Palvella Therapeutics Announces Encouraging Phase 2 Outcomes for QTORIN Rapamycin Gel
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
0mins
Should l Buy PVLA?
Source: NASDAQ.COM
Positive Study Results: Palvella Therapeutics announced positive topline results from its Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel, showing that 73% of participants improved after 12 weeks of treatment for cutaneous venous malformations.
Efficacy and Tolerability: The study achieved statistical significance across multiple efficacy endpoints, with no serious drug-related adverse events reported, indicating that QTORIN rapamycin was generally well tolerated.
Regulatory Plans: Following the positive Phase 2 results, Palvella plans to engage with the U.S. FDA for a potential Breakthrough Therapy Designation and to discuss a Phase 3 pivotal study.
Market Reaction: Palvella Therapeutics' shares rose over 3% in pre-market trading after the announcement, reflecting investor optimism about the drug's potential.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy PVLA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on PVLA
Wall Street analysts forecast PVLA stock price to rise
15 Analyst Rating
15 Buy
0 Hold
0 Sell
Strong Buy
Current: 82.020
Low
133.00
Averages
182.20
High
212.00
Current: 82.020
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 Publishes Systematic Review on Statins for Porokeratosis
- Publication of Findings: Palvella Therapeutics has published a systematic review in Clinical and Experimental Dermatology, synthesizing 24 studies involving 95 patients treated with off-label topical statins for porokeratosis, highlighting the clinical potential and scientific rationale for this therapeutic approach.
- Significant Clinical Need: The review underscores the lack of FDA-approved therapies for porokeratosis, which severely impacts patients' quality of life, positioning Palvella's QTORIN™ pitavastatin as a potential solution, with Phase 2 trials anticipated in the second half of 2026.
- Efficacy Observations: The systematic review indicates that the majority of patients experienced at least partial clinical benefits, with symptom relief and lesion size reduction observed across a broad age range from 2 to 85 years, emphasizing the potential advantages of topical application.
- Future Research Directions: The review calls for controlled clinical trials using standardized endpoints to robustly evaluate the safety and efficacy of statins, aiming to provide more effective treatment options for porokeratosis patients and advance scientific understanding in this area.
See More
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.
See More
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™.
See More
Momentus Inc. Shares Surge 57% Following Fuel Tank Development Announcement
- Stock Surge: Momentus Inc. shares soared 57% to $8.98 following the announcement of an additive-manufactured fuel tank, indicating strong market confidence in its aerospace service potential.
- Flight Testing Plans: The fuel tank is scheduled for flight testing aboard the Vigoride-7 orbital service vehicle, which not only enhances the company's technological capabilities but also opens new revenue streams for future commercial launches.
- FDA Clearance: GH Research PLC shares rose 17% to $15.43 after the FDA lifted the clinical hold on its Investigational New Drug Application, marking a significant breakthrough in the company's development process that could accelerate product commercialization.
- Market Volatility: Despite a generally positive market, Zenas Biopharma Inc. shares plummeted 57% due to results from the INDIGO trial, reflecting the high-risk nature of the biopharmaceutical sector, necessitating cautious investment evaluations.
See More
Palvella Therapeutics Stock Soars to $114.69 Following Pipeline Developments
- Stock Performance: Palvella Therapeutics saw its stock surge from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, reflecting strong market potential in rare disease treatments.
- Product Development: Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and other rare diseases, with potential FDA approval expected to unlock a multi-billion-dollar market opportunity, further solidifying the company's position in the biopharmaceutical sector.
- Acquisition Activity: Cidara Therapeutics agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion, with the deal expected to close in Q1 2026, highlighting major pharmaceutical interest in innovative therapies.
- Clinical Progress: Celcuity's Gedatolisib submitted a New Drug Application to the FDA in November 2025 for HR+, HER2- advanced breast cancer, which, if approved, would significantly enhance its competitive edge in the oncology market.
See More
The $100 Club - Did You Get in Early on the Triple-Digit Surge of ABVX, NUTX, BLTE…?
ABIVAX Société Anonyme: The biotechnology company reached the $100 mark on October 30, 2025, driven by its lead drug candidate, Obefazimod, which is in a pivotal phase III trial for ulcerative colitis. The stock rose from $7.83 in July 2025 to an all-time high of $138.49 in December 2025.
Nutex Health Inc.: This healthcare services company crossed the $100 threshold on April 9, 2025, reflecting significant revenue growth and profitability, with total revenue of $723.6 million for the first nine months of 2025. The stock increased from $33.56 in November 2024 to a peak of $193 in December 2025.
Cidara Therapeutics Inc.: Cidara reached the $100 milestone on October 1, 2025, following its agreement to be acquired by Merck for $221.50 per share. The stock price rose from $18.98 in November 2024, highlighting its growth potential in preventive influenza therapy.
Palvella Therapeutics Inc.: The company, focused on rare diseases, hit the $100 mark on November 24, 2025, after announcing positive results from its phase 2 study. The stock climbed from $25 in March 2025 to a peak of $112 in December 2025, reflecting investor confidence in its ongoing trials.
See More
Palvella Publishes Systematic Review on Statins for Porokeratosis
- Publication of Findings: Palvella Therapeutics has published a systematic review in Clinical and Experimental Dermatology, synthesizing 24 studies involving 95 patients treated with off-label topical statins for porokeratosis, highlighting the clinical potential and scientific rationale for this therapeutic approach.
- Significant Clinical Need: The review underscores the lack of FDA-approved therapies for porokeratosis, which severely impacts patients' quality of life, positioning Palvella's QTORIN™ pitavastatin as a potential solution, with Phase 2 trials anticipated in the second half of 2026.
- Efficacy Observations: The systematic review indicates that the majority of patients experienced at least partial clinical benefits, with symptom relief and lesion size reduction observed across a broad age range from 2 to 85 years, emphasizing the potential advantages of topical application.
- Future Research Directions: The review calls for controlled clinical trials using standardized endpoints to robustly evaluate the safety and efficacy of statins, aiming to provide more effective treatment options for porokeratosis patients and advance scientific understanding in this area.
See More
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.
See More
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™.
See More
Momentus Inc. Shares Surge 57% Following Fuel Tank Development Announcement
- Stock Surge: Momentus Inc. shares soared 57% to $8.98 following the announcement of an additive-manufactured fuel tank, indicating strong market confidence in its aerospace service potential.
- Flight Testing Plans: The fuel tank is scheduled for flight testing aboard the Vigoride-7 orbital service vehicle, which not only enhances the company's technological capabilities but also opens new revenue streams for future commercial launches.
- FDA Clearance: GH Research PLC shares rose 17% to $15.43 after the FDA lifted the clinical hold on its Investigational New Drug Application, marking a significant breakthrough in the company's development process that could accelerate product commercialization.
- Market Volatility: Despite a generally positive market, Zenas Biopharma Inc. shares plummeted 57% due to results from the INDIGO trial, reflecting the high-risk nature of the biopharmaceutical sector, necessitating cautious investment evaluations.
See More
Palvella Therapeutics Stock Soars to $114.69 Following Pipeline Developments
- Stock Performance: Palvella Therapeutics saw its stock surge from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, reflecting strong market potential in rare disease treatments.
- Product Development: Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and other rare diseases, with potential FDA approval expected to unlock a multi-billion-dollar market opportunity, further solidifying the company's position in the biopharmaceutical sector.
- Acquisition Activity: Cidara Therapeutics agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion, with the deal expected to close in Q1 2026, highlighting major pharmaceutical interest in innovative therapies.
- Clinical Progress: Celcuity's Gedatolisib submitted a New Drug Application to the FDA in November 2025 for HR+, HER2- advanced breast cancer, which, if approved, would significantly enhance its competitive edge in the oncology market.
See More
The $100 Club - Did You Get in Early on the Triple-Digit Surge of ABVX, NUTX, BLTE…?
ABIVAX Société Anonyme: The biotechnology company reached the $100 mark on October 30, 2025, driven by its lead drug candidate, Obefazimod, which is in a pivotal phase III trial for ulcerative colitis. The stock rose from $7.83 in July 2025 to an all-time high of $138.49 in December 2025.
Nutex Health Inc.: This healthcare services company crossed the $100 threshold on April 9, 2025, reflecting significant revenue growth and profitability, with total revenue of $723.6 million for the first nine months of 2025. The stock increased from $33.56 in November 2024 to a peak of $193 in December 2025.
Cidara Therapeutics Inc.: Cidara reached the $100 milestone on October 1, 2025, following its agreement to be acquired by Merck for $221.50 per share. The stock price rose from $18.98 in November 2024, highlighting its growth potential in preventive influenza therapy.
Palvella Therapeutics Inc.: The company, focused on rare diseases, hit the $100 mark on November 24, 2025, after announcing positive results from its phase 2 study. The stock climbed from $25 in March 2025 to a peak of $112 in December 2025, reflecting investor confidence in its ongoing trials.
See More
