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Regeneron (REGN) Gets CRL From FDA for Multiple Myeloma Drug
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has received a complete response letter (CRL) from the FDA for its biologics license application (BLA) for pipeline candidate linvoseltamab.
The BLA is seeking FDA approval of linvoseltamab for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate.
The third-party fill/finish manufacturer has since informed Regeneron that it believes the issue has been resolved. The manufacturer is awaiting reinspection of its facility by the FDA that is expected to take place in the coming months.
The CRL delays a potential approval of the candidate.
Linvoseltamab is also under review in the European Union.
Earlier, Regeneron’s efforts to get odronextamab approved in the United States also suffered a setback. The regulatory body issued CRLs for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).
The sole issue with the approval was 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 issue with the clinical efficacy or safety, trial design, labeling, or manufacturing.
Regeneron is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
The successful development of these oncology drugs should be a great boost for REGN. It should also reduce the company’s dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.
Regeneron’s shares have surged 35.7% year to date compared with the industry’s growth of 2.2%.
Image Source: Zacks Investment Research
REGN has a collaboration agreement with Bayer (BAYRY - Free Report) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.
Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
Image: Bigstock
Regeneron (REGN) Gets CRL From FDA for Multiple Myeloma Drug
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has received a complete response letter (CRL) from the FDA for its biologics license application (BLA) for pipeline candidate linvoseltamab.
The BLA is seeking FDA approval of linvoseltamab for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate.
The third-party fill/finish manufacturer has since informed Regeneron that it believes the issue has been resolved. The manufacturer is awaiting reinspection of its facility by the FDA that is expected to take place in the coming months.
The CRL delays a potential approval of the candidate.
Linvoseltamab is also under review in the European Union.
Earlier, Regeneron’s efforts to get odronextamab approved in the United States also suffered a setback. The regulatory body issued CRLs for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).
The sole issue with the approval was 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 issue with the clinical efficacy or safety, trial design, labeling, or manufacturing.
Regeneron is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
The successful development of these oncology drugs should be a great boost for REGN. It should also reduce the company’s dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.
Regeneron’s shares have surged 35.7% year to date compared with the industry’s growth of 2.2%.
Image Source: Zacks Investment Research
REGN has a collaboration agreement with Bayer (BAYRY - Free Report) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.
Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.