Temporal Concept – Page 9

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

3 months ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation

Servier Supercharges Neuro Pipeline with $450M Deal for Fragile X Syndrome Candidate

3 months ago talkbio0Tagged Acquisition, Bioscience, deal, Fragile X Syndrome, Infrequent, Kaerus, KER-0193, orphan drug designation, pediatric drug designation, Phase 2 trial, Servier

Servier; Kaerus Bioscience; KER-0193; Fragile X syndrome; neurology pipeline; $450 million deal; orphan drug designation; rare pediatric drug designation; Phase 2 trial; acquisition

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

3 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

Atlas Venture Raises $400M Opportunity Fund to Bolster Biotech Portfolio

3 months ago talkbio0Tagged Biopharma, biotech startups, Cervical Atlas, Investments, Late stage, M growth fund, Opportunity Fund III, portfolio support, venture

Atlas Venture; $400M growth fund; biotech startups; Opportunity Fund III; portfolio support; venture capital; late-stage funding; biopharma investment

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

3 months ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

Endpoints News to Announce 2025 ‘Endpoints 11’ Biotechs to Watch Live in Boston

3 months ago talkbio0Tagged Biopharma, biotech startups, City of Boston, Endpoints, Industry, innovation, live event, trends qualifier

Endpoints 11; biotech startups; biopharma; Boston; live event; industry trends; biotech innovation

FDA Announces New Rare Disease Approval Programme

3 months ago talkbio0Tagged Accelerated, Approved, Biological Factors, conditional approval pathway, drug review, Endpoints, Infrequent, real-world data, streamlined process, Surrogate, United States Food and Drug Administration

FDA; rare disease; conditional approval pathway; accelerated approval; biologics; drug review; surrogate endpoints; real-world data; streamlined process

How Past Endpoints 11 Winners Fared During the 2025 Biotech Downturn

3 months ago talkbio0Tagged 2025, biotech downturn, Endpoints, Industry, trends qualifier, winners

Endpoints 11; biotech downturn 2025; biotech winners; Xaira Therapeutics; biotech awards; industry trends

Amylyx Discontinues Rare Disease Program After Relyvrio Fails to Show Benefit Over Placebo

4 months ago talkbio0Tagged AMX0035, Amylyx, Amyotrophic Lateral Sclerosis, Clinical trial failure, Discontinuation (procedure), disease program, Infrequent, Placebos, Progressive, Relyvrio, Supranuclear paralysis

Amylyx; Relyvrio; AMX0035; progressive supranuclear palsy; ALS; clinical trial failure; rare disease program; placebo; discontinuation

Regeneron Reports Phase 3 Success for Cemdisiran in Rare Disease Generalized Myasthenia Gravis

4 months ago talkbio0Tagged Alnylam, cemdisiran, Infrequent, Myasthenia Gravis, Generalized, Regeneron, regulatory submission, RNA drug, RNA, Small Interfering, United States

Regeneron; Phase 3 trial; cemdisiran; generalized myasthenia gravis; rare disease; RNA drug; siRNA; Alnylam Pharmaceuticals; U.S. regulatory submission