Pharma and biotech news, week of Oct 19 – Oct 25, 2026

The U.S. FDA has approved a subcutaneous induction regimen for AbbVie's SKYRIZI (risankizumab-rzaa) to treat adults with moderately to severely active Crohn's disease. Approval was based on Phase 3 AFFIRM study data, where subcutaneous SKYRIZI met co-primary endpoints of clinical remission and endoscopic response at week 12. Patients can now start treatment at home using an on-body injector before continuing with maintenance dosing.AI summary

The U.S. FDA has approved Ionis partner GSK's Hibsago (bepirovirsen) in combination with NrtI therapy for adult chronic hepatitis B patients without cirrhosis and with specific baseline surface antigen levels. Approval was supported by Phase 3 B-Well trial data showing a 19% functional cure rate after six months of treatment. GSK continues to advance regulatory submissions globally.AI summary

Ultomiris has received US accelerated approval to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. The approval follows Priority Review and the prespecified interim analysis of the Phase III I CAN trial, which showed a 43.4% reduction in proteinuria vs placebo at 34 weeks. Whether it slows kidney function decline is not yet established, and the eGFR endpoint at week 106 is ongoing.AI summary

The European Commission has approved Merck's KEYTRUDA in combination with Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer. Based on Phase 3 KEYNOTE-B15 trial results, the regimen reduced the risk of event-free survival events by 47% and death by 35%. Commercial availability in individual EU countries will depend on national reimbursement procedures.AI summary

GSK announced that the US FDA has approved Hibsago (bepirovirsen) in combination with NrtI therapy for adult patients with chronic hepatitis B. The decision was supported by B-WELL phase III trial results, which showed a 19% functional cure rate. GSK is continuing to advance regulatory submissions for bepirovirsen across multiple geographies.AI summary

The FDA has granted accelerated approval to GSK's Jemperli (dostarlimab) as the first immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer. Approval was based on phase II AZUR-1 trial data where 68% of evaluable patients achieved sustained clinical complete responses at 12 months per investigator assessment. Regulatory reviews are ongoing internationally.AI summary

The FDA has approved Amgen, Inc.'s biologics license application BLA 761298/Original 2 for Pavblu (aflibercept-ayyh) as interchangeable biosimilar products.AI summary

The FDA approved Formycon AG's biologics license application BLA 761378/Original 2 for Ahzantive (aflibercept-mrbb). The approval provides for Ahzantive as an interchangeable biosimilar product.AI summary

The FDA approved Sandoz, Inc.'s biologics license application (BLA 761382/Original 2) for Enzeevu (aflibercept-abzv) as interchangeable biosimilar products.AI summary

BioCryst Pharmaceuticals announced that the U.S. FDA has approved its supplemental New Drug Application for the oral pellet formulation of once-daily ORLADEYO 150 mg. The approval expands prophylactic therapy options to prevent HAE attacks in adults and adolescents aged 12 years and older. The approval offers an alternative administration option for patients who have difficulty swallowing capsules.AI summary

Opus Genetics announced that the FDA has cleared its Investigational New Drug application for OPGx-RDH12, a gene therapy for RDH12-associated Leber congenital amaurosis. Under a collaboration, the Global RDH12 Alliance committed up to $1.6 million toward the development of the candidate. The company plans to initiate a Phase 1/2 clinical trial this quarter.AI summary

The U.S. FDA has accepted Unicycive Therapeutics' New Drug Application resubmission for oxylanthanum carbonate to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The resubmission includes CMC data from a new manufacturing vendor following a previous Complete Response Letter. The FDA designated the filing as Class II and set a PDUFA target action date of March 25, 2027.AI summary

Positive results from the Phase III SAFFRON trial showed Tagrisso plus Orpathys reduced the risk of disease progression or death by 45% compared with platinum-based chemotherapy (PFS HR 0.55) and the risk of death by 32% (OS HR 0.68) in patients with MET-overexpressed or MET-amplified EGFR-mutated NSCLC after progression on Tagrisso. Median overall survival was 17.8 versus 12.9 months. A New Drug Application has been submitted to the US FDA, and the results were presented at ESMO Congress 2026 and published in The New England Journal of Medicine.AI summary

AstraZeneca's Phase III CLARITY-Gastric01 trial found that sonesitatug vedotin reduced the risk of death by 42% versus investigator's choice of therapy in 2nd- and later-line CLDN18.2-positive advanced gastric/GEJ cancers (HR 0.58; 95% CI 0.47–0.73). Median overall survival was 10.6 months versus 6.4 months. Results will be presented at ESMO Congress 2026, and the progression-free survival endpoint in the overall population did not reach statistical significance.AI summary

Eli Lilly announced updated first-line data for its KRAS G12C inhibitor, olomorasib, in KRAS G12C-mutant non-small cell lung cancer at ESMO 2026. Olomorasib plus pembrolizumab showed median progression-free survival and duration of response were not reached after 20.7 months of follow-up. Lilly expects first randomized Phase 3 data from the SUNRAY-01 trial in the first half of 2027.AI summary

Regeneron announced longer-term Phase 3 C-POST trial data for Libtayo as adjuvant treatment in high-risk cutaneous squamous cell carcinoma. Results showed a 37% reduction in the risk of death with nearly four years of follow-up, alongside sustained disease-free survival benefits regardless of baseline minimal residual disease status. Safety results remained consistent with previously reported data.AI summary

Amgen announced interim Phase 3 DeLLphi-305 trial results showing IMDELLTRA in combination with durvalumab reduced the risk of death by 58% compared to durvalumab alone as a first-line maintenance treatment for extensive stage small cell lung cancer. Combination treatment extended median overall survival to 21.1 months compared to 12.7 months for durvalumab alone. Amgen plans to share these results with regulatory authorities worldwide.AI summary

AstraZeneca reported positive Phase III VOLGA trial results for perioperative Imfinzi plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer. The combination reduced the risk of disease progression, recurrence, not undergoing surgery or death by 49% (EFS HR 0.51) and the risk of death by 42% (OS HR 0.58) versus the comparator arm. The FDA granted Priority Review in September 2026, and the results were presented at ESMO 2026 and published in The New England Journal of Medicine.AI summary

Celcuity presented updated Phase 3 VIKTORIA-1 trial subgroup data at ESMO 2026 for gedatolisib in HR+/HER2- advanced breast cancer. In patients without liver metastases, the gedatolisib triplet achieved a median progression-free survival of 21.5 months versus 9.1 months for alpelisib plus fulvestrant. Celcuity is also evaluating gedatolisib in its ongoing Phase 3 VIKTORIA-2 trial.AI summary

Vertex Pharmaceuticals announced the publication and presentation of Phase 3 RAINIER interim trial results for povetacicept in IgA nephropathy. The study met its primary endpoint, demonstrating a 49.8% reduction in proteinuria versus placebo at Week 36. Vertex is on track for a FDA PDUFA date of November 30, 2026, for potential accelerated approval.AI summary

Genmab announced positive topline results from the Phase 3 RAINFOL-02 trial evaluating rinatabart sesutecan (Rina-S) in platinum-resistant ovarian cancer. Rina-S demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy. Genmab plans to present the data at a future medical meeting and discuss next steps with global regulatory authorities.AI summary

Jazz Pharmaceuticals announced updated overall survival results from the Phase 3 HERIZON-GEA-01 trial of Ziihera (zanidatamab-hrii) in first-line HER2-positive advanced gastroesophageal adenocarcinoma. Ziihera plus tislelizumab and chemotherapy achieved a median overall survival of 27.0 months, reducing the risk of death by 35% compared to trastuzumab plus chemotherapy. Ziihera plus chemotherapy also reduced the risk of death by 24%.AI summary

Revolution Medicines presented exploratory subgroup analyses from the Phase 3 RASolute 302 trial of RASONQUE (daraxonrasib) at ESMO 2026. The data demonstrated that RASONQUE consistently improved overall survival compared to standard chemotherapy across key subgroups in previously treated metastatic pancreatic adenocarcinoma, including patients without identified tumor RAS mutations. Revolution Medicines continues regulatory reviews and clinical development globally.AI summary

Ionis partner Roche announced Phase 3 IMAgINATION study data showing sefaxersen achieved a statistically significant 43.1% reduction in proteinuria relative to placebo at 37 weeks in adults with IgA nephropathy. The investigational drug was well tolerated with no new safety signals. Roche will share the data with health authorities, while the study continues evaluating kidney function over two years.AI summary

SystImmune, Biokin, and Bristol Myers Squibb reported positive Phase 3 PANKU-Breast01 trial results for izalontamab brengitecan (iza-bren) in HR+/HER2- breast cancer. Treatment reduced the risk of disease progression or death by 59% versus chemotherapy, with a median PFS of 8.2 months compared to 4.0 months. Results were presented at ESMO 2026 and published in The Lancet.AI summary

BioNTech announced a clinical trial collaboration and supply agreement with Gilead Sciences to evaluate pumitamig with sacituzumab govitecan as first-line treatment for PD-L1 low or negative triple-negative breast cancer. The global Phase 3 ROSETTA Breast-01 trial will be adapted to replace chemotherapy with sacituzumab govitecan, pending regulatory authority approval, with BioNTech continuing to sponsor the trial and Gilead supplying sacituzumab govitecan. The use of this combination is investigational, and its safety and efficacy have not been established.AI summary

Mineralys Therapeutics presented new Phase 3 Launch-HTN data at ASN Kidney Week 2026 evaluating lorundrostat in hypertension patients with and without chronic kidney disease. At 12 weeks, lorundrostat significantly reduced systolic blood pressure and lowered albuminuria by 52.2% versus placebo in patients with kidney disease. Lorundrostat is currently under FDA review for hypertension, with a PDUFA target date of December 22, 2026.AI summary

Merck and Moderna announced results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene combined with Keytruda in resected stage IIB-IV melanoma. The combination reduced the risk of recurrence or death by 42% and distant metastasis or death by 38% compared to Keytruda alone. The companies are engaging with regulatory authorities based on these data.AI summary

Vor Bio announced final two-year Phase 3 TELIGAN trial results for telitacicept in adults with IgA nephropathy. The study met its Stage B primary endpoint, showing an annualized eGFR slope of -0.6 vs. -5.7 mL/min/1.73 m²/year for placebo (p<0.001). Vor Bio is continuing to advance global Phase 3 programs for telitacicept in myasthenia gravis and Sjögren’s disease.AI summary

AbbVie announced positive topline results from the Phase 3 INTREPID trial evaluating lutikizumab in moderate to severe hidradenitis suppurativa. The trial met its primary endpoint, with 31.4% of patients achieving HiSCR75 at Week 16 compared to 23.4% for placebo, as well as 8 ranked secondary endpoints. Additional trial data expected in 2027 will support regulatory submissions in the second half of that year.AI summary

Roivant and Priovant Therapeutics announced positive results from the Phase 3 CLARITY-1 and CLARITY-2 trials evaluating brepocitinib in non-infectious uveitis. Brepocitinib 45 mg once-daily met the primary endpoint of time to treatment failure and all key secondary endpoints with statistical significance in both trials. Priovant plans to file a supplemental New Drug Application in the first half of calendar year 2027.AI summary

Amgen and AstraZeneca announced full results from the Phase 3 CROSSING trial evaluating TEZSPIRE in adolescent and adult patients with symptomatic, uncontrolled eosinophilic esophagitis. TEZSPIRE achieved statistically significant improvements in co-primary endpoints at week 24, including histologic remission in up to 68.9% of patients, which were sustained through week 52. Detailed results will be presented in a late-breaking oral presentation at United European Gastroenterology Week 2026.AI summary

Revolution Medicines has begun treating patients in the global Phase 3 RASolve 308 trial. The study evaluates zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet versus placebo plus pembrolizumab and chemotherapy as a first-line treatment for metastatic RAS G12D non-squamous non-small cell lung cancer. The primary endpoint of the randomized, double-blind trial is progression-free survival.AI summary

argenx announced that its Phase 3 ALKIVIA study evaluating VYVGART Hytrulo in patients with autoimmune myositis met its primary endpoint. The trial demonstrated a 15.4-point greater improvement in mean Total Improvement Score versus placebo at Week 52. Detailed results will be presented at ACR Convergence 2026.AI summary

Eli Lilly announced positive late-breaking Phase 3 results from the SHINE-2 study evaluating Omvoh in pediatric patients with moderately to severely active ulcerative colitis. After 81% of patients achieved a clinical response at Week 12, 50% of responders reached clinical remission at one year, meeting the primary endpoint. Lilly plans to submit the data to global regulators to support a label expansion.AI summary

Johnson & Johnson announced one-year results from the Phase 3 FUZION study of TREMFYA (guselkumab) in adults with Crohn's disease with perianal fistula. TREMFYA maintained or improved combined fistula remission through 48 weeks across both maintenance dose regimens, increasing to 35% in the 100 mg group. The findings are being presented at UEG Week 2026.AI summary

Biogen announced it will present new data across its nephrology portfolio at ASN Kidney Week. Key presentations include new 76-week Phase 3 EMPAVELI data showing sustained proteinuria reduction and continued eGFR stabilization in C3G and primary IC-MPGN patients. Biogen will also feature presentations on its investigational monoclonal antibody felzartamab across multiple kidney diseases.AI summary

Compass Therapeutics announced the publication and presentation of Phase 2/3 COMPANION-002 study results for tovecimig plus paclitaxel in advanced biliary tract cancer. The trial met its primary endpoint, showing an 18.0% overall response rate compared to 5.3% for paclitaxel alone. Compass will continue working with the FDA toward potential approval.AI summary

BioNTech and Bristol Myers Squibb presented first data from the global Phase 2 ROSETTA Lung-107 trial of pumitamig plus docetaxel in NSCLC that progressed after immunotherapy plus chemotherapy. Among 30 efficacy-evaluable patients, the confirmed objective response rate was 36.7%, and median progression-free survival in 50 treated patients was 6.9 months. The data will inform further development of pumitamig in this patient population.AI summary

Oruka Therapeutics announced it will report Week 16 data for ORKA-001 from its ongoing EVERLAST-B trial on October 26, 2026. The company will host a conference call and webcast to discuss the results. ORKA-001 is being evaluated for the treatment of moderate-to-severe plaque psoriasis.AI summary

Genmab announced updated follow-up analyses from a Phase 2 trial evaluating petosemtamab combined with FOLFOX or FOLFIRI in metastatic colorectal cancer. Treatment yielded confirmed and unconfirmed objective response rates of 75% in first-line patients and 67% in second-line patients, with an 81% response rate in first-line patients with left-sided tumors. The data support ongoing global Phase 3 trials actively enrolling patients.AI summary

GSK announced positive interim results from the phase II AZUR-1 trial evaluating Jemperli monotherapy in adults with MSI-H/dMMR locally advanced rectal cancer. In an exploratory analysis, 76% of evaluable patients achieved a complete response to dostarlimab alone. Ongoing regulatory reviews are proceeding in participating countries through Project Orbis.AI summary

Iovance Biotherapeutics presented final Phase 2 analysis data for lifileucel combined with pembrolizumab in frontline advanced melanoma at ESMO 2026. The combination demonstrated a 62.5% confirmed objective response rate and a 29.2% complete response rate, with median overall survival not reached at 50.9 months of follow-up. These data reinforce the company's ongoing TILVANCE-301 Phase 3 trial.AI summary

Kyverna Therapeutics presented full one-year data from the registrational Phase 2 KYSA-8 trial of miv-cel in stiff person syndrome. In 26 patients, miv-cel demonstrated sustained efficacy across primary and secondary endpoints, with 92% remaining free of chronic immunotherapies. The data strengthens Kyverna's BLA package as it seeks to bring the therapy to patients.AI summary

Immunic, Inc. presented new clinical, biomarker, and preclinical data for vidofludimus calcium in four poster presentations at MSToronto2026. Phase 2 CALLIPER open-label extension data demonstrated that favorable disability trends were maintained during continued treatment with a 6.5% discontinuation rate. Immunic plans to initiate a Phase 3 program in progressive multiple sclerosis later in 2026 and expects top-line results from its Phase 3 ENSURE trials by year-end 2026.AI summary

Neurocrine Biosciences has initiated a Phase 2 clinical study evaluating NBI-1117567 (NBI-'567) in adults with mild to moderate Alzheimer's disease. The randomized, placebo-controlled trial will enroll approximately 135 adults receiving stable acetylcholinesterase inhibitor treatment. Over a 12-week treatment period, the study will assess the primary efficacy endpoint of change from baseline in a Neuropsychological Test Battery composite score.AI summary

Odyssey Therapeutics presented completed Phase 2a induction results for OD-001 in moderate-to-severe ulcerative colitis, meeting the primary endpoint with a 2.4-point reduction in modified Mayo score. The oral selective RIPK2 scaffolding inhibitor was generally well tolerated, supporting 20 mg BID as the projected lowest maximally efficacious dose. Odyssey plans to advance OD-001 into Phase 2b monotherapy and Phase 2a combination trials, with topline results expected in the second half of 2027.AI summary

AbbVie presented Phase 2a results showing its dual-targeting therapy ABBV-466 achieved a 30.2% endoscopic remission rate at Week 12 in Crohn's disease patients, outperforming risankizumab and trosunilimab monotherapies. At Week 24, endoscopic remission with ABBV-466 increased to 40.5%. The findings are being presented as a late-breaking abstract at the UEGW Congress.AI summary

Taiho Oncology and Cullinan Therapeutics announced Phase 2 REZILIENT2 trial results for zipalertinib in NSCLC patients with active CNS metastases. Among 43 evaluable patients, zipalertinib achieved an intracranial objective response rate of 30.2% and a median intracranial duration of response of 9.7 months. The findings will be presented at the ESMO Congress 2026.AI summary

Iovance Biotherapeutics announced it will present data from its TIL cell therapy platform across solid tumors at the ESMO Congress 2026. Presentations include final Phase 2 results for lifileucel combined with pembrolizumab in ICI-naive advanced melanoma and data in soft tissue sarcomas. The efficacy in sarcomas supported Iovance moving toward its ongoing SARATOGA registrational trial of lifileucel in UPS and DDLPS.AI summary

Tango Therapeutics presented updated Phase 1/2 data for vopimetostat in combination with daraxonrasib, showing an 82% objective response rate and an 88% 9-month progression-free survival rate in second- and third-line MTAP-deleted/RAS-mutant pancreatic cancer patients. Following interactions with the U.S. FDA, Tango plans to initiate a global, randomized registrational Phase 3 trial evaluating the combination in front-line patients in the first half of 2027.AI summary

Celcuity presented updated Phase 1b/2 clinical data evaluating gedatolisib plus darolutamide in metastatic castration-resistant prostate cancer. Patients with prior abiraterone exposure achieved a median rPFS of 15.7 months and a six-month rPFS rate of 82.2%. Celcuity plans to initiate the Phase 2 portion of the study in the first half of 2027.AI summary

Eikon Therapeutics presented data at ESMO 2026 from Phase 1/2 trials evaluating its selective PARP1 inhibitors EIK1003 and EIK1004, alongside preliminary data for its WRN helicase inhibitor EIK1005. The studies demonstrated encouraging tolerability and antitumor activity across monotherapy and combination cohorts in solid tumors. Additional data across these programs are expected in 2027.AI summary

Zymeworks presented new Phase 1 trial data for its folate receptor alpha-targeting antibody-drug conjugate ZW191 at the ESMO Congress 2026. In patients with high-grade serous platinum-resistant ovarian cancer, ZW191 demonstrated confirmed objective response rates of 64.5% at the 6.4 mg/kg dose and 55.3% at 9.6 mg/kg. The favorable tolerability profile supports continued clinical development, which Zymeworks plans to pursue in partnership or through a strategic collaboration.AI summary

Eli Lilly presented Phase 1 data evaluating sofetabart mipitecan (Sofe-M) plus bevacizumab in platinum-sensitive ovarian cancer. The combination achieved a confirmed objective response rate of 79.3% and a 100% disease control rate, with consistent activity regardless of FRα expression levels or prior PARP inhibitor exposure. Lilly is advancing Sofe-M in its Phase 3 FRAmework-01 program across platinum-sensitive and platinum-resistant settings.AI summary

Bristol Myers Squibb presented interim safety and efficacy results from the Phase 1 Breakfree-2 study evaluating zolacabtagene autoleucel in patients with relapsing and progressive forms of multiple sclerosis. The therapy showed promising efficacy, with all 60 patients treated at dose level 2 remaining off disease-modifying therapies. Bristol Myers Squibb is continuing to advance the clinical development of zolacabtagene autoleucel.AI summary

GSK presented updated data from the global phase I BEHOLD-1 trial evaluating mocertatug rezetecan (Mo-Rez) in platinum-resistant ovarian cancer. Treatment at the selected phase III dose achieved a 62% confirmed objective response rate and an 11.1-month median progression-free survival. Five pivotal phase III trials are currently underway across gynaecological cancers.AI summary

Kyverna Therapeutics announced updated Phase 1 trial data for miv-cel in progressive multiple sclerosis. All five evaluable patients showed stable to improved disability scores, with four maintaining benefit through one year without chronic immunotherapies. Kyverna expects to provide an update on its development strategy by early 2027.AI summary

Maze Therapeutics and Duke University presented research on MZE829 at the American Society of Nephrology Kidney Week. The HORIZON study evaluated the safety, tolerability, and efficacy of MZE829 in adults with APOL1-mediated kidney disease. Opeyemi A. Olabisi et al. authored the presentation.AI summary

Vera Therapeutics announced positive final efficacy results from the ORIGIN 3 trial evaluating TRUTAKNA in adults with primary IgA nephropathy. The drug achieved statistical significance in all prespecified endpoints, including eGFR change, annualized slope, and composite kidney disease progression risk reduction, with a favorable safety profile comparable to placebo. Vera plans to submit a supplemental BLA in Q4 2026, seeking potential full FDA approval in 2027.AI summary

ImmunityBio has completed the database lock for Cohort A of its registrational QUILT-2.005 trial evaluating ANKTIVA plus BCG in 366 patients with BCG-naïve non-muscle invasive bladder cancer. Topline primary efficacy results from the final analysis are expected in November 2026. The company remains on track to submit an sBLA to the FDA in the fourth quarter of 2026.AI summary

Jade Biosciences announced it will present three posters on its investigational anti-APRIL monoclonal antibody JADE101 for IgA nephropathy at ASN Kidney Week 2026. The company accelerated the planned initiation of its EVERGREEN Phase 3 trial to the fourth quarter of 2026. Additionally, interim data from the ongoing JUNIPER Phase 2 trial is now expected in the second quarter of 2027.AI summary

PolyPid announced it will present an exploratory pooled microbiology analysis of D-PLEX₁₀₀ at IDWeek 2026. Data from 2,185 patients across three trials showed D-PLEX₁₀₀ plus standard of care resulted in less frequent heavy bacterial growth (16% vs 27%, p=0.034) and later breakthrough surgical-site infections compared to standard of care alone. Multidrug-resistant organism proportions were similar between groups.AI summary

Achieve Life Sciences presented 52-week results from the open-label ORCA-OL trial of cytisinicline for cigarette smoking and e-cigarette cessation at CHEST 2026. Four-week sustained abstinence rose to 31.2% in the total study population during Weeks 49–52, and 39.4% of participants who had received placebo in a prior trial and were still smoking or vaping had quit at that point. The most common treatment-related adverse events were abnormal dreams (7.8%), insomnia (6.5%), and headache (3.8%), and the DSMC identified no new safety signals.AI summary

AstraZeneca will present overall survival data from four pivotal Phase III trials in Presidential Symposia at the European Society for Medical Oncology (ESMO) Congress, 23-27 October 2026. The trials are CLARITY-Gastric01 (Sone-Ve), SAFFRON (Tagrisso plus Orpathys), and VOLGA and DeLLphi-305 (Imfinzi). More than 100 abstracts will be presented at the congress.AI summary

Bristol Myers Squibb will present new data across its oncology portfolio at the ESMO 2026 Congress. Presentations include late-breaking Phase 3 results for izalontamab brengitecan, late-breaking Phase 2 data for pumitamig, and long-term Phase 3 survival results for Opdivo in combination with Yervoy. The disclosures cover multiple solid tumor types including non-small cell lung cancer and breast cancer.AI summary

BioNTech will present 16 abstracts at the ESMO 2026 Congress in Madrid, October 23–27, 2026, including first data from the global ROSETTA Lung-107 Phase 2 trial of pumitamig plus docetaxel in metastatic non-small cell lung cancer after prior immunotherapy plus chemotherapy. Global Phase 2 data for pumitamig plus elfetabart drozuntecan in advanced solid tumors show encouraging preliminary antitumor activity and a manageable safety profile, with minimal overlapping toxicities observed. The lung cancer data will be presented in a late-breaking oral presentation on October 25, 2026.AI summary

Milestone Pharmaceuticals announced that data and program updates for CARDAMYST (etripamil) nasal spray will be presented at three upcoming cardiology conferences in October and November 2026. The presentations will cover minimal blood pressure effects, combined efficacy and safety across trials, and study designs including the Phase 3 ReVeRA-301 trial. Presentations will take place at CAPP, TCT, and AHA meetings.AI summary

United Therapeutics Corporation announced that its Board of Directors authorized a new share repurchase program for up to $2 billion of its common stock. The authorization is available through October 21, 2027. Repurchases may occur via accelerated share repurchase programs, open market transactions, or privately negotiated transactions at the company's discretion.AI summary

Zymeworks has entered into an exclusive global license and collaboration agreement with Roche to develop and commercialize ZW209, a trispecific T cell engager targeting DLL3. Zymeworks will receive a $55 million upfront payment, $40 million upon Phase 1b trial initiation, and up to $718 million in potential milestones, plus tiered royalties. Zymeworks will conduct the Phase 1a monotherapy trial in collaboration with Roche.AI summary

Pathos AI announced multi-year strategic collaborations with Bristol Myers Squibb (BMS) and Tempus AI to advance AI-driven drug development for neurological conditions like Alzheimer's disease. Pathos will license a de-identified neurological dataset from Tempus under a five-year, $55 million agreement. Additionally, BMS led Pathos's Series E financing, gaining non-exclusive strategic access to Pathos Foundry and three-year exclusive rights to support its neuroscience development programs.AI summary

Biotechnology company. Total offering $12M; first sale 2026-10-02. Form D is filed up to 15 days after the first sale.

Epicrispr Biotechnologies has been awarded an $8 million grant from the California Institute for Regenerative Medicine. The funding will support the company's ongoing first-in-human Phase 1/2 clinical trial of EPI-321 for facioscapulohumeral muscular dystrophy. Epicrispr will use the grant to continue advancing the clinical development of the epigenetic therapy.AI summary

Incyte and Genmab have entered a clinical trial collaboration to evaluate INCB161734 and petosemtamab in combination with chemotherapy for first-line KRAS G12D-mutated metastatic colorectal cancer. Under the agreement, Genmab will conduct the planned Phase 1/2 study. Incyte will co-fund the trial and supply INCB161734.AI summary

Respighi BidCo S.p.A. announced the end of its acceptance period. Provisional results show that its aggregate shareholding, together with CVC and GBL, represents 74.58%, which fulfils the 66.67% threshold condition. The release also refers to terms reopening.AI summary

AstraZeneca and Oracle Health and Life Sciences announced a collaboration that combines AstraZeneca's scientific, clinical development and regulatory expertise with Oracle's real-world data, cloud infrastructure and AI-enabled clinical capabilities. Initial areas include clinical trial recruitment, earlier diagnosis, drug-safety monitoring and real-world evidence, and the first programme supports hypertension care and clinical research in Abu Dhabi with M42. The companies have signed a non-binding term-sheet agreement, no financials are disclosed, and each proposed project will proceed only once appropriate safeguards are in place.AI summary

Telix Pharmaceuticals and Ekalia announced a collaboration to advance scalable U.S. production of astatine-211 for targeted alpha therapy. The agreement provides Telix with priority isotope access to support early-stage candidates like TLX102-Tx for glioblastoma and leptomeningeal disease. The first alpha-beam cyclotron will be installed at an RLS Radiopharmacies site near Philadelphia.AI summary

aTyr Pharma has announced a research collaboration with Albert Einstein College of Medicine to develop and test ATYR2810 in preclinical studies for pediatric osteosarcoma. ATYR2810 is a monoclonal antibody targeting the neuropilin-2 receptor. The research aims to investigate the role of NRP2 and explore its potential to mitigate primary tumor progression and metastasis in pediatric bone cancer.AI summary

Roche reported third-quarter 2026 sales growth of 7% at constant exchange rates, driven by demand for its innovative medicines and diagnostics. Nine-month Group sales rose 6% at CER to CHF 46.5 billion. The company confirmed its full-year 2026 outlook, expecting mid-single-digit Group sales growth at CER.AI summary

Korro Bio announced preclinical results for KRRO-111, its subcutaneously delivered oligonucleotide program for alpha-1 antitrypsin deficiency. In mouse models, repeat dosing achieved up to 96% SERPINA1 mRNA editing, restored circulating M-AAT, and reduced pathogenic liver Z-AAT by 95%. Korro expects to make a regulatory submission for KRRO-111 in the first half of 2027.AI summary

argenx reported third quarter 2026 financial results, generating $1.7 billion in global product net sales for VYVGART, representing 54% year-over-year growth. The company reported a profit of $506 million for the quarter. Moving forward, argenx expects Phase 3 EMPASSION trial results for empasiprubart in December 2026 and plans an sBLA submission for VYVGART Hytrulo in IMNM by year-end.AI summary

Pharming Group reported preliminary third quarter 2026 total revenues of approximately US$117.6 million, a 21% increase year-on-year. Driven by sales of RUCONEST and Joenja, performance exceeded market expectations. Consequently, Pharming tightened its full-year 2026 total revenue guidance to between US$380 million and US$390 million and will release its full third quarter financial results on October 27, 2026.AI summary

Eli Lilly and Company broke ground on a new $5 billion manufacturing facility in Goochland County, near Richmond, Virginia. The site is Lilly's first fully integrated facility to produce both active pharmaceutical ingredients and finished medicines, specifically focused on antibody-drug conjugates. The investment will create 650 high-wage jobs alongside 1,800 construction jobs.AI summary

Ipsen reported its financial results for the first nine months of 2026, delivering total sales growth of 24.6% at constant exchange rates in the third quarter. The performance was driven by momentum across Oncology, Rare Disease, and Neuroscience. Following these results, the company upgraded its full-year outlook.AI summary

Recordati issued a release titled "Recordati provides update on Isturisa U.S." The text provided contains only website navigation and personal data protection notices. It gives no details of the update, results, or next steps.AI summary

The ADA and EASD published their 2026 consensus report recommending that clinicians screen adults for hypercortisolism if their type 2 diabetes remains difficult to control despite multiple glucose-lowering medications. The report cites findings from Corcept's CATALYST study, which demonstrated that cortisol-directed medical therapy with mifepristone substantially reduced HbA1c in these patients. Moving forward, the report notes that developing a better understanding of the role of cortisol-directed therapy in type 2 diabetes is needed.AI summary

Telix reported Q3 2026 group revenue of US$245 million, up 19% over Q3 2025, with Precision Medicine revenue of US$201 million, up 30%, driven by Gozellix and Illuccix. The company reaffirmed that FY 2026 revenue and other income is expected to exceed US$1 billion and revised its FY 2026 R&D expenditure guidance to US$240 million to US$260 million. The financial information for the quarter is unaudited.AI summary

Truveta has progressed from planning to enrolling participants and collecting samples for the Truveta Genome Project. The initiative collaborates with participating health systems to link genomic and longitudinal clinical data. Truveta aims to enroll tens of millions of consenting participants to build a large genotypic and phenotypic dataset.AI summary