Rejection – Talk Bio

Capricor Therapeutics Reports Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy, Planning FDA Resubmission

7 days ago talkbio0Tagged Capricor Therapeutics, cardiac function preservation, Clinical Trials, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3 clinical trial, regulatory approval pathway, Rejection, United States Food and Drug Administration, upper limb function

Capricor Therapeutics; Deramiocel; Duchenne muscular dystrophy; HOPE-3 trial; Phase 3 clinical trial; FDA rejection; cardiac function preservation; upper limb function; clinical trial results; regulatory approval pathway

FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

1 month ago talkbio0Tagged Ataxia, Spinocerebellar, Biohaven, Clinical Trial Design, Drug Approval, external controls, IL31RA gene, In complete remission, R&D, Rejection, Troriluzole, United States Food and Drug Administration, Vyglxia

Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts

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

2 months 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

2 months 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

3 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

3 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

4 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

4 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

4 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

5 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