Core Viewpoint - Pliant Therapeutics Inc. has decided to discontinue the BEACON-IPF Phase 2b trial for bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) following recommendations from the Data Safety Monitoring Board and an external expert panel [1][2]. Group 1: Trial Discontinuation - The trial was halted due to an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups, despite early evidence of efficacy on the forced vital capacity (FVC) endpoint [2][4]. - The mean exposure duration in the BEACON-IPF trial was approximately 17 weeks, with IPF-related adverse events in both dose groups being comparable at around 10% [3][4]. - The imbalance was primarily attributed to a low IPF-related adverse event rate (below 3%) in the placebo group [3]. Group 2: Future Plans - The company plans to analyze the complete data from the BEACON-IPF trial to better understand the benefit-risk profile and therapeutic window of bexotegrast [5]. - Following the analysis, Pliant will consider additional dose-ranging Phase 2b studies with lower doses for pulmonary fibrosis and potentially explore other non-respiratory indications, including liver diseases [5]. Group 3: Other Developments - Pliant is currently enrolling the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095, both as monotherapy and in combination with pembrolizumab for solid tumors resistant to immune checkpoint inhibitors [6]. - Interim data from the first three cohorts of this trial is expected in the first quarter of 2025 [6]. - Following the announcement, PLRX stock experienced a significant decline of 51%, trading at $1.69 [6].

Core Viewpoint - The Schall Law Firm is investigating Pliant Therapeutics, Inc. for potential violations of securities laws following a significant drop in share price after the company paused a clinical trial [1][2]. Group 1: Investigation Details - The investigation centers on whether Pliant issued false or misleading statements or failed to disclose important information to investors [2]. - Pliant announced a voluntary pause in enrollment and dosing for the BEACON-IPF Phase 2b trial of bexotegrast due to recommendations from the independent Data Safety Monitoring Board [2]. Group 2: Market Impact - Following the announcement of the trial pause, Pliant's shares experienced a dramatic decline of 60.59% on February 10, 2025 [2].

Core Viewpoint - Pliant Therapeutics is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop after pausing a clinical trial for its drug bexotegrast [1][2]. Group 1: Company Developments - On February 7, 2025, Pliant announced a voluntary pause in enrollment and dosing for the BEACON-IPF Phase 2b trial of bexotegrast due to recommendations from the independent Data Safety Monitoring Board [2]. - Following the announcement, analysts from Wells Fargo and Citi downgraded Pliant, indicating uncertainty regarding the future of bexotegrast [2]. Group 2: Stock Performance - Pliant's stock price experienced a significant decline, falling by $4.72 per share, or 60.59%, closing at $3.07 per share on February 10, 2025 [3].

Core Viewpoint - Pliant Therapeutics, Inc. (PLRX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations for stocks, prompting institutional investors to buy or sell, thus affecting stock prices [4]. Company Performance Indicators - Pliant Therapeutics is projected to earn -$3.64 per share for the fiscal year ending December 2024, representing a year-over-year decline of 32.4% [8]. - Despite the negative earnings projection, analysts have raised their estimates for Pliant Therapeutics, with the Zacks Consensus Estimate increasing by 7.6% over the past three months [8]. Zacks Rank System - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - The upgrade of Pliant Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Insights - Pliant Therapeutics has initiated the assembly of an outside expert panel to review unblinded data from the BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) [1] - The decision to form this panel follows the Data Safety Monitoring Board's (DSMB) recommendation to pause enrollment and dosing in the trial, as the company could not determine the rationale for this recommendation through blinded data [2] - The expert panel will provide independent recommendations and will be part of an expanded DSMB to reach a consensus regarding the BEACON-IPF trial [1] Company Overview - Pliant Therapeutics is a late-stage biopharmaceutical company focused on developing novel therapeutics for fibrotic diseases, with its lead product candidate being bexotegrast [3] - Bexotegrast is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins, currently in development for the treatment of IPF [3] - The company has received Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation from the European Medicines Agency for bexotegrast in IPF [3] - Pliant is also conducting a Phase 1 study for another clinical program, PLN-101095, targeting solid tumors, and has received regulatory clearance for a Phase 1 study of PLN-101325 for muscular dystrophies [3]

Core Insights - Pliant Therapeutics has initiated the assembly of an outside expert panel to review unblinded data from the BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) [1] - The decision to form this panel follows the Data Safety Monitoring Board's (DSMB) recommendation to pause enrollment and dosing in the trial, as the company could not determine the rationale for this recommendation through blinded data [2] - The expert panel will provide an independent recommendation and will be part of an expanded DSMB to reach a consensus regarding the BEACON-IPF trial, with the process expected to conclude in two to four weeks [1] Company Overview - Pliant Therapeutics is a late-stage biopharmaceutical company focused on developing novel therapeutics for fibrotic diseases, with its lead product candidate being bexotegrast [3] - Bexotegrast is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins, currently in development for the treatment of IPF, and has received Fast Track and Orphan Drug Designations from the FDA [3] - The company is also conducting a Phase 1 study for PLN-101095, a small molecule targeting solid tumors, and has received regulatory clearance for a Phase 1 study of PLN-101325, a monoclonal antibody for muscular dystrophies [3]

Investors can contact the law firm at no cost to learn more about recovering their losses ​LOS ANGELES, Feb. 12, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Pliant Therapeutics, Inc. (“Pliant Therapeutics, Inc.” or “the Company”) (NASDAQ:PLRX) investors that the firm has initiated an investigation into possible securities fraud and may file a class action on behalf of investors. Pliant Therapeutics, Inc. investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. I ...

Pliant Therapeutics, Inc. PLRX stock is trading lower on Monday.On Friday, during after-hours trading, Pliant Therapeutics announced it has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), a chronic lung disease that causes scarring and stiffening of the lung tissue. Patients currently enrolled in BEACON-IPF will remain in the trial.The move follows a prespecified data review and recommendations by the tria ...

Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current patients while data is reviewed SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX) today announced that following a prespecified data review and recommendations by the trial's independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase ...

Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current patients while data is reviewed SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase ...