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0.00137008381689223 0.00580270793036749 0.00370728562217919 0.00797872340425528 0.00983236621534493 0.0159574468085106 0.0154738878143132 -0.0166827852998066
Stock impact report

Biotech Stock Roundup: PRAX, VKTX Up on Study Results & MRNA, REGN Give Updates [Yahoo! Finance]

Praxis Precision Medicines, Inc. (PRAX) 
Company Research Source: Yahoo! Finance
Recap of the Week's Most Important Stories Setback for Regeneron Regeneron Pharmaceuticals, Inc . REGN suffered a setback as the FDA issued Complete Response Letters (CRLs) for its biologics license application (BLA) for odronextamab. 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. 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 l Show less Read more
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