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Pliant Therapeutics, Inc. (Nasdaq: PLRX) is a pioneering clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing breakthrough treatments for fibrotic diseases. The company leverages the therapeutic potential of integrin biology and TGF-β modulation to create therapies that could prevent or even reverse fibrosis, thereby addressing significant unmet medical needs.
Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule dual selective inhibitor of αvß6 and αvß1 integrins. It is currently in development for treating idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA for both IPF and PSC, as well as Orphan Drug Designation from the European Medicines Agency.
The company is actively advancing several clinical programs:
- INTEGRIS-PSC Phase 2a Trial: Recent interim results demonstrated bexotegrast’s potential in treating PSC, showing reductions in Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels with statistical significance at the 160 mg dose.
- BEACON-IPF Phase 2b/3 Trial: This adaptive trial design aims to accelerate the development timeline by immediately transitioning from Phase 2b to Phase 3 upon enrollment completion.
- PLN-1474: A small molecule selective inhibitor for treating nonalcoholic steatohepatitis (NASH) with liver fibrosis.
- PLN-101095: In Phase 1, this dual-selective inhibitor targets integrins αvß8 and αvß1 for treating solid tumors.
- PLN-101325: A monoclonal antibody agonist targeting muscular dystrophies.
Founded by world-renowned researchers from UCSF, Pliant Therapeutics combines expertise in fibrosis biology and small molecule chemistry to develop novel therapies. The company also aims to build a patient registry to enhance the understanding of fibrotic disease progression and to support biomarker discovery.
With a strong pipeline, significant regulatory designations, and ongoing successful clinical trials, Pliant Therapeutics is well-positioned to make substantial advancements in treating fibrotic diseases. For more information and the latest updates, visit their website or follow them on social media platforms like X, LinkedIn, Facebook, and YouTube.
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology firm, is set to participate in two November investor conferences. The Evercore 4th Annual ISI HealthCONx Virtual Conference will take place on November 29, 2022, where senior management will meet with investors. Additionally, on November 30, 2022, CEO Bernard Coulie will engage in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference. Access to the chat will be available on Pliant's website for 30 days post-event. Pliant focuses on therapies for fibrosis, including its lead candidate, PLN-74809.
Pliant Therapeutics (Nasdaq: PLRX) reported strong third quarter progress on November 8, 2022, showcasing positive data from its lead candidate, PLN-74809 (now known as bexotegrast), for idiopathic pulmonary fibrosis (IPF). The company completed a successful public offering, raising $215.4 million. Positive safety reviews from independent Data Safety Monitoring Boards (DSMBs) for both INTEGRIS-IPF and INTEGRIS-PSC trials were announced. R&D expenses rose to $24.6 million, with a net loss of $30.6 million. Pliant's financial position remains strong, with $360.2 million in cash, which supports operations through mid-2025.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced that leadership will present at the Pulmonary/Lung Disease Mini-Symposium on October 7, 2022. The presentation will feature CEO Bernard Coulie and VP Greg Cosgrove, focusing on novel therapeutics for fibrosis treatment.
The event is part of RBC’s Biotech Expert Insights Series and will cover various lung diseases, including sarcoidosis and idiopathic pulmonary fibrosis (IPF). Interested parties can access the presentation live or via replay on the company’s Investor Relations page.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced the appointment of Dr. Katharine Knobil to its Board of Directors, effective immediately. Dr. Knobil brings over 20 years of clinical and strategic leadership experience, including her current role as Chief Medical Officer at Agilent Technologies. Her expertise will support Pliant as it transitions into a late-stage biotechnology company focused on therapies for fibrosis. Pliant's lead candidate, PLN-74809, is in Phase 2a trials for idiopathic pulmonary fibrosis and primary sclerosing cholangitis, with designations from the FDA and EMA.
Pliant Therapeutics (Nasdaq: PLRX) received a positive safety review from the Data Safety Monitoring Board (DSMB) for its INTEGRIS-IPF Phase 2a trial of PLN-74809 in idiopathic pulmonary fibrosis (IPF). The DSMB recommended that the trial continue without modifications after reviewing safety data, with interim 12-week data expected in early 2023. PLN-74809 has been well tolerated across over 450 participants, with no significant drug-related adverse events reported. The trial is pivotal for assessing the drug's safety and potential efficacy in treating IPF.
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a biotechnology company focused on fibrosis therapies, will participate in two investor conferences in September 2022. The conferences are Citi's 17th Annual BioPharma Conference from September 6-7, and H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, where a pre-recorded fireside chat will be accessible on September 12 at 7:00 a.m. ET. Pliant's lead product candidate, PLN-74809, is under Phase 2a trials for idiopathic pulmonary fibrosis and primary sclerosing cholangitis, having received various designations from the FDA and EMA.
Pliant Therapeutics (PLRX) reported second quarter 2022 financial results and highlighted progress in its clinical trials. The INTEGRIS-IPF Phase 2a trial for PLN-74809 showed positive safety and efficacy data, achieving its primary endpoint with dose-dependent treatment effects in patients with idiopathic pulmonary fibrosis. The company received FDA Fast Track designation for PLN-74809 in treating primary sclerosing cholangitis. Financially, R&D expenses increased to $26.3 million, while the net loss rose to $29.5 million, attributed to higher operating costs. Cash reserves stand at $379.8 million post-fundraising.
Pliant Therapeutics (Nasdaq: PLRX), a clinical-stage biotechnology company, announced that Dr. Bernard Coulie will participate in a panel on drug development in pulmonary medicine at the BTIG Biotechnology Conference 2022. The event is scheduled for August 9, 2022, at 1:00 p.m. ET. Pliant is focused on developing therapies for fibrosis, with its lead candidate, PLN-74809, in Phase 2a trials for idiopathic pulmonary fibrosis and primary sclerosing cholangitis. The panel discussion will be available via the BTIG portal for registered participants.
Pliant Therapeutics (NASDAQ: PLRX) has announced that its lead drug candidate, PLN-74809, received Fast Track designation from the FDA for treating primary sclerosing cholangitis (PSC). This designation aims to expedite the drug's development due to the disease’s severity and lack of FDA-approved therapies. PLN-74809 is currently in the Phase 2a INTEGRIS-PSC trial, with topline data expected in the first half of 2023. PSC affects over 30,000 patients in the U.S. alone, highlighting a significant unmet medical need.
Pliant Therapeutics, a clinical-stage biotechnology company, has successfully completed an upsized underwritten public offering of 12,432,432 shares at $18.50 each, generating approximately $230 million in gross proceeds. The offering included the full exercise of the underwriters' option for additional shares. Pliant intends to utilize the net proceeds to advance ongoing and future clinical programs, including PLN-74809, as well as to support working capital and general corporate purposes. J.P. Morgan and Cowen acted as lead book-running managers for this offering.