Tracking FDA Priority Review Voucher (PRV) issuances, sales, redemptions and other FDA/Biotech news.
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Interesting approach, commitment to returning 25% of a potential future PRV sale directly to shareholders.
Atossa Therapeutics Announces Plan to Issue Stapled CVR for Shareholders Tied to Potential Rare Pediatric Disease Priority Review Voucher.
Read more: bit.ly/4AUcmQ2 $ATOS
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The 5th rare disease priority review voucher issued THIS MONTH!!
Egetis Therapeutics receives FDA approval today for Emcitate (tiratricol) to treat peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome. With this approval Egetis is awarded a Rare Pediatric Disease Priority Review Voucher.
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Attended a talk about carbon credits today, a lot of parallels weirdly with the priority review voucher program.
- without financial incentive, companies wouldn’t address the need
- the concept has led to new companies forming to capitalize
- traded between companies and available supply dictates price
- smaller companies create and large ones buy for commercial benefit
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The Priority for Pediatric Cures Act, seeks to permanently authorize the rare pediatric disease priority review voucher program.
A very simple, one issue Bill, without any contentious add-ons. Hoping this means that it will go through Congress and the Senate without delay.
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Scholar Rock $SRRK gets FDA approval for Isembyld (apitegromab-mstn) to treat spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment. With this approval they get a Priority Review Voucher.
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✅ 73 new products for pediatric rare diseases
✅ >$6.5B in new revenue from priority review voucher sales
✅ $0 cost to the U.S. government to run the PRV programs
all of biotech: god i wish we could have clinical trial abundance…
rare genetic diseases: hi
all of biotech: if only there were ultra-fast and low-cost in-human clinical trial validation loops that we could leverage in the US under existing regulatory frameworks…
rare genetic diseases: 👋 over here
all of biotech: oh didn’t see you at first have you been standing there this entire time?
rare genetic diseases: 😘 mhmm
all of biotech: and you can make money making cures using the Prioritity Review Voucher — PRV — which currently sell for $200M?
rare genetic diseases: 😎 you know it sugar
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"Score every dollar on three questions before you sign. What does it cost in ownership? How fast does it close? What did you give up permanently?
Grants cost time. Royalties cost future economics. Licenses cost territory. Equity costs the company itself.
Raise in that order. Start eighteen months early. And answer the board’s question about which program to fund before the market answers it for you."
Enjoyed this article from David H. Crean, CBO of MediciNova. (I have no affiliation with the author, company or publication, I just like the article)
Edit: formatting
oncozine.com/financing-the-l…
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Fun fact, Xuriden (uridine triacetate) was approved in 2015 by the FDA for hereditary orotic aciduria, a rare disorder with less than 30 cases reported. Xuriden was approved from clinical data of four patients... and was awarded a Priority Review Voucher. FOUR patients to a PRV.
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Ionis Pharmaceuticals, Inc. receives FDA approval today for Zanvastro (zilganersen). The first FDA-approved treatment for Alexander disease, a rare progressive neurological disorder. With this approval, Ionis were awarded a Rare Pediatric Disease Priority Review Voucher.
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I missed this. $MRK Merck in Q2 earnings on Aug 4 said they'll use the Commissioner's National Priority Voucher for the FDA filing of sac-TMT in endometrial cancer. The voucher was awarded for triple-negative breast cancer, unclear if they'll get expedited review for this too.
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