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Palvella Therapeutics

PVLA

Market cap $2.12B

147.47 USD

+14.56

10.95%

At close Updated Oct 28, 4:00 PM EDT

Pre-market

After hours

143.30

-4.17

2.83%

1 day

10.95%

5 days

17.89%

1 month

5.46%

3 months

3.24%

6 months

17.08%

Year to date

47.06%

1 year

100.64%

5 years

-60.7%

10 years

21.27%

About: Palvella Therapeutics Inc is a clinical-stage biopharmaceutical company whose vision is to become the rare disease 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 FDA-approved therapies. Its product candidate, QTORIN 3.9% rapamycin anhydrous gel, is currently in clinical development for microcystic lymphatic malformations and cutaneous venous malformations. It operates in single segment.

Employees: 29

Healthcare Biotechnology

News

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Sentiment 3-Months

Positive 31.3%

Neutral 68.8%

Negative 0%

Palvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set

QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S.

Palvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set

Palvella Therapeutics Eyes QTORIN Launch as Rare-Disease Pipeline Expands

Palvella Therapeutics NASDAQ: PVLA is preparing for a potential commercial launch of QTORIN rapamycin while advancing additional rare skin and vascular anomaly programs, Chief Financial Officer Matt Korenberg said during a Chardan investor session.

Palvella Therapeutics Eyes QTORIN Launch as Rare-Disease Pipeline Expands

Palvella Therapeutics to Present Phase 3 SELVA and Phase 2 TOIVA Results, Along With New Pediatric Analyses, at 2026 PeDRA Annual Conference

Phase 3 SELVA Pediatric Analyses Highlight Improvements in Overall Disease Severity and a Blinded Combined Score of Lesion Height, Vesicle Appearance, and Leaking/Bleeding

Palvella Therapeutics to Present Phase 3 SELVA and Phase 2 TOIVA Results, Along With New Pediatric Analyses, at 2026 PeDRA Annual Conference

Palvella Therapeutics to Participate in the Chardan 10th Annual Healthcare Conference

WAYNE, Pa., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular anomalies for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that members of its management team will participate in a fireside chat at the Chardan 10th Annual Healthcare Conference on Tuesday, October 20, 2026, at 1:45 p.m. ET. A live webcast of the fireside chat will be available on the Events and Presentations section of Palvella's website at www.palvellatx.com.

Palvella Therapeutics to Participate in the Chardan 10th Annual Healthcare Conference

Palvella Therapeutics: FDA Handholding Makes The Regulatory Story Stronger

Palvella Therapeutics, Inc. advances QTORIN rapamycin for microcystic lymphatic malformations, completing NDA submission with strong Phase 3 data and FDA rolling review. Regulatory risk is now significantly reduced, with the FDA awarding a third year of OOPD funding post-positive Phase 3 results and no further efficacy studies required. PVLA's robust $250.6 million cash position supports manufacturing, regulatory, and launch efforts ahead of a targeted US commercial launch in H1 2027.

Palvella Therapeutics: FDA Handholding Makes The Regulatory Story Stronger

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 approved

U.S. Food and Drug Administration Awards Additional Funding for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

Palvella Therapeutics Appoints James R. Treat, M.D.

Brings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas

Palvella Therapeutics Appoints James R. Treat, M.D.

Palvella Therapeutics to Participate in Upcoming Healthcare Investor Conferences

WAYNE, Pa., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in two upcoming healthcare investor conferences.

Palvella Therapeutics to Participate in Upcoming Healthcare Investor Conferences

Palvella Therapeutics Completes Rolling Submission of New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.

Palvella Therapeutics Completes Rolling Submission of New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

Palvella Therapeutics: First Approval Could Unlock A Rare-Disease Commercial Flywheel

Palvella advances QTORIN rapamycin, targeting microcystic lymphatic malformations, with positive Phase 3 SELVA data and a rolling NDA submission underway. PVLA leverages a repeatable regulatory and commercial platform, aiming to expand QTORIN across multiple mTOR-driven dermatological indications, supporting a multi-indication commercial flywheel. Strong liquidity from a recent $230M equity raise enables PVLA to invest in commercialization and pipeline expansion, mitigating typical small biotech funding risks.

Palvella Therapeutics: First Approval Could Unlock A Rare-Disease Commercial Flywheel

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