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Investing.com - Raymond (NSE:RYMD) James initiated coverage on Palvella Therapeutics (NASDAQ:PVLA) with an Outperform rating and a $54.00 price target. The stock, currently trading at $37.52, has shown remarkable momentum with a 210% gain year-to-date, according to InvestingPro data.
The firm is optimistic about QTORIN rapamycin, Palvella’s novel topical therapy designed to overcome toxicity and biodistribution issues associated with systemic administration of rapamycin, an mTOR inhibitor with proven therapeutic activity in skin diseases.
Palvella’s strategy leverages the QTORIN platform to avoid treatment-limiting toxicities associated with systemic administration of rapamycin and other active drug substances, according to Raymond James.
The research firm believes QTORIN rapamycin has potential for a blockbuster launch in microcystic lymphatic malformations (MLMs), with a second potential blockbuster in cutaneous venous malformations (CVMs) following closely behind.
Raymond James highlighted several upcoming catalysts for Palvella, including Phase 2 CVM data in Q4 2025, Phase 3 pivotal MLM data in Q1 2025, an NDA submission for MLM in the second half of 2025, which could lead to the company’s first approval by mid-2027.
In other recent news, Palvella Therapeutics reported a net loss of $8.2 million, or $0.74 per diluted share, for the first quarter of 2025. Despite the financial setback, Truist Securities initiated coverage on Palvella Therapeutics with a Buy rating and a price target of $56.00, highlighting the potential of its QTORIN technology. In addition, the company received initial funding from a grant awarded by the FDA’s Office of Orphan Products Development for its ongoing Phase 3 SELVA trial. This trial is testing QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations and is expected to report top-line results in the first quarter of 2026.
Furthermore, Palvella Therapeutics announced the appointment of Ashley Kline as Chief Commercial Officer. Kline, who previously contributed to the successful U.S. launch of Oxervate® at Dompé Pharmaceuticals, will lead the commercial strategy for Palvella’s lead product candidate. Her expertise is anticipated to be valuable as the company prepares for the potential FDA approval of QTORIN rapamycin. These developments reflect Palvella’s strategic efforts to advance its pipeline and commercial readiness.
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