SEC Form 10-Q filed by Palvella Therapeutics Inc.
$PVLA
Biotechnology: Pharmaceutical Preparations
Health Care
Unavailable
Unavailable
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 12/5/2025 | $167.00 | Buy | BTIG Research |
| 12/4/2025 | $175.00 | Buy | Craig Hallum |
| 11/19/2025 | $143.00 | Outperform → Strong Buy | Raymond James |
| 9/9/2025 | $85.00 | Outperform | Oppenheimer |
| 8/6/2025 | $54.00 | Outperform | Raymond James |
| 7/21/2025 | $56.00 | Buy | Truist |
| 4/9/2025 | $50.00 | Buy | Chardan Capital Markets |
| 3/26/2025 | $45.00 | Buy | Stifel |
Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need With Fast Track designation, QTORIN™ rapamycin for angiokeratomas may be eligible for Accelerated Approval and Priority Review in the future, if applicable criteria are met Palvella plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients WAYNE,
73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall 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 fo
Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD
BTIG Research initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $167.00
Craig Hallum initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $175.00
Raymond James upgraded Palvella Therapeutics from Outperform to Strong Buy and set a new price target of $143.00
8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)
SCHEDULE 13G/A - PALVELLA THERAPEUTICS, INC. (0001583648) (Subject)
SCHEDULE 13G/A - PALVELLA THERAPEUTICS, INC. (0001583648) (Subject)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration
Ms. Kline to lead Palvella's commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline's leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability WAYNE, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing an
73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall 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 fo
Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD
DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN™ pitavastatin for DSAP in the second half of 2026 Company to host webcast conference call today, November 5, 2025 at 8:30am ET WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (