Palvella Therapeutics, Inc

Ligand Pharmaceuticals outlined its royalty-focused growth strategy, highlighting the XOMA acquisition that doubled its portfolio to more than 220 partnered programs and added seven commercial-stage assets, 14 late-stage programs, and over $2 billion in potential milestones. The company expects at least $1.50 in incremental adjusted EPS from XOMA next year, and second-quarter revenue rose 34% to $64 million with adjusted EPS up 48% to $2.37. Ligand raised the low end of its full-year adjusted EPS guidance to $9 and ended the quarter with $1.4 billion in cash and investments, retaining approximately $700 million in deployable capital after the acquisition. Key catalysts include FILSPARI's expansion, positive phase III data for Palvella's rapamycin program, and up to seven pivotal readouts by the end of 2027.

Palvella Therapeutics has filed the initial module of its New Drug Application with the FDA for QTORIN 3.9% rapamycin anhydrous gel, a treatment for microcystic lymphatic malformations. The company plans to submit the remaining modules and complete the NDA process in the second half of 2026, with a potential independent U.S. commercial launch in the first half of 2027 pending approval. QTORIN rapamycin has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA. The filing follows the FDA's grant of a rolling review on June 22, which the company intends to leverage alongside its expedited designations to pursue an efficient path to approval. Palvella is also advancing QTORIN rapamycin in Phase 3 trials for microcystic lymphatic malformations and Phase 2 trials for cutaneous venous malformations.

Palvella Therapeutics has appointed Matt Pauls, a rare disease biotech executive with over 25 years of experience, to its Board of Directors. Pauls currently serves as Chair and CEO of Savara Inc. and previously led Strongbridge Biopharma through its IPO and the commercialization of KEVEYIS and Macrilen. He also held senior commercial roles at Insmed, Shire, Bristol Myers Squibb, and Johnson & Johnson, and served on the Board of Soleno Therapeutics through its $2.9 billion acquisition by Neurocrine Biosciences in 2026. Palvella is preparing for the potential U.S. launch of its lead product candidate QTORIN rapamycin for serious, rare skin diseases and vascular malformations with no FDA-approved therapies.

Palvella Therapeutics Chief Operating Officer Kathleen Goin sold 4,302 shares for approximately $476,000 at a weighted average price of $110.73 per share, according to an SEC filing. The transaction was executed under a Rule 10b5-1 trading plan adopted in August 2025 and reduced her direct common stock holdings to zero, though she retains 17,219 outstanding stock options. The sale comes after Palvella shares surged nearly 620% over the past year, closing at $148.21 on June 26, 2026, amid optimism for its lead therapy QTORIN rapamycin. The FDA recently granted rolling review for the company's New Drug Application in microcystic lymphatic malformations, with management targeting completion of the submission in the second half of 2026.

Six biotech stocks profiled by RTTNews have delivered stunning gains for patient investors, with Inhibrx Biosciences surging as much as 746% since its profile was published on July 8, 2025. Palvella Therapeutics rose up to 505% from its March 10, 2025 profile, driven by positive trial results and an FDA rolling review for its rare-disease therapy. MBX Biosciences gained up to 363% since June 18, 2025, following encouraging data from multiple clinical programs. Protagonist Therapeutics advanced as much as 204% from its January 6, 2025 profile after FDA approval of its psoriasis drug. Absci Corp. climbed up to 290% since September 12, 2025, on positive interim data for its AI-designed hair-loss treatment. Belite Bio increased up to 187% from its September 15, 2025 profile, supported by a completed rolling NDA submission for its retinal-disease therapy.

Apogee Therapeutics shares surged 47% in premarket trading after AbbVie agreed to acquire the biotechnology company for $10.9 billion, marking AbbVie's largest acquisition in more than five years and aimed at bolstering its next-generation immunology pipeline. AbbVie rose 1.5% on the news. BitFuFu gained 8.2% after the Bitcoin miner unveiled a share repurchase program authorizing the buyback of up to $5 million of its Class A ordinary shares over a two-year period. Nuvectis Pharma climbed 5.7% after entering a licensing agreement with Haisco Pharmaceutical Group for exclusive ex-China rights to two clinical-stage drug candidates, adding a Complement Factor B inhibitor and a BRAF inhibitor to its pipeline. Palvella Therapeutics rose 5% after the U.S. Food and Drug Administration granted rolling review for its New Drug Application for QTORIN rapamycin, a treatment under development for microcystic lymphatic malformations. Chevron gained 1.3% after announcing a 20-year power purchase agreement with Microsoft to supply natural gas-fired electricity to a proposed data center campus in West Texas, with the project expected to deliver approximately 2.67 gigawatts of capacity and begin supplying power in 2028.