PVLA

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

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted Palvella remains on track to complete the NDA submission in the second half of 2026 QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 22, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare

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

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

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

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

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

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

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

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

BERKELEY, Calif., June 9, 2026 /PRNewswire/ -- ResVita Bio, a biotechnology company pioneering a topical cell therapy modality where living, genetically engineered bacteria continuously produce protein therapeutics for skin diseases, today announced the appointment of John D. Doux, M.D., M.B.A., to its Board of Directors. "We are thrilled to welcome John to our Board as ResVita prepares to enter the clinic with RVB-003 in Netherton Syndrome and expands our continuous protein therapy platform across a broad range of chronic and rare skin diseases," said Amin Zargar, Ph.D., Chief Executive Officer and Co-Founder of ResVita Bio. "John is a respected voice in rare skin disease drug development w

Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing n

WAYNE, Pa., June 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference 2026 on Tuesday, June 9, 2026 at 8:40 a.m. ET. A live webcast of the fireside chat will be available on the Events and Present

Yale-licensed U.S. patent provides broad protection for topical mevalonate pathway inhibition in porokeratosis, including disseminated superficial actinic porokeratosis (DSAP) DSAP is a serious, rare, premalignant genetic skin disease affecting an estimated more than 50,000 diagnosed patients in the U.S., with no FDA-approved therapies Palvella plans to initiate a Phase 2 clinical trial of QTORIN™ pitavastatin in DSAP in the second half of 2026 WAYNE, Pa., May 27, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the "Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering f

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

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

In SELVA Phase 3 study, 100% of participants (13/13) aged 6–11 years were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24, with a mean improvement of +2.46 (p<0.001) 87% of participants (20/23) in SELVA with moderate or worse leaking/bleeding at baseline were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA Leaking/Bleeding at Week 24, with a mean improvement of +2.48 (p<0.001) 100% of SELVA participants who completed the efficacy evaluation period (43/43) were at least somewhat satisfied with QTORIN™ rapamycin on the TSQM-9 overall satisfaction item at We

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

100% of patients with bleeding at baseline demonstrated a statistically significant improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale (cVM-IGA Bleeding) at Week 12 (+2.5 point improvement; p=0.003) 100% of patients with bleeding at baseline reported being "satisfied" or "very satisfied" with QTORIN™ rapamycin on the overall satisfaction item of the Treatment Satisfaction Questionnaire for Medication at Week 12 Baseline qualitative patient interviews underscore the substantial physical, functional, and psychosocial burden of cutaneous venous malformations QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard

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

Uplisting reflects Palvella's continued progress advancing potential first-in-disease therapies for serious, rare skin diseases and vascular malformations WAYNE, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global

Stephens initiated coverage of Palvella Therapeutics with a rating of Overweight and set a new price target of $220.00

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

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

FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic lymphatic malformations; BEYONDmLM.com disease awareness campaign launched to educate, engage, and empower patients, caregivers, and healthcare professionals Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026 Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic