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Sarepta (SRPT) Stock Down, FDA to Hold Panel Meet for SRP-9001
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Shares of SareptaTherapeutics (SRPT - Free Report) plunged almost 20% on Mar 16, soon after the company announced the FDA's decision to hold an unexpected advisory meeting for the biologics license application (BLA) of its lead gene therapy candidate SRP-9001.
The company's shares were up 84.7% in the past year against the industry's 15.1% decline.
Image Source: Zacks Investment Research
SRP-9001 is an AAV-mediated micro-dystrophin gene therapy candidate for treating duchenne muscular dystrophy. The candidate was earlier granted priority review by the FDA, with a regulatory action date of May 29, 2023.
The decision to hold the advisory meeting ahead of the FDA action date was made after Sarepta's s late-cycle meeting for the SRP-9001 BLA with the agency. The decision was a complete turnaround from FDA's previous communication about not holding an advisory meeting. This took the investor community by surprise.
At the beginning of March, the company had said that the FDA had formally confirmed that there were no significant safety issues regarding the SRP-9001 BLA. It was not planning to hold an advisory committee for the same. This declaration was made along with the fourth-quarter and full-year results announcement. The sudden decision came once the mid-cycle review with the regulatory agency was completed.
Doug Ingram, Sarepta's chief executive officer, said the company was "not disappointed" with the FDA's decision to hold an advisory meeting and was preparing for the same since filing the BLA in the fall of 2022.
Sarepta is also developing gene therapy programs for various Limb-girdle muscular dystrophy (LGMD) forms. The most advanced LGMD product candidate is SRP-9003. The company has several other pre-clinical and clinical stage gene therapy candidates targeting additional indications — Rett Syndrome, cardiomyopathy, Emery-Dreifuss muscular dystrophy type 1 and multiple sclerosis.
Kala Pharmaceuticals’ loss per share estimates have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. The stock has plunged 81.5% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Certera's earnings per share (EPS) estimates have widened from 46 cents to $1.24 for 2023 and from 55 cents to $1.85 for 2024, in the past 60 days. The stock has gained 8% in the past year.
CERT’s earnings beat estimates in one of the last four quarters, missed the mark in two and met the mark in another, the average negative surprise being 3.25%.
Jasper therapeutics’ loss per share estimates have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024, in the past 60 days. The stock has plunged 48.6% in the past year.
JSPR’s earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.
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Sarepta (SRPT) Stock Down, FDA to Hold Panel Meet for SRP-9001
Shares of Sarepta Therapeutics (SRPT - Free Report) plunged almost 20% on Mar 16, soon after the company announced the FDA's decision to hold an unexpected advisory meeting for the biologics license application (BLA) of its lead gene therapy candidate SRP-9001.
The company's shares were up 84.7% in the past year against the industry's 15.1% decline.
Image Source: Zacks Investment Research
SRP-9001 is an AAV-mediated micro-dystrophin gene therapy candidate for treating duchenne muscular dystrophy. The candidate was earlier granted priority review by the FDA, with a regulatory action date of May 29, 2023.
The decision to hold the advisory meeting ahead of the FDA action date was made after Sarepta's s late-cycle meeting for the SRP-9001 BLA with the agency. The decision was a complete turnaround from FDA's previous communication about not holding an advisory meeting. This took the investor community by surprise.
At the beginning of March, the company had said that the FDA had formally confirmed that there were no significant safety issues regarding the SRP-9001 BLA. It was not planning to hold an advisory committee for the same. This declaration was made along with the fourth-quarter and full-year results announcement. The sudden decision came once the mid-cycle review with the regulatory agency was completed.
Doug Ingram, Sarepta's chief executive officer, said the company was "not disappointed" with the FDA's decision to hold an advisory meeting and was preparing for the same since filing the BLA in the fall of 2022.
Sarepta is also developing gene therapy programs for various Limb-girdle muscular dystrophy (LGMD) forms. The most advanced LGMD product candidate is SRP-9003. The company has several other pre-clinical and clinical stage gene therapy candidates targeting additional indications — Rett Syndrome, cardiomyopathy, Emery-Dreifuss muscular dystrophy type 1 and multiple sclerosis.
Sarepta Therapeutics, Inc. Price and Consensus
Sarepta Therapeutics, Inc. price-consensus-chart | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Sarepta Therapeutics has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are Kala Pharmaceuticals (KALA - Free Report) and Certera (CERT - Free Report) and Jasper Therapeutics (JSPR - Free Report) , each holding a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Kala Pharmaceuticals’ loss per share estimates have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. The stock has plunged 81.5% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Certera's earnings per share (EPS) estimates have widened from 46 cents to $1.24 for 2023 and from 55 cents to $1.85 for 2024, in the past 60 days. The stock has gained 8% in the past year.
CERT’s earnings beat estimates in one of the last four quarters, missed the mark in two and met the mark in another, the average negative surprise being 3.25%.
Jasper therapeutics’ loss per share estimates have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024, in the past 60 days. The stock has plunged 48.6% in the past year.
JSPR’s earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.