PVLA Jun 30, 2026PVLAGeneral
Palvella Therapeutics Appoints Accomplished Rare Disease Biotech Executive and Commercial Leader Matt Pauls, J.D., M.B.A., to Board of Directors
Palvella Therapeutics has appointed Matt Pauls, an experienced executive in rare disease biotech, to its Board of Directors. With over 25 years in the industry, Pauls has held leadership roles in several companies and is expected to contribute significantly to Palvella's upcoming regulatory and commercial advancements. His expertise will be crucial as the company prepares for the potential launch of its lead product, QTORIN™ rapamycin.
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PVLA Jun 29, 2026PVLAFDA Updates
Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics has initiated the rolling New Drug Application (NDA) process for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations. The FDA has previously granted Breakthrough Therapy and Fast Track designations for this treatment, highlighting its potential to meet a significant medical need. The company plans to complete the NDA submission by the second half of 2026 and is preparing for a potential commercial launch in 2027.
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PVLA Jun 3, 2026PVLAFDA Updates
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Palvella Therapeutics Announces Completion of FDA Pre-NDA Meeting for QTORIN™ Rapamycin in Microcystic Lymphatic Malformations
Palvella Therapeutics has completed its pre-New Drug Application meeting with the FDA for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations. The company plans to submit the NDA in the second half of 2026, supported by data from its Phase 3 SELVA study. QTORIN™ rapamycin could become the first FDA-approved therapy for this condition, which affects over 30,000 individuals in the U.S.
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PVLA Jun 2, 2026PVLAConferences/Events
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Palvella Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference 2026
Palvella Therapeutics, a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026. CEO Wes Kaupinen will lead a fireside chat, which will be available via live webcast. The company focuses on developing therapies for serious, rare skin diseases and vascular malformations.
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PVLA May 27, 2026PVLAFDA Updates
Palvella Therapeutics Strengthens QTORIN™ Pitavastatin Intellectual Property with Yale-Licensed U.S. Patent Providing Protection into 2043
Palvella Therapeutics announced the issuance of a U.S. patent for QTORIN™ pitavastatin, enhancing its intellectual property for treating disseminated superficial actinic porokeratosis (DSAP). The patent, licensed from Yale University, provides protection until 2043. Palvella aims to begin a Phase 2 clinical trial for this investigational therapy in the latter half of 2026.
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PVLA May 21, 2026PVLAGeneral
Palvella Therapeutics Named Healthcare & Life Sciences Company of the Year at the Philadelphia Alliance for Capital and Technologies (PACT) Ecosystem Awards
Palvella Therapeutics has been awarded the Healthcare & Life Sciences Company of the Year at the 2026 PACT Ecosystem Awards. This recognition underscores the company's dedication to developing innovative therapies for serious, rare skin diseases and vascular malformations. CEO Wes Kaupinen emphasized the team's commitment to advancing treatment options for patients without FDA-approved therapies.
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PVLA May 20, 2026PVLAPhases
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ISSUED BY PALVELLA THERAPEUTICS, INC. ON MAY 20, 2026 EX-99.1 Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Sup
Palvella Therapeutics presented new data from Phase 3 SELVA and Phase 2 TOIVA studies at the ISSVA World Congress, highlighting the efficacy of QTORIN rapamycin for treating microcystic lymphatic malformations and cutaneous venous malformations. The SELVA study reported that all participants aged 6 to 11 years showed improvement on the mLM-IGA scale, while the TOIVA study revealed notable reductions in visual and height scores of cutaneous venous malformations. Palvella plans to submit a New Drug Application to the FDA for QTORIN rapamycin in the latter half of 2026.
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PVLA May 20, 2026PVLAConferences/Events
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Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN™ Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations
Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN™ Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations
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PVLA May 15, 2026PVLAPhases
ISSUED BY PALVELLA THERAPEUTICS, INC. ON MAY 15, 2026 EX-99.1 Palvella Therapeutics Announces New Data from the Phase 2 TOIVA Trial of QTORIN Rapamycin in Cutaneous Venous Malformations Presented at the 83r
Palvella Therapeutics announced positive new data from the Phase 2 TOIVA trial of QTORIN rapamycin for cutaneous venous malformations, presented at the 83rd Annual Meeting of the Society for Investigative Dermatology. Notably, 100% of patients with baseline bleeding exhibited significant improvement in symptoms and reported high satisfaction with the treatment. This therapy has potential to be the first FDA-approved treatment for this condition, aiming to address the substantial burden faced by affected individuals. The trial highlights the importance of both clinical and patient-reported outcomes, reinforcing the need for novel treatment options in this area.
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PVLA May 15, 2026PVLAPhases
Palvella Therapeutics Announces New Data from the Phase 2 TOIVA Trial of QTORIN™ Rapamycin in Cutaneous Venous Malformations Presented at the 83rd Annual Meeting of the Society for Investigative Dermatology
Palvella Therapeutics Announces New Data from the Phase 2 TOIVA Trial of QTORIN™ Rapamycin in Cutaneous Venous Malformations Presented at the 83rd Annual Meeting of the Society for Investigative Dermatology
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PVLA May 13, 2026PVLAGeneral
Palvella Therapeutics Announces Uplisting to the Nasdaq Global Market
Palvella Therapeutics has announced its uplisting to the Nasdaq Global Market, reflecting the company's progress in developing therapies for rare skin diseases and vascular malformations. This transition is effective May 13, 2026, and aims to enhance visibility and support its mission. Palvella continues to comply with Nasdaq listing standards and SEC requirements.
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PVLA May 7, 2026PVLAFDA Updates
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Palvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update FDA Pre-New Drug Application (NDA) meeting granted for QTORIN rapamycin for the treatment of microcystic lymphatic malforma
Palvella Therapeutics has reported its first quarter financial results for 2026, revealing a net loss of $15.8 million. Positive developments include the grant of a Pre-New Drug Application meeting by the FDA for QTORIN rapamycin, aimed at treating microcystic lymphatic malformations, with an NDA submission planned for the second half of 2026. The company also announced successful financing of $230 million to bolster its commercialization strategy. Additionally, advancements in its clinical pipeline were highlighted, including multiple trials scheduled for the second half of 2026.
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PVLA May 4, 2026PVLAPhases
Palvella Therapeutics Announces First Patients Dosed in Phase 2 LOTU Trial of Fast Track-Designated QTORIN™ Rapamycin for Clinically Significant Angiokeratomas
Palvella Therapeutics has initiated dosing of the first patients in its Phase 2 LOTU trial, evaluating QTORIN™ rapamycin for clinically significant angiokeratomas. This trial aims to assess the safety and efficacy of the treatment, with topline results expected in the second half of 2027. The study addresses a significant medical need, as there are currently no FDA-approved therapies for this condition.
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PVLA Apr 30, 2026PVLAConferences/Events
Palvella Therapeutics to Host First Quarter 2026 Financial Results and Corporate Update Conference Call on May 7, 2026
Palvella Therapeutics, a clinical-stage biopharmaceutical company, will report its first quarter 2026 financial results on May 7, 2026. The company will host a conference call at 8:30 a.m. ET to discuss the results and provide a corporate update. Palvella focuses on developing therapies for serious, rare skin diseases and vascular malformations.
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PVLA Apr 20, 2026PVLAConferences/Events
Palvella Therapeutics to Present QTORIN™ Rapamycin Results from Phase 3 SELVA and Phase 2 TOIVA Studies at the International Society for the Study of Vascular Anomalies World Congress 2026
Palvella Therapeutics announced that results from its Phase 3 SELVA and Phase 2 TOIVA studies of QTORIN™ rapamycin will be presented at the ISSVA World Congress 2026. The presentation, led by Dr. James Treat, will showcase significant improvements in treating microcystic lymphatic malformations and cutaneous venous malformations. This highlights Palvella's commitment to developing therapies for rare skin diseases.
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PVLA Apr 13, 2026PVLAGeneral
Palvella Therapeutics Appoints John D. Doux, M.D., M.B.A., Dermatologist and Recognized Leader in Rare Skin Diseases, to Board of Directors
Palvella Therapeutics has appointed Dr. John D. Doux to its Board of Directors. Dr. Doux, a recognized leader in dermatology and rare skin diseases, brings over two decades of experience in clinical practice and biotechnology investing. His expertise is expected to enhance Palvella's efforts in developing novel therapies for serious, rare skin conditions.
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PVLA Apr 7, 2026PVLAConferences/Events
EX-PALVELLA THERAPEUTICS CORPORATE PRESENTATION - APRIL 2026 First-in-disease therapies for patients with rare diseases Corporate Presentation April 2026 Forward Looking Statements This presentation contains forward-look
Palvella Therapeutics recently presented a corporate update highlighting their advancements in developing first-in-disease therapies for rare diseases. The presentation emphasized strong Phase 3 data for their lead candidate targeting Microcystic Lymphatic Malformations and announced a variety of positive developments including FDA designations and upcoming clinical trials. The company laid out a comprehensive plan for commercializing their products in the U.S. and expanding their pipeline within the next 12 months, aiming to address multiple rare conditions. Overall, Palvella's strategic initiatives reflect their commitment to creating therapies for underserved patient populations.
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PVLA Apr 7, 2026PVLAGeneral
Palvella Therapeutics Appoints Accomplished Commercial Leader Kent Taylor as Senior Vice President of Sales
Palvella Therapeutics has appointed Kent Taylor as Senior Vice President of Sales, who will lead the U.S. sales organization for the potential launch of QTORIN rapamycin. Taylor comes with over 25 years of experience in building commercial organizations and has previously contributed to successful launches such as ZORYVE and OPZELURA. His expertise in dermatology will be crucial, as QTORIN is aimed at treating microcystic lymphatic malformations, a rare condition that currently lacks FDA-approved therapies. This appointment highlights Palvella's focus on addressing unmet needs in rare skin diseases.
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PVLA Mar 31, 2026PVLAFDA Updates
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Palvella Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update New Drug Application (NDA) for QTORIN rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) on t
Palvella Therapeutics has reported its financial results for the year ending December 31, 2025, highlighting significant progress toward the submission of a New Drug Application (NDA) for QTORIN rapamycin for microcystic lymphatic malformations, anticipated in the second half of 2026. The company has also initiated Phase 3 and Phase 2 trials for various indications of QTORIN rapamycin, demonstrating positive trial results and significant investor support. With a pro forma cash balance of approximately $274 million, Palvella is focused on advancing its development programs and accelerating U.S. launch preparations.
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PVLA Mar 30, 2026PVLAGeneral
Palvella Therapeutics Announces Scientific Publication in Journal of Vascular Anomalies Highlighting the Infiltrative Growth and Therapeutic Challenges of Microcystic Lymphatic Malformations
Palvella Therapeutics announced a publication in the Journal of Vascular Anomalies detailing the differences in treatment strategies for microcystic versus macrocystic lymphatic malformations. The review emphasizes the urgent need for effective therapies for microcystic conditions, highlighting QTORIN™ rapamycin as a potential targeted treatment. The publication supports the rationale for developing disease-specific clinical trials.
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PVLA Mar 30, 2026PVLAConferences/Events
Palvella Therapeutics Highlights Continued Progress Across Rare Skin Disease Pipeline with Two Poster Presentations at the 2026 American Academy of Dermatology Annual Meeting
Palvella Therapeutics presented two posters at the 2026 American Academy of Dermatology Annual Meeting, highlighting their QTORIN™ rapamycin gel's advancements and a qualitative study on porokeratosis. The QTORIN™ platform aims to enhance rapamycin's bioavailability for treating mTOR-driven skin diseases. The Phase 3 SELVA study demonstrated significant efficacy in treating microcystic lymphatic malformations.
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PVLA Mar 24, 2026PVLAConferences/Events
Palvella Therapeutics to Host Full Year 2025 Financial Results Conference Call and Provide a Corporate Update on March 31, 2026
Palvella Therapeutics will report its full year 2025 financial results on March 31, 2026. The company will host a conference call at 8:30 a.m. ET to discuss these results and provide a corporate update. Palvella focuses on developing therapies for rare skin diseases and vascular malformations.
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PVLA Mar 23, 2026PVLAGeneral
Palvella Therapeutics Strengthens Leadership Team with Appointment of Rare Disease Commercial Leader Jennifer J. McDonough as Senior Vice President of Market Access and Patient Services
Palvella Therapeutics has appointed Jennifer J. McDonough as Senior Vice President of Market Access and Patient Services. McDonough brings over 25 years of experience in rare disease therapies, having previously led the successful launch of VYJUVEK® at Krystal Biotech. Her role will focus on enhancing payer engagement and patient support for Palvella's QTORIN™ programs targeting serious skin diseases.
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PVLA Mar 16, 2026PVLAGeneral
Palvella Therapeutics Announces Issuance of European Patent Covering Anhydrous Compositions of Rapamycin
Palvella Therapeutics Announces Issuance of European Patent Covering Anhydrous Compositions of Rapamycin
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PVLA Mar 10, 2026PVLAGeneral
Palvella Therapeutics Launches "BEYOND mLM" Disease Awareness Campaign for Microcystic Lymphatic Malformations in Collaboration with Leading Lymphatic, Vascular, and Dermatology Nonprofit Organizations
Palvella Therapeutics Launches "BEYOND mLM" Disease Awareness Campaign for Microcystic Lymphatic Malformations in Collaboration with Leading Lymphatic, Vascular, and Dermatology Nonprofit Organizations
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PVLA Mar 2, 2026PVLAGeneral
Palvella Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares
Palvella Therapeutics announced the closing of its upsized public offering, which raised $230 million by selling 1,840,000 shares at $125.00 each. The offering included the full exercise of the underwriters' option for additional shares. The funds will support the development of its therapies for rare skin diseases and vascular malformations.
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PVLA Feb 26, 2026PVLAGeneral
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Palvella Therapeutics Announces Pricing of Upsized Public Offering
Palvella Therapeutics announced the pricing of its upsized public offering, selling 1,600,000 shares at $125.00 each, potentially raising $200 million. The offering will close on February 27, 2026, and proceeds will be used for the development of their drug candidates and general corporate purposes. The company is focused on treating rare skin diseases and vascular malformations.
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PVLA Feb 25, 2026PVLAGeneral
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Palvella Therapeutics Announces Proposed Public Offering
Palvella Therapeutics has announced a proposed public offering of $150 million in common stock, with an option for underwriters to purchase an additional $22.5 million. The proceeds will support the development of its therapies for rare skin diseases. The offering is subject to market conditions and regulatory approvals.
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PVLA Feb 24, 2026PVLAPhases
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Palvella Therapeutics Announces Positive Topline Results from Phase 3 SELVA Clinical Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations
Palvella Therapeutics announced positive topline results from its Phase 3 SELVA study of QTORIN™ rapamycin for microcystic lymphatic malformations. The trial met its primary endpoint with significant improvement in disease severity. Additionally, 95% of participants showed improvement, and the treatment was well-tolerated. Palvella plans to submit a New Drug Application to the FDA in late 2026.
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PVLA Feb 24, 2026PVLAConferences/Events
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Palvella Therapeutics to Host Conference Call to Discuss Topline Results from Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations
Palvella Therapeutics will host a conference call on February 24, 2026, to discuss topline results from its Phase 3 SELVA clinical trial of QTORIN™ 3.9% rapamycin anhydrous gel. The trial assesses the gel's efficacy and safety for treating microcystic lymphatic malformations. A press release with results will be issued prior to the call.
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PVLA Feb 24, 2026PVLAPhases
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ISSUED BY PALVELLA THERAPEUTICS, INC. ON FEBRUARY 24, 2026 EX-99.1 Palvella Therapeutics Announces Positive Topline Results from Phase 3 SELVA Clinical Study of QTORIN 3.9% Rapamycin Anhydrous Gel (QTORIN r
Palvella Therapeutics announced positive topline results from its Phase 3 SELVA study of QTORIN 3.9% rapamycin anhydrous gel for treating microcystic lymphatic malformations. The trial met its primary endpoint with a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment. Additionally, QTORIN rapamycin demonstrated high efficacy scores with 95% of participants improving at Week 24. The company plans to submit a New Drug Application to the FDA in the second half of 2026, potentially making it the first FDA-approved treatment for this condition.
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PVLA Feb 24, 2026PVLAPhases
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CORPORATE PRESENTATION ON PHASE 3 SELVA STUDY OF QTORIN DATED FEBRUARY 24, 2026 First-in-disease therapies for patients with rare diseases Phase 3 SELVA Topline Data in Microcystic Lymphatic Malformations
Palvella Therapeutics presented the Phase 3 SELVA study results for their first-in-disease therapy, QTORIN rapamycin, aimed at treating Microcystic Lymphatic Malformations. The study demonstrated highly statistically significant improvements on the primary endpoint with a mean increase on the mLM-IGA of +2.13. Palvella indicated plans to file for New Drug Application (NDA) by early 2027, within a landscape marked by a lack of approved therapies for this condition affecting an estimated 30,000 patients in the U.S.
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PVLA Feb 2, 2026PVLAPhases
Palvella Therapeutics Announces Scientific Publication in Clinical and Experimental Dermatology Highlighting a Systematic Review of Real-World Statin Evidence and Persistent Treatment Gaps Resulting from the Lack of FDA-Approved Therapies in Porokeratosis
Palvella Therapeutics announced a systematic review published in Clinical and Experimental Dermatology, highlighting the potential of QTORIN™ pitavastatin for treating disseminated superficial actinic porokeratosis (DSAP). The review consolidates evidence on off-label statin use, emphasizing the lack of FDA-approved therapies for this serious skin condition. Phase 2 development for QTORIN™ pitavastatin is expected to begin in late 2026.
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PVLA Jan 29, 2026PVLAGeneral
PALVELLA THERAPEUTICS CORPORATE PRESENTATION - JANUARY 2026 First-in-disease therapies for patients with rare diseases Corporate Presentation January 2026 Forward Looking Statements This presentation contains forward-loo
Palvella Therapeutics has presented its corporate update focused on developing first-in-disease therapies for rare diseases. The presentation outlines the company's late-stage pipeline, highlighting the QTORIN platform and upcoming clinical trials, including a Phase 3 topline data release expected in March 2026. With four programs addressing significant unmet needs in serious skin diseases and vascular malformations, Palvella aims to capture multi-billion dollar market opportunities. The company is also positioned for expedited regulatory review for its lead product candidates.
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PVLA Jan 9, 2026PVLAPhases
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Palvella Therapeutics Provides Corporate Update and 2026 Outlook: Advancing a Late Clinical-Stage Pipeline and Platform to Address Multiple Serious, Rare Skin Diseases and Vascular Malformations with No FDA-Approved Therapies
Palvella Therapeutics provided a corporate update detailing its late clinical-stage pipeline, including the Phase 3 SELVA study for QTORIN™ rapamycin targeting microcystic lymphatic malformations, with results expected in March 2026. The company anticipates a potential NDA submission later in 2026 if results are positive. Additionally, Palvella is preparing for a U.S. launch and has plans for further pipeline expansion.
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PVLA Jan 7, 2026PVLAGeneral
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Palvella Therapeutics Strengthens Leadership Team with Appointment of Veteran Medical Affairs Leader Vimal Patel, PharmD, as Senior Vice President of Medical Affairs
Palvella Therapeutics has appointed Dr. Vimal Patel as Senior Vice President of Medical Affairs, bringing over 25 years of experience in dermatology and immunology. Dr. Patel will lead the Medical Affairs organization, focusing on advancing scientific engagement and disease awareness for the company's QTORIN™ programs. His expertise is expected to enhance Palvella's efforts in developing therapies for serious, rare skin diseases.
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PVLA Dec 16, 2025PVLAFDA Updates
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Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas
Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas
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PVLA Dec 15, 2025PVLAFDA Updates
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Palvella Therapeutics Announces Positive Topline Results from Phase 2 TOIVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Cutaneous Venous Malformations, a Serious, Rare Genetic Disease with No FDA-approved Therapies
Palvella Therapeutics Announces Positive Topline Results from Phase 2 TOIVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Cutaneous Venous Malformations, a Serious, Rare Genetic Disease with No FDA-approved Therapies
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PVLA Dec 15, 2025PVLAPhases
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First - in - disease therapies for patients with rare skin diseases Phase 2 TOIVA Topline Data in Cutaneous Venous Malformations
Palvella Therapeutics announced positive topline results from its Phase 2 TOIVA study of QTORIN rapamycin for treating cutaneous venous malformations. The study showed statistical significance in various efficacy endpoints, with a notable 73% of participants demonstrating at least a one-point improvement after 12 weeks. Furthermore, the therapy proved to be well-tolerated, aligning with findings from prior clinical trials. The company plans to engage the FDA in early 2026 to discuss the possibility of obtaining Breakthrough Therapy Designation and commencing a Phase 3 pivotal study.
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PVLA Nov 11, 2025PVLAPhases
Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Palvella Therapeutics reported its third quarter 2025 financial results, highlighting advancements in its rare disease pipeline. The company is on track to announce top-line results for its Phase 2 and Phase 3 trials of QTORIN™ rapamycin in December 2025 and early 2026, respectively. Additionally, Palvella plans to initiate new Phase 2 studies for other indications in 2026, supported by a solid financial position.
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PVLA Nov 6, 2025PVLAConferences/Events
Palvella Therapeutics to Present at the Stifel 2025 Healthcare Conference
Palvella Therapeutics, a clinical-stage biopharmaceutical company, will present at the Stifel 2025 Healthcare Conference on November 12, 2025. CEO Wes Kaupinen will discuss the company's focus on developing therapies for rare skin diseases. Palvella's lead product candidate, QTORIN™ rapamycin, targets conditions lacking FDA-approved treatments.
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PVLA Nov 5, 2025PVLAPhases
Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies
Palvella Therapeutics has announced QTORIN™ pitavastatin as a new candidate for treating disseminated superficial actinic porokeratosis (DSAP), a rare skin disease with no FDA-approved therapies. The company plans to initiate a Phase 2 trial in the second half of 2026. This therapy aims to inhibit the mevalonate pathway, which is implicated in the disease's progression.
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PVLA Nov 5, 2025PVLAPhases
First - in - disease therapies for patients with rare skin diseases QTORIN Pitavastatin: Developing the First Pathogenesis - directed Therapy for Disseminated Superficial Actinic Porokeratosis
Palvella Therapeutics is advancing the QTORIN Pitavastatin program, targeting Disseminated Superficial Actinic Porokeratosis (DSAP), a serious skin disease with no FDA-approved treatment. The company is working towards potentially being the first to develop a pathogenesis-directed therapy for this condition, with clinical data expected by the end of Q1 2026. The therapy focuses on the mevalonate pathway, which is believed to play a key role in the disease's progression. With over 50,000 patients in the U.S., there is significant commercial potential for this investigational approach.
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PVLA Nov 4, 2025PVLAConferences/Events
Palvella Therapeutics to Host Third Quarter 2025 Financial Results and Corporate Update Conference Call on November 11, 2025
Palvella Therapeutics announced that it will report its third quarter 2025 financial results on November 11, 2025. A conference call with management will follow the report to discuss results and provide a corporate update. Palvella focuses on developing innovative therapies for rare skin diseases and is actively conducting clinical trials for its lead product candidate, QTORIN rapamycin. The company aims to address significant unmet needs in this area.
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PVLA Oct 13, 2025PVLAFDA Updates
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U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics’ Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations
Palvella Therapeutics has received a second year of funding from the FDA for its Phase 3 SELVA trial of QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations. The trial has successfully enrolled 51 subjects, surpassing its target. Top-line data is expected in early 2026, with a New Drug Application planned for later that year.
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PVLA Sep 24, 2025PVLAPhases
Palvella Therapeutics Announces Expansion of QTORIN™ Rapamycin’s Development into Clinically Significant Angiokeratomas, a Rare, Chronically Debilitating Lymphatic Disease with No FDA-approved Therapies
Palvella Therapeutics has announced the expansion of its QTORIN™ rapamycin development program to include clinically significant angiokeratomas, a rare lymphatic disease affecting over 50,000 patients in the U.S. The company plans to initiate a Phase 2 trial in late 2026, aiming to address the lack of FDA-approved therapies for this condition. Palvella's strategy focuses on serious, rare skin diseases, aligning with its goal to introduce the first approved treatment for these conditions.
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PVLA Sep 17, 2025PVLAPhases
Palvella Therapeutics Announces Scientific Publication in Lymphatic Research and Biology Highlighting Recent Advances in the Pathogenesis of Venous Malformations and the Real-World Use of Rapamycin as an Emerging Targeted Therapy
Palvella Therapeutics announced a publication in Lymphatic Research and Biology detailing advances in the understanding of venous malformations and the role of rapamycin as a treatment. The systematic review of 26 studies supports the use of QTORIN™ rapamycin gel for cutaneous venous malformations, highlighting the urgent need for FDA-approved therapies. The Phase 2 TOIVA trial is ongoing, with results expected in December 2025.
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PVLA Sep 15, 2025PVLAPhases
Palvella Therapeutics Completes Enrollment in Phase 2 TOIVA Trial of QTORIN™ Rapamycin for Cutaneous Venous Malformations
Palvella Therapeutics has completed enrollment in its Phase 2 TOIVA trial for QTORIN™ rapamycin, targeting cutaneous venous malformations. The trial successfully recruited 16 subjects, meeting its target. The results are anticipated in mid-December 2025, with the potential for QTORIN™ to become the first FDA-approved treatment for this condition.
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PVLA Sep 3, 2025PVLAGeneral
Palvella Therapeutics Strengthens Leadership with Appointment of Accomplished Scientist and Biopharmaceutical Executive David W. Osborne, Ph.D. as Chief Innovation Officer
Palvella Therapeutics has appointed David W. Osborne, Ph.D., as Chief Innovation Officer. Dr. Osborne, a co-founder of Arcutis Biotherapeutics, brings over 25 years of experience in developing therapies for skin diseases. He will lead the expansion of the QTORIN™ platform, with plans to announce a new product candidate by the end of 2025.
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PVLA Sep 3, 2025PVLAGeneral
First - in - disease therapies for patients with rare genetic skin diseases Corporate Presentation September 2025 2 Forward Looking Statements This presentation contains forward - looking statements of Palvella Therapeut
Palvella Therapeutics is advancing its development of first-in-disease therapies for rare genetic skin diseases, focusing on its QTORIN rapamycin product. The company has recently accelerated U.S. launch planning and made strategic hires to strengthen its R&D and commercial operations. With an anticipated increase in the addressable patient pool and strong management, Palvella is positioned to address the critical lack of FDA-approved therapies for these conditions. However, the company faces substantial competition and inherent risks associated with clinical trials and market dynamics.
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PVLA Aug 28, 2025PVLAConferences/Events
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Palvella Therapeutics to Present at Upcoming Healthcare Investor Conferences
Palvella Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Wes Kaupinen, will present at two upcoming healthcare investor conferences. The presentations are scheduled for September 4 and September 8, 2025. These events aim to showcase Palvella's efforts in developing therapies for rare genetic skin diseases, highlighting their ongoing clinical trials.
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PVLA Aug 14, 2025PVLAGeneral
Palvella Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Phase 3 SELVA trial evaluating QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for microcystic lymphatic malformati
Palvella Therapeutics reported its financial results for Q2 2025, highlighting significant advancements in its clinical trials. The Phase 3 SELVA trial for QTORIN rapamycin achieved enrollment above its target, with top-line results expected in Q1 2026. The company also plans to announce a new clinical indication and an additional candidate from its QTORIN platform later this year. Despite a net loss of $9.5 million for the quarter, Palvella is well-funded to continue its operations through 2027.
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PVLA Aug 7, 2025PVLAConferences/Events
Palvella Therapeutics to Host Second Quarter 2025 Financial Results and Corporate Update Conference Call on August 14, 2025
Palvella Therapeutics, a clinical-stage biopharmaceutical company, has announced the upcoming release of its second quarter 2025 financial results, which will take place on August 14, 2025. During a conference call scheduled for the same day, Palvella management will discuss these results and provide a corporate update to investors. The company is developing therapies for rare genetic skin diseases and is actively conducting clinical trials on its leading product candidate, QTORIN rapamycin.
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PVLA Aug 5, 2025PVLAConferences/Events
Palvella Therapeutics to Participate in the Canaccord Genuity 45th Annual Growth Conference
Palvella Therapeutics to Participate in the Canaccord Genuity 45th Annual Growth Conference
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PVLA Jun 30, 2025PVLAGeneral
Palvella Therapeutics Added to Russell 3000 and Russell 2000 Indexes
Palvella Therapeutics, a clinical-stage biopharmaceutical company, has been added to the Russell 3000 and Russell 2000 Indexes effective June 30, 2025. This inclusion highlights the company's growing market presence and its commitment to developing therapies for rare genetic skin diseases. The Russell indexes, which are utilized by many investment managers and institutional investors, may enhance Palvella's visibility and attract further investment. The company is currently working on its lead product candidate, QTORIN™ rapamycin, which is undergoing clinical trials.
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PVLA Jun 23, 2025PVLAGeneral
Terwisscha van Scheltinga AG, Lub-de Hooge MN, Hinner MJ, Verheijen RB, Allersdorfer A, Hülsmeyer M, Nagengast WB, Schröder CP, Kosterink JG, de Vries EG, Audoly L, Olwill SA (2014) In Vivo Visualization of MET Tumor Expression and Anticalin Biodistribution with the MET-Specific Anticalin 89Zr-PRS-110 PET Tracer
The article discusses a study involving the MET-specific Anticalin 89Zr-PRS-110 PET tracer for in vivo visualization of MET tumor expression and biodistribution. The authors include various researchers and the text provides a brief overview without detailed findings or conclusions. Further information on the study's implications or results is not provided.
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PVLA Jun 23, 2025PVLAGeneral
Gebauer M, Schiefner A, Matschiner G, Skerra A. (2013) Combinatorial design of an Anticalin directed against the extra-domain b for the specific targeting of oncofetal fibronectin
The article discusses a combinatorial design of an Anticalin aimed at targeting oncofetal fibronectin. It highlights the work of Gebauer et al. in 2013, but lacks specific details on the findings or implications of the research. The text appears to be a placeholder with no substantial content provided.
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PVLA Jun 23, 2025PVLAGeneral
Schönfeld, D., Matschiner, G., Chatwel,l L., Trentmann, S., Gille, H., Hülsmeyer, M., Brown, N., Kaye, P.M., Schlehuber, S., Hohlbaum, A.M., Skerra, A. (2009) An engineered lipocalin specific for CTLA-4 reveals a combining site with structural and conformational features similar to antibodies. PNAS 19;106(20):8198-203.
The article presents a study on an engineered lipocalin specific for CTLA-4, highlighting its structural and conformational similarities to antibodies. The research was published in PNAS and contributes to understanding CTLA-4 interactions. However, the article lacks specific details or implications of the findings.
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PVLA Jun 23, 2025PVLAGeneral
Klaus Mross, Heike Richly, Richard Fischer, Dirk Scharr, Martin Büchert, Angelika Stern, Hendrik Gille, Laurent P. Audoly, Max E. Scheulen (2013) First-in-Human Phase I Study of PRS-050 (Angiocal), an Anticalin Targeting and Antagonizing VEGF-A, in Patients with Advanced Solid Tumors
The article discusses the archaeological examination of Arctic whalers' graves in Svalbard, which are being affected by climate change. As permafrost thaws, the remains are deteriorating, highlighting the difficult conditions and health issues faced by these early modern whalers. This research underscores the impact of climate change on heritage sites.
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PVLA Jun 23, 2025PVLAGeneral
Coby M. M. Laarakkers, Erwin T. Wiegerinck, Siem Klaver, Maria Kolodziejczyk, Hendrik Gille, Andreas M. Hohlbaum, Harold Tjalsma, Dorine W. Swinkels (2013) Improved Mass Spectrometry Assay For Plasma Hepcidin: Detection and Characterization of a Novel Hepcidin Isoform
The article discusses the impact of climate change on archaeological sites in Svalbard, particularly the graves of early modern whalers. As permafrost thaws, these remains are deteriorating, providing insights into the health and conditions faced by these historical figures. The research highlights the intersection of climate change and heritage preservation.
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PVLA Jun 23, 2025PVLAGeneral
Olwill SA, Joffroy C, Gille H, Vigna E, Matschiner G, Allersdorfer A, Lunde BM, Jaworski J, Burrows JF, Chiriaco C, Christian HJ, Hülsmeyer M, Trentmann S, Jensen K, Hohlbaum AM, Audoly L. (2013) A highly potent and specific MET therapeutic protein antagonist with both ligand-dependent and ligand-independent activity. Mol Cancer Ther. Sep 3.
The article discusses a research paper detailing a potent MET therapeutic protein antagonist. The study highlights both ligand-dependent and ligand-independent activities of the antagonist. However, the article lacks specific details about the findings or implications of the research.
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PVLA Jun 23, 2025PVLAGeneral
Martz L. (2009) Designer Lipocalins. SciBX 2(28) 8-9. Kim, H.J., Eichinger, A., Skerra A. (2009) High-affinity recognition of lanthanide(III) chelate complexes by a reprogrammed human lipocalin 2. J Am Chem Soc. 131(10):3565-76.
The article references two scientific works related to designer lipocalins and their applications in recognizing lanthanide(III) chelate complexes. It provides a brief overview of the research but lacks detailed insights or specific findings. The text appears to be a placeholder without substantial content.
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PVLA Jun 23, 2025PVLAGeneral
Skerra, A. (2008) Alternative binding proteins: Anticalins – harnessing the structural plasticity of the lipocalin ligand pocket to engineer novel binding activities. FEBS J. 275(11):2677-83
The article discusses alternative binding proteins known as Anticalins, which leverage the structural plasticity of the lipocalin ligand pocket to create novel binding activities. It references a study by Skerra from 2008 published in the FEBS Journal. The text is primarily a placeholder and does not provide detailed insights or findings.
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PVLA Jun 23, 2025PVLAGeneral
Breustedt, D.A., Schonfeld, D.L., Skerra, A. (2006) Comparative ligand-binding analysis of ten human lipocalins. Biochim Biophys Acta. 1764(2), 161-173.
The article presents a comparative ligand-binding analysis of ten human lipocalins conducted by Breustedt, Schonfeld, and Skerra. Published in Biochim Biophys Acta, the study explores the binding characteristics of these proteins. The findings contribute to the understanding of lipocalin functionality and interactions.
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PVLA Jun 23, 2025PVLAGeneral
Nasreen, A., Vogt, M., Kim, H.J., Eichinger, A., Skerra, A. (2006) Solubility engineering and crystallization of human apolipoprotein D. Protein Sci. 15(1), 190-199.
The article discusses solubility engineering and crystallization of human apolipoprotein D, as detailed in a study by Nasreen et al. The research is published in Protein Science and focuses on methods to enhance protein solubility and crystallization techniques. This work contributes to the understanding of protein behavior in biological systems.
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PVLA Jun 23, 2025PVLAGeneral
Vopel, S., Muhlbach, H., Skerra, A. (2005) Rational engineering of a fluorescein-binding anticalin for improved ligand affinity. Biol Chem. 386(11), 1097-1104.
The article discusses a study on the rational engineering of a fluorescein-binding anticalin aimed at improving ligand affinity. The authors, Vopel, Muhlbach, and Skerra, published their findings in a 2005 issue of Biol Chem. The text block provided does not contain specific details about the study's results or implications.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S. & Skerra, A. (2005) Anticalins in Drug Development. BioDrugs, 19(5), 279-288.
The article discusses the role of Anticalins in drug development, highlighting their potential applications. It provides insights into the mechanisms and advantages of using Anticalins in therapeutic contexts. However, the text lacks specific details or recent developments in the field.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S. & Skerra, A. (2005) Anticalins as an alternative to antibody technology. Expert Opin. Biol. Ther. 5(11), 1453-1462.
The article discusses the potential of Anticalins as an alternative to traditional antibody technology. It references a study by Schlehuber and Skerra published in 2005. The text appears to be a placeholder with no detailed insights or findings presented.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S. & Skerra, A. (2005) Lipocalins in drug discovery: from natural ligand-binding proteins to ‘anticalins’. Drug Discov. Today 10, 23-33.
The article discusses the role of lipocalins in drug discovery, highlighting their potential as natural ligand-binding proteins and their evolution into 'anticalins'. It provides insights into the applications of these proteins in therapeutic development. However, the content lacks specific details or recent advancements in the field.
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PVLA Jun 23, 2025PVLAGeneral
Breustedt, D. A., Korndörfer, I. P., Redl, B. & Skerra, A. (2005) The 1.8-Å; crystal structure of human tear lipocalin reveals an extended branched cavity with capacity for multiple ligands. J. Biol. Chem. 280, 484-493.
The article presents a reference to a scientific paper detailing the crystal structure of human tear lipocalin. It highlights the discovery of an extended branched cavity capable of accommodating multiple ligands. This research contributes to the understanding of the protein's structure and potential functions.
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PVLA Jun 23, 2025PVLAGeneral
Nygren, P.-Å;. & Skerra, A. (2004) Binding proteins from alternative scaffolds. J. Immunol. Methods 290, 3-28.
The article discusses binding proteins derived from alternative scaffolds, focusing on their applications in immunology. It references a study published in the Journal of Immunology Methods. The content appears to be an introductory overview without specific findings or conclusions presented.
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PVLA Jun 23, 2025PVLAGeneral
Vogt, M. & Skerra, A. (2004) Construction of an artificial receptor protein (“Anticalin”) based on the human apolipoprotein D. ChemBioChem 5, 191-199.
The article discusses the construction of an artificial receptor protein known as 'Anticalin' based on human apolipoprotein D. It references a study by Vogt and Skerra published in 2004. The text is primarily placeholder content and does not provide specific insights or findings related to the research.
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PVLA Jun 23, 2025PVLAGeneral
Liu, G., Mills, J. L., Hess, T. A., Kim, S., Skalicky, J. J., Sukumaran, D. K., Kupce, E., Skerra, A. & Szyperski, T. (2003) Resonance assignments for the 21 kDa engineered fluorescein-binding lipocalin FluA. J. Biomol. NMR 27, 187-188.
The article discusses resonance assignments for an engineered fluorescein-binding lipocalin, FluA. It cites a study by Liu et al. published in the Journal of Biomolecular NMR. The focus is on the biochemical properties and structural analysis of the 21 kDa protein. The text appears to be a placeholder with no additional details.
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PVLA Jun 23, 2025PVLAGeneral
Korndörfer, I. P., Beste, G. & Skerra, A. (2003) Crystallographic analysis of an “anticalin” with tailored specificity for fluorescein reveals high structural plasticity of the lipocalin loop region. Proteins: Struct. Funct. Genet. 52, 121-129.
The article discusses a study on an 'anticalin' with specific binding for fluorescein, revealing structural plasticity in the lipocalin loop region. The research contributes to understanding the flexibility and adaptability of protein structures. The findings are published in the journal Proteins: Structure, Function, and Genetics.
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PVLA Jun 23, 2025PVLAGeneral
Korndörfer, I. P., Schlehuber, S. & Skerra, A. (2003) Structural mechanism of specific ligand recognition by a lipocalin tailored for the complexation of digoxigenin. J. Mol. Biol. 330, 385-396.
The article discusses the structural mechanism of specific ligand recognition by a lipocalin designed for digoxigenin complexation. It references a study by Korndörfer et al. published in the Journal of Molecular Biology. The content emphasizes the biochemical interactions involved but lacks detailed findings or implications.
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PVLA Jun 23, 2025PVLAGeneral
Götz, M., Hess, S., Beste, G., Skerra, A. & Michel-Beyerle, M.E. (2002) Ultrafast electron transfer in the complex between fluorescein and a cognate engineered lipocalin protein, a so-called anticalin. Biochemistry 41, 4156-4164.
The article discusses a study on ultrafast electron transfer in a complex involving fluorescein and an engineered lipocalin protein, known as an anticalin. The research is published in Biochemistry and highlights the interactions at a molecular level. However, the article lacks specific details about the findings or implications of the study.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S., & Skerra, A. (2002) Tuning ligand affinity, specificity, and folding stability of an engineered lipocalin variant – a so-called ‘anticalin’ – using a molecular random approach. Biophys. Chem. 96, 213-228.
The article discusses a study by Schlehuber and Skerra on tuning ligand affinity, specificity, and folding stability of an engineered lipocalin variant known as 'anticalin'. The research is published in Biophysical Chemistry. The text appears to be a placeholder with no additional details provided.
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PVLA Jun 23, 2025PVLAGeneral
Skerra, A. (2001) ‘Anticalins’: a new class of engineered ligand-binding proteins with antibody-like properties. Rev. Mol. Biotechnol. 74, 257-275.
The article discusses 'Anticalins', a new class of engineered ligand-binding proteins with properties similar to antibodies. It references a review by A. Skerra published in 2001. The text includes placeholder content and does not provide specific details about the proteins or their applications.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S., & Skerra, A. (2001) Duocalins: engineered ligand-binding proteins with dual specificity derived from the lipocalin fold. Biol. Chem. 382, 1335-1342.
The article discusses engineered ligand-binding proteins known as Duocalins, derived from the lipocalin fold. It references a study by Schlehuber and Skerra published in 2001. The content appears to be a placeholder with no specific insights or developments in the biopharma field.
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PVLA Jun 23, 2025PVLAGeneral
Schlehuber, S., Beste, G. & Skerra, A. (2000) A novel type of receptor protein, based on the lipocalin scaffold, with specificity for digoxigenin. J. Mol. Biol. 297, 1105-1120.
The article discusses a novel receptor protein based on the lipocalin scaffold, which has specificity for digoxigenin. The research was published in the Journal of Molecular Biology. The text does not provide further details or implications of the findings.
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PVLA Jun 23, 2025PVLAGeneral
Skerra, A. (2000) Lipocalins as a scaffold. Biochim. Biophys. Acta 1482, 337-350.
The article presents a reference to a work by A. Skerra on lipocalins as a scaffold. It briefly mentions the publication details, including the journal and page numbers. The text appears to be a placeholder or introductory content without substantial information on the topic.
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PVLA Jun 23, 2025PVLAGeneral
Skerra, A. (2000) Engineered protein scaffolds for molecular recognition. J. Mol. Recognit. 13, 167-187.
The article presents a reference to a study by A. Skerra on engineered protein scaffolds for molecular recognition. It discusses the potential applications of these scaffolds in molecular biology. However, the text lacks specific details or findings from the study, making it difficult to assess its impact or relevance.
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PVLA Jun 23, 2025PVLAGeneral
Beste, G., Schmidt, F. S., Stibora, T. & Skerra, A. (1999) Small antibody-like proteins with prescribed ligand specificities derived from the lipocalin fold. Proc. Natl. Acad. Sci. USA 96, 1898-1903.
The article references a scientific work by Beste et al. on small antibody-like proteins derived from the lipocalin fold. It highlights the research published in the Proceedings of the National Academy of Sciences. The content appears to be a placeholder text, lacking specific details about the study's findings or implications.
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PVLA Jun 23, 2025PVLAPhases
Palvella Therapeutics Completes Enrollment in Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations, Exceeding Enrollment Target by Over 25%
Palvella Therapeutics Completes Enrollment in Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations, Exceeding Enrollment Target by Over 25%
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PVLA Jun 18, 2025PVLAGeneral
Palvella Therapeutics Granted Sixth U.S. Patent Covering 0.1–20% Anhydrous Compositions of Rapamycin and Other mTOR Inhibitors
Palvella Therapeutics Granted Sixth U.S. Patent Covering 0.1–20% Anhydrous Compositions of Rapamycin and Other mTOR Inhibitors
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PVLA Jun 9, 2025PVLAPhases
Palvella Therapeutics Receives Initial Proceeds from FDA Orphan Products Grant to Support Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations
Palvella Therapeutics announced the receipt of initial proceeds from an FDA Orphan Products grant to support its ongoing Phase 3 SELVA trial of QTORIN rapamycin for treating microcystic lymphatic malformations. This grant, worth up to $2.6 million, highlights the therapy's potential importance as there are currently no FDA-approved treatments for this rare condition. Top-line data from the SELVA trial is expected in the first quarter of 2026, marking a critical juncture for patients suffering from this debilitating genetic disease. The grant was awarded following a competitive selection process where Palvella's trial was one of only seven funded.
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PVLA May 27, 2025PVLAGeneral
Palvella Therapeutics Strengthens Executive Leadership Team with Appointment of Rare Disease Commercial Veteran Ashley Kline as Chief Commercial Officer
Palvella Therapeutics Strengthens Executive Leadership Team with Appointment of Rare Disease Commercial Veteran Ashley Kline as Chief Commercial Officer
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PVLA May 15, 2025PVLAGeneral
Palvella Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update Phase 3 SELVA trial evaluating QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for the treatment of microcystic lymp
Palvella Therapeutics reported its financial results for the first quarter of 2025 and provided updates on its clinical trials. The Phase 3 SELVA trial of QTORIN rapamycin for microcystic lymphatic malformations has surpassed its enrollment target, with anticipated top-line results expected in the first quarter of 2026. The company's financial position is solid, with cash reserves projected to fund operations well into 2027 despite reporting a significant net loss in this quarter. Additionally, the Phase 2 TOIVA trial is progressing, with results anticipated by late 2025.
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PVLA May 8, 2025PVLAConferences/Events
Palvella Therapeutics to Host First Quarter 2025 Financial Results and Corporate Update Conference Call on May 15, 2025
Palvella Therapeutics to Host First Quarter 2025 Financial Results and Corporate Update Conference Call on May 15, 2025
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PVLA May 5, 2025PVLAConferences/Events
Palvella Therapeutics to Ring the Nasdaq Opening Bell on May 12, 2025
Palvella Therapeutics has announced that it will ring the opening bell at the Nasdaq Stock Market on May 12, 2025. The ceremony will include CEO Wes Kaupinen, the management team, and various stakeholders, signifying the company's milestone as a publicly traded entity. This event aims to showcase Palvella's commitment to developing therapies for serious, rare genetic skin diseases, which currently lack FDA-approved treatments. The live broadcast will take place at Nasdaq's MarketSite in New York City.
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PVLA Apr 23, 2025PVLAConferences/Events
Palvella Therapeutics Announces Abstract Highlighting the Estimated Diagnosed Prevalence and Annual Incidence of Lymphatic Malformations in the U.S. Accepted for Poster Presentation at the 82nd Annual Meeting of the Society for Investigative Dermatology
Palvella Therapeutics announced that an abstract focusing on the estimated prevalence and annual incidence of lymphatic malformations (LMs) with cutaneous involvement in the U.S. has been accepted for poster presentation at the Society for Investigative Dermatology Annual Meeting. The quantitative analysis reveals an estimated 44,553 to 92,967 diagnosed patients with LMs, highlighting the need for multidisciplinary care. The poster presentation is scheduled for May 8, 2025, and aims to shed light on previously underreported statistics in this rare condition, further paving the way for potential treatment advancements.
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PVLA Apr 22, 2025PVLAGeneral
▲ +5.7%on this newsshared move
Palvella Therapeutics Granted Additional U.S. Patent for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics Granted Additional U.S. Patent for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
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PVLA Apr 11, 2025PVLAConferences/Events
▲ +9.5%on this news· ran to +23% by day 1
Palvella Therapeutics Announces QTORIN™ Rapamycin 3.9% Anhydrous Gel for the Treatment of Microcystic Lymphatic Malformations Featured in Oral Presentation by Amy Paller, M.S., M.D.
Palvella Therapeutics Announces QTORIN™ Rapamycin 3.9% Anhydrous Gel for the Treatment of Microcystic Lymphatic Malformations Featured in Oral Presentation by Amy Paller, M.S., M.D.
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PVLA Apr 4, 2025PVLAConferences/Events
Palvella Therapeutics to Present at the Jones Healthcare and Technology Innovation Conference
Palvella Therapeutics to Present at the Jones Healthcare and Technology Innovation Conference
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PVLA Apr 2, 2025PVLAConferences/Events
▲ +14.3%on this newsshared move
Palvella Therapeutics Announces Late-Breaking Oral Presentation at the 15th World Congress of Pediatric Dermatology
Palvella Therapeutics, Inc. announced a late-breaking oral presentation at the 15th World Congress of Pediatric Dermatology scheduled for April 8-11, 2025, in Buenos Aires, Argentina. The presentation will focus on the SELVA clinical trial, which investigates the efficacy of QTORIN™ 3.9% rapamycin anhydrous gel for treating microcystic lymphatic malformations in patients aged three and older. This condition currently lacks FDA-approved treatment options, affecting over 30,000 patients in the United States.
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PVLA Mar 31, 2025PVLAGeneral
Palvella Therapeutics Reports Full Year 2024 Financial Results and Provides Corporate Update Upon close of merger and $78.9mm concurrent private placement from a syndicate of leading healthcare-dedicated investors, compl
Palvella Therapeutics reported its financial results for the full year 2024, highlighting its merger's completion and a $78.9 million funding boost. The company is advancing its QTORIN rapamycin product candidate through clinical trials for serious genetic skin diseases, with significant trial results expected in 2025 and 2026. Despite a net loss in 2024, Palvella's strong cash position and planned pipeline expansions paint an optimistic future for the company's growth and therapy development.
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PVLA Mar 18, 2025PVLAConferences/Events
Palvella Therapeutics to Host Full Year 2024 Financial Results Conference Call on March 31, 2025
Palvella Therapeutics to Host Full Year 2024 Financial Results Conference Call on March 31, 2025
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PVLA Feb 25, 2025PVLAConferences/Events
Palvella Therapeutics to Present at the TD Cowen 45th Annual Healthcare Conference
Palvella Therapeutics to Present at the TD Cowen 45th Annual Healthcare Conference
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PVLA Feb 10, 2025PVLAPhases
Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include Additional Patients
Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include Additional Patients
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PVLA Jan 10, 2025PVLAPhases
Palvella Therapeutics Announces Publication of Results from Phase 2 Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations in the Journal of Vascular Anomalies
Palvella Therapeutics Announces Publication of Results from Phase 2 Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations in the Journal of Vascular Anomalies
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PVLA Jan 8, 2025PVLAPhases
Palvella Therapeutics Announces First Patients Dosed in Phase 2 TOIVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Cutaneous Venous Malformations
Palvella Therapeutics has announced the dosing of the first patients in its Phase 2 TOIVA clinical trial for QTORIN™ 3.9% rapamycin anhydrous gel, targeting cutaneous venous malformations. This single-arm trial aims to assess the safety and efficacy of the novel therapy, with 15 subjects enrolled across multiple U.S. centers. Cutaneous VMs affect a significant number of patients, and QTORIN rapamycin has the potential to be the first approved treatment, addressing an unmet need in genetic skin diseases. The FDA has also designated QTORIN rapamycin with Fast Track status, further emphasizing its promising outlook.
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PVLA Dec 13, 2024PVLAGeneral
Palvella Therapeutics Announces Closing of Merger with Pieris Pharmaceuticals and Concurrent Private Placement of $78.9 Million
Palvella Therapeutics Announces Closing of Merger with Pieris Pharmaceuticals and Concurrent Private Placement of $78.9 Million
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PVLA Nov 7, 2024PVLAPhases
Palvella Therapeutics Announces First Patient Dosed in SELVA Phase 3 Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics Announces First Patient Dosed in SELVA Phase 3 Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
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PVLA Oct 17, 2024PVLAGeneral
Palvella Therapeutics Appoints Matthew E. Korenberg as Chief Financial Officer
Palvella Therapeutics Appoints Matthew E. Korenberg as Chief Financial Officer
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PVLA Oct 15, 2024PVLAConferences/Events
Palvella Therapeutics Announces Presentations at the 12th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference
Palvella Therapeutics Announces Presentations at the 12th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference
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PVLA Oct 3, 2024PVLAFDA Updates
Palvella Therapeutics Awarded Up to $2.6 million Grant from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development to Support Phase 3 Single-Arm, Baseline-Controlled Trial in Microcystic Lymphatic Malformations
Palvella Therapeutics Awarded Up to $2.6 million Grant from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development to Support Phase 3 Single-Arm, Baseline-Controlled Trial in Microcystic Lymphatic Malformations
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PVLA Jul 24, 2024PVLAGeneral
Palvella Therapeutics and Pieris Pharmaceuticals Announce Definitive Merger Agreement
Palvella Therapeutics and Pieris Pharmaceuticals have announced a definitive merger agreement to form a Nasdaq-listed biopharmaceutical company focused on rare genetic skin diseases. The merger is expected to provide approximately $80.5 million in cash, funding clinical trials for QTORIN™ rapamycin, a potential first-line treatment for microcystic lymphatic malformations. The transaction is anticipated to close in Q4 2024, pending stockholder and regulatory approvals.
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PVLA Dec 1, 2023PVLAPhases
Palvella Therapeutics and Ligand Pharmaceuticals Expand Strategic Partnership to Accelerate Phase 3 Development of QTORIN™ rapamycin for Microcystic Lymphatic Malformations and Additional High Unmet Need Clinical Indications
Palvella Therapeutics and Ligand Pharmaceuticals have expanded their strategic partnership to accelerate the Phase 3 development of QTORIN™ rapamycin for treating Microcystic Lymphatic Malformations. Palvella received a $5 million upfront payment, and the partnership will allow Ligand to increase its royalties on global sales. QTORIN has been granted Breakthrough Therapy Designation by the FDA, based on positive Phase 2 trial results showing significant improvement in participants. The partnership highlights a significant market opportunity, as there are no FDA-approved treatments currently available for this condition.
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PVLA Nov 16, 2023PVLAFDA Updates
Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
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PVLA Jul 20, 2023PVLAPhases
Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita
Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita
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PVLA Jul 20, 2023PVLAPhases
Palvella Therapeutics Announces Planned Pivotal Phase 3 Study Design of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations and Topline Results from Phase 2b CODY Study in Gorlin Syndrome
Palvella Therapeutics has announced the design of a pivotal Phase 3 study for QTORIN rapamycin, targeting Microcystic Lymphatic Malformations (Microcystic LMs) after positive Phase 2 results showed all participants improved. With over 30,000 individuals affected in the U.S., this product could fulfill a significant unmet medical need as a potential first approved therapy. The company also disclosed topline results of the Phase 2b CODY study concerning Gorlin Syndrome, indicating it did not meet the primary endpoint, although a secondary endpoint showed some promise. Regulatory interactions are anticipated to determine future steps.
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PVLA Mar 9, 2023PVLAFDA Updates
Palvella Therapeutics Announces Positive Topline Results from Phase 2 Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations, a Serious, Rare Genetic Skin Disease with No FDA-approved Therapies
Palvella Therapeutics Announces Positive Topline Results from Phase 2 Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations, a Serious, Rare Genetic Skin Disease with No FDA-approved Therapies
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PVLA Feb 21, 2023PVLAPhases
Palvella Therapeutics Announces Pipeline Update on QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ Rapamycin) for Serious, Rare Genetic Skin Diseases with No FDA-approved Therapies
Palvella Therapeutics has announced a pipeline update for QTORIN™ rapamycin, which is under investigation for the treatment of serious genetic skin diseases, including Pachyonychia Congenita, Microcystic Lymphatic Malformations, and Basal Cell Carcinomas in Gorlin Syndrome. The company has completed enrollment in several clinical studies and expects to release top-line results in the upcoming months, offering hope for patients suffering from conditions with no FDA-approved therapies. With its robust development model and ongoing studies, Palvella aims to meet urgent unmet medical needs in these areas.
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PVLA Jan 5, 2023PVLAGeneral
Palvella Therapeutics Announces Series D Financing of Up to $37.7 Million to Accelerate Late-Stage Development and Support Commercialization of Novel Therapies for Serious, Rare Genetic Skin Diseases
Palvella Therapeutics Announces Series D Financing of Up to $37.7 Million to Accelerate Late-Stage Development and Support Commercialization of Novel Therapies for Serious, Rare Genetic Skin Diseases
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PVLA Dec 23, 2020PVLAPhases
Palvella Therapeutics Reports Top-Line Results from Pivotal Phase 2/3 VALO Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel in Patients with Pachyonychia Congenita
Palvella Therapeutics Reports Top-Line Results from Pivotal Phase 2/3 VALO Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel in Patients with Pachyonychia Congenita
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PVLA May 28, 2020PVLAGeneral
Palvella Therapeutics Completes $45 Million Series C Financing
Palvella Therapeutics Completes $45 Million Series C Financing
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PVLA Mar 6, 2020PVLAPhases
Palvella Therapeutics Completes Enrollment in Phase 2/3 Pivotal Study of PTX-022 for Treatment of Pachyonychia Congenita
Palvella Therapeutics Completes Enrollment in Phase 2/3 Pivotal Study of PTX-022 for Treatment of Pachyonychia Congenita
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PVLA Nov 13, 2019PVLAPhases
Palvella Therapeutics Commences Phase 3 Portion of Phase 2/3 Pivotal Study of PTX-022 in Pachyonychia Congenita
Palvella Therapeutics Commences Phase 3 Portion of Phase 2/3 Pivotal Study of PTX-022 in Pachyonychia Congenita
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PVLA Mar 12, 2019PVLAGeneral
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
PIERIS PHARMACEUTICALS REPORTS 2018 YEAR-END CASH POSITION AND PROVIDES CORPORATE UPDATE
COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON
TUESDAY, MARCH 12, 2019 AT 8:00 AM EDT
BOSTON, MA, March 12, 2019 - Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnolo
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PVLA Dec 18, 2018PVLAPhases
Palvella Therapeutics Announces $10 Million in Funding from Ligand Pharmaceuticals to Accelerate PTX-022 through Phase 2/3 Clinical Study in Pachyonychia Congenita
Palvella Therapeutics Announces $10 Million in Funding from Ligand Pharmaceuticals to Accelerate PTX-022 through Phase 2/3 Clinical Study in Pachyonychia Congenita
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PVLA Nov 12, 2018PVLAFDA Updates
Palvella Therapeutics Announces FDA Fast Track Designation for PTX-022 for Treatment of Pachyonychia Congenita
Palvella Therapeutics Announces FDA Fast Track Designation for PTX-022 for Treatment of Pachyonychia Congenita
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PVLA Oct 19, 2018PVLAConferences/Events
Palvella Therapeutics to Present Update on PTX-022 at Pachyonychia Congenita Project Patient Support Meeting in London, UK
Palvella Therapeutics to Present Update on PTX-022 at Pachyonychia Congenita Project Patient Support Meeting in London, UK
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PVLA Sep 5, 2018PVLAGeneral
Palvella Therapeutics Appoints Rare Disease Senior Executive Elaine J. Heron, PhD to Board of Directors
Palvella Therapeutics Appoints Rare Disease Senior Executive Elaine J. Heron, PhD to Board of Directors
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PVLA Feb 16, 2018PVLAGeneral
Pieris Pharmaceuticals Announces Pricing of its Public Offering BOSTON, MA (Marketwired) 02/14/18 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) , a clinical-stage biotechnology company advancing novel biotherapeutics throu
Pieris Pharmaceuticals Announces Pricing of its Public Offering
BOSTON, MA (Marketwired) 02/14/18 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing
novel biotherapeutics through its proprietary Anticalin technology platform for cancer
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PVLA Feb 13, 2018PVLAGeneral
Pieris Pharmaceuticals Announces Public Offering of Common Stock BOSTON, MA (Marketwired) 02/13/18 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) , a clinical-stage biotechnology company advancing novel biotherapeutics thro
Pieris Pharmaceuticals Announces Public Offering of Common Stock
BOSTON, MA (Marketwired) 02/13/18 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing
novel biotherapeutics through its proprietary Anticalin technology platform for cance
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PVLA Nov 21, 2017PVLAGeneral
Pieris Pharmaceuticals Appoints James Geraghty as Chairman of the Board of Directors BOSTON, MA (Marketwired) 11/21/17 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) , a clinical-stage biotechnology company advancing novel
Pieris Pharmaceuticals Appoints James Geraghty as Chairman of the Board of Directors
BOSTON, MA (Marketwired) 11/21/17 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing
novel biotherapeutics through its proprietary Anticalin technolog
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PVLA Nov 14, 2017PVLAConferences/Events
Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject
Investor Presentation November 2017 1
Forward Looking Statements Statements
in this presentation that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncerta
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PVLA Nov 8, 2017PVLAGeneral
Pieris Pharmaceuticals Reports Financial Results for the Third Quarter Ended
Pieris Pharmaceuticals Reports Financial Results for the Third Quarter Ended September 30, 2017, and Provides Corporate Update
BOSTON, MA (Marketwired) November 8, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage
biotechnology company advancing novel biotherap
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PVLA Sep 18, 2017PVLAGeneral
Klinikum rechts der Isar Technische Universit t M nchen Safety, tolerability, and pharmacodynamics of the hepcidin antagonist PRS-080#022-DP after single administration -a phase Ib study in anemic chronic kidney disease
Klinikum rechts der Isar Technische Universit t M nchen
Safety, tolerability, and pharmacodynamics of the hepcidin antagonist PRS-080#022-DP after single administration -a phase Ib study in anemic chronic kidney disease patients undergoing hemodialysisPieris Pharmaceuticals, Inc
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PVLA Aug 10, 2017PVLAGeneral
Pieris Pharmaceuticals Reports Financial Results for the Second Quarter Ended
Pieris Pharmaceuticals Reports Financial Results for the Second
Quarter Ended June 30, 2017 and Provides Corporate Update
BOSTON, MA (Marketwired) August 9, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage
biotechnology company advancing novel biotherapeutics
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PVLA Jun 5, 2017PVLAGeneral
Klinikum rechts der Isar A phase Ib study investigating the safety, tolerability, Technische Universit t M nchen pharmacokinetics, and pharmacodynamics of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney d
99.1 Klinikum rechts der Isar A phase Ib study investigating the safety, tolerability, Technische Universit t M nchen pharmacokinetics, and pharmacodynamics of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease
patients undergoing hemodialysis Lutz Renders,
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PVLA May 22, 2017PVLAGeneral
Pieris Pharmaceuticals Appoints James Geraghty to its Board of Directors BOSTON, MA (Marketwired) 05/22/2016 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) , a clinical-stage biotechnology company advancing novel biotherape
Pieris Pharmaceuticals Appoints James Geraghty to its Board of Directors
BOSTON, MA (Marketwired) 05/22/2016 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing
novel biotherapeutics through its proprietary Anticalin technology platform
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PVLA May 11, 2017PVLAGeneral
Pieris Pharmaceuticals Reports Financial Results for the First Quarter Ended
Pieris Pharmaceuticals Reports Financial Results for the First Quarter Ended March 31, 2017 and Provides Corporate Update
Company to Host an Investor Conference Call Tomorrow at 10:00 AM EDT
BOSTON, MA, May 10, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage b
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PVLA May 3, 2017PVLAGeneral
Pieris Pharmaceuticals and AstraZeneca Collaborate to Develop and Commercialize Anticalin-Based Inhaled Treatments for Respiratory Diseases Pieris to receive $57.5 million USD in upfront and near-term miles
Pieris Pharmaceuticals and AstraZeneca Collaborate to Develop and Commercialize Anticalin-Based Inhaled Treatments for Respiratory Diseases
Boston, MA, May 3, 2017 Pieris today announced a strategic collaboration in respiratory diseases with AstraZeneca to
develop novel inhaled
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PVLA Apr 4, 2017PVLAGeneral
Preclinical toxicology and pharmacology for the 4-1BB/HER2 bispecific PRS-343: A first-in-class costimulatory T cell engager Marlon J. Hinner, Rachida-Siham Bel Aiba, Thomas Jaquin, Sven Berger, Manuela D rr, Corinna Sch
Preclinical toxicology and pharmacology for the 4-1BB/HER2 bispecific PRS-343:
A first-in-class costimulatory T cell engager
Marlon J. Hinner, Rachida-Siham Bel Aiba, Thomas
Jaquin, Sven Berger, Manuela D rr,
Corinna Schlosser, Andrea Allersdorfer, Christine Rothe, Louis A. M
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PVLA Mar 22, 2017PVLAConferences/Events
Pieris Pharmaceuticals, Inc. Nasdaq:PIRS 27th Annual Oppenheimer Healthcare Conference Stephen Yoder, President & CEO Forward Looking Statements Statements in this presentation that are not descriptions of historical fac
Pieris Pharmaceuticals, Inc.
27th Annual Oppenheimer Healthcare Conference
Stephen Yoder, President & CEO
Statements in this presentation that are not descriptions of historical facts are
forward-looking statements that are based on management s current expectations and assum
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PVLA Mar 22, 2017PVLAConferences/Events
PIERIS PHARMACEUTICALS REPORTS FULL-YEAR 2016 FINANCIAL RESULTS AND CORPORATE UPDATE COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON THURSDAY, MARCH 23, 2017 AT 10:00
PIERIS PHARMACEUTICALS REPORTS FULL-YEAR 2016
FINANCIAL RESULTS AND CORPORATE UPDATE
COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON
THURSDAY, MARCH 23, 2017 AT 10:00 AM EDT
BOSTON, MA, March 22, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology c
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PVLA Feb 27, 2017PVLAGeneral
Pieris Signs 1st Partnership for Anemia Drug PRS-080, Granting Exclusive Option in Japan to ASKA Pharmaceutical Novel Hepcidin Inhibitor Addressing High Medical Need in Anemia of Chronic Disease Boston, MA,
Pieris Signs 1st Partnership for Anemia Drug PRS-080, Granting Exclusive Option in Japan to ASKA
Novel Hepcidin Inhibitor Addressing High Medical Need in Anemia of Chronic Disease
Boston, MA, 27 February 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotech
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PVLA Feb 7, 2017PVLAGeneral
Pieris Announces Management Transition BOSTON, MA
Pieris Announces Management Transition
BOSTON, MA, February 7, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel
biotherapeutics through its proprietary Anticalin technology platform, today announced that Darlene Deptula-Hic
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PVLA Jan 9, 2017PVLAConferences/Events
Forward Looking Statements Non-Confidential Statements in this presentation that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions
Pieris Pharmaceuticals, Inc.
Nasdaq:PIRS Corporate Presentation January 2017 Exhibit 99.1
Forward Looking Statements
Non-Confidential Statements in this presentation that are not descriptions of historical facts are forward-looking statements that are based on management's cur
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PVLA Jan 5, 2017PVLAGeneral
Pieris Pharmaceuticals and Servier Forge Strategic Immuno-oncology Co-development Alliance Pieris and Servier, an independent international pharmaceutical company headquartered in France with annual sales o
Pieris Pharmaceuticals and Servier Forge Strategic Immuno-oncology Co-development Alliance
Boston, MA, and Suresnes, France, 5 January 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company
advancing novel biotherapeutics through its proprietar
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PVLA Nov 9, 2016PVLAConferences/Events
PIERIS PHARMACEUTICALS REPORTS FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2016 COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON THURSDAY, NOVEMBER 10, 2016 AT 10
PIERIS PHARMACEUTICALS REPORTS FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2016
COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON
THURSDAY, NOVEMBER 10, 2016 AT 10:00 AM ET
BOSTON, MA, November 9, 2016 Pieris Pharmaceuticals, Inc. (NA
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PVLA Oct 24, 2016PVLAGeneral
Costimulatory T-cell engagement by PRS-343, a CD137 (4-1BB)/HER2 bispecific, leads to tumor growth inhibition and CD8(+) T cell expansion in humanized mouse model Marlon J. Hinner1, Rachida-Siham Bel Aiba1, Corinna Schlo
Costimulatory T-cell engagement by PRS-343, a CD137 (4-1BB)/HER2 bispecific, leads to tumor growth inhibition and CD8(+) T cell expansion in humanized mouse model Marlon J. Hinner1,
Rachida-Siham Bel Aiba1, Corinna Schlosser1, Thomas Jaquin1, Andrea Allersdorfer1, Sven Berger1,
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PVLA Sep 22, 2016PVLAGeneral
PIERIS PHARMACEUTICALS APPOINTS CHRISTOPHER KIRITSY TO ITS BOARD OF DIRECTORS Mr. Kiritsy brings extensive life science research and development, business development, finance and commercial experience to P
PIERIS PHARMACEUTICALS APPOINTS CHRISTOPHER KIRITSY
TO ITS BOARD OF DIRECTORS
Mr. Kiritsy brings extensive life science research and development, business
development, finance and commercial experience to Pieris board
BOSTON, MA, September 22, 2016 Pieris Pharmaceuticals, Inc
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PVLA Aug 11, 2016PVLAGeneral
Pieris Pharmaceuticals Reports Financial Results and Provides Corporate Update for the Second Quarter Ended
Pieris Pharmaceuticals Reports Financial Results and Provides Corporate
Update for the Second Quarter Ended June 30, 2016
Company to Host an Investor Conference Call on Thursday,
August 11, 2016 at 10:00 AM ET
August 10, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clin
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PVLA Jul 26, 2016PVLAGeneral
PIERIS PHARMACEUTICALS APPOINTS JULIAN ADAMS, Ph.D., TO ITS BOARD OF DIRECTORS Dr. Adams brings extensive oncology drug discovery and development experience to Pieris board BOSTON, MA
PIERIS PHARMACEUTICALS APPOINTS JULIAN ADAMS, Ph.D.,
TO ITS BOARD OF DIRECTORS
Dr. Adams brings extensive oncology drug discovery and development
experience to Pieris board
July 26, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advanc
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PVLA Jun 8, 2016PVLAGeneral
Pieris Pharmaceuticals Announces Closing of $16.5 Million Private Placement BOSTON, MA
Pieris Pharmaceuticals Announces Closing of $16.5 Million
June 8, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) today announced closing of the private placement consisting of 8,188,804 units at a price of $2.015 per unit, for total gross proceeds of approximately $16.5 million
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PVLA Jun 3, 2016PVLAGeneral
Pieris Pharmaceuticals Announces $16.5 Million Private Placement BOSTON, MA
Pieris Pharmaceuticals Announces $16.5 Million Private Placement
BOSTON, MA June 3, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) announced today that it entered into a securities purchase
agreement for a private placement with a select group of institutional investors, inclu
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PVLA Apr 18, 2016PVLAGeneral
Background. CD137 (4-1BB) is a key costimulatory immunoreceptor and a member of the TNF-receptor (TNFR) superfamily. While multiple lines of evidence show that CD137 is a highly promising therapeutic target in cancer, cu
Costimulatory T-cell engagement by the
CD137/HER2 bispecific PRS-343 leads to strong anti-tumor effect in humanized mouse model Marlon J. Hinner, Rachida-Siham Bel Aiba, Corinna Schlosser, Alexander Wiedenmann, Andrea Allersdorfer, Thomas J. Jaquin, Gabriele Matschiner, Sven Ber
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PVLA Dec 8, 2015PVLAGeneral
Pieris Pharmaceuticals Announces First Cancer Immunotherapy Collaboration Agreement with Roche Leverages Proprietary Anticalin Technology Platform Boston, MA
Pieris Pharmaceuticals Announces
First Cancer Immunotherapy Collaboration
Agreement with Roche Leverages Proprietary Anticalin Technology Platform
Boston, MA, December 8, 2015 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel bio
therapeutic
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PVLA Dec 7, 2015PVLAPhases
PIERIS PHARMACEUTICALS PRESENTS CLINICAL DATA FOR ITS HEPCIDIN ANTAGONIST PROGRAM, PRS-080, AT THE 2015 AMERICAN SOCIETY OF HEMATOLOGY (ASH)
PIERIS PHARMACEUTICALS PRESENTS CLINICAL DATA FOR ITS HEPCIDIN ANTAGONIST PROGRAM, PRS-080, AT THE
2015 AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING
BOSTON, MA, December 7, 2015 Pieris Pharmaceuticals, Inc. (NASDAQ:
PIRS), a biotechnology company advancing its proprieta
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PVLA Nov 19, 2015PVLAPhases
PIERIS PHARMACEUTICALS COLLABORATOR DAIICHI SANKYO DOSES FIRST SUBJECT IN A PHASE 1 CLINICAL STUDY FOR LEAD PARTNERED ANTICALIN PROGRAM Boston, MA
PIERIS PHARMACEUTICALS COLLABORATOR DAIICHI SANKYO
DOSES FIRST SUBJECT IN A PHASE 1 CLINICAL STUDY FOR LEAD
PARTNERED ANTICALIN PROGRAM
MA, November 19, 2015 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel bio therapeutics through its propr
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PVLA Sep 15, 2015PVLAPhases
PIERIS PHARMACEUTICALS COLLABORATOR PRESENTS PROMISING PRECLINICAL DATA ON TETRASPECIFIC INFECTIOUS DISEASE ANTICALIN PROGRAM AT ASM CONFERENCE First-in-Class Multispecific Protein Offers High Differentiati
PIERIS PHARMACEUTICALS COLLABORATOR PRESENTS
PROMISING PRECLINICAL DATA ON TETRASPECIFIC INFECTIOUS
DISEASE ANTICALIN PROGRAM AT ASM CONFERENCE
First-in-Class Multispecific Protein Offers High Differentiation Over Antibodies
Boston, Massachusetts, September 15, 2015 Pieris Ph
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PVLA Sep 2, 2015PVLAGeneral
PIERIS PHARMACEUTICALS STRENGHTENS SENIOR MANAGEMENT TEAM AND ESTABLISHES US HEADQUARTERS IN BOSTON Darlene Deptula-Hicks to Join as Sr. VP and Chief Financial Officer Boston to Serve as Corporate Headquart
PIERIS PHARMACEUTICALS STRENGHTENS SENIOR MANAGEMENT TEAM AND ESTABLISHES US HEADQUARTERS IN BOSTON
Darlene Deptula-Hicks to Join as Sr. VP and Chief Financial Officer
Boston to Serve as Corporate Headquarters and Hub for Anticalin Drug Development
BOSTON, MA, September 2, 201
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PVLA Aug 18, 2015PVLAGeneral
PIERIS PHARMACEUTICALS APPOINTS LOUIS A. MATIS, M.D.
PIERIS PHARMACEUTICALS APPOINTS LOUIS A. MATIS, M.D., AS CHIEF DEVELOPMENT OFFICER
FREISING, GERMANY, August 18, 2015 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel
biotherapeutics through its proprietary Anticalin technology platform, toda
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PVLA May 19, 2015PVLAConferences/Events
NON CONFIDENTIAL Forward Looking Statements 2 Statements in this presentation that are not descriptions of historical facts are forward looking statements that are based on management s current expectations and assumptio
Holbrook Kohrt, M.D., Ph.D.) to validate approach Objective of achieving drug candidate nomination by the end of 2015 23 NON CONFIDENTIAL PRS 080: Intended to Reverse Hepcidin Mediated Functional Iron Deficiency 24 PRS 080 designed to reverse hepcidin mediated anemia by mobilizin
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PVLA May 14, 2015PVLAGeneral
Pieris Pharmaceuticals Appoints Immuno-Oncology Expert, Holbrook Kohrt, M.D., Ph.D., to Spearhead Immuno-Oncology Efforts and Initiates Research Collaboration with Leading Cancer Research Center FRE
Pieris Pharmaceuticals Appoints Immuno-Oncology Expert,
Holbrook Kohrt, M.D., Ph.D., to Spearhead Immuno-Oncology
Efforts and Initiates Research Collaboration with
Leading Cancer Research Center
FREISING, GERMANY, May 14, 2015 Pieris Pharmaceuticals, Inc. (OTCQB: PIRS), a bio
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PVLA May 14, 2015PVLAConferences/Events
Pieris Pharmaceuticals Reports First Quarter 2015 Financial Results Company to Host an Investor Conference Call on Thursday
Pieris Pharmaceuticals Reports First Quarter 2015 Financial Results
Company to Host an Investor Conference Call on Thursday,
May 14, 2015 at 10:00 AM EDT
FREISING, GERMANY, May 13, 2015 Pieris Pharmaceuticals, Inc. (OTCQB:PIRS), a biotechnology company advancing its proprietar
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PVLA May 12, 2015PVLAGeneral
Pieris Pharmaceuticals Appoints Former Celgene and Sanofi Executive, Jean-Pierre Bizzari, M.D., to its Board of Directors - Dr. Bizzari Brings Extensive Oncology Drug Development Experience to the Pieris Board FREISING,
Pieris Pharmaceuticals Appoints Former Celgene and Sanofi Executive,
Jean-Pierre Bizzari, M.D., to its Board of Directors
- Dr. Bizzari Brings Extensive Oncology Drug Development Experience to the Pieris Board
FREISING, GERMANY, May 12, 2015 Pieris Pharmaceuticals, Inc. (OTCQB
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PVLA Mar 26, 2015PVLAConferences/Events
Pieris Pharmaceuticals Reports Full-Year 2014 Financial Results and Provides Corporate Update Company to Host an Investor Conference Call on Thursday
Pieris Pharmaceuticals Reports Full-Year 2014 Financial Results and Provides Corporate Update
Company to Host an Investor Conference Call on Thursday,
March 26, 2015 at 10:00 AM EDT
FREISING, GERMANY, March 25, 2015 Pieris Pharmaceuticals, Inc. (OTCQB:PIRS) (the Company or Pie
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PVLA Mar 9, 2015PVLAConferences/Events
NON CONFIDENTIAL Forward Looking Statements 2 NON CONFIDENTIAL Statements in this presentation that are not descriptions of historical facts are forward looking statements that are based on management s current expectati
FeNo) allow for early clin. read out NON CONFIDENTIAL Clear differentiation from systemic mAbs Broader therapeutic index Low systemic exposure may lead to better side effect profile long term (e.g. role of Th2 in metabolic balance) More convenient Inhalation preferred over s.c. i
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PVLA Dec 23, 2014PVLAGeneral
Pieris Pharmaceuticals, Inc. Completes Private Placement, Raises $13.6M FREISING, GERMANY
Pieris Pharmaceuticals, Inc. Completes Private Placement,
December 23, 2014 Pieris Pharmaceuticals, Inc. (OTC:PIRS) (formerly Marika, Inc.), a biotechnology company advancing its proprietary Anticalin
biotherapeutic technologies, announced today the successful completion of its
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PVLA Dec 18, 2014PVLAGeneral
PIERIS AG Table of Contents Report of Independent Registered Public Accounting Firm 2 Balance Sheets as of
Table of Contents
Report of Independent Registered Public Accounting Firm 2 Balance Sheets as of December 31, 2013 and 2012 3 Statements of Operations for the years ended December 31, 2013 and 2012 5 Statements of Comprehensive Income (Loss) for the years ended December 31, 2
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