FOIAengine: Maker of Elevidys Targeted by 91 FOIA Requests in 19 Months
As biotech firm Sarepta Therapeutics (NASD: SRPT) battles patient deaths, regulatory action, and a cratering stock price, its dealings with the Food and Drug Administration are being monitored closely by law firms, financial institutions, news media, and the Trump Administration.
Sarepta and its gene therapy drug Elevidys were the target of 37 Freedom of Information Act requests during the first seven months of 2025, according to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows. Fifty-four such requests were submitted during 2024.
FOIA requests to the FDA about specific companies usually are filed by financial firms, which explains why Sarepta has been the subject of seven requests from investment professionals. But many of this year’s Sarepta-related requests also have come from journalists covering the company (6) and law firms eyeing or responding to legal actions (9). Among the submitters are Bloomberg News, the Washington Post, and Kelley, Drye & Warren.
Sarepta is a Boston-based genetic drugmaker marketing Elevidys and three other therapies for Duchenne muscular dystrophy, a severe, progressive genetic disorder targeting boys and young men that primarily affects muscle function and often results in an early death.
Sarepta and Elevidys have had a tough year. Three deaths linked to the drug prompted the company to suspend shipments in mid-June, and on July 18 the FDA requested a stop to all shipments, which Sarepta agreed to on July 21. Short sellers smelled blood in the water and went on the attack.
But one week later, the FDA cleared Elevidys for use in ambulatory patients after finding no link between the therapy and a Brazilian patient’s death.
Bloomberg reported earlier this week that the FDA’s about face on Elevidys came after an active campaign organized by Duchenne patients and their families. According to Bloomberg, the parents were “being helped by power players aligned with Donald Trump’s second administration, including Senator Ron Johnson … and influencer Laura Loomer who viewed a top FDA official as disloyal to the president.”
Bloomberg also reported that one day after the agency’s reversal on Elevidys, Vinay Prasad, the head of the FDA’s Center for Biologics Evaluation and Research “resigned following intense criticism from conservative media.” The Bloomberg article’s conclusion: “Sarepta had won, at least for now.”
These developments, along with a large debt payment obligation, restructuring plans, and an erratic stock price prompted the 37 FOIA requests in 2025 seeking adverse event reports, inspection reports, and product approval documentation. An FDA Adverse Event Report (FAERS) describes adverse reactions and medication error reports associated with the use of drug or biologic products.
Sarepta-related requests during July included the following:
- John Kelley of Robbins Geller Rudman & Dowd LLC submitted a request seeking “Case Report Forms and FDA Forms 3500A and 3500 that reported acute liver injury or liver failure associated with Sarepta Therapeutics Inc.’s drug ELEVIDYS … between January 1, 2023, and July 21, 2025; and copies of all documents produced pursuant to FOIA request FDA-FOIA-2025-4419. Case report forms describing liver injury or liver failure provided by Sarepta Pharmaceuticals to the Center for Biologics Evaluation and Research concerning Elevidys.”
- Jason Mast of STAT News submitted a request requesting “access to review documents from the agency’s review of the supplemental Biologics License Application for Elevidys filed by Sarepta Therapeutics, in December 2023, also known as BLA 125781/34. These include internal meeting summaries, informal teleconference summaries, mid and late cycle review meeting summaries, labeling review, information requests and the responses to them, and memorandums.”
- Kareen Ejoh of Kelley Drye & Warren, LLP submitted a request seeking “all safety events in patients using the product Elevidys in DMD, but particularly highlighting liver safety issues (including liver enzyme elevations, liver injury leading to hospitalizations, hospitalization and deaths). I am also looking for the background baseline information of these patients (non-ambulatory/ambulatory status and age) for the period of June 1, 2023, to the present.”
- Gerry Smith of Bloomberg News submitted a request seeking “Communications from May 7, 2025, to Present between Sarepta Therapeutics Inc. and Vinay Prasad, the FDA’s Director of the Center for Biologics Evaluation and Research; and Communications from March 18, 2025, to Present between Sarepta Therapeutics Inc. and Nicole Verdun, the FDA’s Center for Biologics Evaluation and Research.
- Daniel Gilbert of the Washington Post submitted a request seeking “adverse event case reports, including narrative, associated with suspect drug Elevidys.”
- Quinn Lin of Point72 and Anna Edney of Bloomberg News submitted requests for Elevidys adverse event reports.
Roundup: Other FOIA Requests to the FDA During July
Financial Institution Requests were submitted by Point72 (4), Cantor Fitzgerald (4) Acuta Capital Partners (3), Cantor Fitzgerald, Triple Gate Capital (3) and one each from Bank of America, Kinmen Capital, LifeSci Capital, Nomura Financial Advisory and Securities, and Tyro Partners. Hedge fund requests included the following:
- Quinn Lin of Point72 submitted a request seeking “information related to the FAERS monitoring of Vyvgart and Vyvgart HYTRULO.”
- Patrick Curry of Acuta Capital Partners, LLC filed a request asking for “the details of a potential signal of a sever worsening of CIDP from Vyvgart Hytrulo in the FDA’s FAERS update from June 30, 2025.”
- Ashley Mishoe of Pharmalogic Holdings Corp submitted a request seeking “all Form 483 citations, 483 citation responses including attachments if applicable, and Establishment Inspection Reports (EIRs) issued for 3D Imaging Drug Design and Development (FEI 3009143510) from March 2024 to July 22, 2025.”
- Daniel Bronder of Cantor Fitzgerald submitted a request seeking “any written communication pertaining to the NDA Syndax filed for its drug candidate revumenib. The PDUFA data was delayed to allow for review of additional documents that we’d like to view in addition to the originally filed NDA. We’re interested in seeing if any of these documents contained data pertaining to safety concerns of revumenib that the public should be aware of.”
Law Firm Requests included the following:
- Surina Chock of Marler Clark (“the food safety law firm”) filed a request stating that “In 2024 FDA, CDC, and their state and local public health partners investigated a multistate outbreak of Salmonella Typhimurium infections associated with cucumbers grown by Agrotato S.A. de C.V. in Sonora, Mexico. A total of 113 people infected with the outbreak strain were reported from 23 states. The purpose of this letter is to request copies of all documents on file at the FDA (headquarters and all district offices) regarding the investigation of illnesses, traceback, and recalls related to the above referenced outbreak. “
- Tory Trocchia of Gallagher Evelius & Jones submitted a request seeking “all documents and communications that refer or relate to asbestos contamination in Johnson & Johnson products; asbestos contamination in consumer talcum products; and draft or final rules governing the sale of consumer talcum products, including rules related to detecting asbestos in these products.”
News Media Requests included the following:
- Mike Williams of The Capitol Forum submitted a request seeking “a log of inspections conducted by the FDA that resulted in a form 483 report for the month of June 2025, including operation date, firm name, FEI number, facility address, center and product area.”
- Brandon Wissbaum of Gray Media/InvestigateTV submitted a request seeking “data or statistical summaries from the MAUDE system or related adverse event databases covering the period from January 1, 2021, to the present. A list of FDA-cleared or approved diagnostic devices that include artificial intelligence (AI) or machine learning components. For each listed device, the total number of adverse event reports submitted to the FDA between Jan. 1, 2021, and the present, including breakdowns by event type (malfunction, injury, death). Any available summaries or internal trend analysis identifying AI-enabled devices with elevated or unusual adverse event rates.”
- Patrick Wingrove of Reuters submitted a request seeking “all letters/correspondence sent by members of Congress to the FDA’s office of legislation since January 2023 that reference compounded semaglutide or tirzepatide.”
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Next: The latest hedge fund requests to the Securities and Exchange Commission.
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Write to Randy E. Miller at randy@poliscio.com.