Analyst Andrew Fein of H.C. Wainwright reiterated a Buy rating on Palvella Therapeutics (PVLA – Research Report), retaining the price target of $38.00.
Andrew Fein has given his Buy rating due to a combination of factors that highlight the potential of Palvella Therapeutics’ QTORIN 3.9% rapamycin gel. The company is set to report top-line results from its pivotal Phase 3 SELVA trial by Q1 2026, targeting microcystic lymphatic malformations (mLMs). The Phase 2 study showed promising results, with all patients achieving clinically meaningful improvements, which is significant given the lack of spontaneous improvement in this condition. The regulatory environment is favorable, with the FDA’s Breakthrough Therapy, Fast Track, and Orphan Drug designations supporting the program, and precedent exists for approvals based on single-arm studies in similar contexts.
Furthermore, the commercial potential is substantial, with an estimated 20,000–30,000 addressable patients in the U.S. and no current standard of care. The SELVA trial results could de-risk QTORIN’s regulatory path and establish it as a new standard of care for mLMs, potentially launching in 2027. Additionally, the upcoming Phase 2 TOIVA trial for cutaneous venous malformations (cVMs) is expected to provide further clinical efficacy signals, reinforcing the mechanistic rationale of rapamycin’s targeted inhibition. Overall, these factors contribute to a high-impact catalyst for Palvella, justifying the Buy rating and a price target of $38.
In another report released yesterday, Cantor Fitzgerald also maintained a Buy rating on the stock with a $70.00 price target.