Phase 3 – Talk Bio

Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study

4 days ago talkbio0Tagged Antibodies, Bispecific, erbB-2 Receptor, gastroesophageal adenocarcinoma, Jazz, Malignant neoplasm of stomach, orphan drug designation, Overall Survival, Pharmacotherapy, Phase 2 trial, Phase 3, practice-changing, Progression-Free Survival, Zanidatamab, Zymeworks

Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation

Merck Again Brings Out Big Bucks, Buys Cidara in $9.2B Antiviral Push

1 week ago talkbio0Tagged Acquisition, Antiviral Agents, Breakthrough Therapy, CD388, Cidara Therapeutics, Influenza, J&J, Merck, Phase 3, sanofi, United States Food and Drug Administration

Merck; Cidara Therapeutics; CD388; antiviral; acquisition; influenza; phase 3; FDA Breakthrough Therapy; J&J; Sanofi; Keytruda

Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)

2 weeks ago talkbio0Tagged bezuclastinib, Clinical Trials, Cogent Biosciences, Frequency of Responses, Gastrointestinal Stromal Tumors, NDA, Phase 3, Progression-Free Survival, Standard (qualifier), Stock Surge, Submission, sunitinib

Cogent Biosciences; bezuclastinib; sunitinib; GIST; Phase 3; progression-free survival; objective response rate; NDA submission; clinical trial; stock surge; standard of care

No Recent News on BridgeBio’s Thyroid Disorder Phase 3 Win

4 weeks ago talkbio0Tagged BridgeBio, Infrequent, Phase 3, Thyroid Diseases

BridgeBio; Phase 3; Rare Diseases; Thyroid Disorder

Connecticut Biotech Veradermics Secures $150M for Phase 3 Trials of Oral Rogaine

1 month ago talkbio0Tagged Biotechnology, Clinical Development, Clinical Trials, Connecticut biotech, Fund Raising, hair loss treatment, Oral cavity, Phase 3, Rogaine, Veradermics

Veradermics; Connecticut biotech; oral Rogaine; Phase 3 clinical trials; fundraising; hair loss treatment; biotechnology; clinical development

BMS Breaks Clinical Losing Streak with Positive Phase 3 Myeloma Readout for Iberdomide

2 months ago talkbio0Tagged CELMoD, Clinical Trials, EXCALIBER-RRMM, iberdomide, Minimal Residual Disease Negativity, Multiple Myeloma, Myers, Phase 3, Progression-Free Survival, Protein Degradation, Metabolic, Relapsing course, squibb, Unresponsive to Treatment

Bristol Myers Squibb; iberdomide; multiple myeloma; clinical trial; EXCALIBER-RRMM; minimal residual disease negativity; CELMoD; protein degradation; progression-free survival; phase 3; relapsed or refractory

Areteia Therapeutics Posts Phase 3 Win for Oral Asthma Drug Dexpramipexole

2 months ago talkbio0Tagged Areteia, biologic blockbusters, Dexpramipexole, EXHALE-4, oral asthma therapy, Phase 3, Pulmonary Eosinophilia, topline

Areteia Therapeutics; dexpramipexole; Phase 3; oral asthma therapy; biologic blockbusters; eosinophilic asthma; EXHALE-4; topline results

FibroGen Settles with SEC for $1.25M Over Roxadustat Data Tampering Allegations

2 months ago talkbio0Tagged Anemia, cardiovascular safety, Clinical Trials, data manipulation, FibroGen, Kin-Hung Peony Yu, Phase 3, roxadustat, seconds, settlement, United States Food and Drug Administration

FibroGen; SEC; roxadustat; data manipulation; settlement; Kin-Hung Peony Yu; phase 3 clinical trial; anemia drug; cardiovascular safety; FDA

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

2 months 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

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

2 months 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)