等待開盤 07-19 09:30:00 美东时间
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Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on treating serious, rare genetic skin diseases without FDA-approved therapies, has been added to the Russell 3000® and Russell 2000® indexes effective June 30, 2025. Membership in these indexes reflects the company's market capitalization and is part of the annual reconstitution process. Palvella is developing a pipeline of product candidates, including its lead QTOR...
06-30 11:30
Palvella Therapeutics announced the completion of the SELVA Phase 3 trial for QTORIN™ rapamycin in treating microcystic lymphatic malformations (microcystic LMs), enrolling 51 subjects, exceeding the initial target of 40 by 25%. Top-line data is expected in Q1 2026, aiming for an NDA submission in H2 2026. QTORIN™ received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA. Microcystic LMs are a rare, chronic genetic dise...
06-23 11:30
New intellectual property builds on Palvella's multi-layered exclusivity strategyPatent term expected through at least 2038- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical
06-18 19:34
Palvella Therapeutics received U.S. Patent No. 12,329,748 for QTORIN™ 3.9% rapamycin anhydrous gel, providing broad protection for its composition and use in treating rare skin diseases. This marks the company's sixth U.S. patent, reinforcing its exclusivity strategy through intellectual property, proprietary formulations, and regulatory exclusivities. QTORIN™ has received FDA Breakthrough Therapy, Orphan Drug, and Fast Track Designations, with p...
06-18 11:30
FDA Orphan Products Grants are awarded based on rigorous scientific and technical review by rare disease and regulatory expertsUp to $2.6 million in non-dilutive funding anticipated over the grant periodTop-line data
06-09 19:36
Palvella Therapeutics has received an FDA Orphan Products Grant to support its Phase 3 SELVA trial for QTORIN™ rapamycin, targeting microcystic lymphatic malformations. The grant, among only seven awarded from 51 applications, provides up to $2.6 million in non-dilutive funding. The SELVA trial, evaluating QTORIN™ in 40 patients, is on track to report top-line data in Q1 2026. There are no FDA-approved treatments for microcystic LMs, a rare genet...
06-09 11:30
Palvella Therapeutics appoints Ashley Kline as Chief Commercial Officer to lead the U.S. launch of QTORIN™ rapamycin gel for treating rare genetic skin diseases. Kline, with a proven track record in rare disease commercialization, previously spearheaded the successful launch of Oxervate® at Dompé, achieving over $500 million in annual U.S. sales. Palvella aims to become a leading biopharmaceutical company focused on rare skin diseases, with QTORI...
05-27 12:00
Canaccord Genuity analyst Whitney Ijem maintains Palvella Therapeutics (NASDAQ:PVLA) with a Buy and lowers the price target from $53 to $52.
05-16 20:49
Palvella Therapeutics (NASDAQ:PVLA) reported quarterly losses of $(0.74) per share which beat the analyst consensus estimate of $(1.44) by 48.61 percent.
05-15 19:31
Companies Reporting Before The Bell • Edible Garden (NASDAQ:EDBL) is expected t...
05-15 16:32