Regeneron (REGN) Posts Upbeat Data From Multiple Myeloma Study
Regeneron REGN announced updated data from a pivotal phase II study evaluating its investigational BCMAxCD3 bispecific antibody, linvoseltamab, in patients with heavily pre-treated, relapsed/refractory (“R/R”) multiple myeloma.
Data from the study demonstrated that treatment with a 200mg dose of linvoseltamab led to early, deep and durable responses in myeloma patients. With a median follow-up of six months, patients who received the recommended 200mg dose of linvoseltamab showed a 71% objective response rate (“ORR”). This includes 59% patients achieving very good partial response (“VGPR”) or better and 30% patients achieving a complete response (“CR”) or stringent complete response (“sCR”). Management also announced that the median progression-free survival was not reached.
Treatment benefit with linvoseltamab was also observed across prespecified subgroups, including patients with high disease burden and aggressive disease.
Based on these results, Regeneron initiated a phase III development program to evaluate linvoseltamab in earlier stages of multiple myeloma. Management plans to use the data from the above study to support its regulatory submission with the FDA for linvoseltamab in multiple myeloma indication later this year.
The above results were part of the secondary endpoint assessed by a local investigator. The primary endpoint of the study, i.e., ORR assessed by an independent review committee, which will be available when the data are more mature.
In the year so far, Regeneron’s shares have moved up 0.5% against the industry’s 9.2% fall.
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In a separate press release, Regeneron announced positive data from a phase I study evaluating the combination of its investigational LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo in adults with advanced melanoma. Data from the study exhibited ORRs ranging from 56-63% across three independent cohorts of advanced melanoma patients. Based on these encouraging results, management plans to evaluate this combination in phase III studies in the advanced and adjuvant melanoma settings. This fianlimab-Libtayo combination is already being evaluated in an ongoing phase II/III studies in non-small cell lung cancer and research in other solid tumors.
Regeneron’s top line is being driven by a couple of blockbuster drugs like Eylea and Dupixent, which account for nearly half of its total revenues. A successful development and potential commercialization of its pipeline drugs will help the company lower its dependence on the drugs for generating revenue.
Regeneron’s lead drug, Eylea, is approved for various ophthalmology indications like wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Dupixent is jointly marketed by Regeneron and Sanofi SNY under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The Sanofi-partnered drug is approved in the United States and Europe for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Sanofi and Regeneron are also studying Dupixent in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic spontaneous urticaria.
Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. price | Regeneron Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ANI Pharmaceuticals ANIP and Allogene Therapeutics ALLO. While ANI Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Allogene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 14.7% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 244.12%.
In the past 30 days, estimates for Allogene Therapeutics’ 2023 loss per share have improved from $2.44 to $2.31. During the same period, the loss estimates per share for 2024 have narrowed from $2.46 to $2.21. Shares of Allogene Therapeutics have declined 13.0% in the year-to-date period.
Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 5.08%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 7.94%.
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