Palvella Therapeutics (NASDAQ:PVLA) is advancing topical therapies for serious rare skin diseases and vascular malformations that lack FDA-approved treatments, with its lead candidate, QTORIN rapamycin, moving toward a planned New Drug Application submission for microcystic lymphatic malformations.
Palvella Therapeutics (NASDAQ:PVLA) said it remains on track to complete its new drug application submission for QTORIN rapamycin in microcystic lymphatic malformations, or mLM, during the second half of 2026, with potential FDA approval targeted for the first half of 2027.
The company has submitte
Palvella Therapeutics (NASDAQ:PVLA) held its second-quarter earnings conference call on Tuesday. Below is the complete transcript from the call. This transcript is brought to you by Benzinga APIs. For real-time access
Palvella Therapeutics (NASDAQ:PVLA) said it remains on track to submit a New Drug Application in the second half of 2026 for QTORIN rapamycin in Microcystic Lymphatic Malformations, after reporting what executives described as positive Phase 3 results and outlining an expanded commercial plan suppor
Focused on therapies for rare skin diseases, this clinical-stage biotech saw a notable director purchase coincide with a decisive Phase 3 trial announcement and the closing of a $230 million equity offering.
Palvella Therapeutics reported a wider Q3 2025 loss, missing EPS estimates. Investors focus on its strong cash position and upcoming clinical trial data for its rare disease pipeline.
Palvella Therapeutics (PVLA) reported a Q2 2025 net loss of $0.86 per share, missing estimates. Revenue was $0.0 as expected, with $70.4M cash on hand. Stock fell 13% pre-market despite clinical progress in Phase 3 SELVA and Phase 2 TOIVA trials.
