FOIAengine: Requests from Point72, Sofinnova, Holocene, Triple Gate and Others
A review of the latest Freedom of Information Act requests targeting three life-sciences companies – Novo Nordisk (NYSE: NVO); Charles River Laboratories (NYSE: CRL); and iRhythm Technologies (NASD: IRTC) – shows how hedge funds, investment firms, securities analysts, and other financial researchers are seeking Food and Drug Administration records that reveal not simply whether a company encountered regulatory problems, but whether the FDA believes those problems have actually been corrected.
Among the firms submitting the latest FOIA requests are Triple Gate Capital, Sofinnova Investments, Point72 Asset Management, Holocene Advisors, TD Securities, Bank of America Securities, Evercore ISI and other financial organizations whose business depends upon evaluating regulatory risk before it becomes fully reflected in the marketplace.
All the requests were logged by the FDA in June (the most current month available) and can be found in PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out. The requests we’re analyzing this week suggest that sophisticated investors increasingly view FDA records as a way to assess the likelihood of FDA enforcement action, rather than merely documenting past regulatory events.
Taken together, the requests illustrate what appears to be an increasingly sophisticated four-stage approach to regulatory research.
The first stage begins with Form 483 inspection observations, which identify potential deficiencies observed during an inspection. The second examines the company’s response, revealing how management proposes to address those observations. The third focuses on FDA’s own evaluation through Establishment Inspection Reports, providing insight into how regulators viewed both the inspection findings and the company’s corrective actions.
In the fourth stage – as seen in the latest FOIA submissions – requesters ask for post-inspection records such as decisional letters, remediation documents, regulatory correspondence and other records that may reveal the likelihood of further FDA action.
It is this fourth stage that appears to be attracting growing interest from sophisticated healthcare investors.
For example: When healthcare-focused investment firm Triple Gate Capital filed a FOIA request with the FDA in June, it did not ask for the inspection report documenting manufacturing deficiencies at Novo Nordisk’s Bloomington, Indiana manufacturing facility, acquired from Catalent in 2024. Instead, the firm requested something far more revealing: “The 90-day decisional letter following the April 2026 FDA inspection.”
We’ve previously reported on the extraordinary investor interest surrounding Novo Nordisk’s troubled former Catalent manufacturing facility in Bloomington, Indiana – an ongoing saga of FDA inspections, contamination concerns, and a warning letter that transformed the plant into one of the pharmaceutical industry’s most closely watched manufacturing sites. (See our November 19, 2025 story, Hedge Funds Target Novo’s $16.5 Billion Trouble Magnet.)
The newest requests show how investor attention has evolved.
Earlier requests about Novo Nordisk’s Bloomington facility largely sought Form 483 inspection observations and Establishment Inspection Reports – the documents that explain what FDA inspectors observed during an inspection. The latest requests are focused on what happened afterward.
Triple Gate’s request was particularly timely. It sought what’s known colloquially as the FDA’s “90-day decisional letter” – a document that communicates the agency’s regulatory disposition after an inspection and subsequent review of the company’s response. FDA’s April 24, 2026 reinspection of Novo Nordisk’s Bloomington facility ordinarily would have reached the agency’s internal 90-day decision point in late July, meaning the decisional letter Triple Gate requested may already exist even though it has not been publicly disclosed. The 90-day letter thus could provide one of the clearest early indications of whether the FDA believes corrective actions have adequately addressed the deficiencies identified during the inspection.
The Triple Gate FOIA request came from the firm’s founder, Norbert Gottesman, a healthcare investor who has publicly demonstrated a familiarity with FDA procedure, including achieving rare recent success pursuing an FDA citizen petition. Rather than seeking evidence of what inspectors found, Gottesman wanted to know what the FDA concluded after reviewing Novo Nordisk’s response.
That distinction captures an important shift in how sophisticated investors appear to be using FDA records.
Triple Gate Capital’s request for the 90-day decisional letter seeks the FDA’s own evaluation after reviewing Novo’s response to the April inspection. While such letters are not as widely discussed as Form 483s, they can provide insight into whether FDA concluded corrective actions were adequate, whether additional work remained necessary, or whether significant concerns persisted.
Triple Gate’s request was one of many targeting Novo Nordisk’s troubled Bloomington operation. Because Triple Gate isn’t registered as an investment adviser or broker dealer, and doesn’t report its 13F holdings to the Securities and Exchange Commission, we were unable to determine its investment interest in Novo Nordisk.
Among the other Novo Nordisk-related requesters during June, Sofinnova Investments took a shot in the dark. The investment firm, whose most recent 13F filing didn’t list Novo Nordisk as a holding, requested any records relating to a consent decree involving the Bloomington facility: “Can you confirm or provide evidence if there has been a consent decree issued to Novo Nordisk’s manufacturing facility?”
The request was notable because there is no available evidence that a consent decree exists. Consent decrees are public court or administrative orders, and we found nothing about one involving the Bloomington facility.
Instead, the Sofinnova request appears designed to answer a different question: Has FDA’s enforcement response escalated beyond inspections and warning letters?
Earlier, other financial firms pursued similar themes.
TD Securities requested records concerning FDA meetings, reinspections, remediation efforts, establishment classifications and communications involving the Bloomington facility.
Bank of America Securities sought records concerning Novo Nordisk’s post-warning-letter meetings and corrective actions at the Bloomington facility. Bank of America Corporation’s most recent Form 13F disclosed ownership of approximately 10.8 million Novo Nordisk ADRs, although the filing does not indicate whether those holdings are connected to the firm’s research activities or its FOIA request.
Evercore ISI requested corrective and preventive action records, lot holds, recalls, supply disruptions and FDA’s assessment of the Bloomington site’s remediation efforts. Unlike Bank of America, where the parent company disclosed a substantial Novo position, the 13F from Evercore’s wealth management side doesn’t show a Novo holding. Evercore’s FDA FOIA request is more likely related to its equity research, advisory work, or other client services than to a disclosed position in its wealth-management portfolio.
Viewed together, the recent FOIA requests suggest investors are no longer trying merely to understand what inspectors found at Novo’s Bloomington facility. Instead, they are trying to determine what the FDA thinks now about the troubled Novo Nordisk acquisition of Catalent – and what will happen next.
Point72 Asset Management provides a different example.
Rather than pursuing a facility already at the center of public attention, Point72 requested the Form 483, company response, and Establishment Inspection Report for Charles River Laboratories’ Mattawan, Michigan facility – the world’s largest nonclinical safety-assessment laboratory, performing general toxicology, specialized drug testing, and medical device development.
Unlike the Bloomington site, the Charles River facility has not been the subject of a comparable public manufacturing controversy. That makes Point72’s June 10 request noteworthy. Rather than asking about past regulatory history, Point72 appears to be seeking inspection records whose significance may not yet be widely appreciated by the market.
SEC Form 13F filings appear to show that Point72 closed out a $44.2 million position in Charles River during the first quarter of 2026 – coinciding with a steep drop in Charles River’s share price. The share price has since rebounded.
Other recent requests likewise targeted Charles River facilities in multiple states, suggesting continuing investor interest in the company’s regulatory profile.
Whether those inspections ultimately reveal significant compliance concerns remains unknown. The requests nevertheless illustrate how FDA records can function as an early-warning system for investors attempting to identify operational or regulatory risks before they become widely reflected in public reporting.
Holocene Advisors’ June 24 request concerning iRhythm Technologies, a stock whose share price has dropped sharply this year, represents yet another stage of regulatory due diligence.
Rather than requesting records from a single inspection, Holocene – whose most recent 13F filing from March 31 showed over 1.2 million shares of iRhythm – sought virtually the company’s entire regulatory history, including multiple Form 483s, Establishment Inspection Reports, warning-letter correspondence, company responses, corrective-action plans, closeout documentation and communications regarding FDA’s continuing oversight.
The breadth of the request suggests an effort to reconstruct FDA’s evolving assessment of the company over several years.
Earlier requests from other investment firms also focused on iRhythm’s inspections and warning-letter history – indicating sustained institutional interest in whether the FDA believes the company’s corrective actions have been successful.
The requests involving Catalent, Charles River and iRhythm differ in their specifics, but they share a common objective.
Rather than treating FDA inspections as isolated events, some financial players appear to view them as milestones in an ongoing regulatory process.
Although investors have long used FDA records to identify emerging regulatory risks, the latest requests suggest that strategy is evolving once again. Increasingly, Wall Street is using FOIA not simply to discover regulatory problems, but to measure the pace – and credibility – of regulatory recovery. The newest requests seek the final, and perhaps most valuable, piece of the puzzle: whether FDA now believes those corrective actions have worked.
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Next: The latest FOIA requests to the Securities and Exchange Commission.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. He is the author of The Partisan: The Life of William Rehnquist. His latest book is Summer of ’71: Five Months That Changed America, about the fateful year before Watergate. Click here to watch the official book trailer. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.
