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0.0785371114815177 0.377978233160114 -0.0800078439062654 -0.0460829493087558 0.186292773801353 0.0868712618884204 -0.0880478478282185 0.12864006275125
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Palvella Therapeutics Announces Positive Topline Results from Phase 3 SELVA Clinical Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformation...

Palvella Therapeutics, Inc. (PVLA) 
Company Research Source: GlobeNewswire
Primary endpoint met with statistically significant improvement (mean change of +2.13; p Achieved statistical significance on pre-specified key secondary endpoint (p 95% of trial participants aged = 6 who completed the efficacy evaluation period improved on the mLM-IGA at Week 24 86% of trial participants aged = 6 who completed the efficacy evaluation period were rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the mLM-IGA at Week 24 QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported and systemic rapamycin levels below 2ng/mL at all timepoints for all participants 98% of participants who completed the efficacy evaluation period elected to continue to receive QTORIN™ rapamycin in the ongoing treatment extension period Palvella plans to submit a New Drug Application to FDA in the second half of 2026 QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,0 Show less Read more
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