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Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.

Regeneron Pharmaceuticals Inc. (symbol: REGN) is a prominent American biotechnology company headquartered in Westchester County, New York, since its founding in 1988. The core mission of Regeneron is to discover, develop, and commercialize innovative products targeting a range of serious medical conditions. With a diverse portfolio, Regeneron focuses on therapies for eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.

Among its marketed products, Eylea stands out as a treatment for wet age-related macular degeneration and other eye diseases. Praluent is designed to lower LDL cholesterol levels, while Dupixent addresses multiple immunological conditions. In the oncology sector, Libtayo is a key therapy, and Kevzara targets rheumatoid arthritis.

The company is also heavily invested in the development of monoclonal and bispecific antibodies, often in collaboration with Sanofi and other partners. These initiatives include cutting-edge technologies such as RNA interference (RNAi) with Alnylam and CRISPR-based gene editing with Intellia.

Regeneron's recent progress includes significant advancements in its clinical-stage pipeline, which comprises over 35 product candidates. The company's financial health remains robust, supported by strong revenue streams from collaboration with Sanofi and a strategic $3.0 billion share repurchase program authorized by the board.

Latest updates highlight the company's ongoing efforts in gene therapy, particularly in treating genetic deafness and solid tumors. Regeneron's commitment to pioneering genetic medicine and leveraging data insights from the Regeneron Genetics Center® positions it as a leader in the biopharmaceutical industry.

For more information, visit Regeneron Pharmaceuticals.

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Regeneron Pharmaceuticals (NASDAQ: REGN) has completed the acquisition of Sanofi's stake in Libtayo (cemiplimab), granting it exclusive worldwide rights to develop, commercialize, and manufacture the drug. Initially announced on June 2, 2022, this transaction allows Regeneron to record 100% of global net sales and expenses from Libtayo. The company expects to report an acquired in-process research and development charge of approximately $195 million from the recent acquisition of Checkmate Pharmaceuticals, negatively impacting earnings per share by about $1.70 for Q2 2022.

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Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted for review its supplemental Biologics License Application (sBLA) for a 16-week dosing regimen of EYLEA (aflibercept) in treating diabetic retinopathy (DR). If approved by February 28, 2023, this regimen may enhance treatment flexibility for doctors and patients. EYLEA is already approved for various DR treatments using 4- and 8-week regimens. The submission is based on data from the PANORAMA and Protocol W trials, which demonstrated efficacy in improving DR severity scores.

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Intellia Therapeutics and Regeneron Pharmaceuticals announced positive interim results from the Phase 1 study of NTLA-2001, a CRISPR-based therapy for ATTR amyloidosis. The study showed sustained serum transthyretin (TTR) reductions of 93% by day 28 at the 1.0 mg/kg dose, remaining durable through six months. Follow-up data from patients indicate a favorable safety profile, with the majority of adverse events being mild. The companies plan further development, aiming for an 80 mg fixed dose in the next study phase.

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Dupixent has received FDA approval as the first biologic medicine for children aged 6 months to 5 years diagnosed with moderate-to-severe atopic dermatitis. A Phase 3 trial showed that children treated with Dupixent alongside topical corticosteroids achieved 28% clear skin, compared to 4% with corticosteroids alone. The treatment significantly reduced disease severity and itch. Long-term safety data reaffirmed Dupixent's established safety profile. Regeneron and Sanofi aim to address the significant unmet needs of young children suffering from this debilitating condition.

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Regeneron Pharmaceuticals plans to acquire Sanofi's stake in Libtayo for an upfront payment of $900 million, including royalties and milestone payments. This acquisition grants Regeneron exclusive global rights to develop, commercialize, and manufacture Libtayo, which is currently approved in over two dozen countries for various cancers. The deal is expected to close in Q3 2022, contingent on regulatory approvals. Regeneron aims to enhance its oncology portfolio, as Libtayo recorded a 32% sales increase in 2021.

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Regeneron Pharmaceuticals (NASDAQ: REGN) has acquired Checkmate Pharmaceuticals to enhance its immuno-oncology portfolio. This strategic acquisition focuses on Checkmate's lead candidate, vidutolimod, which shows promise in treating PD-1 refractory melanoma. The tender offer concluded with 83.8% of Checkmate's shares validly tendered at $10.50 each. Regeneron anticipates accounting for this transaction as an asset acquisition, with no immediate change to its 2022 financial guidance. The acquisition aims to diversify Regeneron's cancer treatment approaches, emphasizing combination therapies.

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The FDA has accepted Dupixent (dupilumab) for Priority Review to treat prurigo nodularis, a chronic skin disease. If approved, Dupixent will be the first medicine specifically indicated for this condition in the U.S. The target decision date is September 30, 2022. This application is backed by two Phase 3 trials demonstrating significant improvements in symptoms compared to placebo. The most commonly observed adverse event was conjunctivitis. Approximately 75,000 U.S. patients struggle with this disease, highlighting the potential market need for Dupixent.

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Regeneron Pharmaceuticals (NASDAQ: REGN) announced promising results from a Phase 3 trial of Evkeeza® (evinacumab) in children aged 5-11 with homozygous familial hypercholesterolemia (HoFH). The trial showed a significant average LDL-C reduction of 48% after 24 weeks, with 79% of participants achieving at least a 50% decrease. The FDA submission is scheduled for late 2022. Evkeeza, previously approved for older patients, has displayed potential as a breakthrough therapy for managing HoFH in younger patients.

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The FDA has approved Dupixent (dupilumab) 300 mg weekly as the first and only treatment for eosinophilic esophagitis (EoE) in the U.S., benefiting approximately 160,000 patients. In a Phase 3 trial, Dupixent demonstrated a 69% and 64% reduction in symptoms compared to placebo, with a significant histological remission rate of 60% and 59% versus 5% and 6%. This approval marks Dupixent's fourth indication and supports its role in addressing type 2 inflammation-related conditions. Regulatory filings in Europe and other regions are planned in 2022.

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Vyriad, a clinical-stage biotechnology firm focused on oncological virus therapies, secured $29.5M in funding led by Harry Stine of Stine Seed Farms. This investment increases Vyriad's total funding since 2015 to over $100M. The company aims to develop safe, effective oncolytic viruses to treat cancer, leveraging high-throughput screening methods. Dr. James Hampton, a genetics expert, joins Vyriad's Board as part of this funding round. Vyriad has an ongoing collaboration with Regeneron (NASDAQ: REGN) to explore new oncolytic treatments.

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FAQ

What is the current stock price of Regeneron Pharmaceuticals (REGN)?

The current stock price of Regeneron Pharmaceuticals (REGN) is $716.68 as of December 26, 2024.

What is the market cap of Regeneron Pharmaceuticals (REGN)?

The market cap of Regeneron Pharmaceuticals (REGN) is approximately 78.5B.

What types of diseases does Regeneron Pharmaceuticals focus on?

Regeneron focuses on eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.

What are some of Regeneron's key products?

Key products include Eylea for eye diseases, Praluent for lowering LDL cholesterol, Dupixent for immunology, Libtayo for oncology, and Kevzara for rheumatoid arthritis.

Who are some of Regeneron's notable collaborators?

Regeneron collaborates with Sanofi, Alnylam, and Intellia on various projects, including monoclonal and bispecific antibodies, RNAi, and CRISPR-based gene editing.

What recent financial steps has Regeneron taken?

Regeneron has initiated a $3.0 billion share repurchase program and reported strong financial performance in the first quarter of 2024.

How does Regeneron leverage genetic medicine?

Regeneron utilizes data-powered insights from the Regeneron Genetics Center® and employs proprietary technologies like VelociSuite® to advance drug development.

What is the significance of Eylea in Regeneron's product portfolio?

Eylea is a crucial product for treating wet age-related macular degeneration and other eye diseases, contributing significantly to Regeneron's revenue.

What advancements has Regeneron made in gene therapy?

Regeneron is progressing in gene therapy for genetic deafness and solid tumors, showcasing promising early results in clinical trials.

What is Dupixent used for?

Dupixent is used in treating various immunological conditions and has shown significant growth since its launch, treating over 850,000 patients.

What technologies does Regeneron use for drug development?

Regeneron uses proprietary technologies such as VelociSuite®, which includes platforms for producing optimized human antibodies and bispecific antibodies.

How does Regeneron contribute to scientific discovery?

Regeneron pushes the boundaries of scientific discovery with pioneering genetic medicine platforms and data insights, aiming to develop transformative therapies.

Regeneron Pharmaceuticals Inc

Nasdaq:REGN

REGN Rankings

REGN Stock Data

78.48B
106.22M
1.57%
90.68%
1.64%
Biotechnology
Pharmaceutical Preparations
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United States of America
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