Palvella Therapeutics Inc

Palvella Therapeutics Inc(PVLA)资讯与事件

$126.580

+2.721 (+2.15%)收盘时

PVLA 资讯

PVLA 事件

9/28 08:00

Palvella Therapeutics Receives Third Year Grant from FDA

Palvella Therapeutics announced that the Company has received a third year of grant funding from the FDA Office of Orphan Products Development. The funding supports the Phase 3 SELVA trial and ongoing open-label extension study of QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations. The award follows FDA review of Palvella's annual performance progress report, which included results from the Phase 3 SELVA trial.

8/31 08:00

Palvella Therapeutics Completes NDA Submission for Qtorin

Palvella Therapeutics announced that the company has completed the rolling submission of its new drug application, or NDA, to the FDA seeking approval of Qtorin 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations, a serious, rare, and chronically debilitating genetic disease for which there are currently no FDA-approved therapies.

8/4 09:00

Palvella Completes NDA Submission Preparation for QTORIN

"We made significant progress during the second quarter, completing our pre-NDA meeting with FDA and initiating the rolling NDA submission for QTORIN rapamycin in microcystic lymphatic malformations," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "We are working closely with FDA under the program's Breakthrough Therapy and Fast Track designations to expedite development and review, with the objective of potentially introducing the first approved therapy to pediatric and adult patients living with this serious, lifelong disease. Completion of the NDA submission remains on track for the second half of 2026, and we are preparing for a planned standalone commercial launch in the first half of 2027, if approved. We have recruited commercial and medical affairs leaders with deep experience in rare disease and dermatology who are now in the field executing key pre-launch activities, while we continue to advance our other rare disease programs and pursue additional opportunities across the QTORIN platform."

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