Biopharma News Round Up

CHMP gave a positive opinion for once-weekly navepegritide (TransCon CNP) in children with achondroplasia. A final European Commission decision is expected in Q4 2026.

CHMP endorsed Lilly's oral GLP-1 candidate orforglipron, advancing it through a key EU regulatory step and supporting its obesity-launch pathway.

Immunocore dosed the first participant in Phase 1 for IMC-S118AI, its first tissue-specific autoimmune program for type 1 diabetes.

Verdiva terminated a Phase 2 trial of once-weekly oral GLP-1 candidate VRB-101, citing changing market conditions rather than a safety or efficacy issue.

Biomea presented Phase 1 oral-GLP-1 data, emphasizing efficacy and gastrointestinal tolerability while seeking partners; investor reaction was unfavorable and shares fell.

Rezolute completed enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism. Topline data are anticipated in December 2026.

Sironax advanced enrollment in the Phase 2 FORGE-LM study of NAMPT activator SIR4156 for obesity, designed to assess weight loss and preservation of lean mass.

OMass closed a $310M Series C, providing substantial funding for its small-molecule endocrinology and immunology pipeline.

Spyre presented initial clinical data from its SKYLINE study across three IBD antibodies - SPY001, SPY002, and SPY003 - alongside preclinical additive-efficacy findings at UEG Week.

Recursion announced a $200M oversubscribed follow-on offering, positive Phase 1b/2 data for REC-4881 in FAP, early Phase 1 data for REC-1245, and a Sanofi option on an immunology candidate.

Eupraxia completed enrollment in the Phase 2 RESOLVE study of EP-104GI for eosinophilic esophagitis.

Lilly reported that Omvoh (mirikizumab) met the Phase 3 primary endpoint in pediatric ulcerative colitis and presented further analyses supporting use across ulcerative colitis and Crohn's disease.

Reported positive topline results from Cohort 1 of a Phase 1b gluten-challenge study of ANB033, with the initial findings well received by analysts.

Livmarli (maralixibat) met its late-stage primary endpoint, reducing cholestatic pruritus versus placebo across cholestatic liver diseases, including biliary atresia.

Galderma agreed to acquire professional skincare company Zo Skin Health for $1.5B, expanding beyond its existing dermatology and consumer-skincare portfolio.

FDA cleared Edesa's IND for a Phase 2 study of EB06 in vitiligo, allowing U.S. site enrollment to begin. The company expects topline data in Q4 2027.

First patient was treated in the Phase 3 BIOxHEAL study of a placental-derived biologic for diabetic foot ulcers, moving the program into pivotal clinical execution.

Portugal's INFARMED authorized Tilray to conduct key EU-GMP quality testing in-house at its Cantanhede site. The move should shorten release-testing timelines and support faster launches in regulated markets.

Idorsia reported efficacy data for aprocitentan, positioning endothelin-pathway blockade as a differentiated potential approach across cardiometabolic disease, including obesity.

FDA issued an early alert for Edwards' SAPIEN M3 mitral-valve delivery system after reports of one death and one injury. This puts additional safety and regulatory scrutiny on the product.

The company found a buyer for its unwanted cell-therapy pipeline, completing a divestiture as it refocuses its strategy under the Lakefront Biotherapeutics identity.

Biogen-backed Estuary launched and financed with roughly $93M-$103M to advance preclinical gene therapies for ADPKD, an inherited kidney disease.

Par Health recalled 22 lots of IV argatroban because of IV-bag contamination risk - its third U.S. product recall in one month.