Pharma and biotech news, week of Oct 5 – Oct 11, 2026

The FDA has approved Roche's Tecentriq and Tecentriq Hybreza in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III dMMR colon cancer. The approval was based on Phase 3 ATOMIC trial data showing the combination reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. Roche is pursuing further global regulatory filings, including with the European Medicines Agency.AI summary

The FDA has approved a new drug application from AiCuris Anti-infective Cures AG for Hovilpri (pritelivir) tablets. The approval provides for the treatment of refractory mucocutaneous herpes simplex virus lesions in immunocompromised adults.AI summary

AbbVie and Genmab announced positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating epcoritamab in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma. The combination demonstrated a statistically significant improvement in progression-free survival, reducing the risk of disease progression or death by 51%. Genmab and AbbVie will engage global regulatory authorities to determine next steps.AI summary

In the HICKORY Phase III trial, efzimfotase alfa did not achieve statistical significance on the primary endpoint, the Six-Minute Walk Test, but showed a numerical improvement versus placebo, with a least squares mean difference of 17.05 metres at week 25 (p=0.1675). Nominally significant improvement was seen in FACIT-Fatigue (LS mean difference 5.74, p=0.0016). Efzimfotase alfa was recently granted Priority Review in the US, and the results were presented at the 2026 ASBMR Annual Meeting.AI summary

AbbVie presented data from 22 scientific abstracts evaluating SKYRIZI and RINVOQ in inflammatory bowel disease at ACG 2026. Results from the Phase 3 AFFIRM study demonstrated that subcutaneous risankizumab achieved significantly higher rates of clinical remission and endoscopic response versus placebo at Week 12 in Crohn's disease patients. Open-label extension studies and real-world data further demonstrated sustained long-term outcomes for both therapies.AI summary

The FDA has cleared Crescent Biopharma's IND application for CR-002, a PD-L1-targeted topoisomerase inhibitor ADC for advanced solid tumors. Crescent plans to initiate the Phase 1/2 APOLLO global clinical trial in the fourth quarter of 2026. Initial clinical data from the trial are expected in the second half of 2027.AI summary

Scholar Rock has resubmitted its Marketing Authorisation Application to the European Medicines Agency for apitegromab to treat spinal muscular atrophy. The resubmission includes an alternate fill-finish facility replacing the Catalent Indiana site. The company anticipates a Committee for Medicinal Products for Human Use opinion in the first half of 2027.AI summary

Arrowhead Pharmaceuticals announced that the U.S. FDA granted plozasiran entry into the Split Real Time Application Review (STAR) pilot program for an upcoming supplemental new drug application in severe hypertriglyceridemia. Entry into the program qualifies the application for a 6-month Priority Review without needing a Priority Review Voucher. Arrowhead remains on schedule to submit the sNDA to the FDA by year-end 2026.AI summary

AbbVie announced that the U.S. FDA has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan (Temab-A; ABBV-400). The designations cover Temab-A in combination with bevacizumab for refractory, metastatic colorectal cancer and as a monotherapy for locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer.AI summary

Telix Pharmaceuticals announced that the first U.S. patients have been dosed with Pixclara (floretyrosine F 18), its FDA-approved brain cancer imaging drug. The doses were administered in Indianapolis and Cleveland, marking the start of commercial availability in the U.S. Manufacturing and pharmacy distribution partner PharmaLogic Holdings Corp. is supplying finished unit doses to the U.S. market.AI summary

The US FDA has extended its BLA review for Novo's denecimig for haemophilia A due to ongoing manufacturing facility remediation activities. The FDA has not communicated a new action timeline and identified no deficiencies in clinical efficacy or safety data. Pending regulatory approval, Novo aims to launch denecimig in the US in the first half of 2027.AI summary

Roche presented new 52-week Phase III data from the MEERKAT and SANDCAT studies evaluating vamikibart in patients with uveitic macular edema (UME). Results showed sustained improvements in vision and central subfield thickness reduction. The U.S. FDA has accepted Roche's Biologics License Application for vamikibart, with an approval decision expected by July 2027.AI summary

Mineralys Therapeutics presented new analyses from its pivotal Phase 3 Launch-HTN trial and Phase 2 Explore-OSA trial for lorundrostat. In Launch-HTN, 46% of participants with difficult-to-treat hypertension receiving 50 mg lorundrostat achieved a systolic blood pressure target of <130 mmHg at 12 weeks. Additionally, Explore-OSA Phase 2 final results showed a 11.1 mmHg morning systolic blood pressure reduction at Week 4.AI summary

Vertex Pharmaceuticals presented interim Phase 3 data for ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) in children ages 2 to 5 with cystic fibrosis. In an open-label study, treatment restored exocrine pancreatic function in some participants, allowing nearly half to reach pancreatic sufficiency and 37.5% of eligible children to discontinue pancreatic enzyme replacement therapy. ALYFTREK remains investigational in this age group.AI summary

Eli Lilly presented new exploratory data from the TOGETHER-PsO Phase 3b trial at Fall Clinical 2026. Results showed that concomitant use of Taltz and Zepbound yielded broader biomarker changes compared to Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity. The findings provide new insights into the immunometabolic relationship between psoriasis and obesity to inform continued research.AI summary

Alumis announced new Phase 3 data for envudeucitinib showing early and durable improvements in scalp disease, itch relief, and quality of life in moderate-to-severe plaque psoriasis patients. Over 80% of patients in the ONWARD3 extension study maintained clear or almost clear scalp skin at 48 weeks. The company remains on track to submit a New Drug Application in the fourth quarter of 2026.AI summary

Milestone Pharmaceuticals has enrolled the first European patient in its ReVeRA-301 Phase 3 pivotal trial. The study evaluates etripamil nasal spray for treating atrial fibrillation with rapid ventricular rate (AFib-RVR) in approximately 150 patients. Milestone is pursuing a single-study sNDA registration pathway based on safety data demonstrated to date.AI summary

Bristol Myers Squibb announced positive topline results from the Phase 3 EXCALIBER-RRMM study evaluating ZENBEXUS (iberdomide) with daratumumab and dexamethasone in relapsed or refractory multiple myeloma. The combination demonstrated a statistically significant median progression-free survival of 42 months compared to 20 months for standard of care. BMS plans to share full trial results at an upcoming medical meeting.AI summary

Kodiak Sciences announced it will present clinical data for Zenkuda, tabirafusp-ted, and KSI-101 at AAO 2026. The presentations will feature the first scientific presentation of the Phase 3 DAYBREAK study results in wet AMD, Phase 3 GLOW2 data in diabetic retinopathy, and Phase 1b APEX data in MESI. Topline results for DAYBREAK previously met the primary endpoint of non-inferior vision gains compared to aflibercept.AI summary

ViiV Healthcare announced that the phase IIIb CROWN study evaluating long-acting Cabenuva (cabotegravir + rilpivirine) met its primary endpoint. At six months, Cabenuva demonstrated superior viral suppression rates compared to standard-of-care daily oral antiretroviral therapy in people living with HIV-1 who had viremia at study entry. Data will be shared with health authorities for regulatory review.AI summary

Alexion announced it will deliver 16 presentations at the ASBMR 2026 Annual Meeting. Highlights include Phase III HICKORY trial data for efzimfotase alfa in adolescents and adults with hypophosphatasia. The company will also showcase skeletal parameter data from the Phase III CALYPSO trial evaluating eneboparatide in adults with chronic hypoparathyroidism.AI summary

Madrigal Pharmaceuticals announced the publication of a Phase 3 MAESTRO-NASH secondary analysis in the Journal of Hepatology. The analysis of 738 patients demonstrated that Rezdiffra improved histology and biomarkers across common genetic variants associated with MASH progression. Next, Madrigal plans to consult with the FDA on designing a Phase 2 combination trial of Rezdiffra with MGL-0795.AI summary

Capricor Therapeutics presented positive Phase 3 HOPE-3 open-label extension data for Deramiocel in Duchenne muscular dystrophy. DMD patients starting Deramiocel after a year on placebo slowed upper limb function decline by 76% compared to their prior year. The FDA received these data as part of a BLA major amendment, with a PDUFA target action date of November 22, 2026.AI summary

Vaxcyte announced positive topline data from the pivotal OPUS-1 Phase 3 trial evaluating its 31-valent pneumococcal conjugate vaccine candidate, VAX-31, in adults. VAX-31 met all prespecified primary immunogenicity and safety endpoints across the studied age groups. The company expects to report results from its OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027 to support a planned BLA submission in the first half of 2028.AI summary

Revolution Medicines has begun treating patients in the global Phase 3 RASolute 309 clinical trial. The study evaluates the combination of RASONQUE (daraxonrasib) and zoldonrasib compared to gemcitabine and nab-paclitaxel as a first-line treatment for adult patients with metastatic RAS G12D pancreatic adenocarcinoma. The trial's dual primary endpoints are progression-free survival and overall survival.AI summary

Arcutis Biotherapeutics presented data from across its ZORYVE (roflumilast) portfolio at recent medical congresses. Highlights include Phase 2 study results for investigational once-daily ZORYVE cream 0.05% in infants with atopic dermatitis, where 34.4% achieved vIGA-AD success at 4 weeks. ZORYVE cream 0.05% is currently under FDA review for infants 3 to under 24 months, with a PDUFA target action date of February 23, 2027.AI summary

Cullinan Therapeutics has dosed the first patient in its pivotal Phase 2 study of CLN-049 in patients with relapsed/refractory acute myeloid leukemia. The study incorporates a dose-optimization phase followed by an expansion cohort at the recommended Phase 2 dose. Cullinan expects to provide an update from its Phase 1 dose escalation study in December.AI summary

argenx announced positive topline results from its Phase 2 study of FB102 in adults with celiac disease. The trial met its primary endpoint of change from baseline in the ratio of villus height-to-crypt depth at day 78 compared to placebo (p=0.0176). Based on these findings, argenx plans to advance FB102 into Phase 3 development.AI summary

Kyverna Therapeutics announced it will present one-year results from the KYSA-8 registrational trial of miv-cel in stiff person syndrome and updated Phase 1 data in progressive multiple sclerosis at MSToronto2026. The therapy demonstrated sustained clinical benefit and a well-tolerated safety profile in stiff person syndrome. Kyverna expects to complete its BLA submission for miv-cel in stiff person syndrome this quarter.AI summary

Rocket Pharmaceuticals highlighted updates on its FDA-aligned pivotal Phase 2 trial and Phase 1 follow-up for RP-A501 in Danon disease. The first three patients treated under a modified protocol showed initial encouraging safety with no evidence of thrombotic microangiopathy or capillary leak syndrome. Rocket expects to complete pivotal trial dosing by mid-2027 and anticipates topline results in mid-2028.AI summary

Odyssey Therapeutics announced that additional Phase 2a induction data for OD-001 in moderate to severe ulcerative colitis will be presented in an oral session at UEG Week 2026. The company will also host a conference call and webcast on October 20, 2026, to review data beyond those presented at the conference.AI summary

Korro Bio has dosed the first cohort of healthy volunteers in its Phase 1/2 ANCHOR clinical trial evaluating KRRO-121. The first cohort received a single dose of 2mg/kg. Dosing in patients with urea cycle disorders is expected to begin in the first half of 2027, followed by an interim clinical readout in the second half of 2027.AI summary

Epicrispr Biotechnologies announced updated six-month Phase 1/2 data for EPI-321 in patients with facioscapulohumeral muscular dystrophy (FSHD). At six months, treated patients demonstrated increases in whole-body lean muscle volume and improvements in muscle strength with a manageable safety profile. The company plans to present twelve-month data from all patients in the second half of 2027.AI summary

Prime Medicine has dosed the first patient in a global Phase 1/2 clinical trial of PM577a for H1069Q-mutated Wilson disease. Additionally, the U.S. FDA granted Rare Pediatric Disease designation to PM577 for Wilson disease. Prime Medicine expects to report initial clinical data from the trial in 2027.AI summary

Precision BioSciences announced it will deliver a late-breaking oral presentation on PBGENE-HBV at AASLD The Liver Meeting 2026. The presentation will feature data showing durable pgRNA loss in HBeAg positive and negative chronic hepatitis B patients. PBGENE-HBV is currently being evaluated in the Phase 1 ELIMINATE-B study.AI summary

Life Biosciences announced interim Phase 1 clinical trial data evaluating ER-100 in three participants with open angle glaucoma. Single intravitreal administration was well-tolerated through Day 56 with no dose-limiting toxicities, and two participants showed visual field improvements. Based on these results, the Data Safety Monitoring Board recommended escalating to Dose Level 2.AI summary

Arvinas presented final Phase 1 clinical trial data for ARV-102 in 24 patients with Parkinson’s disease. Oral doses ranging from 20 mg to 80 mg demonstrated dose-dependent improvements in saccadic hypometria after 28 days compared to placebo. The findings and associated reductions in CSF LRRK2 protein levels support further clinical evaluation of ARV-102.AI summary

Merck presented one-year results from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig in adults with diabetic macular edema. Both remigromig dose arms met the primary endpoint, demonstrating non-inferiority in best corrected visual acuity compared to ranibizumab. Results will be discussed with regulatory authorities, while evaluation continues in the Phase 2b/3 BAROLO study.AI summary

MannKind Corporation presented new clinical data for Furoscix ReadyFlow at the HFSA Annual Scientific Meeting 2026. Findings demonstrated that the autoinjector delivers IV-equivalent bioavailability, diuresis, and natriuresis across thigh and upper arm injection sites. These presentations build on the therapy's July 2026 FDA approval and U.S. launch.AI summary

Viking Therapeutics has initiated Part 2 of an exploratory maintenance dosing study evaluating oral and subcutaneous regimens of VK2735 in approximately 195 adults with obesity. The trial will assess the safety, tolerability, pharmacokinetic profile, and weight loss maintenance of VK2735 over 33 weeks. Results from Part 2 are expected in 2027.AI summary

Regeneron announced it will present data across 10 abstracts at the European Society for Medical Oncology Congress 2026. Presentations will feature updated overall survival data from the Phase 3 C-POST trial of adjuvant Libtayo in cutaneous squamous cell carcinoma. Additional presentations cover Phase 2 results for Libtayo, as well as data on novel candidates including fianlimab, ubamatamab, cenvacibart, and amrecibart.AI summary

Ascendis Pharma announced it will present clinical data from its hypoparathyroidism and achondroplasia programs at ASBMR 2026. Data includes 5-year results showing normalization of bone mass and microarchitecture in patients treated with TransCon PTH. Additionally, the company will present week 104 results for navepegritide and 78-week Phase 2 results for navepegritide combined with lonapegsomatropin.AI summary

Celcuity announced multiple presentations scheduled for the European Society for Medical Oncology Congress 2026. The presentations feature clinical data for gedatolisib in HR+/HER2- advanced breast cancer and metastatic castration-resistant prostate cancer. Featured data include updated Phase 3 results from the VIKTORIA-1 trial, Phase 1/2 results, a network meta-analysis, and trial details for VIKTORIA-2.AI summary

Eli Lilly announced it will present 21 poster presentations across its dermatology portfolio at the 2026 Fall Clinical Dermatology Conference. The data span key treatments including EBGLYSS, Taltz, Zepbound, and Olumiant across chronic conditions like atopic dermatitis, psoriasis, and alopecia areata. Presentations include Phase 3 findings for EBGLYSS in pediatric patients and long-term BRAVE-AA-PEDS study results for Olumiant.AI summary

AstraZeneca has completed a $2 billion equity investment in Summit Therapeutics. The funding will accelerate the development of ivonescimab in combination with antibody drug conjugates across tumour types. The companies have also entered into a clinical collaboration to evaluate sonesitatug vedotin alongside ivonescimab.AI summary

Viatris agreed to acquire all outstanding Pacira shares for $36.50 per share in cash, an aggregate equity value of $1.65 billion. The deal adds marketed U.S. products EXPAREL and ZILRETTA; Pacira generated approximately $746 million in total revenue over the last twelve months. Viatris will commence a tender offer followed by a second-step merger, with closing expected by the end of 2026.AI summary

Vaxcyte announced the closing of its concurrent public offerings of common stock, pre-funded warrants, and convertible senior notes, yielding aggregate gross proceeds of approximately $1.15 billion. The total includes the full exercise of the underwriters' options to purchase additional shares and notes. Vaxcyte intends to use the net proceeds to fund clinical development of its VAX-31 programs, manufacturing scale-up, commercial launch preparations, and general corporate activities.AI summary

Vaxcyte announced the pricing of public offerings comprising 7,412,500 common stock shares, 400,000 pre-funded warrants, and $500 million of 1.50% convertible senior notes. The aggregate gross proceeds are expected to be approximately $1 billion. Vaxcyte plans to use the net proceeds to fund clinical development, manufacturing scale-up, and commercial launch preparations for its VAX-31 vaccine candidate.AI summary

Vaxcyte announced the commencement of underwritten public offerings of $500 million of its common stock and pre-funded warrants, plus $500 million of convertible senior notes due 2032. The company also intends to grant underwriters options to purchase up to an additional $75 million in common stock and $75 million in notes. Proceeds will fund clinical development of the VAX-31 adult and pediatric programs, manufacturing scale-up, commercial preparation, and general corporate purposes.AI summary

Spyre Therapeutics announced the pricing of an underwritten public offering of 4,117,648 shares of common stock at $85.00 per share, expecting gross proceeds of approximately $350.0 million. The underwriters have a 30-day option to buy up to an additional $52.5 million of shares. Net proceeds will fund pipeline advancement across various indications, including moving SPY072 into late-stage development.AI summary

Rocket Pharmaceuticals has entered into a credit facility agreement with Hercules Capital for up to $150 million, receiving $35 million at closing. The financing provides capital to support execution of its pivotal Phase 2 study of RP-A501 for Danon disease and advance its cardiovascular pipeline. Rocket expects its cash resources and initial draw to fund operations into the third quarter of 2028.AI summary

Atrium Therapeutics announced a private placement financing expected to result in aggregate gross proceeds of approximately $50 million. The company agreed to sell common stock and pre-funded warrants to institutional investors in a transaction priced at-the-market. Proceeds will fund development of Atrium's lead product candidates and fund operations through 2028.AI summary

Biotechnology company. Total offering $80M; first sale 2026-09-18. Form D is filed up to 15 days after the first sale.

Biotechnology company. Total offering $15M; first sale 2026-09-23. Form D is filed up to 15 days after the first sale.

Respighi BidCo SpA has issued a press release regarding an increase in its offer consideration to €53.00 per share. Additionally, the acceptance period for the offer has been extended until October 23, 2026.AI summary

insitro announced that advanced machine learning models developed with Eli Lilly and Company are now available to certain biotech companies in Lilly TuneLab. Built using Lilly's multi-species preclinical data, the models predict in vitro and in vivo pharmacokinetic properties of small molecules. The models will be updated as datasets expand and will also be used by insitro and its partners to advance small molecule drug discovery.AI summary

Spyre Therapeutics has commenced an underwritten public offering of its common stock and expects to grant underwriters a 30-day option to purchase up to an additional 15% of shares. The company intends to use the net proceeds to advance its programs in Gastroenterology, Rheumatology, and Dermatology, including advancing SPY072 into late-stage development for hidradenitis suppurativa.AI summary

Governor Josh Shapiro announced an over $800 million investment from GSK to expand its operations in Montgomery County, Pennsylvania. The project will create more than 300 new jobs over the next five years and retain approximately 4,500 existing full-time jobs. Construction is planned to begin in 2027 to establish a biopharmaceutical innovation and manufacturing hub.AI summary

Quimatryx presented preclinical results showing its oral candidate QTX153 reduced body weight in mice by 19.2% without muscle loss, while preserving skeletal muscle weight. The HDAC6 inhibitor also improved glucose tolerance and reduced liver fat. The company is completing regulatory preclinical studies and plans to start a Phase I trial in 2027.AI summary

Caspian Therapeutics and Kura Oncology announced an upcoming investor webcast to share details on the launch of Caspian and review preclinical data for KO-7246. KO-7246 is a menin inhibitor in IND-enabling development for diabetes and other cardiometabolic diseases. Caspian plans to evaluate KO-7246 in a Phase 1 program and advance a second candidate.AI summary

Caribou Biosciences announced it is exploring strategic alternatives, including a potential merger, acquisition, or business combination. The company plans to discontinue its vispa-cel and CB-011 allogeneic CAR-T cell therapy programs and implement a substantial workforce reduction. Wedbush Securities has been engaged as exclusive financial advisor to assist in the evaluation process.AI summary

insitro and Eli Lilly introduced a new machine learning model for in vivo pharmacokinetic prediction, available in Lilly TuneLab as of October 6. Trained on Lilly's proprietary historical data, the multitask graph-based model predicts pharmacokinetic profiles across mouse, rat, dog, and monkey species. The platform aims to allow drug discovery programs to synthesize fewer compounds and reduce animal testing.AI summary