Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…

ByRidhi RastogiNovember 11, 2025

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Daiichi Sankyo Reports First Patient Dosing in P-I Trial of DS3610 for Solid Tumors

Shots: Daiichi Sankyo has dosed the first patient with DS3610 in P-I trial for the treatment of advanced, metastatic or unresectable solid tumors The P-I trial will evaluate DS-3610 in advanced or metastatic solid tumors to determine the recommended dose, assessing PK & immunogenicity endpoints plus safety endpoints incl. DLTs & AEs. Exploratory endpoints like…

ByRidhi RastogiNovember 11, 2025

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Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Shots: Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26 As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs…

ByRidhi RastogiNovember 11, 2025

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INBRAIN Neuroelectronics Partners with Microsoft to Advance AI-Enabled Brain-Computer Interface Therapeutics

Shots: INBRAIN Neuroelectronics has entered into a strategic collaboration with Microsoft to apply agentic AI powered by Microsoft’s cloud & data infrastructure to enhance real-time precision neurology & next-gen brain-computer interface (BCI) therapeutics The partnership will leverage Microsoft’s Azure AI infrastructure, incl. time-series large language models & data analytics with INBRAIN’s graphene-based neural platform, allowing…

ByRidhi RastogiNovember 11, 2025

NEWS

Transition Bio Inks ~$500M Pact with Voyager Therapeutics to Develop Small Molecules for Neurodegenerative Diseases

Shots: Transition Bio has entered into a drug discovery collaboration & license option agreement with Voyager Therapeutics to identify & develop selective small molecules targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS) & frontotemporal dementia As per the deal, Transition Bio will discover & optimize TDP-43–targeting small molecules, after which Voyager may license exclusive global…

ByRidhi RastogiNovember 11, 2025

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Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

Shots: Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks. Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…

ByRidhi RastogiNovember 10, 2025

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Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

Shots: Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25 Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…

ByRidhi RastogiNovember 10, 2025

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Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy

Shots: The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026 The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney…

ByRidhi RastogiNovember 10, 2025

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SanegeneBio Collaborates with Eli Lilly to Advance RNAi Therapeutics for Metabolic Diseases

Shots: SanegeneBio has entered into a global research & licensing deal with Eli Lilly to advance RNAi candidates for metabolic diseases, leveraging SanegeneBio’s LEAD (Ligand & Enhancer Assisted Delivery) tech Under the deal, SanegeneBio will discover & identify LEAD-based RNAi molecules for each program, while Lilly will oversee IND-enabling studies, clinical development, & commercialization; the…

ByRidhi RastogiNovember 10, 2025

NEWS

Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

Shots: The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 end Both trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88%…

ByRidhi RastogiNovember 10, 2025

Ridhi Rastogi

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Daiichi Sankyo Reports First Patient Dosing in P-I Trial of DS3610 for Solid Tumors

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Transition Bio Inks ~$500M Pact with Voyager Therapeutics to Develop Small Molecules for Neurodegenerative Diseases

Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy

SanegeneBio Collaborates with Eli Lilly to Advance RNAi Therapeutics for Metabolic Diseases

Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

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