SEC Form EFFECT filed by Palvella Therapeutics Inc.
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | January 29, 2026 4:01 P.M. |
| Form: | S-3 | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | January 29, 2026 4:01 P.M. |
| Form: | S-3 | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 1/7/2026 | $205.00 | Outperform | Mizuho |
| 12/5/2025 | $167.00 | Buy | BTIG Research |
| 12/4/2025 | $175.00 | Buy | Craig Hallum |
| 11/19/2025 | $143.00 | Outperform → Strong Buy | Raymond James |
| 9/9/2025 | $85.00 | Outperform | Oppenheimer |
| 8/6/2025 | $54.00 | Outperform | Raymond James |
| 7/21/2025 | $56.00 | Buy | Truist |
| 4/9/2025 | $50.00 | Buy | Chardan Capital Markets |
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
WAYNE, Pa., March 24, 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 the Company will report its full year 2025 financial results before market open on Tuesday, March 31, 2026. Palvella management will host a conference call for investors at 8:30 a.m. ET on that same day to discuss the results and provide a corporate update. To access the live webcast
Ms. McDonough previously served as Senior Vice President of Patient Access, Analytics, and Operations at Krystal Biotech (NASDAQ:KRYS), where she helped lead the U.S. launch of VYJUVEK®, supporting its growth from FDA approval in 2023 to $389 million in annual sales in 2025 Ms. McDonough to lead Palvella's Market Access and Patient Services organizations, advancing payer engagement, patient support, specialty distribution, and access strategy for the Company's QTORIN™ programs targeting serious, rare skin diseases and vascular malformations WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (Nasdaq: PVLA), a clinical-stage biopharmaceut
Patent strengthens global intellectual property protection for QTORIN™ rapamycin, Palvella's lead product candidate from the QTORIN™ platform, in development for serious, rare skin diseases and vascular malformations with no FDA-approved therapies Patent protection extends into 2038 QTORIN™ rapamycin has previously been granted European Orphan Drug Designation for the treatment of microcystic lymphatic malformations, potentially providing 10 years of market exclusivity in the European Union upon approval There are currently no approved therapies in the European Union for microcystic lymphatic malformations WAYNE, Pa., March 16, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. ("P
Mizuho initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $205.00
BTIG Research initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $167.00
Craig Hallum initiated coverage of Palvella Therapeutics with a rating of Buy and set a new price target of $175.00
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)
8-K - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)
424B5 - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)
424B5 - PALVELLA THERAPEUTICS, INC. (0001583648) (Filer)
Ms. McDonough previously served as Senior Vice President of Patient Access, Analytics, and Operations at Krystal Biotech (NASDAQ:KRYS), where she helped lead the U.S. launch of VYJUVEK®, supporting its growth from FDA approval in 2023 to $389 million in annual sales in 2025 Ms. McDonough to lead Palvella's Market Access and Patient Services organizations, advancing payer engagement, patient support, specialty distribution, and access strategy for the Company's QTORIN™ programs targeting serious, rare skin diseases and vascular malformations WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (Nasdaq: PVLA), a clinical-stage biopharmaceut
Seasoned dermatology and immunology executive brings more than 25 years of experience advancing and launching innovative therapies, including OPZELURA®, povorcitinib, ILUMYA®, ODOMZO®, REMICADE®, and STELARA® Dr. Patel to lead Palvella's Medical Affairs organization, advancing scientific engagement, KOL collaboration, disease state awareness, and medical education for the Company's QTORIN™ programs targeting serious, rare skin diseases, including microcystic lymphatic malformations and cutaneous venous malformations WAYNE, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on dev
Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 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
WAYNE, Pa., March 24, 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 the Company will report its full year 2025 financial results before market open on Tuesday, March 31, 2026. Palvella management will host a conference call for investors at 8:30 a.m. ET on that same day to discuss the results and provide a corporate update. To access the live webcast
Primary endpoint met with statistically significant improvement (mean change of +2.13; p<0.001) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) Achieved statistical significance on pre-specified key secondary endpoint (p<0.001) and all four secondary efficacy endpoints (all p<0.001) 95% of trial participants aged ≥ 6 who completed the efficacy evaluation period improved on the mLM-IGA at Week 24 86% of trial participants aged ≥ 6 who completed the efficacy evaluation period were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA at Week 24 QTORIN™ rapamycin was well-tolerated, with no drug-related serious adverse events reported a
WAYNE, Pa., Feb. 23, 2026 (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 skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it will host a conference call and webcast tomorrow, Tuesday, February 24, 2026, at 8:00am ET to discuss topline results from the Phase 3 SELVA clinical trial assessing the efficacy and safety of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic ly