Welcome to our dedicated page for Pliant Therapeutics news (Ticker: PLRX), a resource for investors and traders seeking the latest updates and insights on Pliant Therapeutics stock.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) is a clinical-stage biopharmaceutical company focused on integrin-based therapeutics for fibrotic diseases, solid tumors and muscular dystrophies. This news page aggregates company-issued updates and market-moving announcements so readers can follow how Pliant’s clinical programs and corporate strategy evolve over time.
In its recent press releases, Pliant has highlighted several key themes. The company has reported interim and ongoing data from a Phase 1, open-label, dose-escalation trial of PLN-101095, an oral dual-selective inhibitor of integrins αvβ8 and αvβ1, in patients with advanced or metastatic solid tumors that are resistant or refractory to immune checkpoint inhibitors. These updates describe antitumor activity, including partial and complete responses in certain dose cohorts when PLN-101095 is combined with pembrolizumab, as well as safety and pharmacokinetic observations.
Pliant’s news flow has also covered developments in its bexotegrast (PLN-74809) program in idiopathic pulmonary fibrosis, including the termination and close-out of the BEACON-IPF Phase 2b/3 trial and the company’s decision to discontinue development of bexotegrast in IPF after reviewing safety and efficacy data. Additional communications have described scientific presentations at medical conferences, such as the American Thoracic Society International Conference, where the company has shared clinical and preclinical data related to fibrosis and biomarkers.
Corporate updates, including workforce and operational realignments, financial results and changes in executive roles, are also part of Pliant’s news record. Investors and followers of PLRX can use this page to review these categories of news—clinical trial updates, scientific presentations, program decisions and corporate announcements—in one place and revisit past disclosures as needed.
Pliant Therapeutics (PLRX) has announced the adoption of a duration stockholder rights agreement ('poison pill') by its Board of Directors, effective until March 11, 2026. The measure comes in response to recent stock accumulations and aims to prevent unauthorized control through market purchases.
Under the agreement, stockholders of record by March 25, 2025, will receive one preferred share purchase right per common stock share. These rights activate if an entity acquires 10% ownership (20% for Schedule 13G investors) without Board approval. In such cases, existing stockholders can purchase additional PLRX shares at a 50% discount. Similar provisions apply if Pliant is acquired in a merger after such unauthorized accumulation.
The Board retains the right to redeem these rights at $0.001 per right or exchange them at one common share per right. Existing stockholders above threshold levels will be grandfathered, unless they increase their holdings after the announcement.
Pliant Therapeutics (PLRX) has announced the discontinuation of its BEACON-IPF Phase 2b trial following recommendations from both the data safety monitoring board and an outside expert panel. The trial was halted due to an imbalance in IPF-related adverse events between treatment and placebo groups, though early efficacy signals were observed in forced vital capacity endpoints.
The company continues to advance its other programs, including a Phase 1 trial of PLN-101095 in solid tumors, currently in its fourth of five planned dose cohorts, with interim data expected in Q1 2025. Additionally, PLN-101325 for muscular dystrophies is Phase 1 ready with clinical trial approval in Australia.
Financial results for Q4 2024 show R&D expenses of $38.8M (up from $33.2M YoY) and G&A expenses of $14.5M (up from $13.9M YoY). Net loss increased to $49.7M from $41.1M in the prior-year quarter. The company maintains a strong financial position with $357.2M in cash and investments, expected to fund operations beyond 12 months.
Pliant Therapeutics (PLRX) has discontinued its BEACON-IPF Phase 2b trial of bexotegrast in idiopathic pulmonary fibrosis (IPF) patients following safety concerns, despite showing early efficacy signs in forced vital capacity (FVC). The discontinuation came after reviews by the trial's Data Safety Monitoring Board and an external expert panel.
The trial, with approximately 17 weeks mean exposure duration, showed comparable IPF-related adverse events (around 10%) in both dose groups. However, an imbalance was noted due to unusually low adverse event rates (<3%) in the placebo group. This contrasts with the Phase 2a INTEGRIS-IPF trial, where adverse events were similar between bexotegrast-treated (7%) and placebo groups (10%).
The company plans to analyze the complete data and consider additional Phase 2b studies with lower doses for pulmonary fibrosis and other non-respiratory indications. Meanwhile, Pliant continues developing other assets, including PLN-101095 in oncology, currently in Phase 1 trials.
Pliant Therapeutics (PLRX) has initiated the assembly of an external expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in idiopathic pulmonary fibrosis (IPF) patients. This decision follows a recommendation from the trial's independent Data Safety Monitoring Board (DSMB) to pause enrollment and dosing.
The company has been unable to determine the rationale for the DSMB's recommendation through review of blinded data. The newly assembled panel, comprising experts in pulmonary diseases and biostatistics, will provide an independent recommendation and subsequently join an expanded DSMB to reach a consensus recommendation regarding BEACON-IPF.
The process is expected to conclude in 2-4 weeks. Pliant has voluntarily paused enrollment and dosing while maintaining trial blinding to preserve data integrity and the trial's potential registrational status.
Pliant Therapeutics (PLRX) has announced a voluntary pause in enrollment and dosing in its BEACON-IPF Phase 2b trial of bexotegrast for idiopathic pulmonary fibrosis (IPF) patients. This decision follows recommendations from the trial's independent Data Safety Monitoring Board (DSMB) after a prespecified data review.
Currently enrolled patients will remain in the trial while the company reviews data to understand the DSMB's recommendation. The study will maintain its blinding to preserve trial integrity. The company has informed trial investigators and is notifying global regulatory authorities about this development.
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.
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