Aug. 11 at 5:34 PM
We are adding Amylyx Pharmaceuticals (NASDAQ:
$AMLX ) to the PRISM Emerging Pharmaceuticals Index.
Amylyx has completed the last participant visit in the 16-week double-blind portion of its pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia, with topline data expected in late August or early September. There are no FDA-approved therapies for PBH, and the company estimates the condition affects roughly 160,000 people in the U.S.
Management says NDA sections are being prepared now and a field medical affairs team is already deployed. A dedicated ICD-10 code for PBH takes effect October 1. Amylyx reports a cash runway into 2028, which the company expects to carry it through a potential 2027 launch if avexitide is approved.
We are tracking AMLX because the readout is close, the indication is uncontested, and they provide exposure to a first-in-class opportunity in an underserved metabolic condition.
https://prismmarketview.com/companies/amylyx-pharmaceuticals-inc/
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