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Up to nine months durability of effect observed in patients aged 55 to 76 in the extension cohort following administration of high dose KB301Mean change in Subject Satisfaction Scores from baseline...
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• Received US FDA filing acceptance of B-VEC BLA with Priority Review designation for treatment of dystrophic epidermolysis bullosa; PDUFA target action date of February 17, 2023 • Notified of no...
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PITTSBURGH, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the...
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• Das Unternehmen befindet sich im Zeitplan, um im vierten Quartal 2022 einen Zulassungsantrag für Europa zu stellen • Es sind keine weiteren Studien erforderlich PITTSBURGH, Sept. 23, 2022...
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• La Société est sur la bonne voie pour soumettre sa demande de mise sur le marché européen au 4e trimestre 2022 • Aucune étude supplémentaire n'est requise PITTSBURGH, 23 sept. 2022 (GLOBE...
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• Company on track to submit European marketing application in Q4 2022 • No additional studies required PITTSBURGH, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”)...
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PITTSBURGH, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the...
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FDA granted Priority Review designationPDUFA target action date is February 17, 2023FDA stated that it is not currently planning to hold an advisory committee meeting PITTSBURGH, Aug. 18, 2022 ...
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Biologics License Application for B-VEC filed with the FDA on June 22, 2022FDA accepts IND on KB407 for the treatment of Cystic FibrosisStrong balance sheet, closing the quarter with $438.5 million in...
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Krystal Biotech Announces FDA Acceptance of KB407 IND Application for Cystic Fibrosis Clinical Trial
KB407 is an investigational, redosable gene therapy candidate designed to treat all patients with cystic fibrosis regardless of the underlying genetic mutation PITTSBURGH, Aug. 01, 2022 (GLOBE...