Pharma and biotech news, week of Oct 12 – Oct 18, 2026

Opus Genetics announced that the U.S. FDA approved its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia in adults. The approval was supported by positive results from the pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials. Under a global licensing agreement, commercialization partner Viatris will market the product as RYZUMVI in the U.S., triggering a milestone payment to Opus Genetics.AI summary

The U.S. FDA has expanded the approved indication for ImmunityBio's ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) to include adult patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors. The update broadens the drug's label beyond its initial April 2024 approval for CIS disease. ImmunityBio remains focused on commercialization and helping eligible patients access the therapy.AI summary

Eli Lilly reported post-hoc Phase 3 data evaluating Omvoh (mirikizumab-mrkz) for ulcerative colitis (UC) and Crohn's disease. At one year, 27.7% of UC patients achieved comprehensive disease control and 20.4% of Crohn's patients achieved corticosteroid-free deep remission. These post-hoc data from the LUCENT and VIVID programs will be presented at UEG Week 2026.AI summary

Viking Therapeutics announced the initiation of its SUNRISE Phase 3 clinical program for oral VK2735 in obesity. The program includes SUNRISE-1 and SUNRISE-2, which will each enroll 560 adults with or without type 2 diabetes. Patients will receive once-daily oral doses of 27.5 mg, 35 mg, 55 mg, or placebo for 68 weeks to assess weight loss efficacy and safety.AI summary

Merck announced that first-time results from three pivotal clinical trials will be presented during late-breaking Presidential Symposia at the ESMO Congress 2026. The presentations will feature Phase 3 data for intismeran autogene combined with Keytruda, sacituzumab tirumotecan, and first-line Keytruda monotherapy. Additionally, Merck will host an Oncology Investor Event on October 26 to provide updates on its strategy.AI summary

Revolution Medicines announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorization for RASONQUE (daraxonrasib) to treat adult patients with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy. The decision is based on Phase 3 RASolute 302 trial results showing a 60% reduction in risk of death compared to chemotherapy. The recommendation will now be considered by the European Commission.AI summary

Elevar Therapeutics has resubmitted its New Drug Application to the FDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. The resubmission follows a July 2026 Complete Response Letter and is supported by Phase 3 CARES-310 data showing a median overall survival of 23.8 months. Elevar will now engage with the FDA during its review of the application.AI summary

The FDA has accepted BridgeBio Pharma's New Drug Application for oral infigratinib to treat children with achondroplasia, granting it Priority Review with a PDUFA action date of February 4, 2027. The submission is backed by Phase 3 PROPEL 3 trial results. BridgeBio plans to submit a European marketing application in Q4 2026.AI summary

Legend Biotech announced that the U.S. FDA has cleared the IND application for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting CAR-T cells within the patient, for relapsed or refractory B-cell malignancies including B-cell non-Hodgkin lymphoma. The planned U.S. Phase 1/2 study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of LB2501. LB2501 is currently being evaluated in an ongoing Phase 1 study in China (NCT07002112).AI summary

The EMA's CHMP has issued a positive opinion recommending approval of an updated dosing regimen for Libtayo across all approved cancer indications. The recommendation supports an extended dosing schedule of 700 mg every six weeks following an initial 12 weeks of 350 mg every three weeks. A final decision from the European Commission is expected in the coming months.AI summary

The EMA's CHMP has adopted a positive opinion recommending the EU approval of TRYNGOLZA (olezarsen) for adult patients with severe hypertriglyceridemia. The recommendation is supported by Phase 3 trial data showing up to a 72% reduction in fasting triglycerides and an 85% reduction in acute pancreatitis events. A final European Commission decision is expected in the fourth quarter of 2026.AI summary

Ascendis Pharma announced that the CHMP has adopted a positive opinion recommending marketing authorization for once-weekly TransCon CNP (navepegritide) to treat achondroplasia in children aged two and older with open epiphyses. A final decision from the European Commission is expected in Q4 2026. If approved, Ascendis anticipates launching the therapy in Germany during Q1 2027.AI summary

Aquestive Therapeutics announced that the FDA accepted its NDA resubmission for Anaphylm (dibutepinephrine) sublingual film to treat Type I allergic reactions, including anaphylaxis. Classified as a Class 2 response, the resubmission has been assigned a PDUFA goal action date of March 16, 2027. Internationally, Aquestive remains on track to submit a New Drug Submission to Health Canada in Q4 2026.AI summary

Eikon Therapeutics has submitted an Investigational New Drug application to the U.S. FDA to evaluate EIK1006 for advanced metastatic prostate cancer. EIK1006 is a novel androgen receptor antagonist targeting wild-type and clinically relevant AR variants. The company looks forward to evaluating the candidate's clinical benefit in patients.AI summary

Atara Biotherapeutics announced that the U.S. FDA has accepted the Biologics License Application resubmission for tabelecleucel (Tab-cel) to treat EBV+ PTLD. The Class 2 resubmission has a PDUFA target action date of March 31, 2027. If approved, Atara is eligible to receive a $31 million milestone payment from Pierre Fabre Laboratories.AI summary

Rhythm Pharmaceuticals announced the commercial launch of IMCIVREE (setmelanotide) in Japan for patients with acquired hypothalamic obesity. The launch follows inclusion on Japan's National Health Insurance drug price list and MHLW approval in August 2026. IMCIVREE is the first approved therapy in Japan for this indication.AI summary

AbbVie presented new Phase 3 AFFIRM study data for subcutaneous SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease. At week 24, 35.8% of patients achieved endoscopic remission and 36.6% achieved ulcer-free endoscopy. The subcutaneous induction dosing regimen is currently under regulatory review by the U.S. FDA and EMA.AI summary

Bristol Myers Squibb announced that its Phase 3 ALOFT-IPF trial of admilparant met its primary endpoint at the 60 mg dose, demonstrating a statistically significant improvement in forced vital capacity compared to placebo at Week 52. The 120 mg dose slowed decline but was not statistically significant, and the drug was well-tolerated. The company plans to engage regulatory authorities and present detailed results at a future meeting.AI summary

Regeneron announced positive 84-week results from the Phase 3 OPTIMA trial evaluating Pasatru (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva (FOP). Pasatru demonstrated sustained efficacy with zero new heterotopic ossification lesions observed at week 84 and a generally well-tolerated safety profile. A Phase 3 trial in children and adolescents, OPTIMA 2, is planned to begin later this year.AI summary

Bristol Myers Squibb announced positive topline results from the planned interim analysis of the Phase 3 ACTION-1 trial evaluating RYZ101 in patients with SSTR+ gastroenteropancreatic neuroendocrine tumors. The study met its primary endpoint with a statistically significant improvement in progression-free survival. RayzeBio plans to engage with the FDA to discuss next steps toward a regulatory submission.AI summary

ImmunityBio announced the journal publication of long-term Phase 2/3 QUILT-3.032 trial data evaluating ANKTIVA plus BCG in BCG-unresponsive NMIBC with CIS. Results demonstrated a 71% complete response rate, a 26.6-month median duration of response, and 84% cystectomy-free survival at 36 months among responders. The findings add to peer-reviewed evidence supporting the combination.AI summary

BioNTech announced first topline results from the Phase 2/3 AHEAD-MERIT trial evaluating BNT113 combined with pembrolizumab in patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The combination did not demonstrate a statistically significant improvement in progression-free survival compared to pembrolizumab alone. The trial will continue to evaluate overall survival per the Independent Data Monitoring Committee's recommendation.AI summary

Beacon Therapeutics presented detailed data from its pivotal Phase 2/3 VISTA trial evaluating laru-zova for X-linked retinitis pigmentosa at AAO 2026. The study met its primary endpoint, with 31.0% of high-dose and 24.1% of low-dose participants achieving a ≥15-letter improvement in LLVA at Month 12 versus 0% in control. Beacon plans to begin a rolling BLA submission later this year.AI summary

Spyre Therapeutics announced presentations at UEGW 2026 featuring clinical and preclinical data for its IBD antibodies SPY001, SPY002, and SPY003. Clinical proof-of-concept has been demonstrated across all three antibodies, which are being tested as monotherapies and pairwise combinations in the SKYLINE trial. The company expects to see combination trial results next year.AI summary

Pharming presented positive topline Phase II data for leniolisib in primary immunodeficiencies with immune dysregulation linked to altered PI3Kδ signaling. Leniolisib was well-tolerated and demonstrated mean reductions of 26.4% in spleen volume and 33.7% in lymph node index lesion size. All 12 completing participants enrolled in a three-year extension study.AI summary

Tortugas Neuroscience announced positive Phase 2b trial results for obuprazine (TRTL-107) in acute schizophrenia. The trial met its primary endpoint, with all dose groups showing statistically significant PANSS total score improvements over placebo at Day 42. Tortugas plans to submit a U.S. IND application for TRTL-107.AI summary

Odyssey Therapeutics announced it will present the design of a Phase 2a trial evaluating OD-001 in combination with vedolizumab for moderate-to-severe ulcerative colitis at ACG 2026. The study plans to enroll up to 146 patients globally. Odyssey expects to report topline induction results in the second half of 2027.AI summary

Syndax Pharmaceuticals announced that its MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis did not meet its primary endpoint of annualized rate of decline in forced vital capacity. Based on these results, Syndax will discontinue further development of axatilimab in IPF. Ongoing trials testing axatilimab in other indications, including chronic graft-versus-host disease, remain unaffected.AI summary

Crescent Biopharma announced pipeline progress, including enrolling patients in chemotherapy combination cohorts of its Phase 1/2 ASCEND trial evaluating CR-001. Dose escalation is complete, and initial monotherapy data are expected in Q1 2027. Initial chemotherapy combination data from mid-2027 could support initiating Phase 3 trials in early 2028.AI summary

Verastem Oncology announced positive initial multi-tumor data from the ongoing TARGET-D 101 Phase 1/2 trial of VS-7375 in KRAS G12D-mutated solid tumors. The drug demonstrated a 50% confirmed ORR in 2L pancreatic ductal adenocarcinoma at 900 mg QD. Verastem reached alignment with the FDA on a Phase 3 first-line mPDAC study design, which it plans to open by the end of 2026.AI summary

Arrowhead Pharmaceuticals announced interim Phase 1/2a results for ARO-MAPT, showing a mean cerebrospinal fluid total tau reduction of up to 73% at Day 105 in healthy volunteers. The subcutaneous treatment was generally well tolerated with no serious treatment-emergent adverse events reported. Arrowhead plans to continue enrollment in early Alzheimer's disease cohorts, with data updates expected in 2027.AI summary

Immunocore has dosed the first patient with type 1 diabetes in a Phase 1 trial of IMC-S118AI, its first autoimmune candidate. IMC-S118AI is a novel bispecific molecule designed to protect beta cells and preserve insulin production. The Phase 1 dose escalation study will evaluate the safety, pharmacokinetics, and clinical activity of IMC-S118AI in HLA-A*02:01-positive patients.AI summary

AbbVie announced it will present new and updated clinical data across seven solid tumor assets at the 2026 ESMO Congress. Findings cover multiple antibody-drug conjugates and bispecific antibody programs, including Temab-A, ABBV-706, ABBV-969, and ABBV-1480 across various cancer types. The presentations highlight progress in next-generation platforms, combination therapies, and biomarker-defined populations.AI summary

Eikon Therapeutics announced the availability of seven abstracts highlighting updates across its clinical oncology pipeline for presentation at the 2026 ESMO Congress. The presentations cover clinical updates for four candidates: EIK1001, EIK1003, EIK1004, and EIK1005. The data will be presented during the congress in Madrid beginning on October 23, 2026.AI summary

Eli Lilly announced it will present data across its oncology pipeline at the 2026 ESMO Congress. Presentations will feature first Phase 1 data for sofetabart mipitecan in platinum-sensitive ovarian cancer, updated Phase 1/2 and Phase 3 data for olomorasib in NSCLC, and updated Phase 3 data for Retevmo and Verzenio.AI summary

GSK presented first global data for Ris-Rez (risvutatug rezetecan), a B7-H3-targeted antibody-drug conjugate, from the phase Ib dose-optimisation portion of the EMBOLD PanTumour-101 trial in relapsed extensive-stage small cell lung cancer. The confirmed objective response rate was 61% at 8 mg/kg (11/18) versus 32% at 6 mg/kg (7/22), and the safety profile was manageable at a median follow-up of 100.5 days. The data will be presented at ESMO 2026 and supported selection of the 8 mg/kg dose for the ongoing global phase III EMBOLD SCLC-301 study.AI summary

Incyte announced it will present new oncology data at the ESMO Congress 2026. Presentations include data for KRAS G12D inhibitor INCB161734, TGFβR2×PD-1 bispecific antibody INCA33890, and CDK2 inhibitor INCB123667. Incyte will also host an investor event and webcast on October 26, 2026, to discuss the presented data and portfolio updates.AI summary

AbbVie presented long-term data for Skyrizi and Rinvoq in inflammatory bowel disease at UEGW 2026. In ulcerative colitis, Skyrizi showed sustained outcomes up to three years, achieving week 96 clinical remission rates of 54.0%–73.1%. Rinvoq maintained clinical remission through four years in Crohn's disease, with 144-week rates of 78.9% (15 mg) and 86.6% (30 mg).AI summary

GSK announced it will present over 20 abstracts showcasing its solid tumour portfolio at the 2026 ESMO Congress. Key data includes Phase 1/2 trial results for risvutatug rezetecan in small-cell lung cancer, Phase 1 data for mocertatug rezetecan in ovarian cancer, and Phase 2 AZUR-1 trial results for Jemperli in rectal cancer.AI summary

Opus Genetics presented positive clinical trial data for its gene therapy programs, OPGx-BEST1 and OPGx-LCA5. OPGx-BEST1 showed improved retinal sensitivity in 75% of evaluable low-dose participants, while OPGx-LCA5 demonstrated sustained improvements in visual function through 24 months in adults and six months in pediatric participants. Phase 3 trial dosing for OPGx-LCA5 is expected in the fourth quarter of 2026.AI summary

Alkermes announced plans to present data from its sleep medicine portfolio at Sleep Europe 2026. Presentations will include findings from the Vibrance-1 Phase 2 study and long-term extension evaluating alixorexton in narcolepsy type 1 and type 2. Detailed results from the Phase 3 REVITALYZ study evaluating LUMRYZ in adults with idiopathic hypersomnia will also be shared.AI summary

Generate Biomedicines and Zealand Pharma have entered a strategic collaboration to design and develop multispecific protein therapeutics for obesity and metabolic diseases using generative AI. Generate will receive $30 million upfront, up to $35 million in early preclinical milestones, and up to nearly $1.2 billion in total milestones plus tiered royalties. Generate will lead research through lead-candidate selection, after which Zealand Pharma will handle clinical development, regulatory submissions, and commercialization.AI summary

Verastem Oncology announced the pricing of an underwritten offering of common stock and pre-funded warrants, expecting gross proceeds of approximately $250 million. The offering is expected to close on or about October 15, 2026. The company intends to use the net proceeds to fund clinical development of product candidates, including the VS-7375 program, and for general corporate purposes.AI summary

Agilent Technologies has entered into a definitive agreement to acquire digital pathology software provider Proscia. The all-cash transaction is valued at $240 million at closing, with up to $30 million in additional payments contingent on achieving future performance milestones.AI summary

Recursion announced a $200 million underwritten offering of common stock, extending its cash runway into 2029. The company reported Phase 1b/2 clinical updates for REC-4881 in Familial Adenomatous Polyposis and Phase 1 updates for REC-1245, while Sanofi optioned a first-in-class immunology candidate from their collaboration. Recursion targets initiating a registrational trial for REC-4881 in the second half of 2027.AI summary

Rona Therapeutics has granted Roche an exclusive worldwide license for its investigational ALK7-targeting RNAi therapy for obesity and metabolic diseases. Under the agreement, Rona will receive upfront and near-term milestone payments of up to $100M. Rona is also eligible for up to $1.06 billion in potential milestone payments, plus tiered royalties on net sales.AI summary

Armed Cell Therapeutics raised over €50 million in a strategic investment round led by Mankind Pharma, which is acquiring a majority stake for €48 million. ACTx founders are co-investing in the round. Proceeds will be used to advance ACTx's two lead next-generation armed CAR-T programs into clinical trials and expand its R&D team.AI summary

Biotechnology company. Total offering $73M; first sale 2026-09-30. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $58M; first sale 2026-09-18. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $104M; first sale 2026-07-01. Form D is filed up to 15 days after the first sale.

insitro has entered into a strategic research collaboration with AstraZeneca to discover novel targets and therapeutics for MASH and cardiomyopathies using insitro's AI platform. Under the agreement, insitro receives $40 million upfront, up to approximately $1.46 billion in potential milestones, and single-digit royalties. insitro will advance targets to development candidates, after which AstraZeneca will manage clinical development and commercialization.AI summary

AstraZeneca has entered a new strategic drug discovery collaboration and licensing agreement with insitro, an AI therapeutics company, to identify novel drug targets and advance new therapeutics for MASH and cardiomyopathies. insitro will receive an upfront payment of $40 million and is eligible for up to approximately $1.46 billion in development and commercial milestones, plus potential single digit royalties on global commercial sales. AstraZeneca will have exclusive worldwide rights to advance selected programmes identified under the collaboration.AI summary

Sanofi has optioned the first immunology development candidate from its multi-program collaboration with Recursion. The option triggered a $10 million milestone payment to Recursion, bringing total payments under the collaboration to $144 million. Sanofi will fund and lead further development, with a Phase 1 clinical trial planned to begin in 2027.AI summary

Armed Cell Therapeutics has acquired a portfolio of preclinical multi-targeting, armed CAR-T assets from Lakefront Biotherapeutics. The acquired programs focus on non-Hodgkin lymphoma and small cell lung cancer. Under the agreement, Lakefront receives an upfront payment and is eligible for regulatory and commercial milestones and royalties as Armed Cell advances the programs toward the clinic.AI summary

Eton Pharmaceuticals and Aquestive Therapeutics have entered into an exclusive U.S. licensing and supply agreement for LIBERVANT (diazepam) buccal film for seizure clusters in epilepsy patients. Under the agreement, Eton gains exclusive U.S. commercialization rights to the product. Subject to final FDA approval, Eton anticipates commercial launch of LIBERVANT in April 2027.AI summary

Alentis Therapeutics and PinotBio have entered into a research collaboration and licensing agreement to develop next-generation claudin-1 targeting antibody-drug conjugates for oncology. Under the terms, Alentis receives an exclusive option to in-license PinotBio's linkers and payloads, while PinotBio receives an upfront payment, milestone payments, and royalties on net sales. The collaboration aims to combine PinotBio's technologies with Alentis' antibody portfolio.AI summary

Ironwood Pharmaceuticals announced that its Board of Directors has appointed Chief Commercial Officer Tammi Gaskins as Chief Executive Officer and a member of the Board, effective January 1, 2027. On that date, current CEO Tom McCourt will retire from his role while remaining a Board member. Gaskins will succeed McCourt to lead the company through its next phase of growth.AI summary

Biogen expects its GAAP and non-GAAP third quarter 2026 results to include approximately $284 million in pre-tax acquired in-process R&D, upfront, and milestone expenses. The charge is estimated to reduce GAAP and non-GAAP EPS by $1.65 and $1.70, respectively. An additional $35 million in expenses will shift to the fourth quarter.AI summary

Biologists used Google's agentic science platform, Antigravity, and its ProtNLM model to discover a novel antimicrobial peptide candidate with predicted activity against respiratory tract infection pathogens. The candidate was identified by screening uncharacterized UniProt protein sequences alongside structural and genomic evidence. The lead and several other candidates discovered through the pipeline are now undergoing wet-lab validation.AI summary

Armed Cell Therapeutics has appointed Willemijn Kremer as its founding Chief Executive Officer. Paul Stoffels, MD, who previously served as interim CEO, will remain as Chair of the Board of Directors. The appointment is intended to help position the company as it advances its preclinical armed CAR-T programs toward the clinic.AI summary

Sarepta Therapeutics presented new preclinical data for SRP-1003 in myotonic dystrophy type 1. The investigational siRNA achieved up to approximately 80% knockdown of pathogenic DMPK RNA in both the nucleus and cytoplasm. Sarepta expects to share results from an ongoing Phase 1/2 clinical study later this year.AI summary

Genmab announced that worldwide net trade sales of DARZALEX totaled USD 4,239 million in the third quarter of 2026. Sales were USD 2,528 million in the U.S. and USD 1,711 million in the rest of the world. Genmab receives royalties on these sales under an exclusive worldwide license with Johnson & Johnson.AI summary

Legend Biotech announced that CARVYKTI generated approximately $710 million in net trade sales during the quarter ended September 30, 2026. The figure is based on information provided by Janssen, which Legend Biotech has not independently verified, and it is unaudited. The amount of any revenue or gross profit to be recorded is subject to completion of Legend Biotech's financial statements for the period.AI summary

Johnson & Johnson reported third-quarter 2026 sales growth of 5.9% to $25.4 billion, despite earnings per share of $0.09 reflecting M&A deals and a special charge for talc litigation. Based on strong operational performance, the company raised its 2026 guidance, now estimating reported sales of $101.2 billion and increasing adjusted EPS guidance to $11.10 at the midpoint.AI summary

aTyr Pharma announced the publication of preclinical data demonstrating the anti-fibrotic effects of ATYR0101 in the Journal of Biological Chemistry. In an in vivo bleomycin lung model, ATYR0101 significantly reduced collagen content and Ashcroft score, leading to a marked decline in pulmonary fibrosis. ATYR0101 is undergoing IND-enabling studies and is expected to enter the clinic in 2027.AI summary

Evotec announced preliminary unaudited revenues of approximately €465.0 million and an adjusted EBITDA of approximately -€42.8 million for the first nine months of 2026, beating market expectations. The performance was largely driven by the phasing of consensus estimates. Evotec reaffirmed its full-year 2026 revenue guidance of €570 to €610 million, with full financial results scheduled for publication on November 5, 2026.AI summary

Caspian Therapeutics and Kura Oncology outlined their development strategy for KO-7246, an oral menin inhibitor designed to treat diabetes. Preclinical findings presented at the EASD Annual Meeting demonstrated beta cell expansion and improved glucose control. IND-enabling development is underway to support a planned Phase 1 clinical proof-of-concept study.AI summary