EUR/USD likely to find a peak near 1.25: UBS
On Monday, H.C. Wainwright maintained a Neutral rating on Sarepta Therapeutics (NASDAQ:SRPT) with a $75.00 price target, as the stock trades near its 52-week low of $54.26, having declined over 55% year-to-date. The firm’s analyst, Mitchell S. Kapoor, addressed concerns following a recent patient death associated with the company’s ELEVIDYS treatment for Duchenne muscular dystrophy (DMD). According to InvestingPro analysis, the company appears undervalued based on its Fair Value estimates. Roche, a partner in the development of the treatment, communicated to the DMD community that the European Medicines Agency (EMA) has called for a temporary clinical hold on three key ELEVIDYS trials in Europe.
This pause affects Study 104, Study 302 (ENVOL), and Study 303 (ENVISION), with enrollment and dosing halted at EU and UK study sites. The hold will remain until an analysis into the cause of the patient’s death is concluded. The interruption raises questions about the future of the ELEVIDYS franchise, particularly with regard to its commercial uptake among non-ambulatory and older DMD populations. Despite these challenges, InvestingPro data shows Sarepta maintains strong financial health with a current ratio of 4.2 and revenue growth of 53% in the last twelve months.
Previously, there was an anticipation of placebo-controlled data from the Phase 3 ENVISION study, which was expected to provide important insights by 2027. Payers, according to discussions with the analyst, were looking forward to this data to determine whether to include non-ambulatory and older patient subgroups in their formularies. However, if the clinical hold on these trials is not resolved, this crucial data could be missing, potentially impacting broad payer coverage, which may then be limited to ambulatory patients aged 4-7.
The current situation with ELEVIDYS trials underscores the ongoing uncertainty surrounding the treatment’s prospects. Sarepta Therapeutics’ stock rating and price target reflect these developments and the potential implications for the company’s valuation and market position.
In other recent news, Sarepta Therapeutics announced that clinical trials for its gene therapy Elevidys will resume following a favorable safety review by an independent committee. The trials were initially paused due to concerns over acute liver failure, but the committee’s decision supports the continuation of these trials. Additionally, Barclays (LON:BARC) has maintained its Overweight rating on Sarepta with a $209 price target, expressing confidence in the drug’s prospects despite a temporary suspension by the European Union. Meanwhile, Needham has adjusted its price target for Sarepta to $183 from $202, while maintaining a Buy rating, citing regulatory challenges and a recent patient death during clinical trials. H.C. Wainwright upgraded Sarepta’s stock to Neutral, noting the achievement of its previous target price and anticipating a solid earnings report.
The recent developments have also been influenced by the resignation of FDA’s top vaccine official, Peter Marks, which has sent shockwaves through the biotech sector, affecting several companies, including Sarepta. Sarepta, in collaboration with Roche, is expected to respond to the EU’s temporary halt, with no material impact anticipated on study timelines. The company’s commitment to innovation in genetic medicine continues to draw attention from investors and analysts. These updates reflect the ongoing regulatory and market dynamics surrounding Sarepta’s Elevidys and its impact on the company’s outlook.
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