Clear Street has maintained a Buy rating on Palvella Therapeutics (NASDAQ:PVLA) and kept its $200.00 price target following an update from the company about its Phase 3 SELVA trial in microcystic lymphatic malformation - commonly abbreviated mLM. That target represents a notable premium to the stock's recent trading price of $82.01 and tracks with a broader analyst consensus that holds an average price target of $177.50.
Market data noted by the company shows that PVLA has produced a 475% return over the past year, even after some late weakness in the share price.
In its update, Palvella clarified how the primary clinical scale for the SELVA study maps to meaningful patient benefit. Specifically, the company said a mean improvement of greater than +1.0 on the mLM-IGA scale would equate to roughly 60-70% of patients achieving clinically meaningful improvement. Management characterized that outcome as highly successful in the context of an orphan indication where no approved therapies currently exist.
Palvella also reiterated that its team remains fully blinded and concentrated on study execution. Management confirmed that topline Phase 3 SELVA results will not be presented at the upcoming American Academy of Dermatology - AAD - Annual Meeting scheduled for March 27-31. Instead, the firm indicated the trial readout could be released in that general timeframe as a standalone event separate from its fourth quarter 2025 earnings call.
Full, detailed Phase 3 SELVA data are expected to be presented at the International Society for the Study of Vascular Anomalies - ISSVA - World Congress, which takes place May 19-22. Ahead of that presentation, Palvella plans to provide program updates at the AAD meeting, including a comparison of its QTORIN rapamycin topical formulation versus compounded rapamycin preparations.
Beyond the SELVA update, Palvella announced the publication of a systematic review in Clinical and Experimental Dermatology that the company says supports the clinical potential of QTORIN™ pitavastatin for porokeratosis. That review covered 24 studies and a combined total of 95 patients, and the company indicated the analysis strengthens its plan to move QTORIN pitavastatin into Phase 2 development for disseminated superficial actinic porokeratosis by the second half of 2026.
Analyst activity has accompanied these program developments. TD Cowen raised its Palvella price target from $133.00 to $190.00 and kept a Buy rating after a successful Breakthrough Therapy Designation advice meeting with the U.S. Food and Drug Administration for the QTORIN rapamycin program in cVM. TD Cowen noted confidence in the Phase 3 trial results for QTORIN rapamycin, which are expected in the first quarter of 2026.
Meanwhile, Mizuho initiated coverage of Palvella with an Outperform rating and a $205.00 price target, calling attention to the company’s topical formulation platform aimed at orphan skin diseases. Together, the analyst moves and the clinical updates reflect ongoing efforts by Palvella to advance its development programs and sustain analyst support.
Context and next milestones
Investors should expect a staged flow of information: program updates at the AAD meeting, a potential standalone announcement of topline SELVA results around the AAD dates, and a comprehensive data presentation at the ISSVA World Congress in May. Additional clinical advancement is planned for QTORIN pitavastatin toward a Phase 2 start in the second half of 2026.
Market signals
- Clear Street - Buy, $200.00 price target.
- Consensus average analyst price target - $177.50.
- TD Cowen - raised target to $190.00 and retained Buy after FDA meeting advice on QTORIN rapamycin for cVM.
- Mizuho - initiated with Outperform and $205.00 target.
These data points are consistent with an overall positive view among analysts, supported by the company’s clinical progress and recent publication activity.