[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Matthew Herper [@matthewherper](/creator/twitter/matthewherper) on x 109.5K followers Created: 2025-07-19 18:03:49 UTC A Saturday thought: If the FDA wants to force Sarepta Therapeutics ( $SRPT ) to remove its Duchenne gene therapy Elevidys from the market entirely, it could be a long fight. That the FDA has asked Sarepta to stop shipping Elevidys is unusual; that $SRPT has refused is almost unprecedented. I can think of two cases in XX years. Genentech's Avastin had accelerated approval for breast cancer. After postmarketing trials showed neither safety nor efficacy, the FDA sought to remove it in 2010. There was an adcomm that July that voted for removal, followed by a two-day public hearing in June 2011, followed by a decision by the FDA commissioner in November, meaning the process stretched out at least XX months. The other case is Makena, for preterm birth. A panel recommended revoking its approval in 2019; the drug was not recalled until 2023. Both Avastin and Makena had accelerated approval for those indications, which is supposed to have a built in possibility for an indication to be withdrawn. But for children with Duchenne who can still walk, Sarepta's gene therapy has traditional approval. That makes removal more difficult. There is a lot of potential for controversy. Sarepta has never had a clinical trial meet its primary endpoint! But I was just thinking about how much this could be drawn out. Regulatory followers and industry experts who are following me, I'd love your thoughts, either here or in my DMs. (I'm not saying that this is good for Sarepta -- Wall Street's reaction is understandable and investors are enraged. I'm just thinking about what from the past can shed light on the future.) XXXXXX engagements  **Related Topics** [$srpt](/topic/$srpt) [sarepta therapeutics](/topic/sarepta-therapeutics) [sarepta therapeutics inc](/topic/sarepta-therapeutics-inc) [stocks healthcare](/topic/stocks-healthcare) [Post Link](https://x.com/matthewherper/status/1946632083327340678)
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Matthew Herper @matthewherper on x 109.5K followers
Created: 2025-07-19 18:03:49 UTC
A Saturday thought:
If the FDA wants to force Sarepta Therapeutics ( $SRPT ) to remove its Duchenne gene therapy Elevidys from the market entirely, it could be a long fight.
That the FDA has asked Sarepta to stop shipping Elevidys is unusual; that $SRPT has refused is almost unprecedented. I can think of two cases in XX years.
Genentech's Avastin had accelerated approval for breast cancer. After postmarketing trials showed neither safety nor efficacy, the FDA sought to remove it in 2010. There was an adcomm that July that voted for removal, followed by a two-day public hearing in June 2011, followed by a decision by the FDA commissioner in November, meaning the process stretched out at least XX months.
The other case is Makena, for preterm birth. A panel recommended revoking its approval in 2019; the drug was not recalled until 2023.
Both Avastin and Makena had accelerated approval for those indications, which is supposed to have a built in possibility for an indication to be withdrawn. But for children with Duchenne who can still walk, Sarepta's gene therapy has traditional approval. That makes removal more difficult.
There is a lot of potential for controversy. Sarepta has never had a clinical trial meet its primary endpoint! But I was just thinking about how much this could be drawn out. Regulatory followers and industry experts who are following me, I'd love your thoughts, either here or in my DMs.
(I'm not saying that this is good for Sarepta -- Wall Street's reaction is understandable and investors are enraged. I'm just thinking about what from the past can shed light on the future.)
XXXXXX engagements
Related Topics $srpt sarepta therapeutics sarepta therapeutics inc stocks healthcare