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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 biotechnology company focused on fibrosis treatments, has announced an upsized underwritten public offering of 8,333,334 shares at $30.00 per share, aiming for gross proceeds of approximately $250 million. The offering includes a 30-day option for underwriters to purchase an additional 1,250,000 shares. Proceeds will be used for developing ongoing and future clinical programs, funding working capital, operating expenses, and general corporate purposes. The offering is expected to close around January 27, 2023, pending customary conditions. J.P. Morgan and Piper Sandler are leading the offering.
Pliant Therapeutics, a clinical-stage biotechnology company focused on fibrosis treatments, has initiated an underwritten public offering of $175 million in common stock, with a 30-day option for underwriters to purchase an additional $26.25 million. The net proceeds will be utilized for ongoing and future clinical programs, including bexotegrast and PLN-101095, as well as to support working capital and general corporate needs. J.P. Morgan and Piper Sandler are leading the offering, which is subject to market conditions. The offering is detailed under a SEC registration statement, with preliminary prospectus available online.
Pliant Therapeutics (Nasdaq: PLRX) announced significant interim results from its Phase 2a clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The 320 mg dose group demonstrated a statistically significant increase in forced vital capacity (FVC) at 4, 8, and 12 weeks compared to lower doses and placebo. No patients in this group experienced a decline of ≥10% in FVCpp, indicating no disease progression. Bexotegrast was well tolerated with no severe adverse events. The company plans to continue the trial for at least 24 weeks and expects final data in Q2 2023.
Pliant Therapeutics, a clinical stage biotechnology company focused on fibrosis treatment, announced that President and CEO Bernard Coulie will present a company update at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 7:30 a.m. PT / 10:30 a.m. ET.
The venue is the Elizabethan Room D at The Westin St. Francis, San Francisco. Pliant's lead product, bexotegrast (PLN-74809), is undergoing Phase 2a trials for idiopathic pulmonary fibrosis and primary sclerosing cholangitis, having received multiple designations from the FDA and European Medicines Agency.
Pliant Therapeutics (NASDAQ: PLRX) announced that its drug candidate bexotegrast (PLN-74809) has received Orphan Drug Designation from the European Medicines Agency (EMA) for treating idiopathic pulmonary fibrosis (IPF). Currently, bexotegrast is undergoing the INTEGRIS-IPF Phase 2a clinical trial. Positive interim results were reported in July, and topline data is expected in the first quarter of 2023. This designation facilitates development for rare diseases, offering benefits such as trial design assistance and a decade of market exclusivity.
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.
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