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Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL

Shots: The P-III (BRUIN CLL-322) trial assessed Jaypirca + venetoclax & rituximab vs venetoclax & rituximab in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), with both arms treated ~2yrs. followed by therapy-free period until disease progression The trial met its 1EP, demonstrating improved PFS per IRC, with consistent results across clinically relevant subgroups…

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DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development

Shots: DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…

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C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload

Shots: C4 has entered into a new collaboration with Roche to develop degrader-antibody conjugates (DACs), combining targeted protein degradation with ADCs for cancer treatment Partnership will focus on two oncology programs against undisclosed targets, leveraging C4’ Torpedo platform for degrader payloads, while Roche will select & design the antibodies, conjugate them to payloads, & lead…

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Astellas Exercises Option to License Dyno’s AAV Capsid for AI-Designed Gene Delivery

Shots: Dyno Therapeutics has reported that Astellas has exercised its option to license an AI-engineered AAV capsid for skeletal muscle delivery, marking the first licensed asset from their 2021 collaboration The capsid, designed using Dyno’s AI models trained on large-scale in vivo data, demonstrates improved muscle targeting at lower doses, addressing key safety & manufacturing…

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Garda to Acquire Assertio for ~$125.1M Upfront

Shots: Garda Therapeutics has entered into a definitive agreement to acquire Assertio, delisting it from Nasdaq As per the deal, Garda will acquire Assertio for $18/share in cash (~$125.1M) plus a non-tradeable CVR related to potential future milestones for Sprix, with the deal expected to close in Q2’26 & remaining shares acquired later via a…

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…

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Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

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