifileucel ahead of IOV-LUN-202 data, while UBS, which raised its target to US$7 from US$4 and remains Neutral, noted that a strong Amtagvi quarter and gross margin of 56% came alongside a 74% rally in the stock. The valuation model's future P/E multiple changed from 75.55x to 72.80x and the discount rate moved from 7.47% to 7.50%.
IOVA · Capital · Positive Multiple analysts raised price targets and fair value on stronger Amtagvi launch expectations, margin trends, and revenue guidance.
IOVA · Demand · Positive FY26 revenue guidance tied to U.S. demand for Amtagvi and Proleukin, with an inflection in the Amtagvi launch.
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Johnson & Johnson Reports Sustained Phase 3 Skin Clearance for ICOTYDE in Plaque Psoriasis

Johnson & Johnson reported new Phase 3 results for its oral peptide ICOTYDE in plaque psoriasis at the 2026 EADV Congress, showing sustained skin clearance and improvement across multiple high-impact psoriasis sites, including in adolescent patients. Long-term data from the ICONIC-TOTAL study showed sustained skin clearance through Week 112 at high-impact sites such as the scalp, genital area, hands, feet and nails. The oral IL-23 inhibitor remains in clinical studies for other major inflammatory diseases beyond plaque psoriasis, including psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE is already approved in the U.S., Europe, Japan and China, and the key test ahead is how the evidence translates into prescribing and reimbursement decisions in those markets. Johnson & Johnson is a global healthcare group that develops prescription drugs, medical devices and consumer health products.
JNJ · Technology · Positive Phase 3 ICOTYDE data show sustained skin clearance through Week 112, supporting the oral IL-23 inhibitor's clinical profile.
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Agenus Reports 48% Three-Year Survival for BOT+BAL in Recurrent Ovarian Cancer

Agenus Inc. announced three-year follow-up results from the ovarian cancer cohort of its 400+ patient Phase 1b C-800-01 trial, showing an estimated 48% three-year overall survival for botensilimab plus balstilimab in recurrent ovarian cancer. The estimate was unchanged from two years, with median overall survival of 14.8 months, a 23% objective response rate among 35 evaluable patients, and a median duration of response of 9.7 months. At last follow-up, 25% of the 44 patients who received at least one dose, 11 in total, were alive and off all therapy. The heavily pretreated population had received a median of four prior lines of therapy, 77% had received bevacizumab and 57% a PARP inhibitor, and nearly three-quarters had platinum-resistant or refractory disease; estimated three-year survival was 47% in that subgroup and 61% in the 17 patients whose disease had progressed on a PARP inhibitor. The data were presented by Rebecca L. Porter of Dana-Farber Cancer Institute at the 2026 International Gynecologic Cancer Society Annual Global Meeting in Montréal, and Agenus said no new safety signals or treatment-related deaths were reported.
AGEN · Technology · Positive Agenus reported positive three-year follow-up data for botensilimab plus balstilimab in recurrent ovarian cancer, with 48% three-year overall survival and no new safety signals.
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GRAIL's Galleri Wins Favorable FDA Panel Vote After Strong PATHFINDER 2 Data

GRAIL announced in September 2026 that its Galleri multi-cancer early detection blood test showed strong performance in the PATHFINDER 2 study and received a favorable U.S. FDA advisory committee vote supporting its safety, benefit-risk profile and effectiveness for use alongside standard screening in adults aged 50 and older. The PATHFINDER 2 data indicated that adding Galleri increased cancers detected through screening more than six-fold with a very low false-positive rate, while the test also accurately pointed doctors to the likely cancer origin in over nine out of ten positive cases. The advisory committee's favorable vote and the PATHFINDER 2 results reinforce the core near-term catalyst around potential PMA approval and payer coverage, though GRAIL's high cash burn and lack of profitability remain the biggest risk. GRAIL's narrative projects $348.4 million revenue and $60.1 million earnings by 2029, with a $97.40 fair value implying a 32% downside to its current price, while some of the lowest estimate analysts were assuming only about US$277.6 million of revenue and a small US$49.4 million profit by 2029.
GRAL · Regulation · Positive FDA advisory committee favorable vote supports Galleri's safety and effectiveness, advancing toward potential PMA approval.
GRAL · Technology · Positive PATHFINDER 2 data showed Galleri increased cancers detected six-fold with low false positives and accurate origin identification.
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AstraZeneca Invests $2 Billion in Summit Therapeutics for Ivonescimab Trials

AstraZeneca PLC, Daiichi Sankyo and Summit Therapeutics announced clinical collaboration agreements to test ivonescimab in combination with Datroway and sonesitatug vedotin across multiple tumour types, starting with a planned Phase III trial in first-line triple-negative breast cancer and gastrointestinal cancer. AstraZeneca's approximately US$2.00 billion equity investment via convertible preferred stock, alongside the co-funded oncology trials, prices the preferred stock at an implied US$18.36 per common share and targets roughly a 12% ownership stake in Summit. All parties retain full rights to their respective medicines. The investment strengthens Summit's funding and combination profile ahead of the HARMONi and HARMONi-3 readouts, though the U.S. FDA decision on the HARMONi BLA remains the key near-term catalyst and central source of risk. Summit's narrative projects $1.3 billion revenue and $223.0 million earnings by 2029, while some optimistic analysts model about US$2.7 billion of revenue and nearly US$289 million of earnings by 2029.
AZN.LSE · Capital · Positive AstraZeneca makes a ~$2.00 billion equity investment in Summit via convertible preferred stock and co-funds ivonescimab combination trials.
4568.JP · Technology · Neutral Daiichi Sankyo is a party to the clinical collaboration testing ivonescimab with its Datroway and sonesitatug vedotin, but no financial or efficacy outcome is disclosed.
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Merck Reports Positive Phase 2b Tulisokibart Results in Hidradenitis Suppurativa

Merck reported positive Phase 2b results for tulisokibart in moderate to severe hidradenitis suppurativa on 1 October 2026. The investigational anti TL1A monoclonal antibody met its Phase 2b efficacy goals in patients with this chronic inflammatory skin condition, and Merck stated that the data support advancing the program into Phase 3 trials in hidradenitis suppurativa. The company said the readout backs the idea that tulisokibart can anchor a new immunology franchise rather than patch a niche condition, helping Merck argue it is building multiple disease-area pillars next to oncology, in contrast to peers like AbbVie and Johnson & Johnson that already lean heavily on immunology blocks. The bear case is that one successful readout does not erase execution risk across the rest of the late stage portfolio, especially with analysts already flagging profit margin pressure and safety questions on assets such as remigromig. Merck is a global healthcare group headquartered in GB that develops medicines across multiple disease areas.
MRK · Technology · Positive Positive Phase 2b results for tulisokibart in hidradenitis suppurativa support advancing to Phase 3.
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FDA Extends Review of Novo Nordisk's Denecimig for Hemophilia A

The U.S. FDA has extended its review of Novo Nordisk's biologics license application seeking approval of denecimig for hemophilia A. The Danish pharma said ongoing facility remediation activities at a manufacturing site for the drug are the reason for the delay. Novo noted that the agency did not identify any issues with the clinical trial data used to support its application. Although the FDA did not say when a decision on the BLA would come down, Novo said it is anticipating a U.S. launch in H1 2027.
NVO · Regulation · Negative FDA extended its review of Novo Nordisk's denecimig BLA for hemophilia A due to facility remediation, delaying potential approval and launch.
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FDA Extends Review of Novo Nordisk's Denecimig BLA for Haemophilia A

The US Food and Drug Administration has informed Novo Nordisk that its Biologics License Application review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing, with no new timeline communicated for regulatory action. The FDA attributed the extension to ongoing facility remediation activities at the manufacturing site, and Novo said the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted in the BLA. Novo submitted the application in September 2025 with an anticipated decision in the third quarter of 2026, and is now working with the FDA to address its remediation requests. The additional review time does not affect Novo's financial outlook for 2026, and pending a regulatory decision the company aims to launch denecimig in the US in the first half of 2027. Denecimig, a FVIIIa mimetic bispecific antibody administered under the skin, received a positive CHMP opinion on 17 September and is pending marketing approval from the EMA and under review by other regulatory authorities.
NVO · Regulation · Negative FDA extended its review of Novo's denecimig BLA for haemophilia A due to facility remediation, delaying a potential US launch to H1 2027.
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NeuroSense Regains Nasdaq Bid Price Compliance, Will Appeal MVLS Delisting

NeuroSense Therapeutics said it received a letter from Nasdaq's Listing Qualifications Department on October 1, 2026, stating the company has not regained compliance with Listing Rule 5550(b)(2), which requires a minimum market value of listed securities of $35 million for continued listing on the Nasdaq Capital Market. The company intends to appeal the Staff Determination by timely requesting a hearing before the Nasdaq Hearings Panel and to seek additional time to regain compliance with the MVLS Requirement, which is the only continued listing criterion identified in the determination. Nasdaq had notified NeuroSense on April 2, 2026, that its MVLS had been below $35 million for 30 consecutive trading days, giving it until September 29, 2026, to regain compliance; because it did not, its ordinary shares and warrants face delisting unless it appeals. A timely hearing request stays the suspension of the company's securities and the filing of a Form 25-NSE with the SEC pending the Panel's decision, and the Panel has discretion to grant an exception of up to 180 days from the date of the Staff Determination. Separately, NeuroSense said Nasdaq confirmed it regained compliance with Listing Rule 5550(a)(2), the $1.00 minimum bid price requirement, after its 1-for-20 reverse share split kept the closing bid price at $1.00 or greater for 10 consecutive business days from September 15 through September 28, 2026, closing that matter. Chief Executive Officer Alon Ben-Noon said regaining bid price compliance is an important step and that the company remains focused on advancing PrimeC in ALS, including preparations for its Phase 3 PARAGON trial and a planned New Drug Submission to Health Canada.
NRSN · Regulation · Negative Nasdaq determined NeuroSense failed to regain the $35M minimum market value of listed securities requirement, leaving its shares and warrants facing delisting unless its appeal succeeds.
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Biogen litifilimab shows durable lupus skin clearance at 52 weeks

Biogen's litifilimab produced clear or almost clear skin and reduced disease activity in cutaneous lupus erythematosus patients after one year of treatment, according to long-term phase 2 data. In the phase 2 portion of the AMETHYST Phase 2/3 study, 27.2% of patients on litifilimab met the clinical endpoint of clear or almost clear skin at week 52, as measured by a Cutaneous Lupus Activity Investigators' Global Assessment Revised erythema score of 0 or 1, up from 19% at week 24. The Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-70, a measure of disease activity reduction, also improved with longer treatment, reaching 28.8% at week 52 compared with 21.7% at week 24. Biogen noted that patients who began the study on placebo and switched to litifilimab mid-study saw improvements as early as four weeks after starting active treatment, and by week 52, 33.7% of the crossover participants had clear or almost clear skin.
BIIB · Technology · Positive Litifilimab phase 2 data showed durable skin clearance and reduced disease activity in cutaneous lupus at 52 weeks.
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Bayer to Invest 2.2 Billion Dollars in New Ohio Manufacturing Site

Bayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio. The project builds on more than seven billion dollars in U.S. pharma research, development and manufacturing spend over the past five years and is a central element of Bayer's long-term growth strategy in its largest pharmaceuticals market. Bayer expects to create around 600 high-value jobs in the New Albany International Business Park and roughly 1,500 construction jobs during the facility's construction. The flexible, modular campus will combine drug substance and drug product manufacturing and initially support Bayer's growing portfolio in oncology, cardiovascular and renal care, with the first drug substance module expected to become operational in 2031 and a second drug product module planned for 2034. The new site will complement Bayer's U.S. pharmaceuticals headquarters in Whippany, New Jersey, and its other sites in Pittsburgh, Berkeley, Cambridge, Research Triangle Park and San Diego.
BAYN.XETRA · Capital · Positive Bayer plans a $2.2B investment in a new Ohio pharma manufacturing site, a central element of its long-term growth strategy.
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