For more than a year and a half, Shoshana Shendelman has been at the epicenter of one of the biggest stories in the country: the raging campus battles over Israel’s war on Gaza. Earlier in the year, Columbia University, an institution deeply entwined with Shendelman’s life, was the site of the first major university protest encampment. And the university cracked down, inviting police onto its New York campus where they made violent arrests.
Shendelman, who got two masters’ degrees and her doctorate from Columbia and whose child currently attends the school, had sat on the board of trustees of the university since March 2023. According to a recent New York Magazine story, Shendelman was one of the most active board members in the pro-Israel camp pushing for action to restore order on campus. The university meted out harsh punishments for student protesters, short circuited due process, and, critics say, stifled pro-Palestine speech.
The hard-line faction of trustees had long since gained the upper hand on the board, but the campus — and the nation — continued to be rocked by the debate over Israel’s war on Gaza, including as part of an onslaught from Donald Trump’s administration that has cost the school hundreds of millions in funding.
In November, tumult would reach Shendelman’s life — not, however, in her role on the Columbia board, but in her professional career. In the six months that followed, Shendelman would see controversy erupt over the pharmaceutical company she started and led — including allegations from the federal government of statutory and regulatory violations in clinical trials, and a shareholder lawsuit alleging fraud on her part. Shendelman has since denied doing anything wrong, but she lost her leading roles at the firm.
She maintained, however, her position on the Columbia board of trustees as the body pushed for harsh responses to pro-Palestine protests and sought to consolidate power over the school. Now, the controversies around her pharmaceutical work are raising questions about her role on the university board.
“Keeping Shendelman on the board is just one more indication of how deeply the board has lost its way.”
“At a moment when the board of trustees is leading with a very heavy and misguided hand, keeping Shendelman on the board is just one more indication of how deeply the board has lost its way,” said a tenured professor at Columbia’s Irving Medical Center who asked to remain anonymous for fear of retaliation from the university.
Shendelman did not respond to inquiries from The Intercept. Columbia’s administration did not offer responses to questions for the board of trustees by press time.
Shendelman had been the CEO of a pharmaceutical firm called Applied Therapeutics, a company hoping to bring two drugs to market. Shendelman was a central figure in the firm. She had founded the company; fundraised for it, including taking it public; and spearheaded the development of its lead drug candidate, govorestat, as well as its clinical studies.
Then on November 27, Applied Therapeutics announced that govorestat was rejected by the U.S. Food and Drug Administration. On the same day, Shendelman was issued a stern warning by the FDA. In a letter addressed to her, the agency’s Center for Drug Evaluation and Research, which regulates drugs, called out Applied Therapeutics for the deletion of sensitive data ahead of an FDA inspection and failing to disclose crucial information about “errors” made during clinical trials for their lead drug candidate. The problems, the FDA said, amounted to apparent statutory and regulatory violations. (Applied Therapeutics did not respond to The Intercept’s request for comment.)
In a podcast interview this month, Shendelman said there were no safety or efficacy concerns about govorestat, and that it had been rejected by the FDA for bureaucratic reasons. (The FDA letter said Applied Therapeutic’s failure to disclose certain information to the agency created issues with performing “an evaluation of the safety and effectiveness of the drug.”)
Following the regulator’s letter, the company’s stock price tanked, dropping 80 percent in three days. Within weeks, shareholders filed a lawsuit against Applied Therapeutics, Shendelman, and another company officer, alleging that Shendelman in particular had known about problems with clinical trials since May 2024, and committed securities fraud by failing to disclose information about the issues to investors in a series of rosy public statements. The stock continued to rise on this incomplete information, the suit alleges, and Shendelman sold off stocks totaling more than $6.6 million at an “artificially inflated share price,” as the suit put it. The majority of the sales, more than $4.7 million worth, came in a three-day flurry in August 2024, just days after Shendelman gave a positive assessment of the company’s FDA application process to investors.
In separate responses to the lawsuit, Applied Therapeutics denied all wrongdoing, and Shendelman’s lawyers moved to dismiss the claims. They argue that none of the claims in the suit constitute fraud, that she sold only a fraction of her shares in the company, and that the allegations are based purely on “conjecture, hindsight, and allegations that Dr. Shendelman was unduly optimistic about the possibility of approval.”
On December 19, a little over three weeks after the FDA issued its letter, Shendelman signed an agreement that terminated her employment at the company she had founded. According to the agreement, Shendelman would be paid millions on her way out.
The Board
Even amid the dramatic changes at work, Shendelman’s role at Columbia remained steady. Five months after leaving Applied Therapeutics, she remains on Columbia’s powerful 21-member board of trustees as the body undertakes what critics say is a broad power grab at the university.
Her role on the board has stirred little controversy thus far, but the contours of her unceremonious exit from Applied Therapeutics are taking on heightened relevance amid a crisis at Columbia that has escalated dramatically since Trump took office.
“I am appalled to see the FDA’s warning letter, and the impending class action lawsuit regarding Applied Therapeutics for their mishandling of data collection and storage,” said a second professor at Columbia’s Irving Medical Center, a medical doctor who asked for anonymity for fear of professional retaliation.
Until shortly after The Intercept sent requests for comment to Columbia and Shendelman, her board of trustees biography listed her as the vice chair of the “Clinical Advisory Board” of Columbia’s Irving Medical Center and its Vagelos College of Physicians and Surgeons. There’s little online information about a clinical advisory board, except a 2022 letter from the head of the medical center announcing its formation. Hours after The Intercept sent questions about the clinical advisory board, the word “clinical” was removed from Shendelman’s trustee biography, which now described her as a vice chair of the board of advisors at the medical center.
“Columbia students and faculty are finding ourselves wondering about the real commitments and values of our board.”
“It’s a fundamental responsibility for all of us who conduct research at the medical center to do that work in accordance with the highest standards of ethical research,” said the first, tenured medical professor. “I don’t understand how we can have someone in a senior advisory position who doesn’t adhere to those same standards.”
The school is undergoing an unprecedented upheaval. Columbia’s governance structure used to be a triumvirate, with the board of trustees, the president of the university, and the university senate each playing influential roles. Amid the row over pro-Palestine student protests, however, the trustees appointed one of their own as acting president of Columbia. Now, the administration and board are seeking an overhaul of the university’s storied senate, a democratically elected body and the only part of the three-pronged governance structure where students and faculty hold mandated positions.
Looming over the power struggle is Columbia’s protracted $400 million fight with the Trump administration — a fight where, according to New York Magazine, critics think the hard-line pro-Israel wing of the board of trustees are ushering in Columbia’s capitulation. In the battle with Trump, the trustees and their allied university administration have shied away from answering to the senate, faculty, and other stakeholders. Among the students and faculty raising questions about the need for greater scrutiny of the trustees, Shendelman’s record at Applied Therapeutics is seen as a vindication of their concerns.
A third member of the Columbia faculty who asked for anonymity to avoid retaliation from the university said, “Whether it’s cooperating with the Trump attacks on science and dissent, the horror and cost of the Hadden affair, or now this, Columbia students and faculty are finding ourselves wondering about the real commitments and values of our board far more often than we should.”
Photo: Timothy A. Clary/AFP via Getty Images
Warning Letter
The FDA conducted an inspection in the spring of 2024 into Applied Therapeutics’s lead drug candidate, govorestat. With govorestat, Applied Therapeutics hoped to bring to market the first FDA-approved therapy for a rare pediatric metabolic disorder. The inspection was carried out under an FDA program to ensure compliance with standards around human test subjects in clinical trials.
The FDA investigation that followed reviewed the inspection report, related documents, and the company’s response. On November 27, the regulatory agency sent a letter addressed to Shendelman.
“This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between April 29 and May 3, 2024,” the letter says.
Applied Therapeutics, inspectors found, likely ran afoul of the Federal Food, Drug, and Cosmetic Act, as well as federal regulations that govern clinical studies. In a dense summary of a long back-and-forth with the company, the FDA specified two categories of deficiencies with the clinical trials.
The first was a failure to give FDA inspectors access to records related to clinical trials. On March 25, 2024, the FDA had informed Applied Therapeutics about a forthcoming inspection. Two days later, according to the letter, a third-party vendor deleted electronic records for all 47 subjects in one part of its clinical trials.
“As a result, during the sponsor inspection, FDA was unable to access and copy and verify records and reports relating to the study,” the letter says.
In response to an earlier correspondence from the FDA, according to the November 27 letter, Applied Therapeutics said that it was able to recover data for all but 11 subjects. And the company told the FDA that the vendor had not informed Applied Therapeutics about the deletion of the records.
“While we acknowledge Applied Therapeutics’ response, as well as the corrective and preventive actions that Applied Therapeutics has taken and plans to take, your response is inadequate because you did not include sufficient details about your corrective action plan,” the letter says. “Additionally, we remain concerned that electronic data collected for critical eCOAs” — electronic clinical outcome assessments — “was deleted and cannot be verified, which raises concerns about the validity and integrity of the data collected during the clinical investigation.”
The second major concern revolved around doses of the drug in question reported to the FDA. Because of mislabeling, from March to June 2021 at least 19 subjects in the Applied Therapeutics study had been administered a lower dose than required by the protocols of its study. In June 2021, Applied Therapeutics realized the error and notified its clinical sites, providing them with correct doses and updated pharmacy manuals.
In late 2023, two years after catching these mistakes, the company submitted a report to the FDA that did not, according to last year’s warning letter, disclose “the nature and extent of the dosing errors.”
“It’s certainly a serious problem for a company that doesn’t report this fully to FDA,” Henry Greely, a medical ethics expert and professor of law at Stanford University, told The Intercept.
The November FDA warning letter laid out further issues created by the delayed notification. “This failure raises significant concerns about the validity, reliability, and integrity of the data,” the letter says. “Furthermore, Applied Therapeutics’ failure to disclose this critical information raises significant concerns about the sponsor’s oversight and conduct of clinical investigations, including its compliance with the reporting requirements for human drug products.”
The FDA warning letter concludes, “We emphasize that as a sponsor, Applied Therapeutics has ultimate oversight of the clinical investigation, and was responsible for ensuring compliance with all applicable FDA regulations governing the conduct of clinical investigations.”
The drug regulator gave Applied Therapeutics 15 business days to outline how it would “prevent similar violations in the future.”
The Lawsuit
Just over a month later, on December 17, shareholders in Applied Therapeutics filed a class-action lawsuit against the company, Shendelman, and Riccardo Perfetti, the firm’s chief medical officer, who remains in his position today. The plaintiffs sought compensation and damages for losses sustained due to what they alleged was securities fraud, among other wrongdoing linked to deceiving shareholders. (Perfetti did not respond to a request for comment.)
The lawsuit alleges that Shendelman was made aware of issues with the application to the FDA after the agency’s spring 2024 clinical site inspection. Shendelman, the suit says, continued to make positive statements about the drug trials and the New Drug Application, or NDA, process despite knowing about the problems with the study. In May, shortly after the inspection, the lawsuit quotes Shendelman saying, “things are going very well with the FDA” — and that there are no “major sticking points.”
“We are incredibly pleased by the ongoing collaborative dialogue with the FDA during the NDA review process, and we look forward to continuing to work together with the agency to bring the first potential treatment to Classic Galactosemia patients,” Shendelman said in a September 2024 press release — issued weeks after an exchange of letters with the FDA over the deletion of clinical data.
On November 7, less than three weeks before the drug was rejected and the warning letter issued, Shendelman gave another rosy assessment.
“As we approach the final stages of the NDA review process for Classic Galactosemia in parallel with a near-term NDA submission for SORD Deficiency” — another rare metabolic disease — “we remain confident in the promise of govorestat and its ability to address the underlying mechanisms of both diseases,” Shendelman said. “We look forward to the opportunity to bring govorestat to patients in 2025.”
The November press release came two months after another exchange of letters between Applied Therapeutics and the FDA in early September where the company sought to explain that deletion of the data had been at the hands of a third-party vendor.
As Applied Therapeutics’s FDA application process moved forward, optimism about the company’s business prospects grew. The stock had made steady gains, more than doubling, from around $3.50 a share at the start of 2024 to more than $10 on the eve of the FDA’s rejection. In retrospect, the shareholders in the class-action suit said Shendelman’s rose-tinted assessments had buoyed the stock value.
“Defendants’ materially false and misleading statements artificially inflated the price of Applied common stock,” the lawsuit claims. “Plaintiff and the Class would not have purchased or otherwise acquired Applied securities at the prices they paid, or at all, had they known the truth.”
“Defendants’ materially false and misleading statements artificially inflated the price of Applied common stock.”
As she went back and forth with the FDA over the emerging problems with Applied Therapeutics’s clinical tests, Shendelman began to sell off her substantial holdings in the company, according to the lawsuit. Between early January and late November 2024, she sold more than 1 million shares, worth $6.6 million. The biggest sell-off came from August 12 to 14, a three-day period that saw Shendelman get rid of three-quarters-of-a-million shares, worth more than $4.7 million. The average price per share over those days was around $6.
In a filing responding to the lawsuit, Shendelman said some of her stock sales were for tax purposes and that, after selling off millions in stocks, she still owned a significant stake in the company. The court filing said that “the sheer size of Dr. Shendelman’s holdings after the Sales is entirely inconsistent with fraudulent intent.”
Her response says that her rosy public releases by a business can’t constitute fraud.
“Statements regarding the outlook and progress of drug development and interactions with the FDA are quintessential puffery and expressions of corporate optimism that cannot give rise to securities fraud under settled precedent,” her motion says.
Perfetti, the chief medical officer, moved to dismiss the lawsuit last Friday.
“At its core, this case is about a plethora of allegedly false and misleading statements made or caused to be made to the investing public by Applied Therapeutics, Inc. (‘Applied’ or the ‘Company’) and by Dr. Shoshana Shendelman,” his motion said. “To be sure, Plaintiff does not allege a single statement by Dr. Perfetti — not one — about the NDA or the regulatory process, let alone an actionable statement. Nor does Plaintiff plausibly allege any manipulative or deceptive acts by Dr. Perfetti that would make him a participant in Dr. Shendelman’s alleged scheme, or that he somehow controlled Applied or Dr. Shendelman and is therefore liable for their alleged violations.”
Within two days of news of the FDA rejection on November 27, the stock price tumbled to around $2. Five days after Shendelman received the FDA warning letter, the company acknowledged it in a Securities and Exchange Commission disclosure. A day later, the FDA posted a copy online.
Termination
On December 19, two days after the lawsuit was filed, Shendelman signed an agreement that terminated her employment at Applied Therapeutics — effective immediately. “Regardless of whether you sign this Agreement, the last day of your employment with the Company will be December 19, 2024,” the agreement said. Shendelman left her positions as Applied Therapeutics’s CEO, president, and chair of the board of directors. A day later, on December 20, the stock fell to $0.88. Since the eve of the FDA’s rejection less than a month earlier, the stock had lost around 90 percent of its value.
Her termination agreement said Shendelman would receive more than $3 million on her way out of the company.
Her termination agreement said Shendelman would receive more than $3 million on her way out of the company. She was paid a lump sum of nearly $1 million in cash severance, plus more than $2 million of payment for restricted stocks, of which some $700,000 would go directly to her attorney.
According to an examination of the Internet Archive, Columbia had not updated her board of trustees biography to reflect Shendelman’s departure from Applied Therapeutics until mid-April. By then, she already had other prospects: Since March 2025, according to her LinkedIn profile, Shendelman has been working as president of Retension Pharmaceuticals and Response Pharmaceuticals.
Once in her new positions at Retension and Response, Shendelman began inveighing against what she saw as one of the ills of the pharmaceutical world: FDA regulations.
“Now is the time for us to overhaul the archaic procedural measures, including the Food and Drug Administration’s (FDA) outdated policies and procedures,” Shendelman wrote in an op-ed earlier this month. “If we continue to permit bureaucracy to impede the advancement of science, then people will continue to die waiting for therapeutic advances — and that is unacceptable.”
Then, on a podcast that aired earlier this month, Shendelman again ripped FDA regulations in an episode titled “Innovation on Hold: The FDA’s Regulatory Standstill.”
When the podcast host asked Shendelman for an example of a drug slowed down by the FDA regulatory process that “should have been pushed through,” Shendelman responded with her own drug, govorestat.
“I believe that we showed a very strong safety and efficacy profile,” she said. Shendelman then added that there were no “patient safety issues or any patient safety concerns,” characterizing the FDA rejection as being purely bureaucratic — an assessment out of step with the FDA warning letter, which said the problems were relevant to the agency’s ability to draw solid conclusions about how well the drug worked or whether it was safe.
Even as she advocated for curtailing FDA meddling in drug development, the Columbia board of trustees she serves on was looking to involve itself in everything from academics to hiring to discipline. The small circle running the prestigious New York research university sought to be the ultimate regulatory body of campus life.
At a time when the university’s federal and research funding is under threat from the Trump administration, the trustees have been accused of running the university without seeking input from faculty, staff, and students. Their latest efforts to overhaul the university senate reinforced those concerns.
“Columbia’s governance structure resembles a triangle, with each side representing the Trustees, the President, and the University Senate, respectively,” the university senate student affairs committee co-chairs wrote in an April statement. “That triangle is now collapsing.”
The senate has been from time to time a thorn in the side of the board of trustees. In March, the senate released the sprawling “Sundial Report,” documenting what it said were university actions since October 7, 2023, that ran afoul of the school’s norms, traditions, and mission. The board came in for thinly veiled criticism; the report said the trustees ought to be “ultimately responsible for institutional fidelity to the University’s mission, integrity, and efficiency of its operations.”
For the medical center professor who was shocked by the FDA letter, the missteps made by Applied Therapeutics when Shendelman was at the helm also spoke to her ability to serve on the board.
“It shouldn’t be tolerated for anyone serving on the university’s board of trustees,” the professor said. “Shendelman is someone who is responsible for our fiduciary commitments at the university.”
