Stoke Therapeutics Inc.’s speeded-up timeline for zorevunersen, the antisense oligonucleotide in development with Biogen Inc. as a first-in-class potential disease-modifying treatment for Dravet syndrome, put the rare, severe form of lifelong epilepsy in the spotlight. The news involved completion of enrollment and a phase III data readout from the Emperor study, as officials said signups of 150 patients are expected in the second quarter of the year, which puts the study on track for data in mid-2027.
Ollin Biosciences Inc. is gearing up for global phase III trials this year after disclosing favorable top-line results from its randomized, head-to-head phase Ib Jade study comparing OLN-324, a next-generation VEGF/Ang2 bispecific antibody, to Vabysmo (faricimab, Roche AG), which takes aim at the same targets. The drugs were tested in more than 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD).
Having nailed down alignment with the U.S. FDA in December on a phase III trial that will start in the middle of this year, Immuneering Corp. updated the overall survival and safety data from an ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients (n=34), with more than 13 months median follow-up time.
Monte Rosa Therapeutics Inc. followed up December’s positive prostate cancer data with strong interim findings from a phase I study with MRT-8102, a NEK7-directed molecular glue degrader in the works for inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6.
A would-be psoriasis winner began taking more distinct shape in the competitive oral tyrosine kinase 2 (TYK2) inhibitor space, and shares of Alumis Inc. (NASDAQ:ALMS) closed Jan. 6 at $16.23, up $7.92, or 95% – having traded as high as $22.30 – after unveiling positive top-line results from the phase III Onward1 and Onward2 trials with envudeucitinib (envu). Alumis CEO Martin Babler called 2026 “a value-inflection year. It starts today.”
Zenas Biopharma Inc.’s positive data from the phase III Indigo trial with obexelimab in immunoglobulin G4-related disease (IgG4-RD) set investigators to speculating about the bifunctional antibody’s odds in the marketplace, as the Waltham, Mass.-based firm plans a BLA submission the U.S. FDA in the second quarter of this year.
The strategy of taking aim at IL-4Ra (type I and II receptors) and IL-31 by way of a bispecific antibody in atopic dermatitis (AD) has not worked out as well as Johnson & Johnson (J&J) hoped when, last May, the firm paid $1.25 billion to bring the product aboard by acquiring Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG.
Reporting sales of its hepatitis B vaccine Heplisav-B pretty much in line with consensus and a phase I/II shingles prospect moving along, Dynavax Technologies Corp. scored a takeover deal with Sanofi SA, which is paying $15.50 per share in cash for a total equity value of about $2.2 billion. The amount is a 39% premium to Dynavax’s closing share price yesterday, Dec. 23.
Needle-phobic obesity patients got their first workaround with the U.S. FDA clearance of Novo Nordisk A/S’ once-daily GLP-1 Wegovy (semaglutide) pill, the first of its kind.
