TD Cowen has lifted its price objective on Palvella Therapeutics (NASDAQ:PVLA) to $190.00, up from the prior target of $133.00, while retaining a Buy rating on the stock. The new target remains below an analyst high of $212, according to InvestingPro data.
The broker’s move follows what it described as a "successful" Breakthrough Therapy Designation - or BTD - advice meeting held with the U.S. Food and Drug Administration concerning Palvella’s QTORIN rapa therapy for congenital vascular malformations, or cVM. TD Cowen noted that senior FDA division leadership attended the session and that key opinion leaders provided "strongly supportive" commentary on QTORIN rapa’s efficacy in treating cVM.
Palvella said it intends to file for Breakthrough Therapy Designation in short order, citing the positive outcome of the meeting with regulators. TD Cowen expressed "high conviction" that QTORIN rapa will be granted BTD status for cVM. The firm added that such a designation could allow the FDA to align on a single-arm Phase 3 design, a pathway that could accelerate both data collection and the approval process.
Market interest in Palvella has been pronounced. The stock has returned 489.92% over the past year, though it experienced an 11.83% pullback in the last week.
In parallel regulatory news, Palvella has received a Fast Track designation from the FDA for its QTORIN rapamycin treatment targeting angiokeratomas. The Fast Track status was highlighted as significant because it underscores the potential for more rapid development and review for therapies that address conditions lacking current FDA-approved options.
Analyst activity around the company has been notable. Raymond James recently raised its price target on Palvella to $193 and maintained a Strong Buy rating after results from the company’s Phase 2 TOIVA study in congenital vascular malformations. That study reportedly showed promising outcomes, with two-thirds of patients experiencing meaningful improvements.
TD Cowen previously increased its price target to $133, citing the Phase 2 study’s efficacy and safety data, and reaffirmed its Buy stance while highlighting confidence in upcoming clinical milestones. Separately, Mizuho initiated coverage on Palvella with an Outperform rating and set a $205 price target, pointing to the company’s progress in treatments for orphan skin diseases.
Taken together, the recent regulator interactions, Fast Track designation, and multiple analyst upgrades reflect concentrated optimism from both regulators and research analysts about Palvella’s clinical program and near-term development path. At the same time, the stock’s sharp year-to-date gain alongside a recent pullback underscores active market volatility and close investor attention to forthcoming clinical and regulatory milestones.