Truist Securities has increased its price target for Palvella Therapeutics (NASDAQ:PVLA) to $210 from $190 while maintaining a Buy rating on the shares. The stock was trading at $118.94 and carries a market capitalization of $1.4 billion, representing a 339% gain over the past year.
The brokerage firm updated its internal model after reviewing the positive data from Palvella's Phase 3 SELVA trial for QTORIN 3.9% rapamycin anhydrous gel, the company's lead candidate for microcystic lymphatic malformations (MLM). Following the trial results, Truist raised the probability of success for QTORIN in the MLM indication to 90%.
In its assessment, Truist described the program as de-risked both from a regulatory and a commercial perspective. The firm highlighted that the SELVA trial produced statistically significant and clinically meaningful outcomes across all prespecified efficacy endpoints and that no alarming safety signals emerged in the data set reviewed.
Truist also noted that regulators are likely to be supportive of approval based on the trial readout, and that additional commentary from key opinion leaders on the firm’s call reinforced that outlook. The brokerage expects robust market demand at the time of launch.
Market reaction has reflected the trial's positive tone. According to InvestingPro, the stock is trading near its 52-week high after a 9.68% gain over the past week. Analyst consensus remains at Strong Buy, with published price targets spanning from $143 to $267.
Details from the SELVA trial
Palvella reported that the Phase 3 SELVA trial met its primary endpoint. The primary outcome showed a statistically significant mean improvement of 2.13 points on the Microcystic Lymphatic Malformation Investigator Global Assessment scale. The trial also reached statistical significance on a key secondary endpoint, with a mean improvement of 3.36 points.
Those clinical results prompted multiple firms to revise their valuations. TD Cowen raised its price target to $267 from $190 and maintained a Buy rating. Lucid Capital Markets increased its target to $241 from $212, continued to rate the stock as Buy, and called attention to an 86% responder rate reported in the trial. Stifel moved its target to $250 from $180, also keeping a Buy rating and noting that SELVA met all primary and secondary endpoints with high statistical significance.
Implications for investors and markets
The cluster of upward revisions in price targets and positive outlooks from multiple brokerages reflects growing analyst confidence in Palvella’s clinical advancement for QTORIN in MLM. The combination of a higher modeled probability of success, favorable efficacy data across endpoints, and the absence of alarming safety findings underpins the shift in sentiment among equity analysts covering the company.
While Truist’s commentary specifically cites regulatory and commercial de-risking and anticipates strong demand at launch, its revised probability of success also implies remaining uncertainty. Market participants have reacted positively to the trial readout, and the stock's movement toward its 52-week high indicates investor interest in the clinical milestone.
Context and next steps
Palvella’s SELVA Phase 3 outcome and the subsequent analyst responses are likely to shape near-term investor focus: regulatory interactions, potential approval timelines, and early commercial positioning for QTORIN. The sequence of revised price targets from multiple brokerages underscores how clinical readouts can rapidly alter valuation assumptions for small-cap biopharma names.
Investors assessing Palvella will continue to watch for formal regulatory filings and guidance from the company on next steps, as well as any additional clinical or safety data disclosures. For now, the market’s reaction and the analyst adjustments reflect a materially upgraded view of QTORIN’s near-term prospects based on the SELVA data.