Research Activity – Page 54

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

1 year 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

1 year 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

1 year 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

1 year 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

1 year 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

1 year 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

Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing

1 year ago talkbio0Tagged Acromegaly, Crinetics, Oral treatment, Paltusotine, Phase 3 Clinical Trials, Submission, Symptom reduction, United States Food and Drug Administration

Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction

Bayer’s Menopause Drug Elinzanetant Achieves Successful Long-Term Results in Phase III Trial, Rivalling Astellas’ Veozah

1 year ago talkbio0Tagged Astellas, Bayer, competition, Elinzanetant, Hot flushes, Long-term, Menopause, Phase 3 Clinical Trials, vasomotor symptom, Veozah

Bayer, Elinzanetant, Menopause drug, Phase III trial, Long-term results, Hot flashes, Vasomotor symptoms, Astellas, Veozah, Competition

Contineum Launches IPO Campaign to Accelerate Multiple Sclerosis Pipeline

1 year ago talkbio0Tagged Backed, Contineum, IPO, Johnson and Johnson, Multiple Sclerosis, Phase 2 Clinical Trials, PIPE-307, Public Offering

Contineum Therapeutics, Initial Public Offering (IPO), Johnson & Johnson (J&J) Backed, Multiple Sclerosis (MS) Pipeline, Phase II Trial, PIPE-307

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.