Investing.com - BofA Securities reiterated an Underperform rating and $19.00 price target on Sarepta Therapeutics (NASDAQ:SRPT) shares. The stock currently trades at $16.71, down 79% from its 52-week high of $80.98, though InvestingPro data suggests the company may be undervalued at current levels with a Fair Value of $22.85.
Sarepta announced it intends to submit supplemental new drug applications requesting the conversion of Amondys and Vyondys accelerated approval to traditional approval following feedback from the FDA. The FDA confirmed the company can submit data from ESSENCE as well as real-world evidence data as part of the supplemental applications.
The FDA noted that whether the data supports traditional approval will be determined in the review process. The company plans to submit the supplemental applications by the end of April.
BofA Securities views this as a positive first step in ensuring Amondys and Vyondys could stay on the market following the miss in the confirmatory study. The firm continues to see regulatory risk for the therapies.
BofA Securities currently risk-adjusts revenues for the PMO franchise starting in 2027 and notes the post-marketing dose-findings study for Exondys is expected to readout in the second half of the year.
In other recent news, Sarepta Therapeutics is actively pursuing regulatory advancements with the U.S. Food and Drug Administration. The company plans to submit supplemental new drug applications by the end of April to convert the accelerated approvals of AMONDYS 45 and VYONDYS 53 into traditional approvals. This move follows feedback from the FDA, allowing Sarepta to include data from its ESSENCE confirmatory study and real-world evidence in their submission. Additionally, Sarepta has initiated a trial to evaluate sirolimus in combination with its gene therapy ELEVIDYS, aiming to reduce acute liver injury in non-ambulatory Duchenne muscular dystrophy patients.
Analyst firms have also weighed in on Sarepta's prospects. Jefferies reiterated a Buy rating with a $30 price target, while Mizuho raised its price target to $31, maintaining an Outperform rating. Meanwhile, Cantor Fitzgerald maintained a Neutral rating but lowered its 2026 revenue estimates, citing previous projections as overly aggressive. These developments reflect ongoing interest and adjustments in analyst models concerning Sarepta's future.
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