Latest news with #SareptaTherapeutics
Yahoo
5 hours ago
- Business
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 hours ago
- Business
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
3 days ago
- Business
- Yahoo
The FDA granted Sarepta's rAAVrh74 Viral Vector a Platform Technology Designation
The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy candidate SRP-9003 for limb-girdle muscular dystrophy type 2E/R4 (LGMD2E/R4), as a platform technology. A laboratory technician in a white coat holding a microscope and examining a vial of biopharmaceuticals. Future approvals of treatments utilizing the same delivery technology might be accelerated by this designation. Phase III EMERGENE studies for SRP-9003, sometimes referred to as bidridistrogene xeboparvovec, are anticipated to yield data in the middle of 2025, and the FDA may file a proposal later this year. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses the viral vector rAAVrh74, which is produced from rhesus monkeys, in a number of neuromuscular gene therapy initiatives. Only 14% of DMD patients had pre-existing antibodies, which suggests that the vector has low frequencies of these antibodies, which could improve efficacy and lower safety hazards. The FDA has acknowledged the vector's constancy and adaptability, according to Sarepta Therapeutics, Inc. (NASDAQ:SRPT)'s CSO, Louise Rodino-Klapac. The firm can now expedite development throughout its gene therapy pipeline by reusing clinical data, which will cut the timeframe for future therapies of neuromuscular diseases. While we acknowledge the potential of SRPT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None.
Bloomberg
3 days ago
- Business
- Bloomberg
Regenxbio's Gene Therapy Helps Kids with Deadly Muscle Disease
Children with a deadly muscle disorder had more control of their bodies after getting an experimental gene therapy from Regenxbio Inc. in a small study. The results foreshadow a potential rivalry with Sarepta Therapeutics Inc. and a critical test for the Trump administration's new drug regulators. The first five children with Duchenne muscular dystrophy to receive a higher dose of Regenxbio's treatment showed 'consistent benefit' after nine months, with improvements in motor function and the time it took to stand, walk and climb, the company said Thursday. It's conducting a larger study involving about 30 patients that it expects to be in full swing by the end of the year, with the potential to file for approval by mid-2026.
Forbes
26-05-2025
- Business
- Forbes
Will Moderna's Rally Continue?
CHONGQING, CHINA - APRIL 26: In this photo illustration, the logo of Moderna, Inc. is displayed on a ... More smartphone screen, with the company's branding visible in the background, on April 26, 2025, in Chongqing, China. (Photo illustration by) Moderna (NASDAQ: MRNA) has caught the market off guard with a significant recovery in recent days – reaching current levels of approximately $27 after hitting a five-year low of $23.15 last week – following the FDA's decision to continue advising annual COVID-19 vaccinations for high-risk populations. However, this abrupt rally appears to be a singular occurrence – competitors such as Pfizer (NYSE: PFE), Sarepta Therapeutics (NASDAQ: SRPT), and CureVac (NASDAQ:CVAC) did not replicate Moderna's increase – implying the rise was primarily fueled by the FDA guidance rather than a wider sector uptrend. Nevertheless, the overarching context tempers any lasting excitement. Moderna's stock still remains significantly below its 52-week peak of $170.47 and has decreased by over 65% in the last year. Year-to-date, the stock has declined nearly 40%, reflecting investor worries regarding decreasing vaccine revenues, escalating operating losses, and the absence of near-term growth catalysts. With diminished vaccine demand and increasing competition in the mRNA sector, the recent upsurge may not signify a sustainable turnaround, but instead, a fleeting reaction to favorable regulatory news. As part of this in-depth analysis, we investigate whether one should Buy or Fear Moderna stock. Despite the recent short-term gains, Moderna continues to face significant fundamental challenges. Revenues have dropped by 38.2% year-over-year, falling from $6.8 billion to $3.2 billion in the most recent twelve-month period. The downturn is even more severe on a quarterly basis, with a 35.9% year-over-year decline. This represents the third consecutive year of revenue recession, with the average top-line decrease now at 45.5% annually over the past three years. The company's profitability indicators offer limited solace. Moderna reported a net loss of $3.4 billion during the last four quarters, accompanied by an alarming net income margin of -106.9%. Its operating income margin and cash flow margin are equally bleak at -118.8% and -97.2%, respectively. In summary, the company continues to deplete cash reserves with few indicators of operational recovery. At first sight, Moderna's valuation multiple, indicated by a P/S ratio of 3.2 times, seems neutral when compared to the broader market, aligning its valuation multiple with that of the general market. However, these metrics may conceal deeper risks. Revenue clarity is diminishing, pipeline commercialization is still years away, and cash burn remains elevated – factors that introduce substantial downside risks not captured by a simple P/S evaluation. Moderna's stock has also displayed increased sensitivity during market declines. In the 2022 inflation surge, the stock nosedived 53.4%, compared to a 25.4% drop in the S&P 500. During the COVID-19 pandemic and even the 2008 financial crisis, it lagged behind both the market and many of its biotech counterparts. This history of poor performance during downturns further erodes investor confidence in the stock's capacity to withstand macroeconomic fluctuations. A comparison with Moderna's competitors highlights its current vulnerabilities. While companies like Pfizer and Seagen face their own difficulties, they maintain more stable revenue streams and a broader range of products. Sarepta Therapeutics and Alnylam Pharmaceuticals have made strides in rare disease pipelines with relatively steady financial performance. Moderna's peers have generally not endured such steep financial declines, nor have they drastically adjusted their guidance in recent months. The absence of a similar rally among these companies in the past several days indicates that Moderna's rise was not part of a sector-wide re-evaluation but rather a temporary reaction to regulatory developments. Moderna's recent stock surge is, at most, a fleeting respite in a longer narrative of declining revenues, escalating losses, and a challenging route to profitability. Its solid balance sheet and cash reserves provide some cushion, but without tangible advancements in pipeline commercialization or a shift in vaccine sales trends, the stock remains fundamentally at risk. The current valuation may appear reasonable, but it fails to fully account for the risks associated with dwindling revenues and delayed growth. Although the FDA's updated guidance lifted sentiment, the sustainability of this rally will necessitate more than regulatory optimism. Investors should monitor closely for concrete improvements in revenue patterns and updates on Moderna's pipeline development before considering this rebound as anything more than a short-term occurrence. Investing in a single stock like Moderna can be perilous. Conversely, the Trefis High Quality (HQ) Portfolio, consisting of 30 stocks, has a history of comfortably outperforming the S&P 500 over the last four years. Why is that? Collectively, HQ Portfolio stocks delivered superior returns with less risk compared to the benchmark index, providing a steadier investment experience as demonstrated in HQ Portfolio performance metrics.
