BOSTON PHARMACEUTICALS

Palvella Therapeutics, a rare disease biopharmaceutical company, debuts on Nasdaq as PVLA with $80M cash, aiming to advance QTORIN™ rapamycin for microcystic LMs and cutaneous VMs, potentially becoming the first approved therapy for these conditions.

Palvella Therapeutics, Inc. merged with Pieris Pharmaceuticals, Inc., forming a unified company under the name Palvella Therapeutics, Inc. The new company will trade on Nasdaq under the ticker symbol “PVLA” starting December 16, 2024. Led by CEO Wes Kaupinen, Palvella focuses on rare disease biopharmaceuticals, with a late-stage clinical pipeline including QTORIN™ rapamycin for microcystic lymphatic malformations and cutaneous venous malformations. Backed by $80 million in cash, the company aims to fund operations into 2027 and expand its QTORIN™ platform.

DelveInsight's report on Nonalcoholic Steatohepatitis (NASH) provides insights into historical and forecasted epidemiology, market trends, current treatment practices, emerging drugs, and market size from 2019 to 2032 in the United States, EU5, and Japan. Key companies and therapies in the NASH market are highlighted, including recent developments like Aligos Therapeutics' Phase 1 data presentation.

Boston Pharmaceuticals unveiled Phase II data for efimosfermin alfa, showing significant fibrosis improvements in MASH patients, with 45.2% achieving at least a one-stage improvement in fibrosis without MASH worsening. Efimosfermin alfa, a once-monthly FGF21 analog, also resolved MASH without fibrosis worsening in 67.7% of treated patients, compared to 29.4% in the placebo group. The drug demonstrated good tolerability and will continue Phase II development.

Once-monthly efimosfermin showed significant fibrosis improvement and MASH resolution in a Phase 2 study, with rapid cardiometabolic benefits in MASH patients, and will be presented at AASLD's The Liver Meeting.

Tulisokibart, an anti-TL1A monoclonal antibody, outperformed placebo in inducing clinical remission at week 12 in moderate to severe ulcerative colitis, according to the ARTEMIS-UC trial. The study incorporated a predictive biomarker for response, showing significant clinical remission, endoscopic improvement, and clinical response in patients on tulisokibart compared to placebo. A phase 3 program is planned to confirm these results.