Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Axsome, Corcept, Mabwell, Ultragenyx, Vanda.
Biopharma happenings, including deals and partnerships, and other news in brief: Arbormed, Bioatla, Gatc, Emmaus, Hyloris, Neoimmunetech, Novo Nordisk.
After a volatile but ultimately strong year for biopharma stocks, 2025 delivered a mixed picture marked by sharp workforce reductions alongside resilient capital markets and high-value dealmaking.
Abbvie Inc. signed a $1.1 billion New Year’s Eve deal with China’s Zelgen Biopharmaceuticals Co. Ltd., gaining ex-China rights to Zelgen’s lead oncology asset, alveltamig (ZG-006), a trispecific T-cell engager targeting delta-like ligand 3. Under terms of the deal, Abbvie will pay Zelgen an up-front fee of $100 million, and Zelgen is eligible to receive $60 million in near-term milestones and could receive up to $1.075 billion in additional development, regulatory and commercial milestones, alongside tiered royalties on net sales outside China. Zelgen retains full rights in China.
December 2025 was a big month for announcements from Psithera Inc. The Watertown, Mass.-based newco announced its name change from Psivant Therapeutics, having come out from under the Roivant Sciences Ltd. umbrella – thus the dropping of the “-vant” name. The company also announced a $47.5 million series A financing and disclosed that Eric Shaff had started as the company’s new president and CEO.
Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
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