Matthew Herper
@matthewherper
Writing and events at STAT. This is biology's century; Every data point has a face. ‘21 Polk Award. Signal: MattHerper.92
This is a fairly shocking detail in @adamfeuerstein and @Jasonmmast's latest story on why the FDA acted when it did in response to most recent $SRPT patient death:
EXCLUSIVE: Sarepta Therapeutics’ $SRPT Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says statnews.com/2025/07/22/fda… via @Jasonmmast and me.
To recap what we are reporting on $SRPT and its Duchenne gene therapy. A senior FDA official told us that Elevidys faces an “arduous and treacherous path” to try to get it back onto the market. It would be difficult for Sarepta to prove that any new safety protocols could…
SCOOP from @adamfeuerstein, @Jasonmmast: Sarepta’s Duchenne therapy faces an "arduous" path back to market, a senior FDA official says, suggesting the treatment’s license could be revoked statnews.com/2025/07/22/fda…
Ozzy Osbourne dies: Legendary singer of Black Sabbath passes away at age 76 independent.co.uk/arts-entertain…
FDA now saying up to 5 companies can win one of these new vouchers in the pilot
Companies aligned with U.S. national priorities can now submit statements of interest for participation in the Commissioner’s National Priority Voucher (CNPV) pilot program. Statements of interest are capped at 350 words! More details here: FDA.gov/CNPV
This might be the most brilliant X comment spam post I've seen.
Great progress at Orbital using targeted LNPs for in vivo delivery to T cells — happy to be partnered and supporting this exciting therapeutic approach:
Circular RNA startup Orbital unveils first monkey data as it enters in vivo CAR-T cell therapy race - endpoints.news/circular-rna-s… via @endpts @RLCscienceboss
Quite the uproar over Prasad's past, especially since the CBER director role is not in a political one (or is it?)
🚨 ALERT 🚨 VINAY PRASAD, THE LEFTIST SABOTEUR UNDERMINING TRUMP’S @US_FDA, MUST BE FIRED NOW! We have a crisis at the FDA! A wolf in sheep’s clothing is sabotaging President Trump’s bold “Make America Healthy Again” (MAHA) agenda! Dr. Vinay Prasad @VPrasadMDMPH, a…
Reporting spam replies on X is starting to make one feel like a doctor trying to order an unusual medicing on EPIC.
RFK Jr. Turns to Fringe Medical Journal to Find New Hires bloomberg.com/news/articles/…
Whoa whoa whoa - I was told vaccines were uninvestable
Sanofi $SNY to buy vaccine biotech Vicebio for $1.15B upfront statnews.com/2025/07/22/san… via @DrewQJoseph
this is a problem for biotech re $REPL "The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews. " without communication from the FDA very difficult for small biotechs to manage cc @DrMakaryFDA
Sanofi $SNY to buy vaccine biotech Vicebio for $1.15B upfront statnews.com/2025/07/22/san… via @DrewQJoseph
Drugmakers are racing to help patients stay awake — and could also make billions A great read from my colleague @elaineywchen reporting on the development of orexin inhibitors $ALKS $CNTA $TAK Link below...
The FDA rejected a viral-based treatment from Replimune Group for patients with advanced skin cancer — a decision that signals a hardened stance on drug approvals from Vinay Prasad, the top regulator of cell and gene therapies. By @adamfeuerstein statnews.com/2025/07/22/rep…
$SRPT With Elevidys paused, risk to balance sheet and solvency is an issue again. Obviously, will depend on how long Elevidys remains off the market, and whether Sarepta can restructure debt if necessary.
BREAKING: In surprise reversal, Sarepta $SRPT says it will pause shipments of Duchenne gene therapy statnews.com/2025/07/21/sar… via @Jasonmmast and me
I just subscribed to @statnews specifically to stay on top of this story. . . And I’m a device doc. Amazing story that has ramifications well beyond drugs for Duchenne.
BREAKING: In surprise reversal, Sarepta $SRPT says it will pause shipments of Duchenne gene therapy statnews.com/2025/07/21/sar… via @Jasonmmast and me
$SRPT just announced pause to all Elevidys shipments in the US.