DATE – Page 20 – Talk Bio

Expansion of Pluvicto Use Sought by Novartis Following Positive Prostate Cancer Study Update

2 years ago talkbio0Tagged Malignant neoplasm of prostate, Metastatic castration-resistant prostate cancer, Novartis, Pluvicto, Progression-Free Survival, PSMAfore trial, Radiographic, rPFS

Novartis, Pluvicto, Broader use, Prostate cancer, PSMAfore trial, Radiographic progression-free survival (rPFS), Metastatic castration-resistant prostate cancer (mCRPC)

Verve Temporarily Halts Lead Base Editing Study Following Adverse Event, Prioritizes Alternative Therapy

2 years ago talkbio0Tagged Adverse event, Alanine Transaminase, Alternative Therapies, Cognitive function: initiation, Elevation procedure, Grade three rank, Heart-1 study, Heart-2 clinical trial, Ionizable, Lead base editing program, lipid delivery system, Pause enrollment, Phase Ib Heart-2 clinical trial, Q2 2024, SAEs, Serious adverse events, Thrombocytopenia, VERVE-101, VERVE-102

Verve Therapeutics, Lead base editing program, Adverse event, VERVE-101, Serious adverse events (SAEs), Grade 3 ALT elevation, Thrombocytopenia, Pause enrollment in Heart-1 study, Alternative therapy focus: VERVE-102, Ionizable lipid delivery system, Phase Ib Heart-2 clinical trial, Q2 2024 initiation of Heart-2 clinical trial.

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

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

Boehringer Ingelheim Caps Out-of-Pocket Costs for Asthma and COPD Inhalers in the U.S.

2 years ago talkbio0Tagged Asthma, boehringer ingelheim, Caps, Chronic Obstructive Airway Disease, Inhaler, June 1, 2024, List price reduction, Out of Pocket Payment, under-insured, Uninsured

Boehringer Ingelheim, Out-of-pocket costs, Asthma, COPD, Inhalers, $35 cap, June 1/ 2024, Uninsured and under-insured patients, List price reduction

Boundless Bio, Oncology Startup Targeting Extrachromosomal DNA, Files for $100 Million IPO

2 years ago talkbio0Tagged Arch of foot, Backed, Bayer, bleomycin/dacarbazine/lomustine/vincristine, Boundless, Checkpoint Kinase 1 Inhibitors, extrachromosomal DNA, IPO, Nasdaq Listing, Oncology Startup, Partner in relationship, Phase 1 Trials, Preliminary, Public Offering, Second Half of 2024, small molecule drugs, symbol

Boundless Bio, Oncology Startup, Initial Public Offering (IPO), Extrachromosomal DNA (ecDNA), Small Molecule Drugs (ecDTx), Checkpoint Kinase 1 Inhibitors, Phase 1 Trials, Nasdaq Listing (Symbol: BOLD), Backed by Bayer and Arch Venture Partners, Preliminary Data Expected in Second Half of 2024

Boundless Bio Joins 2024 IPO Surge Amidst Prominent Oncology Trial Outcomes

2 years ago talkbio0Tagged Bio, Boundless, Cancer-focused biotech, Clinical Data, IPO, Oncology trials, Public Offering, rally

Boundless Bio, Initial Public Offering (IPO), Cancer-focused biotech, 2024 IPO rally, Oncology trials, Clinical data readouts

Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy

2 years ago talkbio0Tagged 2025, Acoramidis, Approved, ATTR-CM, Bayer, Blockbuster Potential, BridgeBio Pharma, Cardiovascular Infrastructure, Clarity, Clinical action, EMA Approval, European Rights, Exclusive License, Hope (emotion), investor, low-thirties, milestone payments, November 2024, PDUFA, Phase 3 Data, royalties, Split Strategy, Vyndaqel Rival

Bayer, BridgeBio Pharma, Acoramidis, ATTR-CM, Exclusive License, European Rights, Royalties, Milestone Payments, Phase 3 Data, Potential Approval, Low-Thirties Percent Royalties, EMA Approval 2025, PDUFA Action Date November 2024, Vyndaqel Rival, Blockbuster Potential, Cardiovascular Infrastructure, Investor Hopes for Clarity on Split Strategy.