I don't have access to Stat but here is a similarly-titled article: Sarepta reportedly hired Trump-linked lobbying firm after gene therapy deaths seekingalpha.com
Sarepta Therapeutics (NASDAQ: SRPT) has hired a lobbying firm with close ties to the Trump administration as regulatory scrutiny intensified after two young males who received its gene therapy Elevidys died early this year, according to investigative journalist Lee Fang.
The Cambridge, Massachusetts-based biotech has lost over $10B of its value this year, as critics linked the deaths to the FDA-approved therapy it markets with Roche ( OTCQX:RHHBY) ( OTCQX:RHHBF) for a rare disease called Duchenne muscular dystrophy.
Amid mounting public backlash, on June 10, the company contracted Michael Best Strategies, LLC, where the most notable influence peddler was Chris LaCivita, a former co-manager of President Donald Trump’s 2024 campaign.
According to a lobbying report submitted under Sarepta (NASDAQ: SRPT), Michael Best Strategies disclosed that it worked with the White House, Congress, and the HHS on “rare disease therapeutic development and access” during Q2.
However, following the death of another patient who received a similar gene therapy developed by Sarepta (NASDAQ: SRPT), the company and Roche ( OTCQX:RHHBY) paused the commercial shipments of Elevidys as the FDA imposed a clinical hold on its studies focused on similar treatments.
The regulator made a U-turn several days later, allowing the company to resume U.S. shipments of Elevidys for ambulatory patients with DMD.
In the same week, Vinay Prasad, who headed the FDA division responsible for gene therapies, including Elevidys, resigned abruptly as Trump reportedly called for his resignation despite objections from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. |