Savara BLA Resubmission, Sarepta Gene Therapy Sales Dip, AstraZeneca Stock Decline
Savara resubmits BLA with near-term FDA decision expected; Sarepta reports $331M in Q1 net product revenue but Elevidys sales continue to decline; AstraZeneca stock falls ahead of July 2026 earnings release.
Savara has resubmitted its biologics license application and aligned analytical protocols with the FDA, with a filing decision expected in the near term, while Sarepta Therapeutics reported first-quarter net product revenue that beat expectations but saw its gene therapy Elevidys sales continue to decline, and AstraZeneca shares fell ahead of its upcoming earnings report.
Savara completed a tech transfer to Fujifilm and management expressed confidence in the updated package. A presentation is scheduled for the Guggenheim Securities Emerging Outlook Biotech Summit on February 11. The stock has returned 22.7% over the past 90 days and 104.6% over one year, trading at $5.73, which is below the average analyst price target of $10.81. However, the company reported no revenue and a loss of $115.645 million, and its price-to-book ratio of 15x is significantly above the US biotech sector average of 2.6x, indicating a valuation anchored to future expectations rather than current financials.
Sarepta’s overall net product revenue in the first quarter was $331 million, topping Wall Street estimates. Elevidys contributed $102 million, surpassing the analyst consensus of $95 million, while revenue from other products came in at $229 million, in line with expectations. Earnings per share jumped to $3.16 from a loss of $3.58 in the prior quarter, significantly beating forecasts of $0.90 to $0.99. Despite the beat, shares fell more than 10% to around $20.60. The company has grappled with safety concerns and FDA-imposed restrictions on Elevidys, leading to declining sales. Sarepta laid off over a third of its workforce, halted several programs, and its CEO announced plans to retire by end of 2026. The company is focusing on two siRNA drugs from Arrowhead Pharmaceuticals, SRP-1001 and SRP-1003, which showed positive early results in March for genetic muscle conditions, with more data expected in the second half of the year. Full-year 2026 net product revenue guidance was reiterated at $1.2 billion to $1.4 billion.
AstraZeneca stock fell 3.85% to $171.61 in the latest session, underperforming the S&P 500’s 0.42% gain. Over the past month, shares declined 2.08%, compared with the Medical sector’s 5.6% advance. The company is set to report earnings on July 27, 2026, with an expected EPS of $2.52, a 15.6% year-over-year increase, on projected revenue of $15.27 billion, up 5.65%. AstraZeneca trades at a forward P/E of 17.36, below the industry average of 20.47, and a PEG ratio of 1.45 versus 1.63.