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

Pfizer raised its full-year profit forecast on Tuesday despite another sharp drop in sales of its COVID-19 products, boosted by the performance of its broader drug portfolio. It now expects adjusted 2025 earnings of $3.00 to $3.15 per share, up from a prior range of $2.90 to $3.10 per share, and reaffirmed its full-year revenue guidance of between $61 billion and $64 billion.Third-quarter revenues fell 6% year-over-year to $16.7 billion, hurt by waning demand for its COVID-19 vaccine Comirnaty a

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-

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

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

– New Drug Application for ziftomenib in adults with R/R NPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 – – KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients – – Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidin

iStock, weiyi zhu Both companies have submitted revised bids, with Novo’s coming in $1.9 billion higher than Pfizer’s. The plot has thickened in the Metsera-Pfizer-Novo Nordisk buyout drama. The Danish pharma has revised its proposal to buy Metsera to $10 billion, beating a revised Pfizer offer by about $1.9 billion. Metsera, by this point a winner no matter which parent it ultimately comes under, has deemed Novo’s new proposal “superior.” Novo’s new offer would pay $62.20 per share in cash,