Altimmune Stock Soars After FDA Breakthrough Tag for MASH Drug
Shares jumped over 15% after the U.S. regulator granted Breakthrough Therapy Designation to Pemvidutide, expediting the development path for the promising liver disease treatment.
Shares of Altimmune Inc. (NASDAQ: ALT) surged Tuesday after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company's leading drug candidate for metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease with a significant unmet medical need.
The clinical-stage biopharmaceutical company's stock climbed as much as 19.4% in early trading before closing the session up 15.95% at $4.07. The designation is a significant validation for Altimmune's drug, Pemvidutide, potentially fast-tracking its journey through the final stages of clinical development and regulatory review.
The FDA's decision was based on positive 24-week data from the Phase 2b IMPACT trial, which demonstrated that Pemvidutide led to statistically significant MASH resolution without the worsening of fibrosis, a critical endpoint in treating the disease. According to an announcement from the company, the drug also showed significant benefits in reducing liver fat and improving non-invasive tests for liver inflammation.
"The receipt of Breakthrough Therapy designation is a significant milestone and reflects the FDA’s determination that Pemvidutide has the potential to demonstrate substantial improvement over available therapies for MASH," said Dr. Vipin K. Garg, President and CEO of Altimmune. The designation provides for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for a rolling review and priority review.
MASH, formerly known as non-alcoholic steatohepatitis (NASH), is a progressive condition that can lead to liver cirrhosis, cancer, and the need for a transplant. With a growing prevalence linked to rising obesity rates, the market for an effective treatment is estimated to be worth billions, attracting intense competition from both small biotechs and large pharmaceutical giants. Altimmune is positioning Pemvidutide, a glucagon/GLP-1 dual receptor agonist, as a differentiated option in this competitive landscape.
The strong clinical results and regulatory fast-tracking have bolstered confidence on Wall Street. While Altimmune currently has a market capitalization of approximately $366 million, consensus analyst price targets sit at an ambitious $17.75 per share, reflecting significant optimism about Pemvidutide's long-term commercial potential. The stock carries a "Strong Buy" consensus rating from analysts covering the company.
This development places Altimmune in a stronger position within a field that includes Madrigal Pharmaceuticals, which recently won the first-ever FDA approval for a MASH treatment with its drug Rezdiffra. Altimmune's approach with a dual-agonist therapy aims to provide both liver-related benefits and weight loss, a key factor in the underlying disease pathology.
Looking forward, Altimmune confirmed it has aligned with the FDA on the key elements of a registrational Phase 3 trial. The company plans to evaluate multiple doses of Pemvidutide over a 52-week period, with the primary endpoint being MASH resolution, similar to the successful Phase 2b study. Investors and the medical community will be closely watching for the initiation of this pivotal trial, which will be the next major catalyst for the company and its promising liver drug.