TD Cowen raised its price target on Palvella Therapeutics stock (NASDAQ:PVLA) to $267 from $190 and left its recommendation at Buy following the release of topline phase 3 data for QTORIN rapamycin in microcystic lymphatic malformation. The stock jumped to $120.50 and has recorded a 339% gain over the past year, trading near its reported 52-week high of $114.69.
The firm cited the phase 3 trial's achievement of the primary endpoint as the basis for the change. At 24 weeks, the study showed a statistically significant mean improvement of 2.1 points on the Microcystic Lymphatic Malformation Investigator Global Assessment - mLM-IGA - scale. The topline report highlighted that 95% of patients achieved at least a one-point improvement, while 86% met the threshold of a two-point or greater response. The trial's safety profile was described as favorable, with QTORIN rapamycin characterized as safe and well tolerated in the study population.
Palvella has indicated plans to file a New Drug Application for microcystic lymphatic malformation in the second half of 2026. TD Cowen expects that such a submission would support approval in the second half of 2027.
Company statements accompanying the phase 3 results emphasized the consistency of clinical benefit across the enrolled population. The primary endpoint reached statistical significance with a p-value reported as less than 0.001.
Market participants and sell-side analysts have reacted by adjusting valuations. Palvella carries a market capitalization of $1.42 billion and, according to the consensus cited, maintains a Strong Buy rating among analysts. Several firms updated their targets or reiterated positive ratings in light of the data:
- Stifel raised its price target on Palvella from $180 to $250 and remained at Buy.
- Lucid Capital Markets increased its target from $212 to $241 and kept a Buy rating.
- Raymond James reiterated a Strong Buy rating with a $193 price target and noted the company's internal benchmarks for success had been raised.
Additional details about the phase 3 program were provided in the company release. The SELVA trial of QTORIN 3.9% rapamycin anhydrous gel met its primary endpoint with a reported mean improvement of 2.13 points on the mLM-IGA scale, achieving high statistical significance. The trial also achieved statistical significance on secondary endpoints. The SELVA study enrolled 50 participants aged 3 years and older across U.S. vascular anomaly centers, reflecting an intent to demonstrate applicability across a broad age range within the targeted population.
Overall, the phase 3 findings and the follow-on analyst reactions represent a material development for Palvella's clinical program and near-term regulatory pathway. The company is preparing for an NDA submission in the second half of 2026, a milestone that TD Cowen projects could lead to approval in the second half of 2027 if regulatory review follows expectations.
Investors seeking deeper financial and operational context have access to comprehensive research products that cover Palvella alongside other U.S. equities, though the specific content of those reports is outside the scope of this piece.