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In a close vote 8 to 6 vote, the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted in support of accelerated approval of the therapy.
The vote is not binding but will be considered when the FDA votes on accelerated approval of SRP-9001, which is expected by the regulatory action date of May 29, 2023.
“Today’s advisory committee outcome is extremely important to the patient community, who are in urgent need of new therapies,” said CEO Doug Ingram. “With the May 29 action date our top priority, we will work collaboratively with the FDA to complete the review of our BLA for SRP 9001. We extend our sincere appreciation to the families, clinicians, FDA presenters and committee members who participated in today’s panel and to all those who provided input and comments both in the written record and in the open public hearing.”
Analysts were positive, but not completely surprised by the positive AdCom vote.
“The DMD community showed up in force providing real-world video evidence of ‘9001’s potential clinical benefit,” BofA Securities analysts said. They raised the chance of FDA approval to 90% from 80% and raised its price target to $176 from $164 following the news.
Citi analysts raised the price target to a more aggressive $204 (up $34), and see shares partially pricing in the approval ahead of the PDUFA date. They think shares could trade up to about $160 today on the news, versus Friday’s close of $120.20.
