4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

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8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

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10-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)

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4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

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4/A - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

Truist initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $56.00

Chardan Capital Markets initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $50.00

Stifel initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $45.00

Scotiabank initiated coverage of Palvella Therapeutics with a rating of Sector Outperform and set a new price target of $50.00

Canaccord Genuity initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $39.00

TD Cowen initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $44.00

H.C. Wainwright initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $38.00

Cantor Fitzgerald initiated coverage of Palvella Therapeutics with a rating of Overweight

WAYNE, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced it has been added to the broad-market Russell 3000® Index and the Russell 2000® Index, effective after the U.S. market opens on June 30, as part of the 2025 Russell indexes reconstitution. Annual Russell indexes reconstitution captures the 3,000 largest US stocks, ranking them by total market capitalization. Membership in the

Enrollment of 51 subjects highlights significant unmet need in this serious, lifelong genetic disease which currently has no FDA-approved therapies Top-line data expected in the first quarter of 2026 WAYNE, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the successful completion of SELVA, a Phase 3 trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatme

New intellectual property builds on Palvella's multi-layered exclusivity strategy Patent term expected through at least 2038 WAYNE, Pa., June 18, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the United States Patent and Trademark Office (USPTO) issued patent No. 12,329,748 for claims related to the Company's lead product candidate QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin

FDA Orphan Products Grants are awarded based on rigorous scientific and technical review by rare disease and regulatory experts Up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026 WAYNE, Pa., June 09, 2025 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (NASDAQ:PVLA), a clinical-stage biopharmaceutical company developing and commercializing novel therapies for serious, rare genetic skin diseases with no U.S. Food and Drug Administration (FDA)-approved treatments, today announced it has received the initial proceeds from a previously announced grant from the FDA Office of Orphan Products Development.

Ms. Kline to lead Palvella's commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline's leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability WAYNE, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing an

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026 Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations top-line results on track for the fourth quarter of 2025 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous venous malformations Cash and cash equivalents of $75.6 million as of Ma

WAYNE, Pa., May 08, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that it will report its first quarter 2025 financial results on Thursday, May 15, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on Thursday, May 15, 2025, to discuss financial results and provide a corporate update. To access the live webcast of the call with slides, please click here or visit the "Events & Presentations" se

WAYNE, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, announced today that the Company will ring the opening bell at the Nasdaq Stock Market (Nasdaq) on Monday, May 12, 2025 in New York City. Wes Kaupinen, Founder and Chief Executive Officer, will be joined by members of the Palvella management team, Board of Directors, investors, advisors, and guests at the ceremony which wi

Quantitative analysis of medical claims indicates an estimated 44,553 to 92,967 diagnosed U.S. patients with lymphatic malformations (LMs) with cutaneous involvement Estimates of annual incidence of LMs with cutaneous involvement to be highlighted in the poster presentation Poster to be presented on Thursday, May 8, 2025, 4:30-6:00 pm PT WAYNE, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-appr

Fifth issued patent in the U.S. for QTORIN™ rapamycin with anticipated patent life extending into 2038 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care for microcystic lymphatic malformations in the U.S. WAYNE, Pa., April 22, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the United States Patent and Trademark Office (USPTO) issue

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026 Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations top-line results on track for the fourth quarter of 2025 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous venous malformations Cash and cash equivalents of $75.6 million as of Ma

WAYNE, Pa., May 08, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that it will report its first quarter 2025 financial results on Thursday, May 15, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on Thursday, May 15, 2025, to discuss financial results and provide a corporate update. To access the live webcast of the call with slides, please click here or visit the "Events & Presentations" se

Upon close of merger and $78.9mm concurrent private placement from a syndicate of leading healthcare-dedicated investors, completed transformation to a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic skin diseases Top-line results from SELVA, a Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs), on track for the first quarter of 2026 Top-line results from TOIVA, a Phase 2 single-arm, baseline-controlled trial evaluating QTORIN™ rapamycin for the treatment of

WAYNE, Pa., March 18, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that it will report its full year 2024 financial results on Monday, March 31, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on Monday, March 31, 2025, to discuss financial results and provide a corporate update. To access the live webcast of the call with slides, please click here or visit the "Events & Presentations" sect

Ms. Kline to lead Palvella's commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline's leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability WAYNE, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing an