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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.
Palvella Therapeutics has announced that the first patients have been dosed in the Phase 2 TOIVA clinical trial of QTORIN™ 3.9% rapamycin anhydrous gel for treating cutaneous venous malformations (cutaneous VMs). This single-arm, baseline-controlled trial will enroll around 15 subjects across leading vascular anomaly centers in the U.S.
Cutaneous VMs are a serious genetic disease that affects over 75,000 diagnosed patients in the U.S., causing significant morbidity and functional impairment. Currently, there are no FDA-approved therapies for this condition. QTORIN™ rapamycin aims to be the first approved therapy and standard of care in the U.S. for cutaneous VMs.
The study will evaluate the safety and efficacy of QTORIN™ rapamycin, with safety assessed based on adverse events and efficacy measured by changes from baseline to week 12 in clinician and patient global impression assessments. QTORIN™ rapamycin is a topical mTOR inhibitor designed to minimize systemic exposure and adverse reactions.
The FDA granted Fast Track Designation to QTORIN™ rapamycin in April 2024, highlighting its potential to address the unmet medical needs of patients with venous malformations.
Palvella Therapeutics has completed its merger with Pieris Pharmaceuticals and will trade on Nasdaq as PVLA. The company raised $78.9 million in a private placement co-led by BVF Partners and Frazier Life Sciences. With approximately $80.0 million in cash, operations are funded into second half of 2027.
The company's lead product, QTORIN™ rapamycin, is being developed for microcystic lymphatic malformations (LMs) and cutaneous venous malformations. The drug has received FDA Breakthrough Therapy, Fast Track, and Orphan Drug Designations. A Phase 3 SELVA trial for microcystic LMs is currently enrolling approximately 40 subjects.
Post-merger, former Pieris stockholders own 11% and Palvella stockholders hold 89% of the combined company. The merger was approved by both companies' stockholders in December 2024.
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