Oncology Therapeutics

Alliance Foundation Trials and Natera announced the launch of AFT-70 NAVIGATE, a global randomized phase III trial evaluating an MRD-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer. The trial is sponsored and led by AFT, with collaboration and co-funding from Natera and Genentech, a member of the Roche Group. It pairs giredestrant, Genentech's investigational next-generation oral selective estrogen receptor degrader, with longitudinal Signatera Genome MRD monitoring to identify patients who may benefit from escalation with a CDK4/6 inhibitor. AFT expects to enroll more than 2,000 patients with stage II-III disease at approximately 200 sites across the U.S. and internationally, with the primary endpoint of non-inferiority in 4-year distant recurrence-free survival. Giredestrant was selected based on the phase III lidERA trial, which showed a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard endocrine monotherapy, while Signatera was chosen for its evidence in this setting and its Genome-based technology reporting analytical sensitivity below 1 ppm.

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.

FluoGuide A/S announced a collaboration with Leica Microsystems, a Danaher company and world leading medical technology company, to advance precision surgery for brain tumors. The agreement is a milestone in brain tumor surgery development, aiming to optimize the use of imaging systems and FluoGuide's lead product FG001 to enable better treatment for patients with high-grade glioma cancer. The focus of the current agreement is to support the clinical phase and to gather a body of evidence on Leica's technology platform. The agreement has no initial payment, is non-exclusive, and its terms are not disclosed; it will not have an impact on FluoGuide's financial results in 2026. FG001 has received both Fast Track and Orphan Drug Designations from the FDA, supporting its development in high-grade glioma in the US, and FluoGuide is listed on Nasdaq First North Sweden under the ticker FLUO.

Regeneron shares fell 4% after the biotech company expanded its immunology alliance with Sanofi on terms that left the economics of its blockbuster drug Dupixent untouched. Under the deal, Sanofi will pay Regeneron $1 billion upfront and up to $7 billion in development, regulatory, and commercial milestones for four next-generation, long-acting antibodies, with the two drugmakers splitting global development costs, commercialization expenses, and future profits equally. The agreement settles prior litigation but leaves the existing Dupixent profit-sharing terms unchanged, disappointing investors who had hoped a renegotiation would yield better economics on the franchise; nearly a quarter of investors surveyed by RBC Capital sought more constructive terms, according to Investing.com. Sanofi shares rose roughly 2% in European trading, according to Reuters, while Regeneron reversed an early morning gain, later trading at $736.56, down 2.9% from the previous close. Regeneron is down 5.1% since the start of the year and trades 13.6% below its 52-week high of $852.03.

Foghorn Therapeutics and Eli Lilly will not advance their FHD-909 program into clinical development expansion following a review of Phase 1 data, and will also halt their Selective SMARCA2 degrader program with no further collaboration activities expected. Foghorn will instead prioritize its wholly owned pipeline, including a Selective EP300 degrader, an oral immunology and inflammation program, a Selective CBP degrader, and its induced proximity platform. The pipeline reprioritization and organizational changes, including an approximately 40% workforce reduction, are expected to extend Foghorn's cash runway into the second half of 2029; the company had $167.6 million as of June 30, 2026. Preclinical data for the EP300 degrader showed superior anti-tumor activity with complete responses compared to the clinical benchmark dual CBP/EP300 inhibitor inobrodib, along with safety in body weight loss and platelet counts and tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance. Foghorn is targeting an FDA Investigational New Drug application for human trials in 2027, focused on multiple myeloma and diffuse large B-cell lymphoma. FHTX shares were down 27.17% at $2.60 on Thursday, trading at a new 52-week low.

Roche announced that detailed results from the phase III evERA Breast Cancer study, showing investigational giredestrant plus everolimus significantly improved progression-free survival versus standard endocrine therapy plus everolimus, were published in The New England Journal of Medicine. In the ESR1-mutated population, median PFS was 10.0 months with the giredestrant combination compared with 5.5 months in the comparator arm, a stratified hazard ratio of 0.38, while in the intent-to-treat population median PFS was 8.8 months versus 5.5 months, a hazard ratio of 0.56, corresponding to a 44% reduction in the risk of disease progression or death in the ITT population and 62% in the ESR1-mutated population. Overall survival data were immature but showed a clear positive trend in both the ITT population, with a hazard ratio of 0.69, and the ESR1-mutated population, with a hazard ratio of 0.62, and adverse events were manageable with no unexpected safety findings, including no photopsia and low rates of bradycardia. Based on these data, the US Food and Drug Administration accepted Roche's New Drug Application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer, with a decision expected by 18 December 2026, and also accepted a Priority Review NDA for giredestrant as adjuvant treatment in early breast cancer based on the lidERA results, with a Prescription Drug User Fee Act goal date of 30 November 2026. evERA was the first positive phase III readout for giredestrant, followed by the lidERA Breast Cancer study in the early-stage setting, and additional analyses presented at the 2026 American Society of Clinical Oncology Annual Meeting showed the combination prolongs PFS2 and chemotherapy-free survival compared with standard endocrine therapy.

Pyxis Oncology announced the pricing of its registered public offering for expected gross proceeds of approximately $110M. The offering comprises 36.05M shares of common stock, or pre-funded warrants for 1.88M shares in lieu thereof, alongside accompanying common warrants to purchase up to 49.31M additional common shares at an exercise price of $3.50. The combined public offering price is $2.90 per share and accompanying common warrant, and $2.899 per pre-funded warrant and accompanying common warrant. If all pre-funded and common warrants are exercised in full, Pyxis would receive additional gross proceeds of approximately $172.6M. Following the announcement, PYXS stock fell about 8.8% to roughly $2.64 in after-hours trading. The common warrants will become exercisable only upon stockholder approval of a charter amendment increasing authorized common shares, and will expire five years after the amendment's effective date or 30 days following public disclosure of Phase 1 overall survival data for its lead program in 2L+ head and neck cancer, expected in the first half of 2027, whichever is earlier. The offering is expected to close on or about October 1, 2026, with proceeds earmarked to fund key clinical milestones for lead asset micvotabart pelidotin, including the planned Phase 3 Headliner trial in 2L+ R/M HNSCC, plus general corporate expenses and working capital.

Merck agreed to pay $400 million upfront for worldwide rights to develop, make and sell SciBrunch Therapeutics' oral KRAS G12D inhibitor SPR2015, a cancer drug candidate that has not yet reached human testing. The headline value of the deal is $2.13 billion, though $1.73 billion of that total depends on future milestones, leaving the $400 million upfront payment as the only certain outlay today. The agreement adds to Merck's pipeline as the company prepares for Keytruda patent expirations later this decade. Merck shares fell about 1.5% to $146.48 around 11:08 a.m. ET Tuesday following the announcement, a price that sits 21.21% above their $120.85 GF Value estimate.

IBA has signed a contract with the Istituti Fisioterapici Ospitalieri & Istituto Nazionale Tumori Regina Elena, known as IFO, to provide a turnkey proton therapy solution in Rome, Italy, the first gantry-based proton therapy system available in central and southern Italy. Following a public tender, IBA and its partners Cecchini SRL and Gowen SRL, construction companies and RTI members, were selected by IFO to deliver a turnkey compact gantry-based ProteusONE system at the Istituti Fisioterapici Ospitalieri center in Rome, for both pediatric and adult patients. The contract covers the latest-generation ProteusONE system, design, build, installation, a comprehensive training and education program, and a one-year operation and maintenance agreement, with IFO expecting to start treating patients in 2030. The typical end user price of a ProteusONE system with a multiyear maintenance contract ranges between 35 million euros and 45 million euros. Henri de Romree, Deputy Chief Executive Officer of IBA, said the project will make gantry-based proton therapy available to patients in central and southern Italy for the first time, while Giuseppe Navanteri, Chief Clinical Engineering and Technology officer of IFO, called it an important step forward in expanding access to advanced cancer care in the region.

Ligand Pharmaceuticals has entered a US$47 million financing agreement with AvenCell Therapeutics, comprising up to US$6 million in Series C funding and as much as US$41 million tied to clinical milestones for AvenCell's CAR-T therapy programs. The deal deepens Ligand's royalty-focused model by adding potential royalty streams on AvenCell's current and future pipeline, further broadening its portfolio of over 200 partnered assets following the XOMA Royalty acquisition. The new milestone-linked exposure comes as Ligand faces partner execution questions, including a recent termination notice to Viking Therapeutics over the TR Beta program. Ligand's narrative projects $481.1 million in revenue and $273.9 million in earnings by 2029, with a fair value estimate of $342.82, a 9% upside to its current price. Before the AvenCell deal, the most optimistic analysts had already assumed revenue could reach about US$538 million and earnings about US$277 million by 2029.

Joincare announced that Shanghai Livzon, under its controlling subsidiary Livzon Group, has received the Drug Supplementary Application Approval Notice issued by the National Medical Products Administration. Leuprorelin acetate microspheres for injection 11.25mg, a three-month dosage form, has been approved for market. The drug is a Category B product in the National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug List, with indications including premenopausal breast cancer, prostate cancer and central precocious puberty. To date, cumulative R&D investment in the drug is approximately 94.05 million yuan. Domestically, only Shanghai Livzon holds the approval for this dosage form, excluding the originator. In 2025, terminal sales of long-acting GnRHa sustained-release formulations in China were approximately 10.9 billion yuan, of which the three-month dosage form accounted for 27%.

Merck & Co., Inc. announced positive topline results from its pivotal Phase 2b/3 BRUNELLO trial of remigromig, a potentially first-in-class tri-specific Wnt pathway agonist, in adults with diabetic macular edema. At 52 weeks, both the 0.5 mg and 0.8 mg doses met the primary endpoint by demonstrating non-inferiority to the standard-of-care active control, 0.5 mg ranibizumab, for mean change in best-corrected visual acuity. While remigromig was generally well tolerated, higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and adverse event-related discontinuations were observed in the treatment arms. Full year-one data will be presented at the American Academy of Ophthalmology Annual Meeting on October 10. The company reported $16.6 billion in Q2 worldwide sales, up 5%, with KEYTRUDA and KEYTRUDA QLEX accounting for $8.4 billion, or over 50%, of that total, and full-year 2026 non-GAAP EPS expectations were revised to $2.66–$2.76 due to $3.62 per share in one-time charges following the Terns and Cidara transactions.