Research Activity – Page 78

FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS

2 years ago talkbio0Tagged Agreement, Amyotrophic Lateral Sclerosis, BrainStorm Cell Therapeutics, Early-stage, NurOwn, SPA, Special Protocol Assessment, Trial Phase 3B, United States Food and Drug Administration

BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)

AstraZeneca’s Imfinzi Demonstrates Survival Benefit in Limited-Stage Small Cell Lung Cancer Study

2 years ago talkbio0Tagged ADRIATIC, AstraZeneca, durvalumab, Imfinzi, Immunotherapy, Limited-stage SCLC, Overall Survival, Phase 3 Clinical Trials, Progression-Free Survival, Small cell carcinoma of lung

AstraZeneca, Imfinzi (durvalumab), Small Cell Lung Cancer (SCLC), Limited-stage SCLC, ADRIATIC Phase III study, Overall Survival (OS), Progression-Free Survival (PFS), Immunotherapy

Diagonal Therapeutics Secures $128 Million Funding to Target Rare Diseases

2 years ago talkbio0Tagged Antibodies, Blue-chip, Chronic anemia, Diagonal, Merck's, Orphan disease treatment, Rare diseases focus, research, Winrevair

Diagonal Therapeutics, Antibody biotech, $128 million funding, Rare diseases focus, Orphan disease treatment, Chronic anemia, Merck’s Winrevair related research, Blue-chip investors

Gritstone Cancer Vaccine Trial Misses Primary Endpoint, Stock Plummets

2 years ago talkbio0Tagged Circulating, Circulating Tumor DNA, Colorectal Carcinoma, Gritstone, Personalized Neoantigen Cancer Vaccine, Phase 2 Clinical Trials, Progression-Free Survival, Stock Market Reaction

Gritstone, Personalized Neoantigen Cancer Vaccine, Colorectal Cancer, Phase 2 Study Failure, Circulating Tumor DNA (ctDNA), Progression-Free Survival (PFS), Stock Market Reaction

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

2 years ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment

2 years ago talkbio0Tagged Anemia, Sickle Cell, ClinicalTrials.gov, Grail, inclacumab, Pfizer, Phase 3 Clinical Trials, Poor Accrual, Recruitment Challenges, THRIVE Program

Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies

Praxis’ Mid-Stage Triumph Propels Advancement of Novel Epilepsy Drug

2 years ago talkbio0Tagged Adult Focal Onset, concept, Efficacy Study, Epilepsy, Functionally Selective Small Molecule,, Hyperexcitable State, Phase IIa, PRAX-628, Praxis Precision Medicines, Sodium Channel, Success

Praxis Precision Medicines, PRAX-628, Functionally Selective Small Molecule, Hyperexcitable State of Sodium Channels, Adult Focal Onset Epilepsy Treatment, Phase IIa Proof of Concept Study Success, Second Half of 2024 Efficacy Study Planned

Axsome Therapeutics’ Small Molecule AXS-12 Successful in Phase III Narcolepsy Trial

2 years ago talkbio0Tagged AXS-12, Axsome, Cataplexy, Drowsiness, Improved, memory/, Narcolepsy, Phase 3 Clinical Trials, reboxetine, safety profile, Severities

Axsome Therapeutics, AXS-12 (reboxetine), Phase III trial, Narcolepsy, Cataplexy reduction, Improved cognition/ memory/ sleepiness severity, Safety profile

Roche’s Phase III Trial Success with IL-6 Blocker Enspryng Tempered by Modest Outcomes

2 years ago talkbio0Tagged Blocker, disappointment, Enspryng, Expectations, interleukin-6, Myasthenia Gravis, Generalized, Phase 3 Clinical Trials, Roche (company), satralizumab

Roche, IL-6 blocker, Enspryng (satralizumab), Phase III trial, Generalized Myasthenia Gravis (gMG), Disappointment, Expectations

FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients

2 years ago talkbio0Tagged 12.5 mg, Approved, aprocitentan, aspects of adverse effects, Availability of, Clinical Trials, Combined Modality Therapy, Edema, Endothelin receptor antagonist, Idorsia, Intravascular systolic:Pressure:Point in time:Arterial system:Quantitative, Liquid substance, Precision - temporal, Recommended dosage, Resistant hypertensive disorder, Retention (Psychology), Second Half of 2024, Tryvio, Uncontrolled hypertension, United States Food and Drug Administration

FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects