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Fly News Breaks for February 26, 2020
Feb 26, 2020 | 08:50 EDT
As reported previously, Canaccord analyst John Newman upgraded Regeneron (REGN) to Buy from Hold. The analyst noted its competition decreased when the ASRS warned about 14 cases of vasculitis in patients that received Novartis's (NVS) Beovu. The analyst noted the report should reduce the EYLEA competitive concerns in the wet AMD space. Newman raised his price target to $550 from $409 on Regeneron shares.
News For REGN;NVS From the Last 2 Days
Feb 28, 2021 | 16:09 EST
Regeneron Pharmaceuticals announced detailed results from a Phase 2 proof-of-concept trial evaluating the investigational antibody cocktail REGN1908-1909 in cat-allergic patients with mild asthma. The trial met the primary endpoint of preventing early asthma reactions. The trial also met key secondary endpoints, including improved lung function and an increased amount of cat allergen that patients could tolerate following a single dose of treatment, from as early as the first assessment conducted at week 1. The results were shared in an oral presentation at the virtual 2021 American Academy of Allergy, Asthma and Immunology Annual Meeting. Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats. Fel d 1 is spread to surrounding environments through airborne particles that adhere to clothing, carpets and furniture. Patients typically experience rapid onset of mild to severe symptoms including nasal congestion, itchy and watery eyes, chest tightening and wheezing. Currently, cat-induced allergic rhinitis is treated with antihistamines and intranasal corticosteroids with moderate efficacy. Allergen-specific immunotherapy takes 12-24 months to see clinical benefit and is contraindicated for patients with severe or uncontrolled asthma. Importantly, the association between cat allergy and asthma is significant, as more than 50% of cat-allergic patients have co-existing asthma. Although rare, cat allergy in these patients can potentially trigger life-threatening asthma attacks leading to hospitalization. REGN1908-1909 is a novel cocktail of two fully-human monoclonal IgG antibodies, designed to specifically bind and block the Fel d 1 allergen, thus preventing it from binding and triggering the endogenous antibodies that cause allergies. REGN1908-1909 was invented using Regeneron's proprietary VelocImmune technology. The Phase 2 randomized, double-blind proof-of-concept trial enrolled 56 cat-allergic patients with mild asthma who received a single dose of REGN1908-1909 600 mg or placebo delivered subcutaneously. This was followed by a 12-week assessment period during which patients underwent a 4-hour Cat Allergen Challenge at weeks 1, 4, 8 and 12 in an environmental exposure unit where they were exposed to cat allergen and monitored for allergic reactions. In order to establish a baseline, patients were also exposed to the EEU 1 week prior to receiving either REGN1908-1909 or placebo. Patients who took REGN1908-1909 experienced significant improvements during the Cat Allergen Challenge compared to those on placebo, which included: Reduced time to EAR for up to 3 months, improved ability to breathe, and improved cat allergen tolerance. Adverse events occurred in 76% of patients who received REGN1908-1909 and 78% of patients who received placebo. AEs more commonly observed with those receiving REGN1908-1909 included injection site reactions. The use of REGN1908-1909 to treat cat-allergic patients with mild asthma is investigational and its efficacy and safety have not been fully evaluated by any regulatory authority.
Feb 26, 2021 | 06:50 EST
Regeneron (REGN) announced the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion for the company's investigational COVID-19 antibody cocktail. The CHMP recommends that the antibody cocktail, known as REGEN-COV in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. Regeneron is collaborating with Roche (RHHBY) to increase global supply of the antibody cocktail.