Regeneron Pharmaceuticals, Inc. (REGN Quick QuoteREGN ) recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive opinion for the oncology drug Libtayo (cemiplimab).
The CHMP recommended approval of the drug as a monotherapy for treating adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
A final decision is expected in the coming months.
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.
The positive opinion is supported by results from the phase III EMPOWER-Cervical 1 study, which met the primary endpoint of overall survival. Libtayo reduced the risk of death by 31% in the total population and 27% in the squamous cell carcinoma (SCC) population compared to an investigator’s choice of chemotherapy.
The study was stopped early in March 2021 based on the highly significant effect of Libtayo on overall survival among SCC patients and following a unanimous recommendation by the Independent Data Monitoring Committee.
We note that Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).
Shares of Regeneron have risen 15.8% so far this year against the industry’s decline of 26.7%.
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Regeneron is looking to diversify into the lucrative oncology space with Libtayo. The drug is also indicated in the United States and other countries in certain patients with advanced BCC, advanced cutaneous squamous cell carcinoma CSCC and advanced NSCLC, as well as in advanced cervical cancer in Canada and Brazil.
The drug is currently being evaluated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers.
While Libtayo holds promise, competition is stiff in this oncology space with many formidable drugs. Hence, Libtayo has a long way to go before contributing significantly to the top line.
Regeneron has many arms in its arsenal. Lead drug Eylea (aflibercept), approved for various ophthalmology indications, has been a steady growth driver and should maintain momentum on sustained label expansions.
However, stiff competition from the potential entry of generics and new treatment options weigh on Eylea, forcing Regeneron to diversify its revenue base.
Another growth driver in Regeneron’s armory is Dupixent, for which it has a collaboration with Sanofi (SNY Quick QuoteSNY ) . Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis) have boosted the top line significantly. Sanofi records global net product sales of Dupixent, while REGN records its share of profits/losses in connection with global sales of the drug.
Regeneron is also looking to foray into the challenging but promising nonalcoholic steatohepatitis (NASH) space with Alnylam Pharmaceuticals, Inc. and CRISPR/Cas9 genome editing therapy with Intellia Therapeutics, Inc.
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Bolt Pharmaceuticals (BOLT Quick QuoteBOLT ) and Dynavax (DVAX Quick QuoteDVAX ) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.