It was a pretty low-key week for the biotech sector with nothing much from a majority of the bigwigs. Regeneron Pharmaceuticals REGN was in the spotlight after winning approval for an oncology drug.  This apart, a few pipeline and regulatory updates were in focus.

Recap of the Week’s Most Important Stories:

Regeneron’s Lymphoma Drug Approval:  Regeneron announced that the European Commission (“EC”) approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

The drug has been approved under the brand name Ordspono. The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL. The approval in the EU marks the first regulatory approval of Ordspono for patients across the world. Approval in the EU was mostly expected as the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use recommended approval of odronextamab. The EMA previously granted odronextamab the Orphan Designation for FL and DLBCL.

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

REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Update From Lexicon:  Lexicon Pharmaceuticals, Inc. LXRX announced that the FDA plans to hold an advisory panel meeting to give a recommendation on whether to approve Zynquista (sotagliflozin), which has been developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.

The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled for Oct. 31, 2024. However, despite scheduling an advisory committee meeting, the FDA did not change the PDUFA date of Dec. 20, 2024, for Zynquista.

Lexicon’s shares rose following the announcement. Per the notice provided to the company, the regulatory body is planning to make the background materials available to the public no less than two business days before the meeting is held.

Rhythm Stock Gains on Update: Rhythm Pharmaceuticals RYTM announced the FDA’s acceptance of the supplemental new drug application (sNDA) for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old. The FDA granted Priority Review to the application. A final decision from the FDA is expected on Dec. 26, 2024. The company’s shares rose on the news.