Intel stock extends gains after report of possible U.S. government stake
On Tuesday, H.C. Wainwright reaffirmed a Buy rating and a $38.00 price target for Palvella Therapeutics (NASDAQ: PVLA) shares. Currently trading at $15.72, the stock has shown strong momentum with a 31% gain year-to-date, according to InvestingPro data. The company, with a market capitalization of $176.4 million, has received consistently bullish analyst ratings with price targets ranging from $30 to $44. The firm’s analyst, Andrew Fein, provided insights following Palvella’s recent announcement regarding their Phase 3 SELVA trial for QTORIN rapamycin, which is now set to include younger patients aged three to five years. Previously, the trial was limited to participants six years of age or older.
Fein highlighted that the inclusion of a younger demographic could potentially increase the duration of treatment for patients if QTORIN rapamycin is approved, as it is intended to be a continuous therapy. The safety profile of the drug, as indicated by the Phase 2 trial data, supports this expansion. The analyst also noted that there is a substantial unmet medical need for individuals with microcystic lymphatic malformations (microLMs), a condition often identified at birth or in early childhood.
The Phase 3 SELVA trial is progressing with anticipated data expected in the first quarter of 2026. The U.S. Food and Drug Administration (FDA) has granted the trial several designations that underscore its potential significance, including Breakthrough Designation, Fast Track Designation, and Orphan Drug Designation. Additionally, the FDA has awarded the trial an Orphan Product Grant of up to $2.6 million. InvestingPro analysis shows the company maintains a strong financial health score of 3.13, with liquid assets exceeding short-term obligations, indicating solid positioning for trial completion.
Looking ahead, Palvella Therapeutics plans to commence a rolling New Drug Application (NDA) submission in 2026 for QTORIN rapamycin in treating microLMs, with the possibility of expedited review through a six-month priority review designation. While analysts remain optimistic, InvestingPro data indicates the company is not expected to be profitable this year, with projected EPS of -$1.78. Fein’s statement concluded by reiterating the firm’s Buy rating and price target for Palvella Therapeutics, directing readers to the initiation report for further details on the SELVA trial.
In other recent news, Palvella Therapeutics has been making significant strides in the development of treatments for rare genetic skin diseases. TD Cowen has initiated coverage on Palvella, assigning a Buy rating and setting a price target of $44.00, based on the potential of Palvella’s QTORIN formulation platform. The firm’s optimism is fueled by the upcoming topline data from the Phase 3 clinical trials for the treatment of Pachyonychia Congenita, expected in the first quarter of 2026.
Furthermore, Palvella announced positive results from its Phase 2 study of QTORIN rapamycin anhydrous gel for treating microcystic lymphatic malformations. The study showed significant improvement in all participants after a 12-week treatment period. The company is now conducting a Phase 3 single-arm, baseline-controlled trial named SELVA.
In addition to TD Cowen, H.C. Wainwright has also reaffirmed a positive stance on Palvella Therapeutics, maintaining a Buy rating and a price target of $38.00. The firm is particularly focused on the potential of QTORIN rapamycin, Palvella’s investigational treatment for cutaneous venous malformations, to fulfill the company’s sales ambitions.
Finally, Pieris Pharmaceuticals (NASDAQ:PVLA) has announced updates on its planned merger with Palvella Therapeutics. Upon completion, Palvella will become a wholly owned subsidiary of Pieris. These developments represent the recent progress made by Palvella Therapeutics in the field of rare genetic skin diseases.
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