Welcome to our dedicated page for Palvella Therapeutics news (Ticker: PVLA), a resource for investors and traders seeking the latest updates and insights on Palvella Therapeutics stock.
Palvella Therapeutics Inc (PVLA) is a clinical-stage biopharmaceutical company pioneering therapies for rare genetic skin diseases through its QTORIN platform. This page serves as the definitive source for official press releases, clinical trial updates, and regulatory developments.
Investors and researchers will find timely updates on the company’s lead product candidate—a rapamycin anhydrous gel targeting microcystic lymphatic malformations—along with pipeline progress and strategic partnerships. Content spans clinical trial milestones, regulatory submissions, and scientific collaborations, providing a comprehensive view of PVLA’s advancements.
Bookmark this page to stay informed about breakthroughs in genetic dermatology and Palvella’s role in addressing unmet medical needs. Check regularly for verified updates directly from the company and trusted industry sources.
Palvella Therapeutics (NASDAQ: PVLA) has announced groundbreaking research on lymphatic malformations (LMs) with cutaneous involvement in the U.S., to be presented at the Society for Investigative Dermatology Annual Meeting in May 2025.
The medical claims-based analysis, conducted over 7 years using Komodo Health data, reveals an estimated 44,553 high probability LM patients (with ≥2 diagnosis claims) and 48,414 potential LM patients (with ≥1 diagnosis claim), totaling up to 92,967 patients with cutaneous involvement.
The research, led by Dr. Ionela Iacobas from Texas Children's Hospital and David Lapidus from LapidusData, represents the first quantitative analysis of the U.S. LM population using medical claims data. The findings indicate growing demand for multidisciplinary care in complex vascular anomalies treatment.
Palvella Therapeutics (PVLA) has been granted its fifth U.S. patent (No. 12,268,673) for QTORIN™ rapamycin, extending patent protection until 2038. The patent broadens protection for QTORIN™ 3.9% rapamycin anhydrous gel and its clinical applications in treating microcystic lymphatic malformations (LMs).
QTORIN™ rapamycin has received multiple FDA designations including Breakthrough Therapy, Orphan Drug, and Fast Track for treating microcystic LMs. If approved, it could become the first FDA-approved therapy for this rare genetic skin disease and receive seven years of orphan drug market exclusivity in the U.S.
Palvella Therapeutics (PVLA) announced that QTORIN™ rapamycin 3.9% anhydrous gel for treating microcystic lymphatic malformations (LMs) was featured in an oral presentation at the 15th World Congress of Pediatric Dermatology. The presentation highlighted the expansion of the Phase 3 SELVA trial to include children 3-5 years old.
The Phase 2 study showed promising results with 100% of participants showing improvement, including 41.7% 'Very Much Improved' and 58.3% 'Much Improved' according to clinical assessment. The ongoing Phase 3 SELVA trial, targeting 40 subjects across 13 U.S. centers, is expected to deliver top-line results in Q1 2026.
QTORIN™ rapamycin has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations from the FDA, along with a $2.6 million Orphan Products Grant. If approved, it would become the first FDA-approved therapy for microcystic LMs in the U.S.
Palvella Therapeutics (Nasdaq: PVLA), a clinical-stage biopharmaceutical company specializing in treatments for rare genetic skin diseases, has announced its upcoming participation in the Jones Healthcare and Technology Innovation Conference.
The company's Founder and CEO, Wes Kaupinen, will engage in a fireside chat on Wednesday, April 9, 2025, at 2:00 p.m. PT. The presentation will be accessible through a live webcast on the Events and Presentations section of Palvella's website (www.palvellatx.com), with the replay remaining available for approximately 90 days afterward.
Palvella focuses on developing novel therapies for serious rare genetic skin conditions that currently lack FDA-approved treatments.
Palvella Therapeutics (Nasdaq: PVLA) has announced a late-breaking oral presentation at the 15th World Congress of Pediatric Dermatology in Buenos Aires, Argentina (April 8-11, 2025). The presentation will focus on SELVA, a 24-week Phase 3 clinical trial evaluating QTORIN™ rapamycin 3.9% anhydrous gel for treating microcystic lymphatic malformations.
The presentation, titled 'SELVA: A Phase 3 study with a fit-for-purpose primary endpoint evaluating QTORIN™ 3.9% rapamycin anhydrous gel in the treatment of microcystic lymphatic malformations in patients 3 years of age and older,' will be delivered by Dr. Amy Paller from Northwestern University's Feinberg School of Medicine during the Free Communications VII session on April 11, 2025.
Palvella Therapeutics (NASDAQ: PVLA) reported its full year 2024 financial results and corporate updates. The company completed a merger and raised $78.9 million through a private placement from healthcare investors in December 2024. Key financial highlights include:
- Cash position of $83.6 million as of December 31, 2024, expected to fund operations into second half of 2027
- R&D expenses of $8.2 million (vs $8.8 million in 2023)
- G&A expenses increased to $5.9 million (vs $3.1 million in 2023)
- Net loss of $17.4 million or $7.83 per share
Pipeline updates: The company's lead product QTORIN™ rapamycin is advancing in two clinical trials:
- Phase 3 SELVA trial for microcystic lymphatic malformations (results expected Q1 2026)
- Phase 2 TOIVA trial for cutaneous venous malformations (results expected Q4 2025)
The company plans to expand its QTORIN™ pipeline in the second half of 2025.
Palvella Therapeutics (Nasdaq: PVLA), a clinical-stage biopharmaceutical company specializing in rare genetic skin disease treatments, has scheduled its full year 2024 financial results announcement for March 31, 2025. The company will host a conference call with investors at 8:30 a.m. ET on the same day to discuss financial performance and provide a corporate update.
The presentation will include both a live webcast with slides and a dial-in option for participants. A replay of the webcast will be made available approximately 2 hours after the call concludes and will remain accessible for 90 days through the company's website.
Palvella Therapeutics (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing therapies for rare genetic skin diseases, has announced its participation in the TD Cowen 45th Annual Healthcare Conference.
The company's management team will present on Tuesday, March 4, 2025, at 2:30 p.m. ET. Investors and interested parties can access a live webcast of the presentation through the Events and Presentations section of Palvella's website at www.palvellatx.com.
An archived replay of the webcast will remain available for approximately 90 days following the presentation. Palvella specializes in developing novel therapies for serious, rare genetic skin diseases for which there are currently no FDA-approved treatments.
Palvella Therapeutics (PVLA) announced the expansion of its Phase 3 SELVA clinical trial for QTORIN™ 3.9% rapamycin anhydrous gel to include children aged 3-5 years old, following FDA approval. The trial, previously to patients 6 years and older, evaluates the treatment for microcystic lymphatic malformations (microcystic LMs).
The company is currently enrolling approximately 40 patients in the 24-week, single-arm, baseline-controlled trial. QTORIN™ rapamycin has received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation from the FDA. The study is supported by an FDA Orphan Products Grant of up to $2.6 million and aims to report top-line results in Q1 2026.
If successful, QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic LMs in the U.S.
Palvella Therapeutics has announced the publication of results from its Phase 2 clinical trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel for treating microcystic lymphatic malformations (microcystic LMs) in the Journal of Vascular Anomalies. The study reported that 100% of participants were rated as either “Much Improved” or “Very Much Improved” by the Clinician Global Impression of Change after 12 weeks of treatment. The FDA has previously granted QTORIN™ rapamycin Breakthrough Therapy, Fast Track, and Orphan Drug Designations for this indication.
The ongoing Phase 3 SELVA trial, which is single-arm and baseline-controlled, aims to further evaluate QTORIN™ rapamycin for microcystic LMs, with topline data expected in Q1 2026. If successful, QTORIN™ rapamycin could become the first approved therapy and standard of care in the U.S. for microcystic LMs. The Phase 2 study demonstrated nominal statistical significance across several efficacy endpoints, including clinician and patient global impression assessments. No drug-related serious adverse events were reported, indicating that QTORIN™ rapamycin was generally well-tolerated.
The publication can be accessed in the Journal of Vascular Anomalies, the official journal of the International Society for the Study of Vascular Anomalies (ISSVA). Palvella is currently enrolling approximately 40 subjects in the SELVA trial, which is supported by an Orphan Products Grant from the FDA's Office of Orphan Products Development.
