LIPO

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

Retrieved on: 
Friday, April 5, 2024

Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .

Key Points: 
  • Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .
  • Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, “ASCO’s 2024 meeting is the ideal venue for dissemination of our recent progress in the treatment of bladder cancer.
  • Lipella’s new product candidate, LP-50 (intravesical pembrolizumab), is intended to be indicated for non-muscle invasive bladder cancer (NMIBC).
  • Dr. Michael Chancellor, Lipella’s Chief Medical Officer, emphasized the significance of this milestone for advancing the company’s LP-50 program.

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

Retrieved on: 
Wednesday, December 20, 2023

PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.

Key Points: 
  • PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.
  • Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations granted.
  • Additionally, Lipella's LP-310 has been granted orphan drug designation for the treatment of oral graft-versus-host disease (GVHD) with tacrolimus.
  • The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024.

FDA Grants Orphan Designation for Lipella's LP-310 Drug Candidate for Oral Graft-versus-Host Disease

Retrieved on: 
Friday, November 10, 2023

PITTSBURGH, Nov. 10, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical stage pharmaceutical company addressing serious diseases with significant unmet need based in Pittsburgh, PA, announced today that it has been granted "Orphan Drug Designation" from the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, which has been designed for the treatment of oral Graft-versus-Host Disease (GvHD). 

Key Points: 
  • LP-310 is Lipella's clinical stage pipeline asset intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD.
  • LP-310 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella's lead drug candidate, LP-10.
  • Dr. Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella, said, "We are very pleased to have received Orphan Drug Designation for LP-310 in oral GvHD.
  • Lipella's LP-10 was previously granted Orphan Drug Designation by the FDA, making LP-310 the second of Lipella's leading product candidates to receive this designation.

Lipella Pharmaceuticals Delivers Late-Breaking Presentation at the American Urological Association Annual Meeting

Retrieved on: 
Monday, May 1, 2023

PITTSBURGH, May 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that it has delivered a late-breaking presentation at the annual meeting of the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.

Key Points: 
  • PITTSBURGH, May 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that it has delivered a late-breaking presentation at the annual meeting of the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.
  • Dr. Hafron commented, "The clinical trial was a multi-center, dose-escalation Phase 2a study of 13 subjects with moderate to severe refractory hemorrhagic cystitis.
  • Lipella Pharmaceuticals CEO, Dr. Jonathan Kaufman, added, "We are very pleased to have successfully completed our Phase 2a clinical trial.
  • Lipella anticipates scheduling a Type B meeting with the FDA regarding this program in the next few months.

Lipella Pharmaceuticals Enters Manufacturing Collaboration Agreement with Cook MyoSite

Retrieved on: 
Monday, April 17, 2023

PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. ("Cook MyoSite") to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.

Key Points: 
  • PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. ("Cook MyoSite") to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis.
  • The collaboration with Cook MyoSite, a company with 19 years of Good Manufacturing Practice ("GMP") manufacturing expertise, is expected to greatly accelerate Lipella's ability to bring new treatments to patients with unmet needs.
  • He emphasized that the collaboration with Cook MyoSite will play a crucial role in advancing the commercial approval of LP-10.
  • With this collaboration, Lipella and Cook MyoSite are poised to make a greater impact in addressing the significant unmet need for effective treatments for hemorrhagic cystitis, and further advance LP-10 towards regulatory approval.

Lipella Pharmaceuticals Doses First Patient in Human Study of Innovative Contrast Agent

Retrieved on: 
Wednesday, April 5, 2023

PITTSBURGH, April 5, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces it has dosed the first patient in its human clinical study of a novel bladder MRI contrast agent.

Key Points: 
  • PITTSBURGH, April 5, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces it has dosed the first patient in its human clinical study of a novel bladder MRI contrast agent.
  • Lipella's contrast agent is composed of two MRI contrast agents and is expected to be useful for the diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) and potentially other bladder diseases characterized by bladder wall defects.
  • Lipella believes the agent may also have utility in detecting bladder tumor progression to muscle-invasive bladder cancer.
  • Dr. Michael Chancellor, Chief Medical Officer of Lipella expressed excitement about the milestone in developing a novel MRI contrast agent that can evaluate and detect leaky bladder.

Lipella Provides Business Update and Reports 2022 Financial Results

Retrieved on: 
Friday, March 31, 2023

PITTSBURGH, March 31, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today provided a business update and reported financial results for the year ended December 31, 2022.

Key Points: 
  • • Successfully completed Initial Public Offering, attained NASDAQ CM listing
    PITTSBURGH, March 31, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today provided a business update and reported financial results for the year ended December 31, 2022.
  • During 2022, Lipella achieved several important milestones including the Company's completion of its Initial Public Offering in late December.
  • Lipella Co-Founder and Chief Medical Officer, Dr. Michael Chancellor said, "Looking ahead, we are anticipating a number of significant milestones in 2023.
  • For Lipella's complete financial results for the twelve-month period ended December 31, 2022, see the Company's Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.

Lipella Pharmaceuticals Announces Creation of Oral Health Scientific Advisory Board

Retrieved on: 
Wednesday, March 1, 2023

PITTSBURGH, March 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the creation of a Scientific Advisory Board in oral health.  

Key Points: 
  • PITTSBURGH, March 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the creation of a Scientific Advisory Board in oral health.
  • The five-member Board will initially focus on the development of LP-310, Lipella's product candidate for the treatment of symptomatic oral lichen planus (OLP).
  • Members of the advisory board include:
    Alessandro Villa, DDS, PhD, MPH will serve as the inaugural Chair of the Scientific Advisory Board.
  • Dr. Villa is the Chief of Oral Medicine, Oral Oncology and Dentistry at Miami Cancer Institute and Professor, Herbert Wertheim College of Medicine, Miami, FL.

Lipella Pharmaceuticals to Present at January 2023 Biotech Showcase in San Francisco

Retrieved on: 
Monday, January 9, 2023

PITTSBURGH, Jan. 9, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications, today announced that Dr. Jonathan Kaufman, Co-Founder, Chairman, and CEO will be presenting at Biotech Showcase™ 2023. The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.

Key Points: 
  • PITTSBURGH, Jan. 9, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications, today announced that Dr. Jonathan Kaufman, Co-Founder, Chairman, and CEO will be presenting at Biotech Showcase™ 2023.
  • The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.
  • Location: Hilton San Francisco - Union Square, 333 O'Farrell Street, Ballroom Level, San Francisco, CA 94102
    The Company will be available to meet potential partners, collaborators, and investors.
  • One-to-one appointments may be requested as follows:
    The Biotech Showcase partnering platform: https://informaconnect.com/biotech-showcase/
    Biotechnology Innovation Organization (BIO) partnering platform: https://www.bio.org/events/bio-partnering-jpm
    Jonathan Kaufman, Co-founder, Chairman and CEO of Lipella Pharmaceuticals, commented, "As a newly public company, Biotech Showcase provides a great opportunity to meet with potential partners, collaborators, and investors.

2022 CHUNGBUK BEST PRODUCT PROMOTION Opens in Philippines to Develop Market for Promising Export Companies in Chungcheongbuk-do Province

Retrieved on: 
Friday, November 4, 2022

Chungcheongbuk-do has started to secure export channels for promising exporters in North Chungcheong Province to the Philippines market.

Key Points: 
  • Chungcheongbuk-do has started to secure export channels for promising exporters in North Chungcheong Province to the Philippines market.
  • The 2022 CHUNGBUK BEST PRODUCT PROMOTION will be held by Chungcheongbuk-do and Chungbuk Business Agency for three days from November 5 (Sat) to 7 (Mon) at JAPAN HOME WHOLESALE CENTRE located in Manila, Philippines.
  • 33 companies from Chungcheongbuk-do province will introduce excellent products to local citizens in Philippines through the event.
  • About 99 types of excellent quality products such as food, cosmetics, quarantine products, and pet products of companies in Chungcheongbuk-do Province will be showcased and sold at the promotion.