11 Best Performing Stocks So Far In 2025

6. Palvella Therapeutics Inc. (NASDAQ:PVLA)

Year-to-Date Performance as of March 21: 128.58%

Number of Hedge Fund Holders: 9

Palvella Therapeutics Inc. (NASDAQ:PVLA) is a clinical-stage biopharmaceutical company that develops novel therapies for rare genetic skin diseases. Its lead product, which is QTORIN rapamycin, is in late-stage clinical trials for microcystic lymphatic malformations (LMs) and cutaneous venous malformations. It targets mTOR-driven skin conditions.

Microcystic LMs currently affect an estimated 30,000 people in the US, and there are no approved treatments. QTORIN rapamycin, which is a topical gel, targets the disease’s underlying pathway. Palvella Therapeutics Inc. (NASDAQ:PVLA) aims to make this the first approved therapy for patients with microcystic LMs.

The company is currently running a Phase 3 clinical trial under the name of SELVA for this lead product. It has about 40 participants and expects results in Q1 2026. This trial has been expanded to include children aged 3-5 years old. Positive results from a Phase 2 trial, which showed 100% of participants improving, boosted investor confidence. The FDA has granted multiple designations to QTORIN rapamycin, which include Breakthrough Therapy, Fast Track, and Orphan Drug. The SELVA trial also received a grant of up to $2.6 million from the FDA.