Regeneron Says CHMP Recommends Conditional Marketing Authorization For Odronextamab In EU

RTTNews | vor 425 Tagen
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.

read more
Regeneron Pharma Q2 Results Top Estimates - Update

Regeneron Pharma Q2 Results Top Estimates - Update

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.
RTTNews | vor 391 Tagen
Regeneron Pharma Q4 Results Top Estimates - Update

Regeneron Pharma Q4 Results Top Estimates - Update

Regeneron Pharmaceuticals, Inc. (REGN) reported on Friday that net income for the fourth quarter declined 3 percent to $1.16 billion or $10.19 per share from $1.20 billion or $10.50 per share in the prior-year quarter.
RTTNews | vor 572 Tagen
Regeneron Completes Acquiring Sanofi's Stake In Libtayo

Regeneron Completes Acquiring Sanofi's Stake In Libtayo

Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that it has completed the acquisition of French drug major Sanofi's (SNYNF, SNY) stake in Libtayo (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization, and manufacturing rights to the medicine originally discovered in Regeneron's laboratories. The intent to purchase Libtayo was announced on June 2, 2022.
RTTNews | vor 1153 Tagen
Australian Market Trims Early Losses In Mid-market

Australian Market Trims Early Losses In Mid-market

The Australian market is trimming early losses in mid-market moves on Thursday, giving up some of the gains in the previous session, despite the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling to near the 8,950 level, with weakness in iron ore miners, energy and technology stocks partially offset by gains in financial stocks.
RTTNews | vor 14 Minuten
Asian Markets Trade Mostly Higher

Asian Markets Trade Mostly Higher

Asian stock markets are mostly higher on Thursday, following the broadly positive cues from Wall Street overnight, as traders remain optimistic the US Fed will cut interest rates at their next meeting in September. They also remain cautious ahead of the release of key US economic data later in the week, including second quarter GDP and the Fed's preferred readings on consumer price inflation.
RTTNews | vor 29 Minuten
Swiss Market Settles Modestly Higher

Swiss Market Settles Modestly Higher

The Switzerland market closed modestly higher on Wednesday after staying firm right through the day's session, thanks to fairly strong buying at several counters. The benchmark SMI closed up by 46.23 points or 0.38% at 12,207.12. The index moved between 12,166.23 and 12,226.36 during the session.
RTTNews | vor 1Std 12 Minuten