Phase 2/3 trial (OptimUM-02) of the darovasertib/crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM) to report median PFS data by year-end 2025 to 1Q 2026; on track to complete enrollment by year-end 21.1 month median OS and 7.0 month median PFS reported from single-arm Phase 2 trial (OptimUM-01) evaluating the darovasertib/crizotinib combination in 1L mUM Phase 1 data reported in SCLC for IDE849 (DLL3 TOP1i ADC) at the World Conference on Lung Cancer. Preliminary evi

Even as Pfizer is embroiled in what has become pharma’s most dramatic M&A battle in years, it still has a business to run that has nothing to do with Metsera. The New York drugmaker reported its third-quarter results Tuesday morning, bumping its full-year expectations for adjusted, diluted earnings per share from a range of $2.90 to $3.15 to between $3.00 and $3.15. Pfizer also shrank its pipeline in Q3, going from 108 candidates in development to 101 . That includes axing a Phase 3 sickle cell

ABL Bio, a multi-partnered South Korean biotech, is backing a new Palo Alto, CA-based startup to carry forward two antibody-drug conjugates. NEOK Bio emerged on Tuesday with a $75 million Series A, with ABL Bio as its “principal investor.” It plans to advance two ADCs into the clinic in the US around the middle of 2026 and gather initial clinical data in 2027. The experimental bispecific ADCs are NEOK001 (ABL206) and NEOK002 (ABL209). The first goes after ROR1 and B7-H3, and the second targets E

Nuvation Bio has opted not to test its experimental brain cancer drug safusidenib head-to-head with an approved medicine following talks with the FDA. Its drug could have been tested against Servier’s Voranigo. The New York biotech’s stock $NUVB was down by as much as 8% premarket Tuesday. The study was intended to evaluate safusidenib, an inhibitor of mutant IDH1, in the hope of securing its approval in certain grade 2 IDH1-mutant gliomas. Instead, Nuvation will test the pill in settings where

Backed by Korean biotech ABL Bio, NEOK Bio emerged from stealth on Tuesday with a $75-million series A to advance a pair of bispecific antibody-drug conjugates (ADCs) for thoracic, gastrointestinal and gynaecological cancers. Designed with ABL's linker-payload technology, the assets are intended to have improved stability and "superior biophysical properties." By targeting two cancer markers, NEOK believes its experimental treatments can offer safer, more efficacious treatments than currently ap

After disclosing a setback for its neuropathic pain aspirations during its second-quarter earnings report, Vertex Pharmaceuticals was eager to highlight some positive pipeline momentum Monday on its third-quarter call (see – Spotlight On: Despite setbacks, Vertex keeps its eyes on the chronic pain prize and Vital Signs: Winners and losers of the third quarter). But while management was bullish on its lead nephropathy candidate, povetacicept — and despite a consensus-beating financial print — the

Looking to diversify its portfolio beyond biosimilars, South Korean biotech Celltrion signed a licensing agreement, potentially worth up to $744 million, to secure two of Kaigene’s antibody assets targeting autoimmune disorders.“Our business model is to provide non-clinical antibody candidates to partners through early partnerships that can accelerate development and commercialisation,” said Minjae Shin, chief executive of Kaigene.The deal, announced Monday, centres on KG006 and KG002, built usi

Merck & Co. has pulled in $700 million in external funding as it continues to drive forward its biggest pipeline investment in oncology in the form of sacituzumab tirumotecan (sac-TMT). In return for the funds, Blackstone Life Sciences will receive low-to-mid single-digit royalties on net sales of the TROP2-targeting antibody-drug conjugate (ADC).Being developed as part of an agreement with Sichuan Kelun-Biotech Biopharmaceutical, Merck is currently conducting 15 global Phase III studies of sac-

Platinum sponsorship of NF Caregivers Symposium reinforces commitment to NF1 community MIAMI, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, today announced activation of a new U.S. clinical trial site at the University of Alabama at Birmingham (“UAB”) for its ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patie

Courtesy of Vertex Pharmaceuticals The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy. Vertex clocked 11% growth in the third quarter, meeting investor expectations. But shares of the company saw pressure Tuesday morning as the cystic fibrosis drugmaker’s new products largely stayed in the background. Meanwhile, sales of gene therapy Casgevy actually declined as patients sk