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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?


To: luckydog88 who wrote (63219)8/6/2025 4:32:34 PM
From: bodish1 Recommendation

Recommended By
jhcimmu

  Respond to of 63282
 
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.



To: luckydog88 who wrote (63219)8/7/2025 3:15:42 AM
From: ghettogoulash  Respond to of 63282
 
Clickbait. For $400 you can unlock this exclusive report: Big Pharma has lobbyists! Wait... what?

The real issue with Sarepta is complacency. By god, I think they considered themselves Big Pharma. Dumb asses should have raised money at $100+ before licensing with Arrowhead. (Avoro has a big position in Arrowhead as well as Sarepta, as per last filing.) Now they are forced to cut 36% of their workforce and have to contend with a $1B note due in 2027. Well, it was basically free money at 1.25% and can surely be refinanced, worst case scenario? To be honest, I am horrible with financials.

Sarepta had $850 in cash last quarter, $1B in annual revenue exclusive of the "controversial" Elevidys, and 85% margins on all of these drugs. Arrowhead seems to represent next generation technology, so ok. Sarepta's viral vector may be seen as barbaric ten years from now-- today, patients do not have any alternative. The main risk here is a death in ambulatory DMD after 700+ doses, but patient families will probably still want the therapy anyway.

Believe it or not, Trump (after canning Prasad) is actually the voice of reason in all of this contentious, self-serving muck:

July 31, 2025

The Trump administration is considering a major overhaul of FDA’s biologics division that would split the Center for Biologics Evaluation and Research (CBER) into two separate bodies -- one focused solely on vaccines and another on therapeutic biologics, according to a person familiar with the discussion.


The Arrowhead transaction: