Buxton Helmsley Calls for Senate Hearing on Well-Documented Evident Clinical Data Fraud at Assertio

Rhea-AI Summary

The Buxton Helmsley Group (BHG), which recently converted its position in Assertio Holdings (NASDAQ: ASRT) to a short interest, has called for a Senate Committee investigation into alleged clinical data fraud at Spectrum Pharmaceuticals, now owned by Assertio. This request follows the resignation of Assertio's Chairman and oncologist board member, announced shortly after BHG's release of a 20-page exposé. The report cites former executives-turned-whistleblowers who claim to possess evidence of clinical data tampering related to the cancer treatment Rolvedon. BHG criticizes Assertio's CEO Brendan O'Grady's dismissal of the allegations and the company's failure to engage with whistleblowers or review their evidence.

Positive

• None.

Negative

• Allegations of clinical data fraud for cancer drug Rolvedon
• Abrupt resignation of Chairman and oncologist board member
• Company allegedly failed to investigate whistleblowers' claims
• Potential regulatory investigation risk from Senate Committee
• Short seller targeting the company with fraud allegations

Insights

Legal & Compliance Expert

The allegations of clinical data fraud at Assertio through its Spectrum Pharmaceuticals acquisition represent a significant regulatory and legal risk. The involvement of whistleblowers, alleged data tampering in FDA submissions and board member resignations create substantial liability exposure. If investigations confirm these allegations, potential consequences include:

• FDA enforcement actions and potential product withdrawal
• Securities fraud investigations by the SEC
• Shareholder litigation and class action lawsuits
• Criminal investigations into data falsification

The timing of board resignations following BHG's exposé raises red flags about corporate governance. The company's reported refusal to engage with whistleblowers or review evidence could be interpreted as willful blindness, potentially increasing liability. Grant Thornton's continued involvement despite alleged COSO Framework violations adds another layer of complexity to this developing situation.

Market Risk Analyst

This situation presents severe market risks for Assertio. The company faces multiple threat vectors that could significantly impact shareholder value:

• Regulatory scrutiny could lead to costly investigations and potential fines
• Reputational damage in the healthcare sector could affect business relationships
• Loss of market confidence, reflected in the stock's recent performance
• Potential product liability issues if safety concerns are validated

The short position taken by BHG, combined with their public campaign and call for Senate hearings, suggests a high probability of continued downward pressure on the stock. With a relatively small market cap of $80.7 million, the company has financial resources to weather a prolonged crisis.

Requests that Senate Committee on Health, Education, Labor & Pensions Investigate Evident Falsification of Data Submitted to FDA and Potential Harm to Cancer Patients

Abrupt Resignations by Assertio Board Members Announced One Business Day After BHG’s Letter to Shareholders Regarding Evident Clinical Data Fraud Related to Cancer Treatment Rolvedon

NEW YORK--(BUSINESS WIRE)-- The Buxton Helmsley Group, Inc. (together with certain of its affiliates, “BHG” or “we”), a New York City-based investment fund manager that recently inverted its long equity position into that of a short interest in the publicly traded securities of Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT), today called upon the Senate Committee on Health, Education, Labor & Pensions (the “Committee”) to investigate the evident product-related fraud at Spectrum Pharmaceuticals, Inc., now wholly-owned by Assertio.

The hearing request follows the resignation of Assertio’s Chairman and its M.D. oncologist board member, effective November 7, 2024. However, the announcement of those board-level resignations was made just one business day after BHG’s release of an approximately 20-page exposé, citing multiple former executives-turned-whistleblowers who possess extensive non-public evidence as to the clinical data fraud (those whistleblowers also possessing the real, untampered clinical data). BHG, as previously stated, engaged an outside law firm to independently review the extensive non-public evidence corroborating the allegations of the whistleblowers.

“In Assertio’s November 11, 2024 earnings call, Assertio CEO Brendan O’Grady claimed that their supposed ‘thorough investigation’ of the Rolvedon matter means there is no need to address the evident Rolvedon-related fraud, specifically stating ‘today will be my last comments on this matter.’ Notably, Assertio has never engaged in writing with the former whistleblowers (other than a non-substantive effective autoreply) and never collected, nor reviewed the extensive evidence—including the actual, untampered clinical data—they possess. Further, despite the evident fraud, Assertio’s auditor, Grant Thornton, has thus far opted to continue to back the Company, despite clear violations of Principles 1 and 2 of the COSO Framework,” said Alexander Parker, Senior Managing Director of BHG.

“Since Assertio has shown through its actions that it hopes the corroborating fraud allegations will simply fade away if the board just ignores them, BHG believes that public safety and patient health requires that the Committee hold a hearing and permit the whistleblowers to share their evidence. Patients, shareholders, and other stakeholders need answers, and federal agencies, including the U.S. HHS, FDA and SEC must address and counteract the threat to the public from the Assertio board’s ignorance and evident fraud, particularly with regard to clinical data integrity and the digital FDA submission process,” concluded Parker.

The full text of the letter is published on BHG’s website and can be viewed here: https://www.buxtonhelmsley.com/asrt/

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About Buxton Helmsley

The Buxton Helmsley Group, Inc. (“BHG”) is a New York City-based investment advisory firm and fund manager, engaging both active and passive investment strategies across a range of asset classes, with a general focus on opportunities in North America and Europe. The investment approach is based on deep fundamental analysis and risk management, with a focus on ensuring disclosure obligations are being upheld under applicable accounting standards and securities laws.

Disclosure: BHG holds a short position in the securities of ASSERTIO HOLDINGS, INC. (NASDAQ:ASRT)

Legal Disclaimer:

The use of BHG’s research and analysis is at your own risk. In no event will BHG or any affiliated party be liable for any direct or indirect trading losses caused by any information in this press release. You further must do your own research and due diligence, and consult with your own financial, legal, and tax advisors before making any investment decision with respect to transacting in any securities covered herein. You should assume that as of the publication date of this communication, BHG (possibly along with or through our members, partners, affiliates, employees, and/or consultants) has a short position in the stock, bonds, derivatives or securities covered herein, and therefore stands to realize significant gains in the event that the price of the securities of the issuer discussed in this press release declines. Following publication of this press release, BHG intends to continue transacting in the securities discussed herein, and may be long, short, or neutral at any time thereafter regardless of BHG’s initial position or views. BHG’s investments are subject to its risk management guidance, which may result in the de-risking of some or all of its positions at any time following publication of any report or letter depending on security-specific, market or other relevant conditions. This is not an offer to sell or a solicitation of an offer to buy any security, nor shall any security be offered or sold to any person, in any jurisdiction in which such offer would be unlawful under the securities laws of such jurisdiction. BHG is registered as an investment advisor with the State of New York. To the best of BHG’s knowledge and belief, and except as otherwise described herein, all information contained herein is accurate and reliable, and has been obtained from public sources believed to be accurate and reliable, and who are not currently insiders or, to BHG’s knowledge, who may otherwise owe any fiduciary duty or duty of confidentiality to the issuer discussed in this press release. Such information is presented “as is,” without warranty of any kind – whether express or implied. BHG makes no representation, express or implied, as to the accuracy, timeliness, or completeness of any information contained herein, or with regard to the results to be obtained from its use. All expressions of opinion are subject to change without notice, and BHG does not undertake to update or supplement this report or any of the information contained herein or its position in any securities.

Cautionary Statement Regarding Forward-Looking Statements:

The information herein contains “forward-looking statements.” Specific forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and include, without limitation, words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “potential,” “targets,” “forecasts,” “seeks,” “could,” “should” or the negative of such terms or other variations on such terms or comparable terminology. Similarly, statements that describe our objectives, plans or goals are forward-looking. Forward-looking statements are subject to various risks and uncertainties and assumptions. There can be no assurance that any idea or assumption herein is, or will be proven, correct or that any of the objectives, plans or goals stated herein will ultimately be undertaken or achieved. If one or more of such risks or uncertainties materialize, or if BHG’s underlying assumptions prove to be incorrect, the actual results may vary materially from outcomes indicated or suggested by these statements. Accordingly, forward-looking statements should not be regarded as a representation by BHG that the future plans, estimates or expectations contemplated will ever be achieved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241115259407/en/

Media:

Buxton Helmsley Group

Press@BuxtonHelmsley.com

Source: The Buxton Helmsley Group, Inc.

FAQ

What allegations is Buxton Helmsley making against Assertio (ASRT)?

Buxton Helmsley alleges that Assertio's subsidiary Spectrum Pharmaceuticals committed clinical data fraud related to the cancer treatment Rolvedon, citing evidence from former executives-turned-whistleblowers who claim to possess untampered clinical data.

Why did Assertio's (ASRT) board members resign in November 2024?

Assertio's Chairman and oncologist board member resigned effective November 7, 2024, one business day after Buxton Helmsley Group released a 20-page exposé alleging clinical data fraud.

What action is being requested against Assertio (ASRT) regarding the Rolvedon allegations?

Buxton Helmsley is requesting the Senate Committee on Health, Education, Labor & Pensions to investigate the alleged falsification of data submitted to FDA regarding the cancer treatment Rolvedon.