Shares of Zenas Biopharma Inc. (NASDAQ:ZBIO) were trading at $15.04, down $19.46, or 56%, on positive results from the phase III Indigo trial with obexelimab in immunoglobulin G4-related disease (IgG4-RD). A bifunctional antibody that binds to CD19 and FcyRIIb to target B-cell mediated autoimmune diseases, obexelimab met the primary endpoint, showing a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. The drug also turned up highly statistically significant activity vs. placebo on all four key secondary endpoints. Waltham, Mass.-based Zenas plans to submit a BLA in the second quarter of this year. The rare disease is characterized by an abnormal increase in IgG4 antibodies, and multiple organs may be affected.

FDA lifts clinical hold as GH Research preps for pivotal depression trial

GH Research plc is ready to move forth with pivotal testing for GH-001, its inhaled version of psychedelic mebufotenin, in treatment-resistant depression (TRD), following the lifting of a U.S. FDA clinical hold. The agency initiated the hold on the company’s IND submitted in August 2023, requesting additional information, including an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, along with additional information on the aerosol delivery device. In the meantime, GH Research has reported positive phase II data in TRD, bolstering the overall prospects of psychedelics in the space.

Insilico inks $888M drug discovery partnership with Servier

After raising $292 million in its Hong Kong IPO, AI discovery and development biotech, Insilico Medicine, signed an R&D collaboration with French pharma Servier SA valued at $888 million to discover and develop innovative oncology therapies by combining Insilico's AI-driven drug discovery platforms with Servier's global expertise in cancer drug development. Insilico will be eligible to receive $32 million in up-front and near-term R&D payments to leverage its AI-powered technologies to identify and advance potential drug candidates. The two companies will share R&D costs, and once candidates are identified, Servier will lead clinical validation, regulatory interactions, and worldwide commercialization of the resulting drug candidates.

AI drug discovery brings $2B+ Sanofi deal to 1-year-old Earendil

Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases. The deal equates to $160 million in up-front and near-term payments for Wilmington, Del.-based Earendil, which is barely a year old following its December 2024 incorporation. The rest of the deal’s potential value comes on the back end through development and commercial milestones. Low double-digit percentage royalties on net product sales also are part of the agreement.

EMA gets to work on implementing new EU pharmaceutical rules

After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation. A new group with representatives from the EMA, its management board and the European Commission will oversee the work, which includes streamlining the agency’s operations from five specialized committees to two.

Scinopharm wins US FDA approval of multiple sclerosis drug

Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis (MS). Glatiramer acetate is an FDA-approved immunomodulator used to reduce the frequency of relapses in patients with MS. Israel-based Teva Pharmaceutical Industries Ltd. originally developed glatiramer acetate under license from the Weizmann Institute of Science and Proneuron Biotechnologies Inc., winning FDA approval under the brand name of Copaxone in 1996. Patent protection for Copaxone ended in 2014.

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Aktis, Alvotech, Biogen, Evotec, Genelux, Genmab, Hemostemix, Innocan, Mesoblast, Outlook, Roche, Samsung Biologics, Valneva