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Regeneron's (REGN) Application for Blood Cancer Drug Accepted
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Medicines Agency accepted to review the Marketing Authorization Application (MAA) for its pipeline candidate odronextamab.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T-cells to facilitate local T-cell activation and cancer-cell killing.
The MAA is seeking approval of the candidate to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) who have progressed after at least two prior systemic therapies.
The MAA is supported by data from a phase I and pivotal phase II study, ELM-1 and ELM-2, evaluating odronextamab in FL and DLBCL.
The regulatory body in the EU had earlier granted Orphan Drug Designation to odronextamab for FL and DLBCL.
Per the release, FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, with patients often relapsing within five years. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). With the progress of these blood cancers, it is difficult to treat patients, especially in the third-line setting and beyond, leaving patients with few treatment options.
Currently, Regeneron is conducting a broad phase III program to evaluate odronextamab in earlier lines of therapy and additional B-NHLs.
Regeneron is looking to solidify its presence in the lucrative oncology space. Its portfolio already includes an approved PD-1 inhibitor, Libtayo, which is approved to treat people with a type of skin cancer called cutaneous squamous cell carcinoma that has spread or cannot be cured by surgery or radiation.
It is also approved to treat certain people with a type of skin cancer called basal cell carcinoma and adults with non-small cell lung cancer.
The company is also evaluating multiple CD28 costimulatory bispecific antibodies, including PSMAxCD28, EGFRxCD28, MUC16xCD28 and CD22xCD28, in ongoing phase I studies in a variety of tumor settings in combination with Libtayo or in combination with corresponding CD3 bispecifics.
Another pipeline candidate, linvoseltamab, a bispecific antibody targeting BCMA and CD3, is being evaluated in patients with heavily pre-treated, relapsed/refractory multiple myeloma.
Regeneron’s shares have gained 10.4% so far this year against the industry’s decline of 13.9%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base, with lead drug Eylea facing stiff competition. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Earlier in the month, the company reported better-than-expected second-quarter 2023 results even though lead drug Eylea’s sales declined.
Nevertheless, the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) , maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
The loss per share estimate for SPRO for 2023 has narrowed by 54 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 5 cents to 27 cents for 2023 in the past 30 days. Dynavax has risen 33.8% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Regeneron's (REGN) Application for Blood Cancer Drug Accepted
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Medicines Agency accepted to review the Marketing Authorization Application (MAA) for its pipeline candidate odronextamab.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T-cells to facilitate local T-cell activation and cancer-cell killing.
The MAA is seeking approval of the candidate to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) who have progressed after at least two prior systemic therapies.
The MAA is supported by data from a phase I and pivotal phase II study, ELM-1 and ELM-2, evaluating odronextamab in FL and DLBCL.
The regulatory body in the EU had earlier granted Orphan Drug Designation to odronextamab for FL and DLBCL.
Per the release, FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, with patients often relapsing within five years. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). With the progress of these blood cancers, it is difficult to treat patients, especially in the third-line setting and beyond, leaving patients with few treatment options.
Currently, Regeneron is conducting a broad phase III program to evaluate odronextamab in earlier lines of therapy and additional B-NHLs.
Regeneron is looking to solidify its presence in the lucrative oncology space. Its portfolio already includes an approved PD-1 inhibitor, Libtayo, which is approved to treat people with a type of skin cancer called cutaneous squamous cell carcinoma that has spread or cannot be cured by surgery or radiation.
It is also approved to treat certain people with a type of skin cancer called basal cell carcinoma and adults with non-small cell lung cancer.
The company is also evaluating multiple CD28 costimulatory bispecific antibodies, including PSMAxCD28, EGFRxCD28, MUC16xCD28 and CD22xCD28, in ongoing phase I studies in a variety of tumor settings in combination with Libtayo or in combination with corresponding CD3 bispecifics.
Another pipeline candidate, linvoseltamab, a bispecific antibody targeting BCMA and CD3, is being evaluated in patients with heavily pre-treated, relapsed/refractory multiple myeloma.
Regeneron’s shares have gained 10.4% so far this year against the industry’s decline of 13.9%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base, with lead drug Eylea facing stiff competition. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Earlier in the month, the company reported better-than-expected second-quarter 2023 results even though lead drug Eylea’s sales declined.
Nevertheless, the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) , maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Zacks Rank and Stocks to Consider
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The loss per share estimate for SPRO for 2023 has narrowed by 54 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 5 cents to 27 cents for 2023 in the past 30 days. Dynavax has risen 33.8% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.