Clinical updates for biopharma and med tech, including data readouts and publications: Aptevo, Atossa, Avalo, Bioxodes, Braintree, Cairn Surgical, Eupraxia, Helio Genomics, Hoth, Lytix, Medicus, Mingmed, Spago, Verrica.
New hires and promotions in the biopharma and med-tech industries, including: Abli, Actuate, Anavex, Cellprothera, Cristcot, Cytora, Immutrin, Turbett Surgical.
Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA.
Infectious disease-focused biopharma stocks, tracked on the BioWorld Infectious Disease Index (BIDI), saw their collective shares roughly follow the path of broader markets like the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) in early 2026. The BIDI ended April up 3.8%, followed by the DJIA with a 3.31% gain and 2.73% for the NBI, following a similar pattern to 2025.
Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.
A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite the cohort meeting the safety and tolerability primary objective.
Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.
Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash deal worth $4.1 billion. The acquisition gives Angelini ownership of three marketed drugs for treating epilepsy and neuromuscular diseases that had combined sales of $589 million in 2025, a 19.8% increase over 2024.
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