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Ono and Mediar Partner to Develop Antibody Therapies for Fibro-Inflammatory Diseases

Shots: Ono has entered into a drug discovery partnership & option agreement with Mediar Therapeutics to develop novel antibody therapeutics for fibro-inflammatory diseases As per the deal, Mediar will conduct research using its fibrosis-focused research platform, while Ono will gain exclusive worldwide option rights to select candidates for development, manufacturing, & commercialization The partnership will…
August 7, 2026

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FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

Shots: FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results…
August 7, 2026

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Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals for ~$800M

Shots: Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, incl. its lead asset gildeuretinol (ALK-001), expanding Tarsus’ presence in retina care As per the deal, Alkeus will receive ~$450M upfront ($270M cash + $180M in Tarsus stock priced at $61.38/share), plus ~$350M in regulatory & commercial milestones, & low single-digit tiered descending…
August 6, 2026

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Schrödinger and Bristol Myers Squibb Expand AI Collaboration with Bunsen

Shots: Schrödinger has entered into a strategic agreement with BMS to deploy Bunsen, its agentic AI co-scientist, across BMS's research organization, expanding the companies' long-standing partnership As per the deal, Schrödinger will work with BMS to develop new Bunsen capabilities alongside its computational technologies for large-scale chemical exploration & RetroSynth, its AI-driven synthesis planning platform …
August 6, 2026

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Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
August 5, 2026

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Natera Seeks PMDA Approval for Signatera CDx in MIBC

Shots: Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC) The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026 Application is supported by data from…
August 5, 2026

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