Clinical Trials – Page 5

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

2 months ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

2 months ago talkbio0Tagged Appointments, biotech startup, CEO, Clinical Trials, Immunology, Inflammation, Intent Biologics, Pfizer vet, Phase 3, Regenerative Medicine, Suneet Varma

Suneet Varma; Pfizer vet; Intent Biologics; CEO appointment; regenerative medicine; Phase 3 clinical trials; biotech startup; inflammation and immunology

Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates

2 months ago talkbio0Tagged agonists, alixorexton, Alkermes, Cataplexy, Clinical Trials, Daytime Somnolence, Excessive (qualifier value), Maintenance, MWT, Narcolepsy, orexins, oveporexton, Phase 3, Takeda, Wakefulness Test

Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)

Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

2 months ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, Clinical Trials, CLL, CLL-313, eli lilly, expansion, First line treatment, Jaypirca, Labels (device), Progression-Free Survival

Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion

Takeda’s Phase 3 Success Positions Oveporexton (TAK-861) as Potential First Mover in Multibillion-Dollar Narcolepsy Market

2 months ago talkbio0Tagged Clinical Trials, multibillion-dollar market, Narcolepsy type 1, oveporexton, Phase 3, Standard of Care, TAK-861, Takeda, TPRG1L gene

Takeda; Phase 3; narcolepsy type 1; oveporexton; TAK-861; orexin agonist; multibillion-dollar market; clinical trial results; first mover; standard of care

Recent Developments in Logistical Coordination for Decentralized Clinical Trials (DCTs)

2 months ago talkbio0Tagged Clinical Trials, decentralized, Digital Trial, Guidance 2024, Logistics, platforms, Preventive monitoring, Remote, supply chain management, United States Food and Drug Administration

Decentralized Clinical Trials; Logistics; FDA Guidance 2024; Remote Patient Monitoring; Supply Chain Management; Digital Trial Platforms

Wave RNA Editing Restores Enzyme in Genetic Disorder but Fails to Impress Investors

2 months ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, enzyme restoration, Investor Reaction, RNA Editing, Wave Life Sciences, WVE-006

Wave Life Sciences; RNA editing; AATD; alpha-1 antitrypsin deficiency; enzyme restoration; clinical trial; investor reaction; WVE-006

Treeline Announces $200M Funding Boost, Moves Three Cancer Drugs into Clinic

2 months ago talkbio0Tagged BCL6 gene, cancer drugs, Clinical Trials, Degrader, EZH2 protein, human, Funding, Inhibitor, K-ras Oncogene, Lymphoma, Series, Solid Neoplasm, TLN-121, TLN-254, TLN-372, Treeline

Treeline Biosciences; cancer drugs; clinical trials; TLN-121; TLN-372; TLN-254; BCL6 degrader; KRAS inhibitor; EZH2 inhibitor; Series A funding; lymphoma; solid tumors

Wave Life Sciences Shares Dip After Mixed Data Update on GSK-Partnered AATD Therapy

2 months ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, protein levels, RNA Editing, SmithKline Beecham, Wave Life Sciences, WVE-006

Wave Life Sciences; GSK; AATD; RNA editing; WVE-006; clinical trial; protein levels; stock dip; biotech

Merck’s Oral PCSK9 Inhibitor Enlicitide Decanoate Achieves Third Consecutive Phase 3 Success

2 months ago talkbio0Tagged Administration of prophylactic statin, Clinical Trials, CORALreef Lipids, enlicitide decanoate, Hypercholesterolemia, LDL Cholesterol Lipoproteins, Merck, Oral cavity, oral PCSK9, PCSK9 inhibitor

Merck; oral PCSK9 inhibitor; enlicitide decanoate; Phase 3 trials; CORALreef Lipids; hypercholesterolemia; lowering LDL cholesterol; statin therapy; first oral PCSK9; clinical trial results