Clinical

Infex has positive phase IIa data in bronchiectasis; preps for next trial

Thu, 21 May 2026 12:00:00 -0400

Infex Therapeutics Ltd. has published positive phase IIa data for its lead program, RESP-X, in the treatment of exacerbations of chronic respiratory infections caused by Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new capital.

Subgroup analysis of the Champion-AF trial shows age not a factor

Wed, 20 May 2026 12:00:00 -0400

A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris.

All Women data show Allegra edge in female TAVR patients

Wed, 20 May 2026 12:00:00 -0400

Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.

Immunovant rises on IMVT-1402 data in difficult-to-treat RA

Wed, 20 May 2026 12:00:00 -0400

Shares of Immunovant Inc. (NASDAQ:IMVT) gained 35% after the firm disclosed early but “compelling” data from a phase IIb study testing next-generation FcRn inhibitor IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis (D2T RA), including those whose disease has persisted despite treatment with TNF and JAK inhibitors.

Vincentage’s oral GLP-1 meets phase III obesity endpoints

Tue, 19 May 2026 12:00:00 -0400

Vincentage Pharma Co. Ltd.’s once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met the primary endpoints in a pivotal phase III trial in overweight or obese patients in China. Based on the top-line data, the Chengdu, China-based company plans to submit an NDA for chronic weight management to China’s National Medical Products Administration.

Elixir Dynamx system sees lower event rates than drug-eluting stent

Tue, 19 May 2026 12:00:00 -0400

Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.

Relay’s zovegalisib hits in phase II vascular anomalies trial

Tue, 19 May 2026 12:00:00 -0400

Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.

Regeneron’s fianlimab lags in melanoma, does $2.3B deal with Parabilis

Mon, 18 May 2026 12:00:00 -0400

Regeneron Pharmaceuticals Inc. stuck with the tradition of releasing bad news on Friday afternoon and good news on Monday morning with a pair of announcements bracketing the weekend. On May 15, 2026, the Tarrytown, N.Y.-based company announced disappointing data for its LAG-3 inhibitor fianlimab. And then on May 18, 2026, Regeneron announced better news in the form of a deal with Parabilis Medicines Inc.

Sonomind raises €20M for ultrasound neuromodulation technology

Fri, 15 May 2026 12:00:00 -0400

Sonomind SAS raised €20 million (US$23 million) in a series A funding round for its ultrasound-based neuromodulation technology for depression. The funds will be used for clinical trials of the non-invasive device, which uses a custom-made acoustic lens to precisely target deep regions within the brain to bring relief to patients suffering from treatment-resistant depression.

Will FDA show Affinity for fast yes to Regenxbio in DMD?

Thu, 14 May 2026 12:00:00 -0400

How the U.S. FDA might view the latest Duchenne muscular dystrophy (DMD) phase III data with gene therapy RGX-202 became the question for Regenxbio Inc., shares of which (NASDAQ:RGNX) closed May 14 at $6.25, down 38%, or $3.80, after the results were made public.

Biogen AD drug shows tau, cognition benefit, despite trial miss

Thu, 14 May 2026 12:00:00 -0400

Biogen Inc. has decided to advance diranersen (BIIB-080) into registrational trials for early Alzheimer’s disease, even though the antisense oligonucleotide therapy, originally discovered by Ionis Pharmaceuticals Inc., missed its phase II primary endpoint.

MBX highlights early data for monthly obesity drug MBX-4291

Mon, 11 May 2026 12:00:00 -0400

Shares of MBX Biosciences Inc. hit a 52-week high on preliminary phase I data for its MBX-4291, a GLP-1/GIP co-agonist prodrug for obesity. Though early and still blinded, findings from the trial showed promising efficacy, along with good tolerability and the potential for once-monthly dosing, factors that will likely be critical for MBX to compete in the crowded obesity space.

Budo judo moves aplenty for Climb in autoimmune

Fri, 08 May 2026 12:00:00 -0400

Climb Bio Inc. outlined May 5 an enticing data spill ahead this year with Fc-enhanced monoclonal antibody budoprutug (budo) in autoimmune diseases. Mizuho analyst Joseph Catanzaro appreciated in his report Wellesley Hills, Mass.-based Climb’s “conviction that CD19 represents a best-in-class pan-B-cell depletion target across antibody-mediated autoimmune diseases – a relative white space for conventional mAbs.”

Phase II Engene trouble: NMIBC detalimogene data throttle stock

Thu, 07 May 2026 12:00:00 -0400

Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.

Entrada sinks on mixed DMD data with ENTR-601-44

Thu, 07 May 2026 12:00:00 -0400

A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite the cohort meeting the safety and tolerability primary objective.

Abdakibart phase II graded, puts Avalo in HS upper class

Wed, 06 May 2026 12:00:00 -0400

Avalo Therapeutics Inc. may have designed in lead asset abdakibart, a drug for hidradenitis suppurativa (HS) that offers a novel mechanism of action, wide dosing interval, and more-than-satisfying outcomes on the Hidradenitis Suppurativa Clinical Response 75 endpoint, just what the doctor – and Wall Street – ordered.

Bio Korea 2026 kicks off with spotlight on oligonucleotides