Core Viewpoint - Pliant Therapeutics has discontinued the development of bexotegrast for idiopathic pulmonary fibrosis (IPF) following an unfavorable risk-benefit profile identified in the BEACON-IPF Phase 2b/3 clinical trial [1][3][5] Group 1: Clinical Trial Results - The BEACON-IPF trial was a randomized, double-blind, placebo-controlled study that revealed an imbalance in IPF-related adverse events, leading to its voluntary discontinuation [2] - Analysis of safety and efficacy data indicated that bexotegrast at doses of 160 mg and 320 mg increased the risk of adverse events related to IPF progression, with an average time to disease progression of 33 weeks for treated participants [3] - At Week 12, the 160 mg and 320 mg treatment groups showed improvements in forced vital capacity (FVC) decline of 72 mL (p<0.05) and 46 mL (p>0.05) respectively, while at Week 24, improvements were 58 mL (p>0.05) and 8 mL (p>0.05) respectively compared to placebo [4] Group 2: Future Development Plans - The company continues to enroll patients in a Phase 1 trial for PLN-101095, a dual-selective inhibitor targeting solid tumors resistant to immune checkpoint inhibitors, with interim results showing 50% confirmed partial responses at the highest dose tested [6] - Pliant's drug discovery platform includes over 15,000 integrin binding molecules and aims to support early-stage programs across multiple disease areas, focusing on tissue-specific delivery mechanisms [7][9]

Core Insights - Pliant Therapeutics presented clinical and preclinical data at the ATS 2025 International Conference, highlighting the antifibrotic activity of bexotegrast and its potential in treating fibrotic diseases [1] Group 1: Antifibrotic Activity of Bexotegrast - Bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, demonstrated reduced expression of genes related to TGF-β signaling and fibrogenesis in alveolar type 1 cells and various fibroblast subpopulations [2] - Single-nuclei RNAseq analysis showed that bexotegrast significantly reduced the expression of type I collagen and other profibrotic genes in aberrant basaloid cells and fibroblasts, indicating its distinct pharmacodynamic profile compared to nintedanib [4] Group 2: Biomarker Analysis - A comparative analysis of circulating plasma biomarkers identified dysregulated biomarkers across multiple ILD subtypes, which could aid in clinical decision-making for ILD [3] Group 3: Company Overview - Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for fibrotic diseases, with bexotegrast as its lead product candidate undergoing evaluation for idiopathic pulmonary fibrosis [6] - The company has received Fast Track and Orphan Drug Designations from the FDA for bexotegrast, and is also conducting Phase 1 studies for other drug candidates targeting solid tumors and muscular dystrophies [6]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Pliant Therapeutics, Inc and its officers or directors [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 [3] - Following this announcement, analysts from Wells Fargo and Citi downgraded Pliant, expressing uncertainty regarding the future of bexotegrast [3] 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 [4]

Core Viewpoint - Pliant Therapeutics, Inc 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][3]. 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 [3]. - Following this announcement, analysts from Wells Fargo and Citi downgraded Pliant, indicating uncertainty regarding the future of bexotegrast [3]. Stock Performance - After the announcement of the trial pause, Pliant's stock price fell by $4.72 per share, representing a 60.59% decrease, closing at $3.07 per share on February 10, 2025 [4].

Core Viewpoint - Pliant Therapeutics is under investigation for potential securities fraud following significant stock price declines related to the discontinuation of its BEACON-IPF Phase 2b trial for bexotegrast, raising concerns about the company's future prospects [1][2][4]. Group 1: Company Actions and Responses - On February 7, 2025, Pliant announced a voluntary pause in enrollment and dosing for the BEACON-IPF Phase 2b trial based on recommendations from the independent Data Safety Monitoring Board (DSMB) [2]. - Following the announcement on February 7, Pliant's stock price dropped by $4.72, or 60.59%, closing at $3.07 per share on February 10, 2025 [3]. - On March 3, 2025, Pliant disclosed the discontinuation of the BEACON-IPF trial due to an imbalance in unadjudicated IPF-related adverse events between treatment and placebo groups, as recommended by both the DSMB and an outside expert panel [4]. - After the March 3 announcement, Pliant's stock price fell by $2.06, or 59.88%, closing at $1.38 per share [5]. Group 2: Market Reactions - Analysts from Wells Fargo and Citi downgraded Pliant's stock following the February 7 announcement, citing uncertainty regarding the future of bexotegrast [2].