Palvella Therapeutics Announces Positive Topline Results from Phase 2 TOIVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Cutaneous Venous...
Palvella Therapeutics, Inc. (PVLA)
Company Research
Source: Acquire Media Monitor
cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints, including dynamic change endpoints and static severity endpoints QTORIN™ rapamycin was generally well-tolerated, with no drug-related serious adverse events reported Based on Phase 2 results, Palvella to pursue near-term discussions with FDA regarding the potential for Breakthrough Therapy Designation and a Phase 3 pivotal study; FDA previously granted Fast Track Designation to QTORIN™ rapamycin for venous malformations QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 75,000 individuals with cutaneous venous malformations in the U.S. Company to host conference call at 8:30am ET today WAYNE, Pa., Dec. 15, 2025 (GLOBE NEWSW
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News
- High Analyst Confidence on Palvella Therapeutics (PVLA) Following Encouraging Phase 2 Data for QTORIN Rapamycin [Yahoo! Finance]Yahoo! Finance
- Assessing Palvella Therapeutics' Valuation After Its Rare Disease Momentum-Driven Surge in 2024 [Yahoo! Finance]Yahoo! Finance
- Palvella Therapeutics price target raised to $200 from $120 at Oppenheimer [Yahoo! Finance]Yahoo! Finance
- Palvella Therapeutics (NASDAQ:PVLA) was given a new $204.00 price target on by analysts at Canaccord Genuity Group Inc..MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) had its price target raised by analysts at TD Cowen from $97.00 to $133.00. They now have a "buy" rating on the stock.MarketBeat
PVLA
Earnings
- 11/11/25 - Miss
PVLA
Sec Filings
- 12/19/25 - Form 4
- 12/17/25 - Form 144
- 12/15/25 - Form 8-K
- PVLA's page on the SEC website