Kiromic BioPharma Announces Company Will Directly Submit Amended IND for Procel™ to the FDA in Second Half of 2022
Kiromic BioPharma, Inc. (KRBP)
Company Research
Source: Business Wire
Company Provides Regulatory Update on Progress to Address Previously Outlined Chemistry, Manufacturing, and Control (CMC) Issues Related to Clinical Hold on Investigational New Drug Applications (INDs)A Type A FDA Meeting Will Not Be PursuedCompany Announces Ongoing Progress Towards the Implementation by the Beginning of the Third Quarter of 2022 of a Current Good Manufacturing Practice (cGMP) Mammalian Master Cell Bank (mMCB), a Key Component to Manufacture a GMP-Grade Retroviral Vector for Gamma Delta T (GDT) Cell Engineering HOUSTON--(BUSINESS WIRE)--Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, today announces the Company will submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy c
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News
- Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients [Yahoo! Finance]Yahoo! Finance
- Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three PatientsBusiness Wire
- Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial [Yahoo! Finance]Yahoo! Finance
- Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical TrialBusiness Wire
- Early Efficacy Results Show Primary Lung Tumor Stabilization and Complete Disappearance of Brain Metastases in Second Patient in Kiromic BioPharma's Deltacel-01 Clinical Trial [Yahoo! Finance]Yahoo! Finance
KRBP
Sec Filings
- 4/19/24 - Form 8-K
- 4/10/24 - Form RW
- 4/5/24 - Form 8-K
- KRBP's page on the SEC website