Antibody-Drug Conjugates (ADC)

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.

Gilead Sciences raised its 2026 product sales outlook to $30.1 billion-$30.4 billion, while Danaher cut its full-year core revenue growth guidance to 3%-4% from 3%-6%. Gilead's quarterly product sales excluding Veklury rose 10% to $7.6 billion, with HIV sales up 12% to $5.7 billion, Biktarvy generating $3.8 billion, Descovy jumping 48% to $967 million, and the injectable HIV prevention medicine Yeztugo reaching $232 million from $15 million a year earlier. Danaher reported fiscal Q2 revenue up 5.5% to $6.3 billion, core revenue growth of 3%, or 4.5% excluding respiratory testing, and adjusted EPS up 8% to $1.94, and it raised full-year adjusted EPS guidance to $8.45-$8.60 from $8.35-$8.55. Danaher's bioprocessing orders grew at a mid-teens rate even as revenue was held back by customer project timing, and management expects to exit 2026 at a mid-single-digit core revenue growth rate. Gilead's HIV franchise still accounted for $5.69 billion of its $7.63 billion in quarterly product sales, and the company recorded $11.2 billion of acquired in-process R&D expenses tied mainly to Arcellx, Tubulis, and Ouro Medicines, contributing to GAAP and non-GAAP losses per share of $8.45 and $6.75.

The KRAS inhibitor market across the seven major markets was valued at approximately $526 million in 2025 and is projected to reach approximately $7.85 billion by 2034, a compound annual growth rate of roughly 35% over its 2024 to 2034 forecast period, according to DelveInsight, with the United States expected to account for nearly 70% of the total. Roots Analysis sizes the category differently, projecting the global KRAS market will grow from approximately $557 million in 2025 to approximately $3.98 billion by 2035, a CAGR of about 21%, and expects intravenously administered therapies to grow faster than the oral drugs that dominate the category today. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, according to Eli Lilly and Company, while in colorectal cancer KRAS mutations appear in approximately 40% of all cases, according to Amgen, yet the G12C subtype targeted by the first approved inhibitors is present in only about 3% to 5% of colorectal cancers. The clinical bar moved sharply in April 2026, when a Phase 3 trial of an oral RAS(ON) multi-selective inhibitor in previously treated metastatic pancreatic cancer reported a median overall survival of 13.2 months versus 6.7 months for chemotherapy, according to the sponsor's SEC filing. Oncolytics Biotech announced positive preclinical results on September 10, 2026 from a study evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model, reporting that pelareorep activity was maintained alongside RAS inhibition without evidence of antagonism, though the company said the incremental activity associated with pelareorep became less evident after a transition to less frequent weekly dosing. Oncolytics also said it received written FDA feedback on August 18, 2026 on the design of a potential pivotal Part B expansion of its ongoing REO 033 study in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer, with objective response rate potentially supporting accelerated approval and progression-free survival potentially supporting full approval; the ongoing Part A enrolls 60 patients. Revolution Medicines announced the FDA accepted for review its New Drug Application for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma, supported by the Phase 3 RASolute 302 trial in which daraxonrasib delivered a median overall survival of 13.2 months versus 6.7 months for chemotherapy with a hazard ratio of 0.40. Amgen reported LUMAKRAS/LUMYKRAS sales up 23% year-over-year to $111 million in its second quarter 2026 results, while total revenues rose 10% to $10.1 billion, and Eli Lilly announced the FDA granted Breakthrough Therapy designation to olomorasib as a monotherapy for adults with advanced pancreatic cancer with a KRAS G12C mutation. Verastem Oncology said it will host an investor event on October 14, 2026 to present initial efficacy and updated safety and tolerability data for VS-7375, its investigational oral KRAS G12D inhibitor, and reported second quarter 2026 net product revenue of $25.1 million for AVMAPKI FAKZYNJA CO-PACK.

Merck has entered into an exclusive global licensing agreement with SciBrunch Therapeutics for SPR2015, an investigational oral KRAS G12D (ON) inhibitor. Under the deal, SciBrunch granted Merck exclusive worldwide rights to develop, manufacture, and commercialize SPR2015. Merck will pay $400M upfront, with SciBrunch eligible for additional development, commercialization, and other milestone payments across multiple indications, bringing the deal's total potential value to $2.13B. The transaction has closed, and Merck expects to record a $400M pre-tax charge, or approximately $0.13 per share, in its third-quarter 2026 GAAP and non-GAAP results.

Roche Holding announced new R&D alliances focused on AI-powered therapeutics and metabolic disease programs in late September 2026. The group signed a research partnership with Earendil Labs to apply AI to bispecific antibody cancer therapies across multiple tumor types, and agreed a collaboration with Atavistik Bio to pursue allosteric small molecules for cardiovascular, renal and metabolic conditions. Enicepatide, also known as CT-388, reported positive Phase 2 results in type 2 diabetes and obesity, highlighting Roche's GLP-1/GIP pipeline ambitions. The company's late stage pipeline includes 10 new molecular entities moving into Phase III and the potential launch of up to 19 medicines by the end of the decade, and the full story points toward a CHF370 fair value for Roche Holding. Analysts still flag execution and pricing pressure, especially in China and in obesity where Eli Lilly and Novo Nordisk are strong competitors.

BigHat Biosciences announced the completion of a $75 million Series C financing, bringing its total funding raised to date to $223 million. The round was co-led by DFJ Growth and Premji Invest, with participation from Catalio Capital Management, LG Technology Ventures, Sigmas Group, and existing investors including 8VC, Alexandria Venture Investments, Amgen Ventures, Andreessen Horowitz, Discovery Ventures, GRIDS Capital, Intermountain Ventures, Eli Lilly and Company, Merck Global Health Innovation Fund, Quadrille Capital, and Section 32. Proceeds will support growth of BigHat's platform for rapid data generation to power frontier intelligence for protein design and advancement of its pipeline of AI-designed therapeutics, including BHB810 and BHB299, to key clinical readouts. BHB810, a CDH17-directed antibody-drug conjugate for gastric cancer and other advanced gastrointestinal tumors, is one of the first AI-driven biologics to reach humans and has begun dosing patients in a Phase 1 trial, while BHB299, an avidity-driven T-cell engager targeting CEACAM6-expressing solid tumors, is nearing completion of preclinical development with human trials planned for 2027. The financing follows the company's $80 million Series B in 2022 and a $44 million Series B extension in 2025, and comes as BigHat has forged collaborations with Amgen, Merck, Johnson & Johnson, AbbVie and Lilly.

The consensus analyst price target fair value for Genmab has been lowered to DKK 2,303.24 from DKK 2,453.79, reflecting a slightly lower central target for the stock. Analysts attribute the adjustment to a mix of confidence in Genmab's pipeline, including Epkinly, rinatabart sesutecan and petosemtamab, and caution over concentration risks, clinical assumptions and the reported $3.6b Darzalex patent cliff. TD Cowen points to those pipeline assets as potential offsets to the Darzalex patent cliff, while H.C. Wainwright raised its price target to US$40, citing the EPCORE DLBCL-4 trial meeting its primary objective, and Guggenheim lifted its target to US$42 after what it called robust Q2 results and higher 2026 guidance. Deutsche Bank increased its target to DKK 2,500 and maintained a positive stance, and William Blair added Genmab to its Analyst Conviction List. Morgan Stanley kept an Equal Weight rating despite a higher US$35 target. Alongside the fair value change, the revenue growth assumption was updated to 16.00% from 16.33%, the net profit margin to 25.85% from 25.84%, the future P/E multiple to 13.80x from 14.66x, and the discount rate to 6.16% from 6.12%.

VERAXA Biotech is entering a new phase of development following its transition to the NASDAQ market and a series of scientific and corporate milestones centered on its proprietary BiTAC platform. The Swiss biotechnology company began trading on the NASDAQ Capital Market under the ticker VRXA in June following the completion of its business combination with Voyager Acquisition Corp. The transaction was accompanied by financing arrangements that included a $27.5 million senior secured note and a securities purchase agreement for up to an undisclosed additional amount. VERAXA is advancing an oncology pipeline built around BiTAC, an AND-gated therapeutic approach in which two complementary components must engage the same cancer cell before the intended cytotoxic mechanism is activated, alongside additional antibody-drug conjugate and engineered-antibody technologies. The company has reported early preclinical evidence for both its BiTAC-TCE and BiTAC-ADC approaches, including an in-vitro proof of concept for BiTAC-ADC announced in June, and recently appointed Raju Willener as CFO and Christoph Erkel, Ph.D., as chief scientific officer.

Innate Pharma said its first-half 2026 developments included closing a strategic partnership with Sobi for lacutamab, completing dose-escalation enrollment for IPH4502, and completing enrollment in the PACIFIC-9 phase III study of monalizumab. Chief Executive Officer Jonathan Dickinson said the Sobi transaction became effective on closing and included a $75 million upfront payment, which combined with a €30 million equity financing is expected to extend the company's projected cash runway through the end of the first quarter of 2028. The Sobi agreement also carries up to $40 million in near-term Sézary syndrome milestones, up to an additional $465 million tied to development-rights options and future regulatory and commercial milestones, and tiered double-digit royalties on future net sales. Innate has initiated the TELLOMAK-3 confirmatory phase III trial of lacutamab in cutaneous T-cell lymphoma, with the first patient expected in the first quarter of 2027, and plans to seek accelerated approval in Sézary syndrome in the second half of 2027. The company expects key clinical updates in the second half of 2026, including a PACIFIC-9 phase III readout for monalizumab and initial phase I data for IPH4502, an antibody-drug conjugate that has shown preliminary responses in several heavily pretreated solid-tumor populations.

Corbus Pharmaceuticals announced positive results from its phase Ib CANYON-1 study of CRB-913, an oral cannabinoid-based small molecule for obesity, with once-daily treatment achieving statistically significant and clinically meaningful weight loss across all three dose levels at 12 weeks. The 20-mg and 40-mg doses delivered placebo-adjusted mean weight loss of 2.8% and 3.3%, respectively, while the 60-mg dose achieved 5%, with no evidence of a weight-loss plateau at any dose. Corbus said treatment discontinuations due to adverse events were lower than those reported for approved oral GLP-1 drugs such as Eli Lilly's Foundayo and Novo Nordisk's Wegovy pill, and that preclinical studies showed CRB-913 was 15 times more peripherally restricted than Novo Nordisk's monlunabant, which Novo discontinued in the second quarter of 2026. Detailed CANYON-1 results are expected at ObesityWeek 2026 in November, and Corbus intends to engage with the FDA on a clinical plan to advance CRB-913 to phase II development. Beyond the obesity candidate, Corbus has an oncology program in CRB-701, a Nectin-4-targeting antibody-drug conjugate that the FDA has cleared for the registrational phase III TEMPO-1 study in second-line oropharyngeal squamous cell carcinoma, with enrollment expected to start later this month. Corbus had about $118 million in cash, cash equivalents and investments as of June 30, 2026, which it expects to support operations into 2028.

BlossomHill Therapeutics closed up better than 18% on Wednesday, its strongest one-day performance since its August 7 IPO. The surge followed the company's Tuesday release of updated data from its ongoing Phase 1/2 SOLARA trial of lead program BH-30643 in EGFR-mutant non-small cell lung cancer. As of a May data cutoff, 16 of 40 patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, achieved a confirmed possible response and another two had an unconfirmed response, for an objective response rate of 45% and a disease control rate of 88%, with median follow-up of 6.9 months. BlossomHill said BH-30643 is designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC. One of the most prescribed therapies for NSCLC is AstraZeneca's Tagrisso, a third-generation EGFR inhibitor with a first-line indication that brought in $3.8B in the first half of 2026.

Pfizer has signed a co-development and license deal with Medicus Pharma for an early clinical-stage CD228-targeting antibody-drug conjugate. The agreement grants Medicus exclusive global rights to develop and commercialize the CD228V candidate across multiple human disease areas, while Pfizer retains economic participation through financial milestones, royalties and ongoing involvement in the CD228V development program. Pfizer, a US-based pharmaceuticals group with a market value of about $158.0 billion, is handing Medicus day-to-day development and commercialization duties while keeping the patents, milestone rights and royalties, limiting its upfront spend on an early clinical asset and preserving a cut of future upside across indications. The next real test comes when Medicus moves CD228V toward a first pivotal trial and Pfizer must decide whether to exercise its option to fund later-stage development, a decision point that, alongside any detail shared at events such as the Morgan Stanley Global Healthcare Conference on 14 September 2026, will show how important Pfizer sees the asset within its oncology plans.

Whitehawk Therapeutics has appointed Vijay Iyengar, MD, to its Board of Directors, effective September 9, 2026. Dr. Iyengar spent nine years in senior leadership roles at Incyte Corporation, where he helped launch five brands across eight indications, expand the company into more than 20 countries and grow annual revenue from approximately $1B to more than $4B. Before Incyte, he held senior oncology leadership positions at Novartis and was an Engagement Manager in the healthcare practice at McKinsey & Company. Whitehawk President and Chief Executive Officer Dave Lennon said Dr. Iyengar's expansive oncology leadership experience will be valuable as the company advances its clinical programs and expands its ADC portfolio. Whitehawk Therapeutics is a clinical-stage oncology therapeutics company whose portfolio includes HWK-007, HWK-016 and HWK-206, antibody-drug conjugates in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement.

InnoCare Pharma announced that China's drug regulator has approved its Investigational New Drug application to begin clinical trials for ICP-B381, a novel bispecific antibody-drug conjugate targeting PSMA and STEAP1 for solid tumors including prostate cancer. This marks InnoCare's first bispecific ADC to enter the clinic and its third ADC overall. In preclinical studies, ICP-B381 showed robust antitumor activity in a prostate cancer model, outperforming single-target ADCs. No bispecific ADC targeting these proteins has been approved globally yet.