Stifel has increased its price target for Palvella Therapeutics (NASDAQ:PVLA) to $250 from $180 and retained a Buy recommendation after the company disclosed positive Phase 3 results from the SELVA study of QTORIN rapamycin 3.9% in microcystic lymphatic malformations (MLM).
The analyst firm pointed to the trial's performance across both primary and secondary endpoints, noting the results showed high statistical significance. Stifel also upgraded its commercial forecast, raising its peak U.S. sales projection for QTORIN to $1.6 billion and indicating that pricing assumptions will reflect clinical value and penetration dynamics typical of rare disease therapies.
Market activity has moved sharply ahead of and following the announcement. Palvella's shares have climbed 339% over the past year and were trading at $116.10, near the company's 52-week high, representing a market capitalization of $1.38 billion.
Clinical outcomes highlighted by SELVA
The SELVA study demonstrated a mean improvement of 2.13 points on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale, meeting the trial's primary endpoint. The trial also recorded an 86% response rate and a 1.9-point mean improvement on the Patient Global Impression of Change (PGI-C) scale, with measurable gains across clinician- and patient-rated severity assessments.
A key secondary measure, the blinded mLM Multi-Component Static Scale, also achieved statistical significance with a mean improvement of 3.36 points, according to the reported results.
Importantly from a safety perspective, QTORIN rapamycin remained below systemic circulation in the study population and was well tolerated, findings Stifel said support positioning the topical therapy for first-line use and for rapid clinical adoption.
Wall Street reactions and commercial outlook
Alongside Stifel's revision, other brokerages have reiterated bullish stances. Raymond James reaffirmed a Strong Buy rating and retained a $193.00 price target, citing the company's clear Phase 3 success in its MLM program. Clear Street kept a Buy rating with a $200.00 price target and emphasized the potential for meaningful clinical benefit for patients.
Stifel's updated forecasts reflect the firm's view that QTORIN could achieve significant uptake, underpinned by the trial's efficacy and tolerability profile. The firm explicitly stated that pricing will be informed by demonstrated clinical value and rare disease penetration rates when modeling peak sales.
Related development program and regulatory path
Separately, Palvella reported that a systematic review supported the clinical potential of its QTORIN pitavastatin program for porokeratosis. That assessment is consistent with the company's plans to advance QTORIN pitavastatin into Phase 2 development for disseminated superficial actinic porokeratosis, with Phase 2 expected to begin in the latter half of 2026.
The combination of the SELVA results, broker commentary, and the pitavastatin program contributed to renewed investor interest in Palvella's shares.
Context on valuation tools referenced
Data cited from InvestingPro indicated Palvella's stock was trading above its Fair Value estimate and referenced additional proprietary analysis tools available to subscribers, including detailed research and tips. The article did not provide further detail on those analytic outputs.