PFIZER INC.

Vepdegestrant + abemaciclib showed 62.5% clinical benefit rate & 26.7% overall response rate in ER+/HER2- breast cancer patients previously treated with CDK4/6 inhibitor. Safety & tolerability consistent with known profiles; no significant drug-drug interaction. Recommended Phase 2 dose: 200 mg QD vepdegestrant & 150 mg BID abemaciclib.

uniQure's QURE surged 109.7% after aligning with FDA on an accelerated approval pathway for AMT-130, a gene therapy for Huntington's disease. The FDA agreed that data from ongoing studies are sufficient for regulatory filing, avoiding additional pre-submission studies. The therapy's safety profile is manageable, and uniQure plans to submit a biologics license application in 2025.

Candel Therapeutics' stock surged 172% after CAN-2409, a viral immunotherapy for localized prostate cancer, met its primary endpoint in a Phase III trial. The therapy, combined with radiation and valacyclovir, showed a 14.5% improvement in disease-free survival and a higher PSA rate, with a consistent safety profile. The company plans to use these results to seek FDA approval.

The Inflation Reduction Act's drug price negotiation program faces uncertainty under Trump's administration. The 'pill penalty' provision, which allows small molecule medicines to be eligible for selection nine years after FDA approval, four years before large molecule medicines, has sparked controversy. Critics argue this disparity could harm investment in small molecule drug development. Proposed bills like the EPIC Act aim to provide parity for the two drug classes, but budgetary concerns and arguments against extending small molecules' exclusivity period complicate the issue. The biopharma industry, including organizations like PhRMA and BIO, strongly opposes the 'pill penalty', fearing reduced R&D investment and fewer small molecule medicines developed.

The report covers idiopathic inflammatory myositis epidemiology, market trends, and emerging drugs in the US, EU4, UK, and Japan. Key highlights include 191,589 diagnosed cases in 2023, expected to rise by 2034, with the US having the highest cases (91,734). Marketed drugs like OCTAGAM 10% and VENOGLOBULIN-IH 5% IV, and emerging therapies such as Dazukibart and Efgartigimod are discussed. The market size was $447M in 2023, projected to grow due to emerging therapies.

The 'Idiopathic Inflammatory Myositis - Market Insights, Epidemiology, and Forecast to 2034' report by ResearchAndMarkets.com provides an in-depth analysis of the market, epidemiology, and emerging therapies for idiopathic inflammatory myositis. Key highlights include the projected growth of the market driven by innovative therapies like dazukibart and efgartigimod, the rising prevalence of cases, and the market size of approximately USD 447 million in 2023, expected to grow at a CAGR of 21.1% by 2034. The report also covers current treatment practices, unmet medical needs, and market share by therapies in the 7MM (US, EU4, UK, Japan).

DelveInsight's report on PD-1 Non-Small Cell Lung Cancer Market (2020-2034) highlights market growth, approvals, prevalence, therapies, and companies like Merck, Bristol-Myers Squibb, Genentech, and others. Key therapies include KEYTRUDA, OPDIVO, TECENTRIQ, and TIZVENI. Market drivers include premium-priced targeted agents and therapy expansion, while barriers include premium pricing of emerging therapies.

The global oncology-based in-vivo CRO market was valued at USD 1.4 billion in 2024 and is expected to grow at an 8.8% CAGR from 2025 to 2034, driven by demand for immuno-oncology therapies, advancements in in-vivo models, and growing oncology drug approvals from small biotech and pharmaceutical companies. Small firms lead in oncology drug approvals, focusing on innovative treatments like CAR-T cell therapy and monoclonal antibodies. The market is segmented by service, model, end use, and region, with preclinical testing dominating. Key trends include the rise of immunotherapies, outsourcing by biotech firms, AI integration, and strategic alliances between companies and CROs.

Arvinas and Pfizer report preliminary Phase Ib trial results of vepdegestrant plus abemaciclib for ER+/HER2- breast cancer, showing a 62.5% clinical benefit rate and a tolerable safety profile.