Buy Rating Driven by Strong Phase 3 SELVA Data and Favorable FDA Pathway for QTORIN in Rare MLM Indication

LifeSci Capital analyst Sam Slutsky maintained a Buy rating on Palvella Therapeutics today and set a price target of $222.00.

Sam Slutsky has given his Buy rating due to a combination of factors tied to both clinical data and the regulatory backdrop. He highlights the positive Phase 3 SELVA results for QTORIN 3.9% rapamycin in microcystic lymphatic malformations and stresses that the FDA has recently granted numerous first-time approvals based on single-arm studies, particularly in rare diseases.

He also notes that QTORIN has Breakthrough designation, Phase 3 design alignment, and partial funding from an FDA Orphan Drug Grant, all of which support regulatory momentum. In addition, the use of a clinically meaningful primary endpoint, the absence of approved therapies in MLMs, the biologically rational mTOR-inhibition mechanism, and precedent for off-label topical rapamycin further strengthen the approval and commercialization case for Palvella’s lead asset.

Slutsky covers the Healthcare sector, focusing on stocks such as Palvella Therapeutics, Oruka Therapeutics, and Cogent Biosciences. According to TipRanks, Slutsky has an average return of 40.2% and a 51.74% success rate on recommended stocks.

In another report released on March 2, BTIG also maintained a Buy rating on the stock with a $215.00 price target.