Kiromic BioPharma on plans to submit revised clinical trial application [Seeking Alpha]
Kiromic BioPharma, Inc. (KRBP)
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Source: Seeking Alpha
Kiromic BioPharma on plans to submit revised clinical trial applicationMay 11, 2022 7:43 AM ETKiromic BioPharma, Inc. (KRBP)By:Dulan LokuwithanaSA News EditorGrandbrothers/iStock Editorial via Getty ImagesKiromic BioPharma (NASDAQ:added ~21%cancer-focused biotech announced its plans to submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy candidate, Procel.The decision follows the clinical hold imposed by the FDA on the company’s INDs last July. Over the past ten months, the company implemented a plan to address certain issues cited by the agency, Kiromic (Following expert advice, the company has decided not to pursue a Type A meeting and instead directly submit the amended IND for Procel in H2 2022.In addition, the company outlined its progress towards the establishment of a current good manufacturing practice (cGMP) mammalian master cell bank (mMCB), a key step in the clinical path and a major issue cited by the FDA in the clinical hold let
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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
- 5/10/24 - Form 10-Q
- 5/9/24 - Form 3
- 5/9/24 - Form SC
- KRBP's page on the SEC website