The mean estimate comprises 17 short-term price targets with a standard deviation of $22. While the lowest estimate of $165 indicates a 14.8% increase from the current price level, the most optimistic analyst expects the stock to surge 63.4% to reach $235. It's very important to note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts. Sarepta Therapeutics (SRPT) closed the last trading session at ...

While many investors like to look for momentum in stocks, this can be very tough to define. There is a lot of debate surrounding which metrics are the best to focus on and which are poor quality indicators of future performance. The Zacks Momentum Style Score, part of the Zacks Style Scores, helps address this issue for us. It's also important to note that Style Scores work as a complement to the Zacks Rank, our stock rating system that has an impressive track record of outperformance. Sarepta Therapeutics ...

Sarepta developed Elevidys in collaboration with Roche (RHHBY) . Both companies entered into a licensing agreement in 2019 to develop and market Elevidys. Per the agreement, Sarepta is responsible for marketing the therapy in the United States, while Roche is responsible for marketing the gene therapy outside the country. Sarepta is also eligible to receive collaboration revenues on the ex-U.S. sales made by Roche. This latest approval significantly expands the company's target market as it can increase its ...

Sarepta Therapeutics (SRPT) shares ended the last trading session 30.1% higher at $160.72. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 2.9% loss over the past four weeks. The label expansion is mainly supported by data from the phase III EMBARK study, announced last October. Though the study failed to achieve its primary endpoint, it achieved statistical significance on all pre-specified key secondary endpoints ...

Company Overview - Sarepta's shares increased nearly 34% in after-market trading following FDA approval for expanded use of its gene therapy Elevidys for Duchenne muscular dystrophy (DMD) [1] - Elevidys is now approved for all DMD patients aged four years and older, with traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients [1][9] - The therapy generated over $200 million in revenue last year, indicating strong market potential despite its recent commercial launch [3] Clinical Data and Approval Process - The label expansion is supported by data from the phase III EMBARK study, which, although it did not meet its primary endpoint, showed statistical significance in all pre-specified key secondary endpoints [2] - A confirmatory study is required to convert the accelerated approval for non-ambulatory patients to full approval, with the phase III ENVISION study currently underway [10] Competitive Landscape - Sarepta is the market leader in DMD treatment, with Elevidys being the only one-shot gene therapy for DMD in the U.S. [3][12] - Other companies, such as Regenxbio and Solid Biosciences, are developing their own gene therapy candidates for DMD, indicating a competitive environment [5][6] - Solid Biosciences has received FDA clearance to start a phase I/II study for its gene therapy candidate SGT-003, with initial data expected by the end of the year [6] Market Position and Future Outlook - Sarepta has three additional therapies in its portfolio targeting DMD, which could address nearly one-third of all DMD patients in the U.S. [12] - Year-to-date, Sarepta's shares have risen 28.1%, outperforming the industry, which has seen a 7.9% decline [11]

Sarepta Therapeutics $167.85 +44.35 (+35.91%) 52-Week Range $55.25 $173.25 P/E Ratio 1,525.91 Price Target $164.00 Add to Watchlist Sarepta Therapeutics NASDAQ: SRPT is leading the game in precision genetic medicine and biotechnology. Sarepta Therapeutics' stock price has witnessed a surge of over 40% after receiving expanded FDA approval for its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. This pivotal decision marks a turning point in treating this debilitating disease and underscores Sarepta ...

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SRPT stock, which traded below $117 per share early on June 20, was trading at nearly $160 in pre-market trading this morning. This brought the market capitalization from $11.7 billion to nearly $16 billion. Elevidys, Sarepta's gene therapy, is a single-dose infusion usually given to children in the early stages of the disease. The agency gave traditional approval for these patients and accelerated approval for older ones. Sarepta CEO Doug Ingram called approval "a defining moment for the Duchenne community ...

Loading... Confirming the functional benefits, the FDA granted traditional approval for ambulatory patients (patients who can walk) and accelerated approval for non-ambulatory patients (patients who cannot walk). Continued approval for non-ambulatory Duchenne patients may be contingent upon verification of clinical benefit in a confirmatory trial. ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. Consistent with the accelerated approval pathway, Sarepta will ...

Kagenmi/iStock via Getty Images Sarepta Therapeutics, Inc. (NASDAQ:SRPT), submitted a request to the FDA aiming to erase the ambulation and age restrictions for Elevidys, as well as a switch in the designation from accelerated to standard approval. The company reported, in its Q1 2024 conference call, that the FDA will be issuing a response by June 21st or earlier. SRPT's management seems very certain about their chances to obtain the label expansion. However, I believe the FDA has enough grounds to support ...