Truist Securities initiates Palvella Therapeutics stock with Buy rating

Investing.com - Truist Securities initiated coverage on Palvella Therapeutics (NASDAQ:PVLA) Monday with a Buy rating and a price target of $56.00. The stock, currently trading at $29.51, has shown remarkable momentum with a 146% gain year-to-date and is trading near its 52-week high of $31.50.

The research firm highlighted PVLA’s QTORIN technology, a high-concentration formulation of rapamycin designed to treat rare skin conditions, describing it as a "pipeline-in-a-product" with significant potential.

Truist cited clean proof-of-concept data for QTORIN in treating microcystic lymphatic malformations (MLMs), a rare genetic skin disease, and noted that PVLA has optimized its registrational trial to replicate Phase 2 findings.

The firm identified PVLA as a potential blockbuster opportunity with no marketed competition in its target indication, positioning the company in what it called "the sweet spot for biotech investment."

Truist also pointed to PVLA’s current valuation as attractive with significant potential upside, with value inflection expected in the next 5-9 months. While analyst targets range from $38 to $70, InvestingPro analysis suggests the stock is currently trading above its Fair Value. Subscribers can access 14 additional ProTips and comprehensive valuation metrics for PVLA through InvestingPro’s detailed research reports.

In other recent news, Palvella Therapeutics reported a net loss of $8.2 million for the first quarter of 2025, attributed to increased research and development expenses. The company maintains a cash reserve of $75.6 million, providing a runway for two years, and plans to spend approximately $30 million in 2025. Palvella is advancing its Phase 3 SELVA trial for QTORIN™ rapamycin, with top-line results expected in early 2026. The FDA has granted a significant grant to support this trial, which aims to address microcystic lymphatic malformations, a condition with no current FDA-approved treatments.

Palvella also announced the appointment of Ashley Kline as Chief Commercial Officer, who will lead the commercial strategy for QTORIN™ rapamycin, pending regulatory approval. Kline’s previous experience at Dompé Pharmaceuticals, where she successfully launched Oxervate®, is expected to be beneficial for Palvella’s upcoming product introduction. The company anticipates announcing new programs in the latter half of 2025, further expanding its pipeline based on the QTORIN™ platform. These developments reflect Palvella’s ongoing commitment to addressing unmet medical needs in the rare disease sector.

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