ORG – Page 2 – Talk Bio

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

2 days 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 days 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

LB Pharmaceuticals Files for $228M IPO to Fund Phase III Schizophrenia Drug

2 days ago talkbio0Tagged Alzheimer 's psychosis, amisulpride, Clinical Nurse Specialists, Depression, Bipolar, IPO, LB-102, Nasdaq, Phase 3 Clinical Trials, Pounds, Schizophrenia, United States Food and Drug Administration

LB Pharmaceuticals; IPO; Phase III trial; schizophrenia; LB-102; biotech; CNS therapeutics; bipolar depression; Alzheimer’s psychosis; amisulpride; FDA; Nasdaq

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

2 days 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)

Epigenic Therapeutics and NRG Therapeutics Each Secure ~$60M in Series B Rounds for Epigenetic and Neuroscience Advances

2 days ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Biotechnology, epigenetic therapy, Epigenic, Gene Silencing, Hepatitis B, Hypercholesterolemia, Investments, NRG, Parkinson Disease, Series B funding

Epigenic Therapeutics; NRG Therapeutics; Series B funding; epigenetic therapy; hepatitis B; hypercholesterolemia; Parkinson’s disease; ALS; biotechnology investment; gene silencing

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

2 days 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

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

3 days ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation

AstraZeneca Escalates EGFR Lung Cancer Rivalry with J&J: Tagrisso Combo Posts Survival Win

3 days ago talkbio0Tagged AstraZeneca, Combined, EGFR-mutated, FLAURA2 trial, Johnson & Johnson, Lazcluze, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Overall Survival, Pharmacotherapy, Rybrevant, Tagrisso

AstraZeneca; Tagrisso; EGFR-mutated NSCLC; Johnson & Johnson; Rybrevant; Lazcluze; Flaura2 trial; overall survival; lung cancer; chemotherapy combination

Servier Supercharges Neuro Pipeline with $450M Deal for Fragile X Syndrome Candidate

3 days ago talkbio0Tagged Acquisition, Bioscience, deal, Fragile X Syndrome, Infrequent, Kaerus, KER-0193, orphan drug designation, pediatric drug designation, Phase 2 trial, Servier

Servier; Kaerus Bioscience; KER-0193; Fragile X syndrome; neurology pipeline; $450 million deal; orphan drug designation; rare pediatric drug designation; Phase 2 trial; acquisition

BioNTech and BMS Announce First Global Data for PD-L1xVEGF Bispecific in Small Cell Lung Cancer, Set Phase 3 Dose

3 days ago talkbio0Tagged BioNTech, BNT327, Burning Mouth Syndrome, Myers, Overall response rate, PD-L1, PD-L1xVEGF, Pharmacotherapy, pumitamig, Small cell carcinoma of lung, squibb, Vascular Endothelial Growth Factor A

BioNTech; Bristol Myers Squibb; BMS; PD-L1xVEGF bispecific; BNT327; pumitamig; small cell lung cancer; SCLC; phase 2 trial; phase 3 dose; overall response rate; VEGF-A; PD-L1; chemotherapy