ZEALAND PHARMA AS

The FDA granted breakthrough therapy status to Boehringer Ingelheim's survodutide for MASH, based on Phase 2 trial results showing significant MASH reduction without fibrosis worsening. Two global Phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, are underway to further assess survodutide's safety and efficacy in MASH patients with moderate to advanced liver fibrosis and compensated cirrhosis, respectively.

GLP-1 receptor weight loss drugs like Zepbound and Wegovy dominate the market, but alternatives are emerging. Zealand Pharma's petrelintide, targeting amylin and calcitonin receptors, could offer advantages over GLP-1 drugs. BioAge Labs' azelaprag, targeting the APJ receptor, aims to enhance GLP-1 drugs' efficacy while mitigating side effects. Both companies present potential investment opportunities in the growing weight loss market.

Turnstone Biologics to lay off 60% of workforce, focus on cancer cell therapy. FDA approves Roche's Itovebi for breast cancer, competing with Novartis' Piqray. Gritstone bio files for bankruptcy, in talks for potential buyer. Sanofi halts Denali Therapeutics' Phase 2 MS trial after study failure. Pfizer's Talzenna-Xtandi combo extends prostate cancer survival. Paul Parker joins Flagship Pioneering as managing partner. Zealand Pharma's hypoglycemia drug dasiglucagon rejected by FDA again.

The FDA issued a complete response letter to Zealand Pharma, declining approval for dasiglucagon to treat hypoglycaemia in infants with congenital hyperinsulinism, due to a need for reinspection at a third-party manufacturing facility. The CRL did not question dasiglucagon's clinical data or safety profile, and Zealand Pharma aims to submit additional data by end of 2024.

Boehringer Ingelheim announced FDA's Breakthrough Therapy designation for survodutide, a dual glucagon/GLP-1 receptor agonist for treating non-cirrhotic MASH and moderate/advanced fibrosis. Two phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, will assess survodutide's efficacy in MASH and fibrosis stages 2-3 and compensated cirrhosis (stage 4), respectively.

The FDA issued a Complete Response Letter for dasiglucagon (Zegalogue) for hypoglycemia prevention/treatment in pediatric congenital hyperinsulinism patients due to third-party manufacturing facility inspection timing issues. Zealand Pharma is committed to resolving these issues to bring dasiglucagon to patients.

The FDA issued a second CRL for dasiglucagon (Zealand Pharma) due to a third-party manufacturing facility reinspection timing issue. Dasiglucagon aims to treat hypoglycemia in CHI patients via a wearable pump system. Phase 3 trials showed dasiglucagon reduced glucose infusion needs and hypoglycemia duration, though it didn't significantly reduce hypoglycemia events in homecare settings. Zealand Pharma remains committed to bringing dasiglucagon to CHI patients.

Boehringer Ingelheim's survodutide receives U.S. FDA Breakthrough Therapy designation for MASH treatment, initiating two Phase III trials. LIVERAGE and LIVERAGE-Cirrhosis aim to assess survodutide's efficacy in reducing liver disease outcomes in MASH patients with fibrosis stages 2-3 and compensated cirrhosis, respectively.