Gene editors steady despite latest leadership shake-up at FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 20 2025
0mins
Should l Buy SRPT?
Source: SeekingAlpha
Leadership Changes at CBER: The FDA's Center for Biologics Research and Evaluation (CBER) has experienced significant leadership changes, with the recent departure of key officials including Dr. Peter Marks and the sudden administrative leave of Nicole Verdun and Rachael Anatol, following a divergence in views with new head Dr. Vinay Prasad.
Market Reaction: Despite the turmoil within CBER, shares of major gene-editing companies like Editas Medicine and Intellia Therapeutics remained stable, while Capricor Therapeutics saw a decline due to concerns over its cell therapy candidate under FDA review.
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Analyst Views on SRPT
Wall Street analysts forecast SRPT stock price to rise
18 Analyst Rating
4 Buy
10 Hold
4 Sell
Hold
Current: 17.400
Low
5.00
Averages
20.80
High
45.00
Current: 17.400
Low
5.00
Averages
20.80
High
45.00
About SRPT
Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company. The Company is focused on helping patients through the discovery and development of ribonucleic acid (RNA)-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases. It has developed multiple approved products for the treatment of Duchenne muscular dystrophy (Duchenne) and is developing potential therapeutic candidates for a range of diseases and disorders, including Duchenne, Limb-girdle muscular dystrophies (LGMDs) and other neuromuscular and central nervous system (CNS) related disorders. The Company has developed and commercialized four approved products for the treatment of Duchenne: EXONDYS 51 (eteplirsen), Injection (EXONDYS 51), VYONDYS 53 (golodirsen) Injection (VYONDYS 53), AMONDYS 45 (casimersen) Injection (AMONDYS 45), and ELEVIDYS. Its pipeline includes over 40 programs at various stages of discovery, pre-clinical and clinical development.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Sarepta Therapeutics to Report Q4 and Full-Year 2025 Financial Results
- Earnings Report Schedule: Sarepta Therapeutics is set to release its fourth quarter and full-year 2025 financial results after the Nasdaq Global Market closes on February 25, 2026, reflecting the company's ongoing commitment to precision genetic medicine.
- Conference Call Details: Following the earnings release, Sarepta will host a conference call at 4:30 p.m. E.T. to discuss the financial results, with participants required to register in advance to obtain dial-in information, ensuring smooth communication of key insights.
- Investor Relations Focus: The company emphasizes transparency by providing a live webcast of the event on its investor relations website, with a replay archived for one year post-event, highlighting its commitment to keeping investors informed.
- Company Mission: Sarepta is dedicated to engineering precision genetic medicine for rare diseases, holding a leadership position in Duchenne muscular dystrophy and showcasing a robust portfolio across muscle, central nervous system, and cardiac diseases.
See More
Sarepta Therapeutics Set to Release Financial Results for Q4 and Full Year 2025
- Company Announcement: Sarepta Therapeutics has announced its financial results for the fourth quarter and the full year of 2025.
- Financial Performance: The report includes key metrics and insights into the company's financial health and operational progress during the specified period.
See More
Sarepta Receives Approval for SRP-1005 Clinical Trial in New Zealand
- Clinical Trial Approval: Sarepta Therapeutics announced that Medsafe has approved its clinical trial application for SRP-1005, with the first-in-human trial expected to begin in Q2 2026, marking a significant advancement in the treatment of rare diseases.
- Study Design: The INSIGHTT study is a Phase 1, multi-center, dose escalation trial that plans to enroll approximately 24 participants to evaluate the safety and tolerability of SRP-1005, potentially providing a new treatment option for Huntington's disease patients and filling a market gap.
- Technological Innovation: SRP-1005 utilizes an advanced TfR1 approach with subcutaneous administration to avoid saturating the transferrin receptor, enabling efficient delivery to the central nervous system, indicating a potential breakthrough in treating neurodegenerative diseases.
- Market Potential: With about 40,000 symptomatic Huntington's disease patients and an additional 200,000 at risk in the U.S., the successful development of SRP-1005 could present significant market opportunities and revenue growth potential for Sarepta as demand for effective treatments increases.
See More
Analysis of Risks and Returns in Selling SRPT Options
- Options Selling Risk: Selling puts on SRPT does not provide the same upside potential as owning shares, as the put seller only acquires shares if the contract is exercised, otherwise they only collect the premium.
- Market Price Impact: If Sarepta Therapeutics' shares do not decline by 26.4%, the put seller can only achieve a 22.2% annualized return, highlighting the asymmetric risk-reward profile of this options selling strategy.
- Volatility Analysis: With a trailing twelve-month volatility of 119% calculated from the last 251 trading days, this metric serves as a crucial reference for investors assessing the risk-reward of selling the January 2027 put at the $15 strike price.
- Market Strategy Recommendation: Investors should carefully evaluate whether selling SRPT puts under current market conditions is worthwhile, ensuring a reasonable alignment between risk and potential returns based on historical volatility and fundamental analysis.
See More
U.S. Natural Gas Prices Surge Over 30% Amid Winter Storm
- Natural Gas Surge: U.S. natural gas prices soared over 30% on Monday due to Winter Storm Fern disrupting supply and sharply increasing heating demand, with the Henry Hub front-month contract now trading above $6 per million British thermal units, marking a 125% increase from just a week ago.
- Precious Metals Rally: The weakening dollar fueled a broader commodity breakout, with gold rising 2.2% to $5,100 and silver surging 13% to $116 per ounce, achieving its best one-day gain since September 2008 and lifting its rolling 12-month gain to 266%, the strongest since 1980.
- Tech Stocks Outperform: Amid ongoing supply disruptions in the DRAM market, memory-linked stocks such as Seagate, Western Digital, and SanDisk extended their gains, contributing to a stronger performance in technology stocks as the S&P 500 sits less than half a percentage point from record highs.
- Major Indices Performance: The Nasdaq 100 rose 0.7% to 25,796.15, the S&P 500 increased 0.7% to 6,966.04, and the Dow Jones Industrial Average climbed 0.5% to 49,350.28, reflecting overall market optimism.
See More
Sarepta Therapeutics Reports Significant Three-Year Study Results
- Clinical Trial Results: Sarepta Therapeutics reported significant three-year results from the EMBARK study, showing that patients treated with Elevidys demonstrated statistically significant efficacy in motor function assessments, leading to a 9.8% stock price increase to $23.20, indicating enhanced competitiveness in Duchenne muscular dystrophy treatment.
- Positive Market Reaction: Following the release of favorable clinical data, there was a surge in demand for Sarepta's shares, reflecting investor optimism about the biopharmaceutical sector's outlook, which may attract more capital into the industry.
- Industry Impact: Sarepta's success could inspire other biopharmaceutical companies to increase investments in rare disease research and development, thereby fostering innovation and growth across the sector.
- Investor Confidence Boost: The success story of Sarepta may bolster investor confidence in biotech stocks, particularly as market conditions continue to favor increased focus on the healthcare sector.
See More
Sarepta Therapeutics to Report Q4 and Full-Year 2025 Financial Results
- Earnings Report Schedule: Sarepta Therapeutics is set to release its fourth quarter and full-year 2025 financial results after the Nasdaq Global Market closes on February 25, 2026, reflecting the company's ongoing commitment to precision genetic medicine.
- Conference Call Details: Following the earnings release, Sarepta will host a conference call at 4:30 p.m. E.T. to discuss the financial results, with participants required to register in advance to obtain dial-in information, ensuring smooth communication of key insights.
- Investor Relations Focus: The company emphasizes transparency by providing a live webcast of the event on its investor relations website, with a replay archived for one year post-event, highlighting its commitment to keeping investors informed.
- Company Mission: Sarepta is dedicated to engineering precision genetic medicine for rare diseases, holding a leadership position in Duchenne muscular dystrophy and showcasing a robust portfolio across muscle, central nervous system, and cardiac diseases.
See More
Sarepta Therapeutics Set to Release Financial Results for Q4 and Full Year 2025
- Company Announcement: Sarepta Therapeutics has announced its financial results for the fourth quarter and the full year of 2025.
- Financial Performance: The report includes key metrics and insights into the company's financial health and operational progress during the specified period.
See More
Sarepta Receives Approval for SRP-1005 Clinical Trial in New Zealand
- Clinical Trial Approval: Sarepta Therapeutics announced that Medsafe has approved its clinical trial application for SRP-1005, with the first-in-human trial expected to begin in Q2 2026, marking a significant advancement in the treatment of rare diseases.
- Study Design: The INSIGHTT study is a Phase 1, multi-center, dose escalation trial that plans to enroll approximately 24 participants to evaluate the safety and tolerability of SRP-1005, potentially providing a new treatment option for Huntington's disease patients and filling a market gap.
- Technological Innovation: SRP-1005 utilizes an advanced TfR1 approach with subcutaneous administration to avoid saturating the transferrin receptor, enabling efficient delivery to the central nervous system, indicating a potential breakthrough in treating neurodegenerative diseases.
- Market Potential: With about 40,000 symptomatic Huntington's disease patients and an additional 200,000 at risk in the U.S., the successful development of SRP-1005 could present significant market opportunities and revenue growth potential for Sarepta as demand for effective treatments increases.
See More
Analysis of Risks and Returns in Selling SRPT Options
- Options Selling Risk: Selling puts on SRPT does not provide the same upside potential as owning shares, as the put seller only acquires shares if the contract is exercised, otherwise they only collect the premium.
- Market Price Impact: If Sarepta Therapeutics' shares do not decline by 26.4%, the put seller can only achieve a 22.2% annualized return, highlighting the asymmetric risk-reward profile of this options selling strategy.
- Volatility Analysis: With a trailing twelve-month volatility of 119% calculated from the last 251 trading days, this metric serves as a crucial reference for investors assessing the risk-reward of selling the January 2027 put at the $15 strike price.
- Market Strategy Recommendation: Investors should carefully evaluate whether selling SRPT puts under current market conditions is worthwhile, ensuring a reasonable alignment between risk and potential returns based on historical volatility and fundamental analysis.
See More
U.S. Natural Gas Prices Surge Over 30% Amid Winter Storm
- Natural Gas Surge: U.S. natural gas prices soared over 30% on Monday due to Winter Storm Fern disrupting supply and sharply increasing heating demand, with the Henry Hub front-month contract now trading above $6 per million British thermal units, marking a 125% increase from just a week ago.
- Precious Metals Rally: The weakening dollar fueled a broader commodity breakout, with gold rising 2.2% to $5,100 and silver surging 13% to $116 per ounce, achieving its best one-day gain since September 2008 and lifting its rolling 12-month gain to 266%, the strongest since 1980.
- Tech Stocks Outperform: Amid ongoing supply disruptions in the DRAM market, memory-linked stocks such as Seagate, Western Digital, and SanDisk extended their gains, contributing to a stronger performance in technology stocks as the S&P 500 sits less than half a percentage point from record highs.
- Major Indices Performance: The Nasdaq 100 rose 0.7% to 25,796.15, the S&P 500 increased 0.7% to 6,966.04, and the Dow Jones Industrial Average climbed 0.5% to 49,350.28, reflecting overall market optimism.
See More
Sarepta Therapeutics Reports Significant Three-Year Study Results
- Clinical Trial Results: Sarepta Therapeutics reported significant three-year results from the EMBARK study, showing that patients treated with Elevidys demonstrated statistically significant efficacy in motor function assessments, leading to a 9.8% stock price increase to $23.20, indicating enhanced competitiveness in Duchenne muscular dystrophy treatment.
- Positive Market Reaction: Following the release of favorable clinical data, there was a surge in demand for Sarepta's shares, reflecting investor optimism about the biopharmaceutical sector's outlook, which may attract more capital into the industry.
- Industry Impact: Sarepta's success could inspire other biopharmaceutical companies to increase investments in rare disease research and development, thereby fostering innovation and growth across the sector.
- Investor Confidence Boost: The success story of Sarepta may bolster investor confidence in biotech stocks, particularly as market conditions continue to favor increased focus on the healthcare sector.
See More
