Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas
Palvella Therapeutics, Inc. (PVLA)
Company Research
Source: GlobeNewswire
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, Pa., Dec. 16, 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 skin diseases for which there are no
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News
- 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
- Palvella Therapeutics (NASDAQ:PVLA) had its "strong-buy" rating reaffirmed by analysts at Raymond James Financial, Inc..MarketBeat
- Palvella Therapeutics (NASDAQ:PVLA) had its "buy" rating reaffirmed by analysts at Cowen Inc.MarketBeat
PVLA
Earnings
- 11/11/25 - Miss
PVLA
Sec Filings
- 12/15/25 - Form 8-K
- 11/21/25 - Form 4
- 11/19/25 - Form 144
- PVLA's page on the SEC website