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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 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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The US FDA has approved Yuvezzi (carbachol & brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults; commercially available by Q2’26
Approval was backed by 2 P-III (BRIO I & BRIO II) trials (n>800), with BRIO I showing superior benefit vs individual actives & BRIO II…
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The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement
NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…
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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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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 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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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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Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC
Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…
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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…

