Palvella's QTORIN™ Rapamycin Shows Significant Phase 3 Trial Results for Microcystic Lymphatic Malformations
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy PVLA?
Source: Newsfilter
- Clinical Trial Success: Palvella's QTORIN™ 3.9% rapamycin gel achieved its primary endpoint in the Phase 3 SELVA study, with a mean improvement of 2.13 on the mLM-IGA scale and a p-value of less than 0.001, indicating significant efficacy and potential for treating microcystic lymphatic malformations.
- High Improvement Rates: Among participants aged 6 and older who completed the efficacy evaluation, 95% (41/43) showed at least a 1-point improvement, and 86% (37/43) were rated as
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: 85.660
Low
133.00
Averages
182.20
High
212.00
Current: 85.660
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 Therapeutics to Present Phase 3 Trial Results for QTORIN Gel
- Trial Results Announcement: Palvella Therapeutics is set to present topline results from its pivotal Phase 3 SELVA clinical trial evaluating QTORIN 3.9% rapamycin anhydrous gel for treating microcystic lymphatic malformations, addressing a significant unmet medical need.
- Positive Market Reaction: Ahead of the data release, PVLA shares rose over 5% in pre-market trading, climbing from $87.84 to $93.01, reflecting investor optimism regarding the forthcoming clinical data.
- Unmet Medical Need: Microcystic lymphatic malformations are rare, lifelong vascular malformations with no FDA-approved therapies available, highlighting the potential market opportunity and significance of QTORIN rapamycin.
- Future Development Plans: Palvella is also advancing additional QTORIN-based candidates, including QTORIN Pitavastatin for disseminated superficial actinic porokeratosis, demonstrating the company's ongoing innovation and growth potential in rare skin diseases.
See More
Palvella to Host Conference Call on SELVA Trial Results
- Clinical Trial Announcement: Palvella Therapeutics will host a conference call on February 24, 2026, at 8:00am ET to discuss topline results from the SELVA clinical trial, with a press release expected prior to the call, indicating significant progress in rare skin disease treatments.
- Lead Product Candidate: The company's primary candidate, QTORIN™ 3.9% rapamycin anhydrous gel, is being developed for microcystic lymphatic malformations, and if successful, it will address a market gap for FDA-approved therapies, presenting substantial commercial potential.
- Investor Engagement: The conference will be accessible via live webcast and phone, providing a platform for investors to engage directly with management, enhancing transparency and potentially boosting market confidence, which may attract more investor interest.
- Company Overview: Palvella Therapeutics focuses on developing innovative therapies for serious rare skin diseases, leveraging its patented QTORIN™ platform to showcase its expertise and market prospects in the biopharmaceutical sector.
See More
Palvella Therapeutics Shares Surge 45% on Positive Phase 3 Study Results
- Clinical Trial Success: Palvella Therapeutics reported positive topline results from its Phase 3 SELVA study, significantly improving the outlook for its lead candidate QTORIN 3.9%, resulting in a nearly 45% surge in pre-market trading.
- Primary Endpoint Achieved: The study demonstrated a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment scale, indicating QTORIN's effectiveness in treating this rare vascular condition and paving the way for a potential FDA submission.
- Strong Secondary Endpoint Performance: The trial also met its key secondary endpoint and all four additional secondary endpoints, each showing statistical significance, further validating QTORIN's efficacy in patients with microcystic lymphatic malformations and boosting market confidence in the drug.
- Future Plans: The company intends to submit a New Drug Application (NDA) to the FDA in the second half of 2026, with potential U.S. approval expected in the first half of 2027, providing investors with a clear business development timeline.
See More
Palvella's QTORIN™ Rapamycin Shows Significant Phase 3 Trial Results for Microcystic Lymphatic Malformations
- Clinical Trial Success: Palvella's QTORIN™ 3.9% rapamycin gel achieved its primary endpoint in the Phase 3 SELVA study, with a mean improvement of 2.13 on the mLM-IGA scale and a p-value of less than 0.001, indicating significant efficacy and potential for treating microcystic lymphatic malformations.
- High Improvement Rates: Among participants aged 6 and older who completed the efficacy evaluation, 95% (41/43) showed at least a 1-point improvement, and 86% (37/43) were rated as
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 Therapeutics to Present Phase 3 Trial Results for QTORIN Gel
- Trial Results Announcement: Palvella Therapeutics is set to present topline results from its pivotal Phase 3 SELVA clinical trial evaluating QTORIN 3.9% rapamycin anhydrous gel for treating microcystic lymphatic malformations, addressing a significant unmet medical need.
- Positive Market Reaction: Ahead of the data release, PVLA shares rose over 5% in pre-market trading, climbing from $87.84 to $93.01, reflecting investor optimism regarding the forthcoming clinical data.
- Unmet Medical Need: Microcystic lymphatic malformations are rare, lifelong vascular malformations with no FDA-approved therapies available, highlighting the potential market opportunity and significance of QTORIN rapamycin.
- Future Development Plans: Palvella is also advancing additional QTORIN-based candidates, including QTORIN Pitavastatin for disseminated superficial actinic porokeratosis, demonstrating the company's ongoing innovation and growth potential in rare skin diseases.
See More
Palvella to Host Conference Call on SELVA Trial Results
- Clinical Trial Announcement: Palvella Therapeutics will host a conference call on February 24, 2026, at 8:00am ET to discuss topline results from the SELVA clinical trial, with a press release expected prior to the call, indicating significant progress in rare skin disease treatments.
- Lead Product Candidate: The company's primary candidate, QTORIN™ 3.9% rapamycin anhydrous gel, is being developed for microcystic lymphatic malformations, and if successful, it will address a market gap for FDA-approved therapies, presenting substantial commercial potential.
- Investor Engagement: The conference will be accessible via live webcast and phone, providing a platform for investors to engage directly with management, enhancing transparency and potentially boosting market confidence, which may attract more investor interest.
- Company Overview: Palvella Therapeutics focuses on developing innovative therapies for serious rare skin diseases, leveraging its patented QTORIN™ platform to showcase its expertise and market prospects in the biopharmaceutical sector.
See More
Palvella Therapeutics Shares Surge 45% on Positive Phase 3 Study Results
- Clinical Trial Success: Palvella Therapeutics reported positive topline results from its Phase 3 SELVA study, significantly improving the outlook for its lead candidate QTORIN 3.9%, resulting in a nearly 45% surge in pre-market trading.
- Primary Endpoint Achieved: The study demonstrated a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment scale, indicating QTORIN's effectiveness in treating this rare vascular condition and paving the way for a potential FDA submission.
- Strong Secondary Endpoint Performance: The trial also met its key secondary endpoint and all four additional secondary endpoints, each showing statistical significance, further validating QTORIN's efficacy in patients with microcystic lymphatic malformations and boosting market confidence in the drug.
- Future Plans: The company intends to submit a New Drug Application (NDA) to the FDA in the second half of 2026, with potential U.S. approval expected in the first half of 2027, providing investors with a clear business development timeline.
See More
Palvella's QTORIN™ Rapamycin Shows Significant Phase 3 Trial Results for Microcystic Lymphatic Malformations
- Clinical Trial Success: Palvella's QTORIN™ 3.9% rapamycin gel achieved its primary endpoint in the Phase 3 SELVA study, with a mean improvement of 2.13 on the mLM-IGA scale and a p-value of less than 0.001, indicating significant efficacy and potential for treating microcystic lymphatic malformations.
- High Improvement Rates: Among participants aged 6 and older who completed the efficacy evaluation, 95% (41/43) showed at least a 1-point improvement, and 86% (37/43) were rated as
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
