Shares of Sarepta Therapeutics SRPT dropped greater than 6% yesterday after the EMA positioned a scientific maintain on all research evaluating Elevidys, its one-shot gene remedy for Duchenne muscular dystrophy (DMD). The remedy has been developed in collaboration with pharma large Roche RHHBY.
This maintain has been positioned in response to a patient’s death post-treatment with Elevidys, which was reported final month. Although the demise was attributable to acute liver failure (a recognized danger of Elevidys), Sarepta believes that the affected person’s current CMV an infection might need contributed to the result. Investigation continues to be ongoing.
In a letter to the World Duchenne Organization, Roche talked about that the businesses are pausing enrollment and dosing of research individuals in three research evaluating the remedy on the EU research websites. This maintain will stay ‘till the evaluation into the reason for demise is full.’
The paused research embody Sarepta-sponsored part III ENVISION research (in boys aged 8-17 years), the Roche-sponsored part II ENVOL research in infants and newborns, and Sarepta’s early-stage research in boys aged 4 to 9 years with pre-existing antibodies to a selected serotype. Roche has additionally paused enrolment and dosing for the ENVOL research being performed on the U.Ok. research websites.
SRPT and RHHBY entered right into a licensing settlement in 2019 to develop Elevidys. Per the settlement, Sarepta retains the rights to market the gene remedy in america whereas Roche has unique rights to launch and market the remedy exterior the nation.
SRPT Inventory’s Efficiency
The draw back in Sarepta inventory was seemingly attributable to considerations that this newest improvement may make docs much more hesitant to prescribe Elevidys, negatively impacting the remedy’s total market adoption in america. Additionally, the scientific maintain additional delays the launch plans for the gene remedy within the European Union.
Elevidys is a significant contributor to Sarepta’s topline. The remedy’s gross sales accounted for almost 60% of the corporate’s complete revenues within the fourth quarter of 2024. For full-year 2025, SRPT expects web product revenues within the vary of $2.9-$3.1 billion, two-thirds of that are anticipated to come back from Elevidys’ gross sales. Any additional destructive developments regarding the gene remedy may adversely affect each SRPT’s development trajectory and inventory efficiency.
Yr up to now, Sarepta’s shares have plunged almost 52% in opposition to the industry’s 1% development.
Picture Supply: Zacks Funding Analysis
Sarepta’s Robust Industrial DMD Portfolio
Sarepta’s portfolio consists of 4 authorized therapies, all focusing on DMD indications.
At present, Elevidys is the primary and solely one-shot gene remedy for DMD in america. Since its industrial launch in June 2023, the gene remedy has demonstrated blockbuster potential. Sarepta added about $821 million from Elevidys gross sales in 2024 in contrast with $200 million within the year-ago interval.
Other than Elevidys, Sarepta has three different therapies in its industrial portfolio focusing on the DMD affected person inhabitants. Exondys 51 is the primary authorized disease-modifying remedy for DMD in america in addition to the corporate’s first product to obtain advertising approval. Exondys 51 recorded spectacular gross sales development up to now few quarters regardless of the COVID-19 pandemic. Vyondys 53 and Amondys 45 have additionally seen sturdy demand since their launch. Per administration, these three medicine have the potential to handle almost a 3rd of all sufferers with DMD in america.
SRPT’s Zacks Rank
Sarepta at present carries a Zacks Rank #3 (Maintain).
Sarepta Therapeutics, Inc. Worth
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Key Picks Amongst Biotech Shares
Some better-ranked shares from the sector are ANI Prescription drugs ANIP and CytomX Therapeutics CTMX, every sporting a Zacks Rank #1 (Robust Purchase) at current. You possibly can see the complete list of today’s Zacks #1 Rank stocks here.
Up to now 60 days, estimates for ANI Prescription drugs’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have elevated from $6.75 to $7.21 throughout the identical interval. Yr up to now, shares of ANIP have risen 24%.
ANIP’s earnings beat estimates in every of the trailing 4 quarters, delivering a median shock of 17.32%.
Up to now 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a lack of 31 cents to revenue of 25 cents. Throughout the identical timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Yr up to now, shares of CytomX have misplaced 47%.
CTMX’s earnings beat estimates in three of the trailing 4 quarters and missed the mark as soon as, delivering a median shock of 180.70%.
7 Greatest Shares for the Subsequent 30 Days
Simply launched: Specialists distill 7 elite shares from the present listing of 220 Zacks Rank #1 Robust Buys. They deem these tickers “Most Doubtless for Early Worth Pops.”
Since 1988, the total listing has overwhelmed the market greater than 2X over with a median achieve of +23.9% per yr. So make sure you give these hand picked 7 your instant consideration.
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report
CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
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