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Fifth Third Bancorp bought a new stake in Palvella Therapeutics, Inc. (NASDAQ: PVLA) in the undefined quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The institutional investor bought 19,947 shares of the company's stock, valued at approximately $2,486,000. Fifth Third Bancorp owned approximately 0.14%
Brings more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options
FDA's rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted
4,302 common shares were exercised and sold on June 17, 2026, for $476,000 at a weighted average price of around $110.73 per share. This was a derivative transaction involving the exercise and immediate sale of options.
FDA's rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted
Palvella Therapeutics, Inc. (PVLA) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Palvella Therapeutics is now a much more credible bet on QTORIN after their positive mLM data. They've also received some FDA feedback, which bodes well for their upcoming NDA submission. PVLA is now targeting a 2H2026 NDA submission for QTORIN rapamycin in mLM.
Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced completion of its pre-New Drug Application (NDA) meeting with FDA for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) in microcystic lymphatic malformations (microcystic LMs).
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Transcripts source: company-published earnings calls. Speaker attribution and formatting are processed in-app.