Palvella Receives FDA Fast Track Designation for QTORIN Rapamycin in Treating Angiokeratomas
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
0mins
Source: NASDAQ.COM
FDA Fast Track Designation: Palvella Therapeutics has received Fast Track Designation from the FDA for QTORIN rapamycin, aimed at treating angiokeratomas, which may lead to accelerated approval and priority review if criteria are met.
Development Program Expansion: In September 2025, Palvella announced the expansion of the QTORIN rapamycin development program to include clinically significant angiokeratomas, with plans for a Phase 2 study involving approximately 1020 patients.
Upcoming FDA Meeting: The company intends to meet with the FDA in the first half of 2026 to discuss the proposed design for the Phase 2 study.
Study Initiation Timeline: The initiation of the Phase 2 study is expected in the second half of 2026.
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Analyst Views on PVLA
Wall Street analysts forecast PVLA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PVLA is 182.20 USD with a low forecast of 133.00 USD and a high forecast of 212.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
15 Analyst Rating
15 Buy
0 Hold
0 Sell
Strong Buy
Current: 78.710
Low
133.00
Averages
182.20
High
212.00
Current: 78.710
Low
133.00
Averages
182.20
High
212.00
About PVLA
Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. The Company is developing a pipeline of product candidates based on its patented QTORIN platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Its QTORIN product candidates are developed to accommodate the cargo at high concentrations in order to drive sufficient drug to its target deep in the epidermis and dermis. The Company's lead product candidate, QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin), is being evaluated in the Phase III SELVA clinical trial in microcystic lymphatic malformations and the Phase II TOIVA clinical trial in cutaneous venous malformations.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Palvella Advances QTORIN™ Drug Development, Expected Approval in 2026
- Clinical Trial Progress: The Phase 3 SELVA study of QTORIN™ rapamycin for microcystic lymphatic malformations is on track, with topline results expected in March 2026; pending positive outcomes, an NDA submission is planned for the second half of 2026, potentially making it the first FDA-approved therapy.
- Market Potential: Microcystic lymphatic malformations affect over 30,000 patients in the U.S., and if approved, QTORIN™ could fill a significant market gap, becoming the first-line standard treatment and greatly improving patient quality of life.
- R&D Expansion: Palvella plans to initiate Phase 2 clinical studies for cutaneous venous malformations and clinically significant angiokeratomas in the second half of 2026, further expanding the QTORIN™ product line and enhancing market competitiveness.
- Leadership Team Strengthening: The company has recently strengthened its leadership team by appointing several industry experts to support the R&D and commercialization of QTORIN™ programs, which is expected to accelerate U.S. launch readiness.
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Palvella Advances QTORIN™ Drug Development, Expected Approval in 2026
- Clinical Trial Progress: Palvella's QTORIN™ rapamycin in the Phase 3 SELVA study for microcystic lymphatic malformations exceeded its recruitment target by enrolling 51 patients instead of the planned 40, with topline results expected in March 2026, which could lead to the first FDA-approved treatment if successful.
- Market Potential: With over 30,000 patients affected by microcystic lymphatic malformations in the U.S., QTORIN™ rapamycin could become the first-line standard of care upon approval, addressing a significant unmet medical need and presenting substantial commercial value.
- New Product Candidates: Palvella plans to announce a fourth clinical indication for the QTORIN™ platform in the second half of 2026, further expanding its product line and enhancing market competitiveness to meet unmet medical needs.
- Leadership Team Strengthening: The company has recently bolstered its leadership team, including the appointment of Ashley Kline as Chief Commercial Officer, who previously led the successful launch of a first-in-disease orphan drug, expected to provide strong support for the market introduction of QTORIN™.
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