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 Insights - Immutep Limited has reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 trial for its immunotherapy treatment in advanced non-small cell lung cancer [1][7] Group 1: Trial Results - The INSIGHT-003 trial evaluated eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer [1] - The trial showed a significant improvement in overall response rates compared to historical controls, with a 60.8% response rate versus 48.0% in previous registrational trials [4] - In patients with PD-L1 expression below 50%, the response rate was 59.6%, compared to a historical control of 40.8% [5] Group 2: Patient Demographics - Approximately 92% of evaluable patients in the INSIGHT-003 study had PD-L1 Tumor Proportion Score (TPS) below 50%, indicating a high unmet medical need [3][7] - The breakdown of PD-L1 expression levels among evaluable patients included 49% with TPS of 1-49% and 43% with TPS below 1% [3] Group 3: Safety and Future Steps - The safety profile of the triple combination therapy remains favorable, with no new safety signals reported [9] - Additional data updates from the INSIGHT-003 trial are expected to be presented at a medical conference later in 2025 [10] Group 4: Company Background - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [14] - Eftilagimod alpha (efti) is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity for cancer treatment [12]