Tracking FDA Priority Review Voucher (PRV) issuances, sales, redemptions and other FDA/Biotech news.
Joined January 2025
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PRV Watch retweeted
most people in biotech don't even know the PRV exists, but the data are there for anyone who's curious 📊👀
at the current clearing price of ~$200M, it now pays to invest in rare disease drug development
the demand for PRVs is going up because pharma is hungry for blockbusters
PRV Watch retweeted
Following President Trump’s directive to accelerate medical treatments for serious mental illnesses, FDA announced major steps to support the development of serotonin-2A agonists & related products—a class of medications historically referred to as "psychedelic" drugs.
✅ National priority vouchers for psilocybin (for treatment-resistant depression and major depressive disorder)
✅ National priority voucher for methylone (for post-traumatic stress disorder)
✅ First-ever noribogaine study authorized for alcohol use disorder
✅ Advancing guidance for sponsors developing these products
Learn more: fda.gov/news-events/press-an…
PRV Watch retweeted
Immedica wins accelerated approval for once-rejected rare disease drug, plans to sell PRV - endpoints.news/immedica-wins…
PRV Watch retweeted
Every minute the Priority Review Voucher program remains expired means lost hope for children with rare diseases.
Together with @alliancerm and over 60 CEOs at the forefront of rare disease innovation, the RDCC urges Congress to reauthorize this vital program.
PRV Watch retweeted
Thank you @DrMakaryFDA for reiterating support for the rare pediatric disease PRV program, a vital incentive that spurs innovation for children living with a rare disease. We are grateful for your recognition of the rare disease community as a top priority for the Administration.
PRV Watch retweeted
As @DukeFuqua professor Dr. David Ridley points out, the Priority Review Voucher program is a critical tool for rare disease innovators.
Every minute the PRV program remains expired, we risk losing out on life-saving treatments. Congress must reauthorize this important program.
PRV Watch retweeted
RDCC was back on Capitol Hill! Leaders from @argenxglobal, @Ultragenyx, @alexionpharmaus, and @bridgebiopharma advocated for the reauthorization of the PRV program.
Congress must act now to pass the Give Kids a Chance Act. The #raredisease community can’t afford to wait.
PRV Watch retweeted
Leaders from RDCC member companies, including @Neurocrine, @BridgeBioPharma, and @Stoketx, were on Capitol Hill this week, advocating for the reauthorization of the PRV program.
The PRV program is a proven policy - Congress must act now to pass the Give Kids a Chance Act.
