Palvella Therapeutics, Inc. (PVLA) News
Follow Palvella Therapeutics, Inc. (PVLA) news in one place: company catalysts, earnings, analyst actions and wider market developments. Review 15 public stories across 9 publication days to understand how the story developed. Public news appears after a 15-minute delay; LiveCast subscribers can follow new headlines and hear important updates without this additional delay.
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Palvella Therapeutics, Inc. (PVLA) Gets More FDA Orphan Funding; NDA Filed for QTORIN
Palvella received a third year of FDA Orphan Products grant funding supporting its Phase 3 SELVA program for QTORIN rapamycin. The NDA has been completed following positive Phase 3 results; potential U.S. launch in H1 20
REGULATION | Sep 28, 2026, 11:32 AM UTC
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U.S. Food and Drug Administration Awards Additional Funding for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approvedQTORIN™ rapamycin has the potential to become the first FDA-approved therapy and e
REGULATION | Sep 28, 2026, 11:32 AM UTC
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PVLA: NDA for QTORIN rapamycin submitted; commercial launch and pipeline expansion expected next year
Focused on first-in-disease therapies for rare skin and vascular diseases, the company has submitted an NDA for QTORIN rapamycin and is advancing multiple clinical programs with strong FDA support. Launch planning is rob
REGULATION | Sep 15, 2026, 05:02 PM UTC
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PVLA files NDA for QTORIN microLM; FDA approval expected in 2027
PVLA advanced its QTORIN platform for rare skin and vascular diseases, filing a lead NDA for microLM and anticipating FDA approval in 2027. The company cites strong IP, regulatory exclusivity and clinical data.
REGULATION | Sep 09, 2026, 06:52 PM UTC
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Palvella Therapeutics names James R. Treat as Chief Medical Officer
Palvella Therapeutics appointed James R. Treat, M.D., a pediatric dermatologist, as Chief Medical Officer, citing expertise in cutaneous vascular anomalies and nearly 20 years of clinical, research and academic experienc
EQUITY | Sep 09, 2026, 11:32 AM UTC
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Palvella Therapeutics appoints James R. Treat as Chief Medical Officer
Palvella Therapeutics appointed James R. Treat as Chief Medical Officer.
EQUITY | Sep 09, 2026, 11:30 AM UTC
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PVLA appoints James R. Treat as Chief Medical Officer
PVLA appointed James R. Treat, M.D., as Chief Medical Officer.
EQUITY | Sep 09, 2026, 11:30 AM UTC
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Palvella Therapeutics to participate in upcoming healthcare investor conferences
Palvella Therapeutics, Inc. said it will participate in upcoming healthcare investor conferences, according to a Globe Newswire announcement.
EQUITY | Sep 02, 2026, 11:37 AM UTC
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PVLA - Palvella Therapeutics to Participate in Upcoming Healthcare Investor Conferences
PVLA - Palvella Therapeutics to Participate in Upcoming Healthcare Investor Conferences
EQUITY | Sep 02, 2026, 11:30 AM UTC
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PVLA - Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
PVLA - Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
EARNINGS | Aug 04, 2026, 11:30 AM UTC
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PVLA - Palvella Therapeutics Chief Scientific Officer Jeff Martini, Ph.D. Selected to Present at Upcoming FDA Public Workshop on Drug Repurp
PVLA - Palvella Therapeutics Chief Scientific Officer Jeff Martini, Ph.D. Selected to Present at Upcoming FDA Public Workshop on Drug Repurposing
REGULATION | Jul 30, 2026, 11:30 AM UTC
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H.C. Wainwright says Palvella selloff 'an overreaction' to FDA's BTD denial
H.C. Wainwright notes...
EQUITY | Jul 21, 2026, 05:12 PM UTC
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Palvella Therapeutics Submits First Module Of Rolling NDA To FDA Seeking Approval Of QTORIN 3.9% Rapamycin Anhydrous Gel For Treatment Of Mi
Palvella Therapeutics submits first module of rolling NDA to FDA for QTORIN 3.9% rapamycin anhydrous gel approval
REGULATION | Jun 29, 2026, 11:33 AM UTC
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PVLA: FDA Starts Review
Palvella Therapeutics announces FDA rolling review of its new drug application for Qtorin Rapamycin
EQUITY | Jun 22, 2026, 11:41 AM UTC
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PVLA: FDA Grants Rolling Review
Palvella's QTORIN Rapamycin NDA for Microcystic Lymphatic Malformations receives rolling review from FDA
EQUITY | Jun 22, 2026, 11:30 AM UTC