Phase 3 – Talk Bio

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

4 days 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

2 weeks 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

1 month 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)

Takeda’s Phase 3 Success Positions Oveporexton (TAK-861) as Potential First Mover in Multibillion-Dollar Narcolepsy Market

2 months ago talkbio0Tagged Clinical Trials, multibillion-dollar market, Narcolepsy type 1, oveporexton, Phase 3, Standard of Care, TAK-861, Takeda, TPRG1L gene

Takeda; Phase 3; narcolepsy type 1; oveporexton; TAK-861; orexin agonist; multibillion-dollar market; clinical trial results; first mover; standard of care

Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

2 months ago talkbio0Tagged AChR-Ab, Adaptation, Argenx, expansion, Labels (device), LRP4 gene, Musk, Myasthenia Gravis, Phase 3, SERON, Seronegative, triple seronegative, United States Food and Drug Administration, Vyvgart

Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

3 months ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials