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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 (PLRX) has granted stock options to its newly appointed Chief Technical Officer, Delphine Imbert, Ph.D., as part of her employment package. The grant includes options to purchase 275,000 shares of common stock at an exercise price of $11.07 per share, matching the company's closing price on January 21, 2025.
The options will vest over a 4-year period, with 25% vesting after the first year and the remaining shares vesting monthly at a rate of 1/48th over the subsequent 36 months, contingent on continued employment. The options have a 10-year term and are subject to the Company's 2022 Inducement Plan terms.
Pliant Therapeutics (PLRX) has appointed Delphine Imbert, Ph.D. as Chief Technical Officer. Dr. Imbert brings 25 years of strategic clinical to commercial-stage manufacturing and drug development experience across multiple drug modalities. In her new role, she will lead chemistry, manufacturing and control (CMC)-related activities supporting Pliant's commercial-stage readiness plan.
Dr. Imbert most recently served as Senior Vice President of CMC and Technical Operations at Chinook Therapeutics (acquired by Novartis), where she managed a fully outsourced CMC, manufacturing and supply chain organization. Previously, she held senior roles at Dermira (acquired by Eli Lily) and Anacor Pharmaceuticals (acquired by Pfizer), demonstrating expertise in pharmaceutical development, manufacturing processes, supply chain, logistics, and regulatory filings.
Pliant Therapeutics (PLRX) has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference. Bernard Coulie, M.D., Ph.D., the company's President and Chief Executive Officer, will deliver a presentation on Tuesday, January 14, 2025, at 1:30 p.m. Pacific Time at the Westin St. Francis Hotel in San Francisco.
Interested investors and stakeholders can access the presentation through a live webcast available on the Investors & Media section of Pliant's website at www.PliantRx.com. The presentation recording will remain accessible on the website for 30 days after the event concludes.
Pliant Therapeutics (PLRX) has announced its participation in four major investor events in December 2024. The company will attend the Evercore 7th Annual HealthCONx Conference on December 3 and the Citi 2024 Global Healthcare Conference on December 4. At the Piper Sandler 36th Annual Healthcare Conference, key executives including CEO Bernard Coulie will participate in a fireside chat on November 5. Additionally, company officials will join a panel discussion on 'Differentiated Approaches for Pulmonary Diseases' at the Oppenheimer Movers in Rare Disease Summit on December 12.
The Piper Sandler fireside chat will be available via live webcast on Pliant's website Investor Relations page, with a replay accessible for 30 days after the event.
Pliant Therapeutics (PLRX) presented clinical data for bexotegrast, their oral integrin inhibitor, at The Liver Meeting® 2024. The Phase 2 INTEGRIS-PSC trial results showed that bexotegrast was well-tolerated and demonstrated antifibrotic and anti-cholestatic activity in primary sclerosing cholangitis (PSC) patients. The drug improved liver stiffness, Enhanced Liver Fibrosis scores, liver biochemistry, and MRI results.
Additionally, the company presented research identifying novel inflammatory biomarkers for PSC through proteomic screening, discovering potential serum and urine biomarker candidates that could help predict disease progression.
Pliant Therapeutics (PLRX) reported Q3 2024 financial results and provided updates on its clinical programs. The company's BEACON-IPF Phase 2b/3 trial for bexotegrast in IPF patients remains on track for full enrollment in Q1 2025, with data expected mid-2026. Q3 financial results showed R&D expenses of $47.8M (up from $32.3M YoY), G&A expenses of $14.3M (down from $15.3M YoY), and a net loss of $57.8M (increased from $41.5M YoY). The company maintains a strong cash position of $406.0M as of September 30, 2024.
Pliant Therapeutics (Nasdaq: PLRX) announced its participation in the upcoming Stifel 2024 Healthcare Conference. Chief Financial Officer Keith Cummings, M.D., and Greg Cosgrove, M.D. FCCP, will engage in a fireside chat on Tuesday, November 19, 2024, at 8:35 a.m. Eastern Time. The event will take place at the Lotte New York Palace Hotel in New York.
A live webcast will be available through Pliant's website Investor Relations' Events & Presentation page, with a replay accessible for 30 days after the event.
Pliant Therapeutics (Nasdaq: PLRX), a late-stage biotechnology company focused on fibrotic diseases, has appointed Gary Palmer, M.D., MBA as Senior Vice President of Medical Affairs. Dr. Palmer, with over 25 years of global leadership experience, will lead the company's global medical affairs activities, including scientific communications and patient advocacy.
Dr. Palmer's extensive background includes leadership roles at Bristol Myers Squibb, where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team. He has also held senior positions at Myovant Sciences, Actelion, Eisai Pharmaceuticals, and Pfizer. His expertise spans pulmonary medicine, immunology, and neurology, with experience in supporting successful and orphan disease products.
Éric Lefebvre, M.D., Chief Medical Officer at Pliant, highlighted Dr. Palmer's experience in building best-in-class Medical Affairs organizations as beneficial for Pliant's growth and portfolio advancement towards commercial stage.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has announced the granting of stock options to Gary Palmer, M.D., the company's newly appointed Senior Vice President of Medical Affairs. The grant, made on September 30, 2024, includes options to purchase 120,000 shares of common stock as a material inducement to his employment.
The stock options have an exercise price of $11.21 per share, equal to the closing price of Pliant's common stock on the grant date. The options will vest over 4 years, with 25% vesting on the one-year anniversary and the remaining shares vesting monthly at a rate of 1/48th over the subsequent 36 months. The stock options have a 10-year term and are subject to the terms and conditions of the Company's 2022 Inducement Plan.
Pliant Therapeutics (Nasdaq: PLRX) presented data from its bexotegrast program at the European Respiratory Society International Congress 2024. Key findings include:
1. Reduction in type 1 collagen deposition in IPF patients after 12 weeks of bexotegrast treatment, suggesting antifibrotic effects and favorable lung remodeling.
2. Integrated safety summary showing bexotegrast was well-tolerated in Phase 2a trials for IPF and PSC.
3. Preclinical data demonstrating antifibrotic effects in lung slices from various ILD patients, supporting further investigation in ILD-associated progressive pulmonary fibrosis.
4. Post-hoc biomarker analysis revealing reduced levels of ILD progression markers in IPF patients receiving bexotegrast.
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