Core Insights - Biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and investor conference appearances across several small- and mid-cap companies [1] Company Summaries - **Immutep Ltd. (IMMP)**: Shares rose by 4.37% to $1.67 after-hours, following a decline of 6.98% during regular trading. The stock's rebound was fueled by the acceptance of data from its EFTISARC-NEO Phase II trial for oral presentation at CTOS 2025, focusing on a rare cancer with high unmet need [2][3] - **Nautilus Biotechnology Inc. (NAUT)**: Shares surged by 12.25% to $0.7521 after-hours, recovering from a 4.42% decline in regular trading. The increase was attributed to insider buying by CEO Sujal M. Patel, who purchased 83,500 shares, signaling confidence in the company [4][5] - **Pliant Therapeutics Inc. (PLRX)**: The stock ended regular trading at $1.75, up 1.16%, and jumped 16.00% to $2.03 after-hours. The upcoming third-quarter earnings report on November 6, 2025, is expected to provide updates on its lead candidate targeting idiopathic pulmonary fibrosis [6][7] - **Jin Medical International Ltd. (ZJYL)**: Shares closed at $0.6532, gaining 3.65% during regular trading and rising 7.15% to $0.6999 after-hours. The catalyst for this movement was the announcement of expanded production capabilities in China, aimed at enhancing global delivery of medical equipment [7][8] - **Phio Pharmaceuticals Corp. (PHIO)**: The stock rose 8.20% to $2.64 after-hours, building on a 13.49% increase during regular trading. The momentum was driven by participation in the H.C. Wainwright 27th Annual Global Investment Conference, where updates on its Phase 1b clinical trial for PH-762 will be presented [8][9] - **Kura Oncology Inc. (KURA)**: Shares increased by 6.12% to $8.50 after-hours, following a 1.60% decline in regular trading. The rally was linked to the company's presentation at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for Ziftomenib [10][11][12]

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].

Core Viewpoint - Pliant Therapeutics has discontinued the BEACON-IPF Phase 2b trial based on recommendations from an independent data safety monitoring board (DSMB) and an outside expert panel due to an imbalance in adverse events, despite early signs of efficacy in forced vital capacity (FVC) [2][3] Group 1: Clinical Trials and Programs - The BEACON-IPF trial, a 52-week multinational study evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), has been halted following safety concerns [2] - The Phase 1 trial of PLN-101095, an oral small molecule targeting solid tumors, continues to enroll patients, with interim data expected in Q1 2025 [3] - PLN-101325, a monoclonal antibody for muscular dystrophies, is Phase 1 ready with clinical trial approval in Australia [4] Group 2: Corporate Developments - Delphine Imbert, Ph.D., has been appointed as Chief Technical Officer, bringing 25 years of experience in product development and manufacturing [5] Group 3: Financial Results - Research and development expenses for Q4 2024 were $38.8 million, up from $33.2 million in Q4 2023, primarily due to costs associated with the BEACON-IPF trial [6] - General and administrative expenses increased to $14.5 million from $13.9 million year-over-year, driven by higher employee-related costs [6] - The net loss for Q4 2024 was $49.7 million, compared to $41.1 million in the same quarter of the previous year, attributed to increased operating expenses and reduced interest income [6] - As of December 31, 2024, the company had cash and short-term investments totaling $357.2 million, expected to fund operations for the next 12 months [6]

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].