Novavax, Inc.

FDA The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.” Shares of several biotechs tumbled Monday after news broke this weekend that Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, had resigned. Marks’ “abrupt resignation” equals a “new wave of uncertainty at FDA,” BMO Capital Markets said in a Monday investor note. Marks, who has helmed the CBER division since 2016, has been a staunch supporter of vaccines, accelerated approval and regulatory flexibility for gene therapies for rare diseases . While Marks had made clear his intention to stay in his role under the new Trump administration, he was forced Friday to choose between resignation and being fired, according to several media outlets . In his resignation letter , Marks said he was “willing to work” to address the concerns expressed by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. about the safety of vaccinations. However, “it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” he wrote. Kennedy, who was confirmed as HHS secretary in February, has a long history of vocal vaccine mistrust—something that was broadly raised during his Senate confirmation hearings . “We view this departure as a significant negative for the biopharma and biotech sectors, as FDA’s independence rooted in sound scientific rigor is critical for their efficient functioning,” the BMO analysts added in their note. Marks’ departure follows that of several other prominent FDA leaders, including Patrizia Cavazzoni, who left her post as head of the agency’s Center for Drug Evaluation and Research (CDER) in January, resurfacing as Pfizer’s new chief medical officer last month. According to a Monday investor note by William Blair, Oncology Center of Excellence (OCE) deputy directors Paul Kluetz and Marc Theoret also plan to leave the agency “imminently” and “there are concerns that [OCE Director] Richard Pazdur . . . may also be at risk of leaving.” As was indicated by Marks in his resignation letter, the main points of contention between him and Kennedy were vaccine safety and transparency , the latter of which has also been a concern for the FDA and biotech companies since President Donald Trump took office in January. In reference to the job cuts enacted at the FDA in February shortly after Kennedy’s confirmation, Ovid Therapeutics CEO Jeremy Levin told BioSpace , “The extent and the rapidity of the actions taken has been remarkable, and that has perhaps led to, in many cases, the concern that there is no understanding of exactly why they’re being done.” In a LinkedIn post this weekend, Levin expressed “grave concern” over Marks’ resignation. “His resignation is far more than the departure of a highly respected figure. It is a stark and unequivocal warning,” Levin wrote. “In this letter—especially in the final paragraphs—Dr. Marks makes clear that the FDA, long held as the gold standard in global regulatory science, is now under threat from political interference and the systematic distortion of scientific truth.” The biotech stock market appeared to heed this warning, as gene therapy– and vaccine-focused companies including Taysha Gene Therapies, Solid Biosciences, Sarepta and Novavax, all fell between 5% and 10% before the bell on Monday, Reuters reported . “Our industry conversations over the weekend suggest the resignation of Dr. Peter Marks . . . was a negative surprise, and we expect companies with vaccine businesses to be volatile this week as investors digest this update,” Truist Securities wrote in a note Monday morning. The analysts also expressed concern that “a CBER yes-person may expand the influence of RFK Jr’s vaccine rhetoric.” Marks’ last day at CBER will be this Saturday, April 5.

International vaccine organization Gavi has discontinued a COVID vaccine partnership with China's Clover Biopharmaceuticals and is asking for repayment of $224 million. Last year, Novavax reached a settlement with Gavi, the Vaccine Alliance, after the international partnership demanded repayment following the termination of an advance purchase agreement for COVID-19 vaccines.Thirteen months later, Gavi may be on its way to a similar skirmish with China’s Clover Biopharmaceuticals after discontinuing another purchase agreement surrounding COVID shots.In a regulatory filing, the Shanghai-based company said that Gavi has sent notice of the termination of their vaccine deal and is demanding that the company return an advance payment of $224 million. “The Company rejects such claim for a repayment, believing it is without merit based on the terms of the Advance Purchase Agreement, and will defend itself vigorously,” Clover wrote, adding that it was not aware of any associated legal claims.Gavi did not respond immediately to a request for comment. In June of 2021, Clover and Gavi signed on to their partnership, with the company agreeing to provide up to 414 million doses of SCB-2019, its protein-based COVID shot, through 2022. But like Novavax, Clover struggled to meet regulatory targets in developing its vaccine.If Gavi succeeds in its latest demand, Clover may not have enough cash to pay the organization back. The biotech is struggling financially. In its most recent earnings release, after the first half of 2024, the company reported negative revenue. Its cash and cash equivalents had shrunk from 1.8 billion Chinese yuan ($248 million) at the end of 2022 to 830 million Chinese yuan ($114 million).  With the COVID shot now a dud, Clover is banking its future on a respiratory syncytial virus (RSV) vaccine candidate coded SCB-1019. The company also revealed on Monday that the FDA has cleared its application to start an in-human clinical trial of the non-adjuvanted bivalent RSV vaccine.The company added that it has enrolled the first participants in a phase 1 revaccination trial of the prefusion-stabilized F (PreF)-Trimer subunit shot. Results from another phase 1 trial last year indicated that SCB-1019 is a potential best-in-class vaccine compared to GSK’s Arexvy, Clover said.

BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market. Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession: obesity. In this space, Novo Nordisk has had a rough week, reporting lower-than-expected results from a second straight trial of its next-gen weight loss drug CagriSema. And in an effort to protect revenues from its blockbuster weight-loss drug Wegovy, Novo jumped into the legal battle between the FDA and compounding pharmacies over the regulator’s decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing “multiple metric tons” of its investigational obesity medication VK2735 in a deal with CordenPharma. Meanwhile, companies continue to tackle adverse events associated with GLP-1s. Another space that has seen its fair share of failures in the past couple of years is depression. The latest flop comes from J&J, which announced it would discontinue its a kappa opioid receptor blocker aticaprant after a disappointing Phase III readout. J&J joins Biogen and Sage Therapeutics, Relmada Therapeutics and Alto Neuroscience, all of whom have suffered regulatory misses or trial flops. Finally, two of Donald Trump’s healthcare nominees, Marty Makary and Jay Bhattacharya , sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.