Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.
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.
As widely expected, GSK plc and Ionis Pharmaceuticals Inc. reported positive findings from two pivotal trials testing bepirovirsen in chronic hepatitis B, showing the antisense oligonucleotide therapy achieved a statistically and clinically meaningful functional cure rate, indicating a potential transition in CHB treatment beyond the current viral suppression-focused standard of care.
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.
Eye disease specialist Oculis SA is laying plans to branch out into multiple sclerosis (MS) after the phase II trials of its acute optic neuritis (AON) drug, privosegtor, showed it reduced levels of neurofilament release, a key biomarker of neuronal damage and neurodegeneration.
Biopharma industry zeal for obesity therapeutics does not appear to be dying down any time soon, with Eli Lilly and Co. entering a $1.3 billion deal with Nimbus Therapeutics LLC for a new small molecule, and Arrowhead Pharmaceuticals Inc. rolling out phase I/IIa data of its RNAi therapeutics used in combination with Lilly’s GLP-1/GIP receptor agonist tirzepatide.
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.”
With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.
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