Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab), demonstrating significant efficacy in improving lung function and reducing severe asthma attacks in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial revealed a 65% reduction in asthma attacks and rapid improvements in lung function within two weeks. FDA approval for this indication is expected by October 21, 2021. The study highlights Dupixent's potential as a best-in-class treatment, targeting type 2 inflammation, a common cause of asthma in this population.

Regeneron and Sanofi announced positive Phase 3 trial results for Libtayo (cemiplimab) in advanced cervical cancer, demonstrating a 31% reduction in the risk of death compared to chemotherapy. Significant improvements were observed in overall survival, progression-free survival, and objective response rate. The study included 304 patients in each treatment group, revealing a median response duration of 16 months for Libtayo versus 7 months for chemotherapy. The findings support Libtayo as a potential second-line treatment, with regulatory submissions expected in 2021.

Regeneron Pharmaceuticals reported a strong first quarter of 2021 with revenues of $2.53 billion, up 38% from 2020. Net sales of EYLEA rose 15% to $1.35 billion, and Dupixent global net sales increased 48% to $1.26 billion. GAAP diluted EPS reached $10.09, a significant increase compared to $5.43 in Q1 2020. The company received three FDA approvals and reported positive Phase 3 results for REGEN-COV in COVID-19 treatment and prevention. Strong growth is anticipated in EYLEA and Dupixent, with a solid pipeline of approximately 30 product candidates in clinical development.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 3 results for two of its medicines at the upcoming 2021 ATS International Conference, scheduled for May 17. The studies include REGEN-COV™, an investigational COVID-19 treatment for high-risk outpatients, and Dupixent®, for children aged 6 and older with uncontrolled asthma. These findings underscore Regeneron's commitment to advancing healthcare solutions. Presentations also cover Dupixent's impact on corticosteroid use in adults and data on chronic rhinosinusitis treatment.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced nearly 30 presentations on Dupixent at AAD VMX 2021 and ESPD 2021. The data highlights Dupixent's effectiveness in providing rapid itch relief and improving disease severity in patients as young as 6 years old with moderate-to-severe atopic dermatitis. Clinical trials showed long-term efficacy and a favorable safety profile, with lower infection rates compared to placebo. Key findings include significant improvements in quality of life and disease measures across various age groups, supporting Dupixent's essential role in managing atopic dermatitis.

Regeneron Pharmaceuticals announced positive results from its Phase 3 trial evaluating REGEN-COV in asymptomatic COVID-19 patients. The trial reported a 31% reduction in the risk of progressing to symptomatic COVID-19 and a 76% reduction after three days. Among 204 participants, the treatment also shortened symptom duration by 45% and reduced viral levels by more than 90%. There were no hospitalizations among REGEN-COV patients compared to 6% in the placebo group. This trial reinforces REGEN-COV's potential for early intervention in non-hospitalized COVID-19 cases.

Regeneron Pharmaceuticals announced positive results from a Phase 3 trial for REGEN-COV, demonstrating an 81% reduction in symptomatic COVID-19 infections among household contacts of infected individuals. Administered as a 1,200 mg subcutaneous dose, REGEN-COV provided 72% protection in the first week and 93% thereafter. Participants who contracted COVID-19 experienced faster symptom resolution compared to the placebo group. Regeneron plans to submit these findings to the FDA for Emergency Use Authorization to expand REGEN-COV's application in COVID-19 prevention.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the NIH COVID-19 Treatment Guidelines now strongly recommend REGEN-COV™ (casirivimab with imdevimab) for non-hospitalized COVID-19 patients at high risk of clinical progression. This strong 'AIIa' rating is based on clinical trials involving over 4,500 outpatients, showing a 70% reduction in hospitalization or death risk. The FDA has issued Emergency Use Authorization for REGEN-COV, which retains potency against emerging COVID-19 variants. Regeneron aims to improve access and explore simpler administration methods for REGEN-COV.