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Biotech Stock Roundup: REGN's Drug Approval, LXRX, RYTM Stocks Gain on Update & More
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It was a pretty low-key week for the biotech sector with nothing much from a majority of the bigwigs. Regeneron Pharmaceuticals (REGN - Free Report) 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.
Update From Lexicon: Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) 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 - Free Report) 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.
Imcivree, an MC4R agonist, is already approved in the United States and EU for chronic weight management in adult and pediatric patients aged six years and older. The eligible patient population includes those with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.
Rhythm’s sNDA is looking to expand the eligible patient population for the drug by lowering the minimum required age to receive Imcivree treatment to two years in the United States. In July 2024, the drug’s label was expanded in the EU to include children aged two years with obesity due to BBS or POMC/PCSK1, or LEPR deficiency.
Galapagos Stock Up on Regulatory Update: Galapagos NV (GLPG - Free Report) announced that the FDA cleared its investigational new drug application to begin an early to mid-stage study of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Shares of GLPG rose on this update.
GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate, which is administered as a single, fixed, intravenous dose. The planned phase I/II ATALANTA-1 study will evaluate the feasibility, safety and efficacy of GLPG5101 for the R/R NHL indication in the United States.
The main goal of the phase I portion of the ATALANTA-1 trial is to assess the safety and initial effectiveness of GLPG5101 to establish the appropriate dosage strength for the phase II portion. Additionally, the phase I portion will evaluate the efficacy and feasibility of decentralized manufacturing of GLPG5101 as a secondary objective.
The primary goal of the phase II portion is to assess the objective response rate, while secondary goals include evaluating the complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetics and the feasibility of decentralized manufacturing. The treatment period for all enrolled patients will be 24 months.
Image: Bigstock
Biotech Stock Roundup: REGN's Drug Approval, LXRX, RYTM Stocks Gain on Update & More
It was a pretty low-key week for the biotech sector with nothing much from a majority of the bigwigs. Regeneron Pharmaceuticals (REGN - Free Report) 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 - Free Report) 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 - Free Report) 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.
Imcivree, an MC4R agonist, is already approved in the United States and EU for chronic weight management in adult and pediatric patients aged six years and older. The eligible patient population includes those with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.
Rhythm’s sNDA is looking to expand the eligible patient population for the drug by lowering the minimum required age to receive Imcivree treatment to two years in the United States. In July 2024, the drug’s label was expanded in the EU to include children aged two years with obesity due to BBS or POMC/PCSK1, or LEPR deficiency.
Galapagos Stock Up on Regulatory Update: Galapagos NV (GLPG - Free Report) announced that the FDA cleared its investigational new drug application to begin an early to mid-stage study of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Shares of GLPG rose on this update.
GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate, which is administered as a single, fixed, intravenous dose. The planned phase I/II ATALANTA-1 study will evaluate the feasibility, safety and efficacy of GLPG5101 for the R/R NHL indication in the United States.
The main goal of the phase I portion of the ATALANTA-1 trial is to assess the safety and initial effectiveness of GLPG5101 to establish the appropriate dosage strength for the phase II portion. Additionally, the phase I portion will evaluate the efficacy and feasibility of decentralized manufacturing of GLPG5101 as a secondary objective.
The primary goal of the phase II portion is to assess the objective response rate, while secondary goals include evaluating the complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetics and the feasibility of decentralized manufacturing. The treatment period for all enrolled patients will be 24 months.
Performance
The Nasdaq Biotechnology Index has gained 0.52% in the past five trading sessions and GSK’s shares have risen 6.13%. In the past six months, shares of REGN have rallied 20.98%. (See the last biotech stock roundup here: Biotech Stock Roundup: CRL for REGN, GILDs Drug Approval, LQDA Down on News).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.