FOIAengine Breaks Down the Action
Financial firms are continuing to monitor many of the pharmaceutical manufacturers we’ve reported on in recent months, including Krystal Biotech, Apellis Pharmaceuticals, Establishment Labs, Catalent and Astellas. That’s according to a review of Freedom of Information Act requests made to the Food and Drug Administration during December 2023 and January 2024.
The hedge fund requests represented a small fraction of the 1,899 FOIA requests logged by the FDA from all sources during those two months.
But, as always, the requests carried an outsize significance. FOIA requests from analysts and other financial professionals generally seek to identify positive or negative news about a manufacturer. Such requests are signals of market-moving interest that could affect a company’s stock price.
After a desultory December, with just 11 FOIA requests to the FDA from financial players (out of a total of 863 from all sources), the number of hedge fund requests to the agency more than doubled in January, to 26 (out of 1,036), according to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real time as their availability allows.
Point72 was again the leading financial institution requester, submitting 16 FOIA requests to the FDA during the two-month period. And the New York financial firm Newtyn Management was a newcomer to our reports, filing a number of requests about PolyPeptide Group AG companies.
POINT72 FOIA Requests
Point72 requested FDA Form 483 plant inspection reports, Establishment Investigation Reports (EIR), and Adverse Event reports (FAERS) relating to seven different drug manufacturers. A Form 483 report is issued by FDA inspectors to firms at the conclusion of an inspection that has found indications that a drug has been or may become adulterated or injurious to health. An Establishment Investigation Report is a more detailed follow-up report written within 30 working days of the inspection. An Adverse Event is a report on adverse reactions and medication error reports associated with the use of drug or biologic products.
Following are brief summaries of Point72’s FOIA December and January requests:
- A January 22 request for any adverse events reported for Xydemvy, marketed by Krystal Biotech, since July 25, 2023.
- A January 22 request for any adverse events reported for Vyjuvek, marketed by Krystal Biotech, since May 19, 2023.
- A January 22 request for any adverse events reported for Syfovre, marketed by Apellis Pharmaceutical, since February 17, 2023.
- A January 10 request for a Form 483 summary inspection report for Establishment Labs’ manufacturing facility in Sulayom, Costa Rica, since January 2023. See our December 13 article on Establishment Labs.
- A January 4 request for any adverse events reported for Vyjuvek, marketed by Krystal Biotech, since May 19, 2023.
- A January 4 request for any adverse events reported for Syfovre, marketed by Apellis Pharmaceutical, since February 17, 2023.
- A January 4 request for any adverse events reported for Izervay, marketed by Astellas Pharma, since August 1, 2023.
- A January 3 request for any “agency documentation or communication” regarding two case IDs.
- A January 2 request for “AML/MDS cases from carvykti post marketing trials.”
- Two nearly identical December 27 requests for “any agency documentation, observations or communication” regarding the Form 483 inspection report issued to Catalent Indiana LLC of Bloomington, Indiana, since October 1, 2023.
- A December 26 request for “copies of any agency documentation, observations or communication” regarding any Form 483 inspection report, 483 response, and EIR Summary issued to Intuitive Surgical, Inc., located in Sunnyvale, California, since November 1, 2023.
- A December 5 request for all Form 483 inspection reports issued to Zoetis Animal Health at its plants in Lincoln, Nebraska, and Salisbury, Maryland, since January 1, 2023.
- A December 4 request for any adverse events reported for Izervay, marketed by Astellas, since August 1, 2023.
- A December 4 request for any adverse events reported for Syfovre, marketed by Apellis Pharmaceutical, since February 17, 2023.
- A December 4 request for any adverse events reported for Vyjuvek, marketed by Krystal Biotech, since May 19, 2023.
Newtyn Management Investigates PolyPeptide Group AG
New York investment firm Newtyn Management is taking a close look at the PolyPeptide Group AG, a contract drug development and manufacturing firm that trades on the SIX Swiss Exchange. During January, Newtyn submitted seven FOIA requests seeking information about all Form 483 inspection reports, EIR inspection reports, and other FDA reports for the past two years and “all FDA internal communications (including emails, memos, and attachments)” over the past 12 months relating to a number of PolyPeptide affiliates: PolyPeptide Laboratories (Sweden), PolyPeptide Laboratories (France), PolyPeptide Laboratories Private Limited, Polypeptide Laboratories San Diego, PolyPeptide SA Belgium, and PolyPeptide Laboratories in Torrance, California.
This attention falls on the heels of a Simply Wall St report on December 31 that PolyPeptide Group shares could be priced 49% below their intrinsic value. Simply Wall St has published several articles over the past year tracking PolyPeptide Group’s performance, including a May 23 article noting that the company’s stock price had slipped by 65% from the prior year before a 23% rebound in early 2023.
Newtyn describes itself as a “value-oriented investment firm.” It was founded in 2011 by Noah Levy and Eugene Dozortsev and provides portfolio management services to private investment funds. The firm’s website says its “primary objective is to generate above-average risk-adjusted returns while maintaining low net exposure to overall financial market performance.” The firm has outperformed the S&P 500 in recent years. From the third quarter 2020 through the third quarter of 2023, Newtyn’s cumulative return on its weighted top 50 holdings was 46.83%. As of December 31, 2022, assets under management were approximately $1.2 billion.
Founded in 1952, PolyPeptide manufactures peptide- and oligonucleotide-based active pharmaceutical ingredients whose customers are primarily in the pharma and biotech fields. The company develops and produces the active ingredients for therapies that range from the treatment of wide-spread metabolic diseases like diabetes or obesity to cancer and cardiovascular or neurological disorders.
Peptides are strings of amino acids, which are the building blocks of proteins. Lab-made peptides can mimic some of those found in the human body. Some are used in medications for conditions ranging from diabetes to multiple sclerosis. Oligonucleotides are a novel class of therapeutic molecule for the treatment of a wide variety of diseases. They are short pieces of modified DNA that can bind to complementary DNA sequences, which gives them a unique ability to treat diseases that have been considered untreatable by traditional small molecule therapeutics.
Other Financial Industry FOIA Requests
The following are other financial industry requests submitted to the FDA in December and January.
- Affinity Asset Advisors submitted a January 25 request for information about “the double-blind period of the Apollo-B trial.”
- Aristotle Capital Management filed a January 5 request for reports on all inspections completed at facilities operated by Alcon Inc. or its global subsidiaries.
- ExodusPoint submitted two January 30 requests for a number of FDA case IDs and a Form 483 inspection report for Philips North America.
- Hudson Bay Capital submitted a January 9 request regarding “Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis.”
- J.P. Morgan submitted a December 18 request for a form 483 issued to Moderna following an FDA inspection in September 2023 at its facility in Norwood, Massachusetts.
- Leerink Partners submitted a January 16 request for FAERS adverse event reports for a number of case IDs.
- Magnetar Capital submitted December 15 and January 4 requests for a summary inspection report for Establishment Lab’s manufacturing facility in Sulayom, Costa Rica since July 2023, as well as a January 24 request for a Form 483 inspection report for Elanco Animal Health Facilities in several U.S. locations.
- UBS submitted a December 11 request for adverse event reports for the following pharmaceuticals: Izervay, manufactured by Astellas; and Syfovre, manufactured by Apellis Pharmaceutical.
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Next from FOIAengine: The latest FOIA 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 new venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Learn more about FOIAengine here. Sign up here to become a beta user of FOIAengine.
Write to Randy E. Miller at randy@poliscio.com.
