File (record) – Talk Bio

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Eikon Therapeutics Files for IPO Amid Biotech Rally Test

2 weeks ago talkbio0Tagged cancer drugs, Eikon, File (record), IPO, Nasdaq EIKN, rally

Eikon Therapeutics; IPO filing; biotech rally; cancer drugs; Nasdaq EIKN

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

3 months ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418

3 months ago talkbio0Tagged Acoramidis, Approved, BBP-418, Biological Markers, BridgeBio, commercial, disease drug, File (record), Infrequent, Limb-girdle muscular dystrophy type 2A, NDA, New Drug Application, Phase 3 success, Ribitol, United States Food and Drug Administration

BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy

PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom

5 months ago talkbio0Tagged cash runway, Clinical Trials, Familial mitral valve prolapse, File (record), Frequency of Responses, Funding, ovarian neoplasm, TP53 gene, United States Food and Drug Administration

PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway

AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success

5 months ago talkbio0Tagged aldosterone synthase inhibitor, AstraZeneca, baxdrostat, File (record), Hypertensive disease, regulatory approval, United States Food and Drug Administration

AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval

Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings

6 months ago talkbio0Tagged Clinical Trials, File (record), Narcolepsy, Narcolepsy type 1, orexin agonist, oveporexton, Phase 3 Clinical Trials, Takeda, United States Food and Drug Administration

Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results

Axsome Plots New Fibromyalgia Trial After FDA Refuses Review of Former Pfizer Candidate

8 months ago talkbio0Tagged Analgesics, AXS-14, Axsome, Clinical Trials, esreboxetine, Fibromyalgia, File (record), Pfizer, refusal, trial design, United States Food and Drug Administration

Axsome Therapeutics; esreboxetine; fibromyalgia; FDA; refusal to file; clinical trial; Pfizer; AXS-14; trial design; pain medicine

Sionna and Odyssey Therapeutics Kick Off 2025 Biotech IPO Wave with SEC Filings

1 year ago talkbio0Tagged 2025, File (record), Health care facility, Industry, IPO, JPM, Market, Odyssey, Sionna

Sionna Therapeutics, Odyssey Therapeutics, IPO filings, biotech industry, JPM Healthcare Conference, 2025 IPO market

Outlook Therapeutics Stock Crashes Following Clinical Trial Failure for Wet AMD Therapy

1 year ago talkbio0Tagged AMD, Attitude, Clinical Trials, Failure (biologic function), File (record), Glycogen storage disease type II, OTLK, Prices, United States Food and Drug Administration

Outlook Therapeutics, OTLK, stock price, clinical trial failure, wet AMD therapy, ONS-5010, FDA filing

Axsome Therapeutics Narcolepsy Drug AXS-12 Achieves Phase III Success, Paving Way for US FDA Filing

1 year ago talkbio0Tagged AXS-12, Axsome, Encore, File (record), Narcolepsy, NDA, Phase 3 Clinical Trials, United States Food and Drug Administration

Axsome Therapeutics, AXS-12, narcolepsy, Phase III trial, ENCORE trial, FDA filing, NDA