Rejection – Talk Bio

FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues

4 weeks ago talkbio0Tagged biotech, CUTX-101, Cyprium Therapeutics, Fortress, Hypocupremia, manufacturing deficiencies, Menkes disease, Rejection, Sentynl, United States Food and Drug Administration

FDA rejection; Menkes disease; CUTX-101; copper deficiency; manufacturing deficiencies; Cyprium Therapeutics; Sentynl Therapeutics; Fortress Biotech

IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path

4 weeks ago talkbio0Tagged biotech, Cancer Vaccines, Clinical Trials, Cylembio, Financial cost, Io satellite, layoffs, melanoma, Regulatory Setback, Rejection, United States Food and Drug Administration

IO Biotech; layoffs; cancer vaccine; FDA rejection; Cylembio; Phase 3 trial; melanoma; regulatory setback; cost cutting; clinical trial

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

2 months ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

2 months ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial

FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies

2 months ago talkbio0Tagged Clinical Research, Complete Response Letter, drug efficacy, factor IX, Friedreich 's ataxia, Rejection, United States Food and Drug Administration, vatiquinone

FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

2 months ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

3 months ago talkbio0Tagged Clinical Trials, Drug Approval, Heterogeneity, IGYNTE, melanoma, Oncolytic Immunotherapy, Rejection, Replimune, RETINITIS PIGMENTOSA 1, scientist protest, United States Food and Drug Administration

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

3 months ago talkbio0Tagged Antineoplastic Agents, Clinical Trial Design, Complete, Drops - Drug Form, Frequency of Responses, melanoma, Prices, Rejection, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

3 months ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter