Biopharma dealmaking was up 32% month over month in September, reaching $27.15 billion in total value, up from $20.52 billion in August. It was the fourth-highest month for deals of the year, which through the month average $23.6 billion a month. Year-to-date deal value (January through September) reached $212.44 billion, surpassing the nine-month totals of all previous years.
Eight years after Novartis AG gained U.S. FDA approval of the first CAR T therapy, Kymriah (tisagenlecleucel), for B-cell acute lymphoblastic leukemia, developers are advancing prospects that could significantly impact another disease space outside of cancer – autoimmunity. The efforts are getting a swirl of attention, with Bristol Myers Squibb Co. (BMS) announcing Oct. 10 that it would offer $1.5 billion in cash to buy three-year-old privately held Orbital Therapeutics Inc., including its lead, next-generation CAR T-cell therapy OTX-201, which is designed to reprogram cells in vivo for autoimmune diseases.
While recent advances in gene therapy have offered unprecedented options for patients with hemophilia, new data presented at the 32nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), held in Seville Oct. 7-10, revealed persistent concerns regarding the durability of these treatments and their potential liver toxicity.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Boehringer Ingelheim, Vivace, Werewolf.
Biopharma happenings, including deals and partnerships, and other news in brief: Accent, Apotex, Benchsci, Boehringer Ingelheim, Catalent, Citius, Evaxion, Klotho, Lisata, Nasus, Sanofi, Searchlight, Turn.
Clinical updates, including data readouts and publications: Aardvark, Alligator, Bavarian Nordic, Carsgen, Cervomed, Gain, Herantis, Hope, ITM, Oncoinvent, Sanofi.
Total biopharma financings reached $18.69 billion in the third quarter (Q3) of 2025, rising 14% from $16.41 billion in Q2 and 42% from $13.12 billion in Q1. While still far below the pandemic-era peaks, when quarterly totals often surpassed $30 billion, Q3’s raise stands among the highest since 2022.