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Regeneron Pharmaceuticals Inc (NASDAQ:REGN) shares are back on the mend in a big way. Tuesday’s action saw powerful gains in reaction to the company’s announcement, along with Sanofi, that two pivotal Phase 3 placebo-controlled trials evaluating Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps met all primary and secondary endpoints.

As the gears up for an eventful ESMO in a couple days time (the advance word is that they plan to present new data that support rationale for pursuing registrational trials of Libtayo in lung, cervical and skin cancers), this very successful Dupixent data serves as a reminder for how potent the REGN pipeline is at this point.

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) bills itself as a biopharmaceutical company with a strong program in macular degeneration. But this is a diversified play with a ton in the pipeline, and R&D that spans eyes, skin, and oncology.

For a sense of perspective, the company’s products include EYLEA injection to treat wet age-related macular degeneration and diabetic macular edema (DME); myopic choroidal neovascularization; and diabetic retinopathy in patients with DME, as well as macular edema following retinal vein occlusion, including macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.

It also provides Dupixent injection to treat adult patients with moderate-to-severe atopic dermatitis; Praluent injection, an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease; and Kevzara solution for subcutaneous injection to treat rheumatoid arthritis in adults.

In addition, the company offers ARCALYST injection for cryopyrin-associated periodic syndromes; and ZALTRAP, an injection for intravenous infusion, which is used in combination with 5-fluorouracil, leucovorin, and irinotecan for the treatment of metastatic colorectal cancer.

Further, it develops EYLEA, a trap-based clinical product that is in Phase III study for the treatment of neovascular glaucoma; and Dupixent, Praluent, Kevzara, Suptavumab, Cemiplimab, Fasinumab, Evinacumab, Nesvacumab/aflibercept, Trevogrumab, REGN1908-1909, REGN1979, REGN3470-3471-3479, REGN2477, REGN3500, REGN3767, and REGN3918, which are antibody-based clinical programs under various stages of development.

REGN also has a number of key CLA’s, including agreements with Sanofi, Bayer, Mitsubishi Tanabe Pharma, Teva, Intellia Therapeutics, Adicet Bio, Decibel Therapeutics, Astellas, Alnylam Pharmaceuticals, Inc., bluebird bio, Inc., and others.

 

Packs a Punch

As we discussed earlier, REGN just announced, along with Sanofi, that two pivotal Phase 3 placebo-controlled trials evaluating Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps met all primary and secondary endpoints.

This news, while obviously helpful, figures into a tape that has been defined by some heavy action, with shares of REGN dealing with some pressure. That said, coming back on the news to close the last five days more or less flat is a win for shareholders, especially given a volatile broad market context.

“Dupixent has now demonstrated significant late-stage efficacy in three Type 2 or allergic inflammatory diseases, indicating that IL-4 and IL-13 are required drivers of Type 2 or allergic inflammation in general. With these data, Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “We look forward to U.S. regulatory action on our moderate-to-severe asthma application later this month, and are continuing our development program in additional Type 2 or allergic inflammatory diseases with high unmet need including pediatric asthma, pediatric and adolescent atopic dermatitis, eosinophilic esophagitis, and food and environmental allergies.”

REGN shares have been relatively flat over the past month of action, with very little net movement during that period. However, in recent days, we have explored the lower end of the recent range and come roarding back, setting up a possible test of the upper edge of the range, which could imply a move in shares back above $400 and a possible test of the $410-415 area.

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) managed to rope in revenues totaling $1.6B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 9.4%, as compared to year-ago data in comparable terms.

In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($1.7B against $1.3B).



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