Idea or Concept
Experts Commend Amylyx for Withdrawing ALS Drug Relyvrio Following Trial Failure
Amylyx, Relyvrio, ALS drug, Trial failure, Market withdrawal, Promise kept
Ipsen Secures Exclusive Rights for Sutro’s Antibody-Drug Conjugate (ADC) Portfolio in a $900 Million Agreement
Ipsen, Sutro, Antibody-Drug Conjugate (ADC), $900 million agreement, Exclusive rights
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
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
Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges
Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development
FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults
Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data
Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial
Pfizer/ Sickle Cell Disease/ FDA Approval/ Inclacumab/ THRIVE Program/ Monoclonal Antibody/ Terminated Trial/ Poor Accrual
Praxis’ Mid-Stage Triumph Propels Advancement of Novel Epilepsy Drug
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
Roche’s Phase III Trial Success with IL-6 Blocker Enspryng Tempered by Modest Outcomes
Roche, IL-6 blocker, Enspryng (satralizumab), Phase III trial, Generalized Myasthenia Gravis (gMG), Disappointment, Expectations
MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)
MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues
Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy
Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR