FDA approves MAVYRET for acute hepatitis C in 8-week treatment

WATERTOWN, Mass. - The U.S. Food and Drug Administration has approved an expanded indication for MAVYRET (glecaprevir/pibrentasvir) as the only eight-week treatment for acute hepatitis C virus (HCV) infection, Enanta Pharmaceuticals (NASDAQ:ENTA), a $173 million market cap biotech company, announced Tuesday. According to InvestingPro data, the company has seen strong momentum with a 32% year-to-date return.

The approval allows healthcare providers to treat HCV patients immediately upon diagnosis with a therapy that demonstrated a 96% cure rate in clinical trials. MAVYRET is now approved for both acute and chronic HCV infection in adults and pediatric patients three years and older without cirrhosis or with compensated cirrhosis. While the company maintains strong liquidity with a current ratio of 5.29, InvestingPro analysis indicates rapid cash burn amid ongoing development efforts.

The FDA’s decision was based on data from a Phase 3 multicenter study evaluating MAVYRET’s safety and efficacy in adults with acute HCV infection. The trial enrolled 286 treatment-naïve patients across 70 global locations.

"The FDA granted Breakthrough Therapy Designation for MAVYRET for the treatment of acute HCV," the company stated in a press release. The designation is designed to expedite development and review of medicines showing substantial improvement over existing therapies.

HCV is a blood-borne disease that can lead to serious liver complications if untreated. Acute HCV refers to recent infection that can progress to chronic infection without treatment. The World Health Organization aims to eliminate HCV as a public health problem by 2030.

Glecaprevir, one of MAVYRET’s two direct-acting antivirals, was discovered by Enanta and developed and commercialized by AbbVie. More than one million patients with chronic HCV have been treated with MAVYRET globally.

The most common adverse events reported in clinical trials were fatigue, asthenia, headache, and diarrhea, with most adverse events being mild or moderate in severity. With the next earnings report due August 11, 2025, investors can access comprehensive analysis and 8 additional key insights through InvestingPro’s detailed research reports, helping navigate the company’s growth trajectory in the competitive biotech sector.

In other recent news, Enanta Pharmaceuticals has reported its second-quarter fiscal year 2025 results, ending the quarter with a cash reserve of $193 million. The company anticipates that its financial resources will support operations into fiscal year 2028. Enanta received a $33.8 million tax refund in April, which has influenced analysts at JMP to raise their price target for the company’s stock to $23, based on a risk-adjusted, discounted cash flow analysis. Similarly, Citizens JMP analysts increased their price target to $24, maintaining a Market Outperform rating, citing the company’s focus on immunology as a key factor.

Enanta is set to present data from its Phase 2 study of zelicapavir, a pediatric RSV treatment, at the 43rd Annual Meeting of the European Society for Paediatric Infectious Diseases in 2025. The company is also conducting a Phase 2 trial, RSVHR, involving adults at higher risk of RSV, with results expected in the third quarter of 2025. Enanta’s ongoing developments include its oral KIT and STAT6 inhibitor candidates, with plans to announce a third immunology program later this year. Analysts have adjusted their financial models to reflect these developments and the company’s recent performance.

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