BUY Rating on Palvella Therapeutics: De-Risked SELVA Phase 3 Design Positions QTORIN Rapamycin for First-in-Class MLM Approval and Compelling Risk–Reward

Palvella Therapeutics, the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Sam Slutsky from LifeSci Capital maintained a Buy rating on the stock and has a $150.00 price target.

Sam Slutsky has given his Buy rating due to a combination of factors tied to both clinical and regulatory visibility for Palvella Therapeutics. He highlights that the Phase 3 SELVA study in microcystic lymphatic malformations (MLM) with QTORIN 3.9% rapamycin is well designed, with a longer 24-week treatment period, a structured baseline assessment using photos, and an efficacy endpoint aligned with prior Phase 2 work but refined to reduce variability among investigators. Enrollment exceeded the original target, boosting the robustness of the dataset, and the trial is statistically powered at a very high level to detect clinically meaningful improvement, which he views as increasing the likelihood of a clearly positive outcome. Slutsky also notes that there is no expectation of spontaneous regression in MLMs, so observed improvements are more likely to be attributable to the drug, which supports the potential for a strong efficacy signal in the upcoming March 2026 topline readout.

In his view, the SELVA trial’s structure and the FDA’s prior agreement on the trial design and endpoints position QTORIN rapamycin well for regulatory approval if results are positive. He underscores that QTORIN could become the first FDA-approved therapy specifically labeled for MLMs, which would differentiate it from compounded, lower-strength rapamycin products that are already used off-label but have important limitations QTORIN aims to address. This first-in-class, on-label status could drive prescriber uptake and reimbursement, underpinning a meaningful commercial opportunity. Additionally, the company’s plans to broaden QTORIN’s clinical reach with a fourth indication to be disclosed in the second half of 2026 add a pipeline expansion angle and potential upside beyond the initial MLM opportunity, further supporting a favorable risk–reward profile that justifies his Buy recommendation.

In another report released today, Mizuho Securities also reiterated a Buy rating on the stock with a $205.00 price target.