Regeneron Says CHMP Recommends Conditional Marketing Authorization For Odronextamab In EU

RTTNews | 159 days ago
Stocktwits
Regeneron Says CHMP Recommends Conditional Marketing Authorization For Odronextamab In EU

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.

The European Commission is expected to announce a final decision in the coming months. FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL).

The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority.

Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas.

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Regeneron Pharma Q2 Results Top Estimates - Update

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Biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) reported on Thursday that net income for the second quarter increased to $1.43 billion or $12.41 per share from $968 million or $8.50 per share in the prior-year quarter.
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Japanese Market Significantly Higher

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Australian Market Modestly Higher

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RTTNews | 5h 56min ago
Hong Kong Shares May Bounce Higher On Thursday

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RTTNews | 6h 8min ago
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