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. reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on integrin-based therapeutics. Its lead program, PLN-101095, is an oral small-molecule dual-selective inhibitor of αvβ8 and αvβ1 integrins being developed for solid tumors, including immune checkpoint inhibitor-refractory advanced or metastatic disease.
Company updates commonly cover Phase 1 and Phase 1b oncology data, scientific-conference presentations, combination studies with pembrolizumab, financial results, and healthcare investor-conference participation. Pliant also describes preclinical platform work using integrin receptor-binding molecules for tissue-specific delivery and internalization of drug payloads, including programs directed to skeletal muscle cells, adipocytes, and renal cells.
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.
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.