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Seamless Therapeutics and Eli Lilly Forge ~$1.12B Deal to Develop Hearing Loss Therapies

Shots: Seamless has entered into a strategic global research collaboration & licensing deal with Eli Lilly to develop & commercialize programmable recombinase-based therapies for hearing loss using Seamless’ proprietary recombinase platform Under the deal, Seamless will design site-specific recombinases to correct hearing-loss–related gene mutations, while Lilly will receive an exclusive license to advance these programmed…

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nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Shots: nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing Additionally, the company…

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Crinetics

Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Shots: Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…

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BPGbio’s BPM31510 Receives the US FDA Orphan Drug Designation to Treat Primary CoQ10 Deficiency

Shots: The US FDA has granted ODD to BPM31510, for the treatment of primary coenzyme Q10 (CoQ10) deficiency (PCQD) Designation was supported by insights from BPGbio’s NAi Interrogative Biology platform, which leverages Bayesian AI to analyze & map thousands of human biological data points, validating BPM31510’s therapeutic potential BPM31510 is designed for IV administration of CoQ10 directly…

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Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…

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Janux Therapeutics and BMS Forge ~$850M Deal to Develop Therapies in Oncology

Shots: Janux has entered into a collaboration & exclusive global license agreement with BMS to develop a novel, undisclosed tumor-activated therapy targeting a validated solid-tumor antigen expressed across multiple cancer types Janux will advance the program through preclinical development & IND submission, after which BMS will hold the IND, lead global development & commercialization, with…

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