Regeneron's (REGN) Lymphoma Candidate Rejected by the FDA [Yahoo! Finance]
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: Yahoo! Finance
Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor complex while binding and bridging T-cells to a protein expressed on B-cells. The BLA is seeking the approval of the candidate in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. Regeneron stated that the sole issue with approvability is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the clinical efficacy or safety, trial design, labeling or manufacturing of the candidate. We remind investors that REGN has been actively enrolling patients in multiple phase III trials for odronextamab as part of the OLYMPIA program. The program is expected to change the treatment paradigm of several B-cell non-Hodgkin lymphoma subtypes, including in earlier lines
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REGN
Earnings
- 2/2/24 - Beat
REGN
Sec Filings
- 4/25/24 - Form ARS
- 4/25/24 - Form DEFA14A
- 4/25/24 - Form DEF
- REGN's page on the SEC website