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An announcement from Clinuvel Pharmaceuticals ( (AU:CUV) ) is now available.
Clinuvel Pharmaceuticals said the U.S. Food and Drug Administration has removed a requirement for a post‑authorisation cardiac repolarisation, or QT, study for its flagship drug SCENESSE after reviewing extensive long‑term safety data. The decision reflects the regulator’s confidence in the therapy’s safety profile, easing Clinuvel’s postmarketing obligations and reinforcing SCENESSE’s position as the only approved treatment for erythropoietic protoporphyria, a rare metabolic disorder, after more than 20,000 doses administered worldwide.
The most recent analyst rating on (AU:CUV) stock is a Buy with a A$39.20 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.
More about Clinuvel Pharmaceuticals
Clinuvel Pharmaceuticals is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic and acute life‑threatening disorders. A pioneer in photomedicine and melanocortin peptides, its lead therapy SCENESSE is the first systemic photoprotective drug, approved in multiple regions for preventing phototoxicity in adults with erythropoietic protoporphyria.
YTD Price Performance: -27.45%
Average Trading Volume: 114,462
Technical Sentiment Signal: Sell
Current Market Cap: A$455.9M
Learn more about CUV stock on TipRanks’ Stock Analysis page.