FOIAengine Identifies 14 Financial Players Making Requests
Financial institutions made numerous Freedom of Information Act (FOIA) requests last month to the Food and Drug Administration seeking information about adverse events and drug-manufacturing-facility inspections identifying health risks. Both types of reports can significantly affect a pharmaceutical company’s financial performance and stock price.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, 14 different financial institutions submitted a total of 46 FOIA requests to the FDA during June. Hedge fund Point72 led the list with 14 requests, followed by Balyasny Asset Management with 10 requests, and Farallon Capital Management with seven.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation, or stock price movements to come. Noteworthy financial industry FOIA requests to the FDA in June included:
Catalent’s plant in Harman, Md. was inspected by the FDA on March 10, 2023. In June, six different financial players submitted seven FOIA requests for the release of reports resulting from that inspection, including Form 483 inspection reports and an Establishment Investigation Report (EIR).
A Form 483 report is issued by FDA inspectors to firm management at the conclusion of an inspection when investigators have observed conditions or practices that indicate any drug has been adulterated or is being prepared and packed under conditions in which it may become adulterated or injurious to health. Companies are encouraged to respond to a Form 483 in writing with their corrective action plan and then quickly implement the plan. An Establishment Investigation Report is a more detailed follow-up report written within 30 working days of the inspection.
Catalent’s inspection reports have contributed to disappointing financial results, the Wall Street Journal reported last week. The company said in June that revenue for the three-month period ending March 31 fell 19 percent to $1.04 billion. Catalent booked a net loss of $22 million, compared with net earnings of $141 million in the same period a year ago.
Catalent also has been targeted by activist shareholder Elliott Investment Management, which took a significant stake in the company and is pressing for a shake-up of the company’s board. Catalent played a critical role in the rapid mass production of vaccines during the Covid-19 pandemic and has more recently been seen as a possible takeover target.
Elliott Investment Management was founded and is led by Paul Singer, who has been described as one of the “smartest and toughest money managers” in the hedge fund industry. A New Yorker profile in 2018 went further, calling him the “Doomsday Investor.” Elliott Management is known for its activist campaigns, in which it takes an equity stake in a company and pushes, using voting rights and influence, to encourage change.
Elliott Management also is a leading critic of the Securities and Exchange Commission’s draft regulations that seek to require earlier public disclosure by activist hedge funds. The draft rules, first proposed in 2020, would require an activist investor to disclose its investment position in a SEC filing within five days of owning more than five percent of a company, rather than the current 10-day disclosure period.
Apellis Pharmaceuticals: Three financial institutions (Actua Capital Partners, Balyasny Asset Management, and Point72) submitted a total of seven requests asking for any FDA Adverse Event Reporting System (FAERS) reports regarding Apellis Pharmaceutical’s prescription eye-disease injection Syfovre (generic name pegcetacoplan). Syfovre is the first and only FDA-approved treatment for geographic atrophy, the advanced form of age-related macular degeneration.
FAERS is a computerized database containing reports of adverse events that supports the FDA’s post-market safety surveillance program for all approved drugs and therapeutic biologics. An adverse event can be any side effect or undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
The adverse event reports requested by the three financial firms may be reflected in Apellis’ stock price. Shares in the company dropped sharply – from $84.50 on July 14 to $34.39 on July 21 – almost immediately after the FDA’s disclosure of the hedge-fund FOIA requests. One news account attributed this price drop in part to reports that six recipients of Syfovre experienced inflammation in their eyes. Many analysts remain bearish on Apellis’ outlook.
Other financial-sector FOIA requests to the FDA in June included:
- Two requests from Balyasny Asst Management for inspection reports in early 2023 at WuXi Biologics and WuXi STA Pharmaceutical, located in Wuxi, China.
- Two requests from Farallon Capital Management for adverse event reports for Filspari (generic name sparsentan) manufactured by Travere Therapeutics, Inc.
- Two requests from Farallon Capital Management LLC for inspection reports at several Agilent Technologies facilities in Colorado and California.
- Four requests from Morgan Stanley and Point72 regarding inspection reports for the iRhythm Technologies plant in Cypress, Cal.
- Two requests from Point72 for inspection reports on the Lonza AG plant in Visp, Switzerland.
- Two requests from HSBC Securities and Motilal Oswal Financial Services for Form 483 inspection reports of Ipca Laboratories’ Ratlam, India facility. For more context, read our story “Big Safety Questions About India’s Pharma.”
- Two requests from Triple Gate Capital for inspection reports at Delcath Systems’ manufacturing facility in Queensbury, NY.
- Other FOIA requests from traders and analysts targeted Revance Therapeutics, Patheon France, Aldeyra Therapeutics, Sarepta Therapeutics, REATA, UCB, Eli Lilly, DICE Therapeutics, Fulcrum Therapeutics, Penumbra, Patheon Italia, and Respironics.
Following is a fund-by-fund tally of all FOIA request activity from financial institutions to the FDA during June: Point72 (14 requests), Balyasny Asset Management (10), Farallon Capital Management (7), Triple Gate Capital (3), Morgan Stanley (2), and Hudson Bay Capital (2). Eight other financial institutions submitted one request each: Acuta Capital Partners, AWH Capital, Barclays, Berenberg Bank, HSBC Securities, JS Capital, Magnetar Capital, and Motilal Oswal. To review the FOIA requests mentioned in this article, become a beta user of FOIAengine.
Next: The latestFOIA requests made by law firms to the FDA.
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information companies and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Randy 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.
