Clinical Trials – Talk Bio

Patient Hospitalized After Receiving Intellia’s CRISPR Therapy Dies, Prompting FDA Hold on Trials

11 hours ago talkbio0Tagged Amyloidosis, Clinical Trials, Comorbidity, CRISPR therapy, Intellia, Liver, nex-z, nexiguran ziclumeran, Patient Death, Phase III MAGNITUDE trial, Toxicity aspects, TTR wt Allele, United States Food and Drug Administration

Intellia Therapeutics; CRISPR therapy; nexiguran ziclumeran (nex-z); patient death; liver toxicity; Phase III MAGNITUDE trial; ATTR amyloidosis; clinical trial hold; FDA; comorbidities

Puma Biotechnology Reports Third Quarter 2025 Financial Results

23 hours ago talkbio0Tagged beat, Clinical Trials, EPS, exophthalmos producing substance, financial results, Neoplasms, Nerlynx sales, net income, Puma Biotechnology, Q3, Revenue Decline, revenue guidance

Puma Biotechnology; Q3 2025; financial results; EPS beat; revenue decline; Nerlynx sales; net income; oncology; clinical trials; revenue guidance

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

23 hours ago talkbio0Tagged BEACON-IPF, cash reserves, Clinical Trials, development expenses, financial results, net loss, oncology program, Oxford Finance, Pliant Therapeutics, PLN-101095, Q3, research

Pliant Therapeutics; Q3 2025 financial results; PLN-101095; oncology program; BEACON-IPF trial; net loss; research and development expenses; cash reserves; Oxford Finance loan repayment

Immunome Reports Third Quarter 2025 Financial Results and Provides Business Update

23 hours ago talkbio0Tagged B-Cell Lymphomas, Business Update, Cancer Therapeutic Procedure, cash position, Clinical Trials, financial results, Immunome, net loss, pipeline update, Q3, RINGSIDE trial, therapeutic autologous dendritic cells, varegacestat

Immunome; Q3 2025; financial results; business update; pipeline update; cancer therapies; RINGSIDE trial; varegacestat; IM-1021; B-cell lymphoma; clinical trials; ADC; net loss; cash position

TriNetX Achieves Record as the Most Cited Real-World Electronic Health Record Dataset in Peer-Reviewed Research

2 days ago talkbio0Tagged Citation, Clinical Trials, Data Analytics, Electronic Health Records, global network, Medical Research activity, Peer-Reviewed Research, Rare Diseases, real-world data, TriNetX

TriNetX; real-world data; electronic health records; peer-reviewed research; citations; medical research; data analytics; global network; rare disease; clinical trials

Syndeio Biosciences Appoints Aaron Koenig, M.D., as Chief Medical Officer (CMO)

3 days ago talkbio0Tagged Aaron Koenig, Alzheimer 's disease, Chief Medical Officer, Clinical Trials, CNS disorder, neuropsychiatric, neuroscience drug development, synaptic health, Syndeio Biosciences, zelquistinel

Syndeio Biosciences; Aaron Koenig; Chief Medical Officer; CNS disorders; synaptic health; neuroscience drug development; zelquistinel; Alzheimer’s disease; neuropsychiatric; clinical trials

uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy

4 days ago talkbio0Tagged Accelerated, AMT-130, Approved, Clinical Trials, gene therapy, Huntington 's disease, Regulatory Setback, UniQure, United States Food and Drug Administration

uniQure; AMT-130; Huntington’s disease; gene therapy; FDA; accelerated approval; regulatory setback; clinical trial

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

1 week ago talkbio0Tagged Accelerated, Approved, Biological Markers, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, Effectiveness, Functional improvement, Muscular Dystrophy, Duchenne, regulatory approval, z-rostudirsen

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval

Wave Life Sciences Obesity Biomarker Data Raise Hopes for Future Readouts

1 week ago talkbio0Tagged Activin E :* *, Biological Markers, Body Composition, Clinical Trials, INHBE gene, INLIGHT trial, Obesity, RNA therapeutics, RNA, Small Interfering, Wave Life Sciences, Weight Loss, WVE-007

Wave Life Sciences; WVE-007; obesity; biomarker data; siRNA; Activin E; INHBE gene; RNA therapeutics; clinical trial; body composition; weight loss; INLIGHT trial

Viking Therapeutics to Highlight VK2735 Clinical Data at ObesityWeek 2025

1 week ago talkbio0Tagged Clinical Data, Clinical Trials, GLP-1/GIP Dual Agonist, Metabolic Syndrome X, Obesity, ObesityWeek 2025, Prediabetes syndrome, VANQUISH-1, venture, Viking Therapeutics, VK2735

Viking Therapeutics; VK2735; ObesityWeek 2025; VENTURE trial; VANQUISH-1 trial; GLP-1/GIP dual agonist; clinical data; obesity; prediabetes; metabolic syndrome