The front page of AI-driven biology
Friday, October 16, 2026Fri, Oct 16
Updated 12:01 AM PT
Clinical readouts, approvals, and setbacks, financing, dealmaking, platform progress, and reported research across biotech and biopharma, including the companies building AI into biology.
Johnson & Johnson's oral M1 muscarinic receptor antagonist, JNJ-5120, failed its primary efficacy endpoint in a Phase 2 trial of 107 patients with major depressive disorder, showing no improvement over placebo on a standard depression rating scale at day five.
Novo has ended its metabolic disease collaboration with Ascendis Pharma less than two years after committing up to $285 million in milestones to develop a once-monthly weight-loss therapy.
GSK has agreed to pay up to $750 million in a licensing deal for Chimagen Biosciences' preclinical trispecific T-cell engager, with plans to begin Phase 1 trials in multiple myeloma next year.
Sionna Therapeutics will cut roughly 46% of its workforce to preserve capital after its add-on NBD1 stabilizer SION-719 failed to lower sweat chloride in cystic fibrosis patients already taking Vertex Pharmaceuticals' Trikafta.
The FDA approved Telix Precision Medicine's Pixclara (floretyrosine F-18) for positron emission tomography imaging of gliomas in patients aged one month and older.
Eli Lilly entered a multi-program research partnership with Toronto-based QurCan Therapeutics, offering an upfront payment, equity investment, and up to $237 million in milestones per program to deliver genetic medicines across the blood-brain barrier.
Connect Biopharma reported that its IL-4R alpha antibody rademikibart missed the primary endpoint in a 160-patient Phase 2 trial in individuals with asthma and type 2 inflammation.
The FDA unveiled an expedited investigational new drug pilot under its Operation Trialblazer initiative to speed the transition of drug candidates into early clinical testing.
Vera Therapeutics reported that its dual BAFF and APRIL inhibitor Trutakna met all prespecified endpoints in the pivotal Phase 3 ORIGIN 3 trial for IgA nephropathy, an autoimmune kidney disorder.
RegCell closed a $44 million Series A round led by Playground Global alongside non-dilutive grants from Japan's Agency for Medical Research and Development, bringing total financing to $66 million.
In a Phase 3 trial in China, MediLink and Roche's antibody-drug conjugate tambotatug pelitecan extended median overall survival in relapsed small cell lung cancer to 13.3 months compared with 9.4 months on topotecan chemotherapy.
Electra Therapeutics aims to raise net proceeds of $296.6 million, rising up to $341.9 million if underwriters exercise their option, by offering 21.7 million shares priced between $14 and $16 each, matching the reported $342 million goal.
In an early-stage clinical trial, Corbus Pharmaceuticals' experimental pill CRB-913 achieved up to 5% placebo-adjusted weight loss after 12 weeks without the prominent neuropsychiatric safety issues that derailed earlier drugs in its class.
The Food and Drug Administration has approved Curium's Bexlutry, clearing the first generic radioligand therapy equivalent to Novartis' Lutathera.
Camizestrant, an oral selective estrogen receptor degrader, failed to outperform standard care at delaying disease progression when paired with another therapy in a pivotal Phase 3 trial for advanced breast cancer.
Cellectis is seeking partners to offload its clinical-stage donor-derived cell therapies for leukemia and lymphoma, lasme-cel and eti-cel, effectively ending its pioneering work in allogeneic CAR-T treatments.
Akeso and Summit Therapeutics reported that their bispecific antibody targeting PD-1 and VEGF extended median overall survival to 30.8 months compared with 22.6 months for pembrolizumab in the Phase 3 HARMONi-2 trial in non-small cell lung cancer.
Scholar Rock has secured FDA approval for apitegromab, an injectable monoclonal antibody targeting muscle loss in spinal muscular atrophy.
GE HealthCare is considering a buyout of cancer-imaging chemical developer Sofie Biosciences for up to $1 billion, according to a report by the Financial Times.
Novartis lost roughly $30 billion in market value after delpacibart etedesiran failed to beat placebo on hand opening time at 54 weeks in the Phase 3 HARBOR trial for myotonic dystrophy type 1. The drug is an antibody-oligonucleotide conjugate, designed to deliver siRNA to muscle cells via the transferrin receptor 1, which Novartis acquired in its $12 billion buyout of Avidity Partners.
The B7-H3-directed antibody-drug conjugate risvutatug rezetecan reached a median overall survival of 18.5 months versus 10.3 months for topotecan chemotherapy in a Phase 3 study of relapsed small-cell lung cancer.
Adding the kinase inhibitor zipalertinib to platinum-based chemotherapy extended median progression-free survival to 14.5 months compared to 8.5 months for chemotherapy alone in previously untreated non-small cell lung cancer with EGFR exon 20 insertion mutations.
BioNTech's gotistobart, an antibody targeting the immune checkpoint CTLA-4, reached a median overall survival of 18.5 months versus 10 months for docetaxel chemotherapy in patients with relapsed squamous non-small cell lung cancer.
Definium Therapeutics reported that its single-dose oral LSD formulation, DT120 ODT, met the primary endpoint of the 245-patient Phase 3 Panorama trial in generalized anxiety disorder.
The FDA cleared Scholar Rock's myostatin-inhibiting monoclonal antibody Isembyld, also known as apitegromab, for spinal muscular atrophy in patients aged two and older who take SMN2-targeting therapies.
A combination of Amgen's T-cell engager Imdelltra (tarlatamab) and AstraZeneca's checkpoint inhibitor Imfinzi prolonged overall survival compared to Imfinzi alone in untreated, extensive-stage small-cell lung cancer.
The FDA has placed a partial clinical hold pausing enrollment in the RISE-2 trial of opakalim (BHV-7000), an investigational potassium-channel activator for focal epilepsy.
The FDA has granted first-line approval to Bayer's tyrosine kinase inhibitor Hyrnuo for patients with HER2-mutant non-small cell lung cancer.
Novo Nordisk reported that 40% of pediatric participants receiving the GLP-1 receptor agonist Wegovy (semaglutide) were no longer classified as having obesity in a Phase 3 pediatric trial.