Sarepta Therapeutics Inc. ( SRPT ) shares are down during Thursday’s session following a regulatory update regarding its treatments for Duchenne muscular dystrophy.

Sarepta Seeks Regular FDA Approvals

The stock’s decline comes as the company plans to submit supplemental new drug applications to the U.S. Food and Drug Administration (FDA) by the end of April, as detailed in the regulatory update.

Sarepta requested a meeting with the FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the accelerated approvals of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) to traditional approvals.

Sarepta received FDA confirmation that it can submit ESSENCE data and real-world evidence as part of supplementary applications.

COVID-19 Impacted Trial Data

Topline results from ESSENCE, presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Congress, found that numerical trends favored treatment versus placebo.

However, the observed difference of 0.06 steps/second in least square means (LSM) did not reach statistical significance (P=0.309) on the primary endpoint, the 4-step ascend velocity at 96 weeks.

The ESSENCE study was conducted over a time period that included the COVID-19 pandemic, which impacted the study.

An updated analysis that excludes data from 23 participants (~10% of the intent-to-treat population) whose baseline 4-step ascend velocity occurred during the COVID-19 impact period, shows the LSM difference of 4-step ascend velocity at week 96 was 0.12 steps/second (P=0.050).

Sarepta Technical Analysis

The stock is currently trading 2.3% below its 20-day simple moving average (SMA) and 15.3% below its 100-day SMA, demonstrating a bearish trend.

Shares have decreased 78.54% over the past 12 months and are positioned closer to their 52-week lows than highs.

The RSI is at 45.93, which is considered neutral territory.

Meanwhile, MACD is at -0.5928, with the signal line at -0.7171, indicating bullish momentum as the MACD is above the signal line.

The combination of neutral RSI and bullish MACD suggests mixed momentum.

Key Resistance: $19.50

Key Support: $16.50

Analyst Consensus & Recent Actions: The stock carries a Hold Rating with an average price target of $21.29. Recent analyst moves include:

Mizuho: Outperform (Raises Target to $31.00) (Mar. 13)

Citigroup: Sell (Raises Target to $9.00) (Mar. 10)

HC Wainwright & Co.: Sell (Maintains Target to $5.00) (Mar. 2)

SRPT Stock Price Activity: Sarepta Therapeutics ( SRPT ) shares were down 2.04% at $16.80 at the time of publication on Thursday, according to Benzinga Pro data.

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