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Regeneron Pharmaceuticals

Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: EYLEA, Dupixent, Praluent, Kevzara, Libtayo, ARCALYST, and ZALTRAP. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.

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Regeneron reports robust Q4 earnings, eyes strategic launches and collaborations

Regeneron Pharmaceuticals showcased strong financial performance and pipeline advancements in Q4 2022.
The company's focus on safety, efficacy, and strategic imperatives positions it for future growth.
Challenges include competitive positioning, trial data anticipation, and managing uncertainties.
Opportunities in market launches, accelerated approvals, and innovative collaborations drive future potential.

Regeneron excels in Q1 with strong revenue growth and pipeline advancements

Regeneron Pharmaceuticals delivered a strong performance in Q1 2023, driven by revenue growth and pipeline advancements in key therapeutic areas like DUPIXENT and EYLEA.
Despite operational challenges in market positioning and regulatory considerations, the company's strengths in research capabilities and strategic planning present growth opportunities.
With a focus on commercialization efforts, expanding indications, and leveraging genetic insights, Regeneron is poised to capitalize on opportunities for sustained success and innovation.
Navigating challenges in market competition and regulatory uncertainties, Regeneron remains proactive in addressing key issues to maintain its position as a leading biopharmaceutical company.

Regeneron reports strong Q2 earnings, eyes aflibercept launch

Regeneron Pharmaceuticals demonstrated strong financial performance and commercial success in Q2 2023.
While facing regulatory challenges, the company remains optimistic about pipeline advancements and potential launches.
Balancing efficacy and safety in treatments, Regeneron aims to capitalize on growth opportunities and strategic partnerships.
Robust cash position and focus on patient well-being position Regeneron for continued success and market expansion.

Regeneron posts robust Q3 results, eyes innovation and market growth

Regeneron's Q3 performance reflects strong revenue growth, financial stability, and promising market potential for key products like Dupixent and EYLEA HD.
While facing legal challenges and competitive pressures, the company's strategic focus on innovation, R&D, and shareholder value management positions it for long-term success.
With a robust pipeline, unique therapeutic targets, and a solid financial foundation, Regeneron is poised for continued growth, market leadership, and innovation in the biopharmaceutical industry.

Regeneron posts strong Q4 results, eyes growth through innovation

Regeneron Pharmaceuticals delivered a strong performance in Q4 2023, driven by successful product launches and financial results in line with expectations.
The company's focus on innovation, strategic leadership, and capital allocation priorities position them well for future growth and market success.
While facing challenges in market dynamics and competition, Regeneron has opportunities to leverage new product approvals and innovative treatment approaches.
Overall, Regeneron's performance highlights their resilience, strategic vision, and commitment to advancing healthcare through groundbreaking therapies.

Regeneron posts solid Q1 results, faces FDA request challenges

Regeneron Pharmaceuticals delivered strong financial performance in Q1 2024, driven by Dupixent and EYLEA HD.
The company's robust pipeline and focus on innovation position it well for future growth.
Challenges include FDA requests for Dupixent efficacy analyses and market entry hurdles for new products.
Opportunities lie in advancing therapies for COPD, severe food allergies, and expanding cancer treatment options.

Regeneron posts robust Q2 earnings, eyes pipeline expansion opportunities

Regeneron Pharmaceuticals demonstrated strong financial performance and product sales growth in Q2.
While facing regulatory challenges, the company's pipeline and market position remain robust.
Opportunities for expansion and innovation present avenues for future growth.
Overall, Regeneron's Q2 results reflect resilience and strategic focus.

Regeneron Pharmaceuticals reports strong Q3 results and eyes innovative growth

Regeneron's Q3 performance reflects solid revenue and earnings growth driven by key products. While facing regulatory challenges and capital allocation decisions, the company's focus on innovation and strategic investments positions it well for future growth.

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Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, George Damis Yancopoulos, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.

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Sanofi

The FDA has accepted for review the supplemental marketing application seeking approval for Dupixent (dupilumab). It is an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, jointly developed by Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) under a global collaboration agreement.

Sanofi/Regneron's Dupixent Application For Asthma In Children Accepted For FDA Review

FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

Regeneron Pharmaceuticals, Inc. (REGN) Management Presents at Cowen 41st Annual Health Care Conference (Transcript)

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has announced detailed results from a Phase 2 proof-of-concept trial evaluating an antibody cocktail, REGN1908-1909, in cat-allergic patients with mild asthma. Regeneron presented the results at the virtual 2021 American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting.

Regeneron's Single-Dose REGN1908-1909 Shows Rapid, Durable Benefit In Cat-Allergic Asthma Patients

TARRYTOWN, N.Y., Feb. 27, 2021 /PRNewswire/ -- Single administration of novel antibody cocktail controlled patients' allergic response to cat allergen, preventing early asthma reactions for the duration of the 3-month trial Patients experienced significant improvements in lung function...

Regeneron Announces Positive Phase 2 Data Evaluating Fel d 1 Antibody Cocktail in Cat-allergic Patients with Mild Asthma

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has received a positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, dubbed as REGEN-COVTM 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's COVID-19 Antibody Cocktail Wins EU Positive Opinion

TARRYTOWN, N.Y., Feb. 26, 2021 /PRNewswire/ -- EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization Regeneron has collaborated with Roche to develop and manufacture...

EMA Issues Advice on Regeneron's Antibody Cocktail (casirivimab with imdevimab) for Certain COVID-19 Patients

Shares of Regeneron Pharmaceuticals Inc. were up 0.2% in trading on Thursday after the company said an independent committee recommended the placebo no longer be given to COVID-19 patients in a Phase 3 clinical trial because the company's antibody cocktail demonstrated "clear" efficacy. The committee said the treatment, REGEN-COV, which received emergency authorization in November, reduced hospitalizations and deaths at two dose levels, and it would continue to enroll non-hospitalized COVID-19 patients who will receive either dose of the therapy.

Regeneron to share new data about COVID-19 antibody cocktail in March

Following recommendations from the Independent Data Monitoring Committee (IDMC), Regeneron Pharmaceuticals Inc (NASDAQ: REGN) will make changes to the Phase 3 trial evaluating REGEN-COV (casirivimab with imdevimab) in outpatients with COVID-19. The company said that an independent panel found the company's COVID-19 antibody cocktail at both 1,200mg and 2,400mg doses have "clear clinical efficacy" in reducing the rates of hospitalization and deaths in patients.

Regeneron To Stop Giving Placebo In COVID-19 Antibody Trial After 'Clear Efficacy'

Health Canada has approved Sanofi's SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) DUPIXENT (dupilumab injection) for the treatment of moderate-to-severe atopic dermatitis in children aged six to 11 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT is also approved in Canada to treat adult patients with severe chronic rhinosinusitis with nasal polyposis and for the treatment of severe asthma in patients 12 years and older.

Sanofi/Regeneron's DUPIXENT Wins Canada Approval For Atopic Dermatitis In Children Aged 6-11

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The FDA encourages companies to evaluate the impact of COVID-19 virus variants on the efficacy or performance of their COVID-19 vaccines, tests and medicines.

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The FDA approved expanded use of Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi's SA (NASDAQ: SNY) immunotherapy Libtayo (cemiplimab-rwlc) as monotherapy in newly diagnosed advanced lung cancer, marking the third approval for Libtayo and second this month. The drug is now cleared for adults with non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression of at least 50%, a protein that's correlated with response to immunotherapy, and have metastatic or locally advanced tumors that can't be removed by surgery and must not have EGFR, ALK or ROS1 aberrations.

FDA Approves Regeneron/Sanofi's Libtayo For Front-Line Lung Cancer

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FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

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ARKG: Precautionary Measures, But Transformational Objectives Remain Intact

Shares of Regeneron Pharmaceuticals Inc. were up 0.7% in premarket trading on Friday, the day after the company said it received regulatory approval in the U.S. for its homozygous familial hypercholesterolemia treatment. The wholesale acquisition cost of treatment is $450,000 per year, though the price may fluctuate based on an individual's weight.

Regeneron's therapy for rare heart disorder gets approved by FDA

Amgen

Genmab - ADR

Hijacking the immune system to destroy cancer with bispecific antibodies could be a lucrative business for biotech stocks like Amgen, Genmab and Regeneron Pharmaceuticals. The post The $12 Billion Market That Has Biotech Stocks Hijacking The Immune System appeared first on Investor's Business Daily.

The $12 Billion Market That Has Biotech Stocks Hijacking The Immune System

TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ -- Upholds decision by U.S. District Court to invalidate Amgen's patent claims directed to PCSK9 antibodies Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the United States Court of Appeals for the Federal Circuit upheld the...

U.S. Federal Circuit Court of Appeals Rules in Favor of Regeneron and Sanofi in Praluent® (alirocumab) Patent Litigation

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The FDA approves Sanofi (SNY)/Regeneron's Libtayo for treating patients with advanced/metastatic basal cell carcinoma. The is the second approved indication for the drug in the United States.

Sanofi (SNY)/Regeneron's Libtayo Gets FDA Nod for 2nd Indication

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Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) immunotherapy Libtayo (cemiplimab-rwlc) has scored approval from the FDA for the treatment of advanced basal cell carcinoma (BCC), the most common type of skin cancer in the U.S. The FDA has indicated Libtayo for treating previously-treated, advanced BCC patients who have already received a hedgehog pathway inhibitor (HHI) or who cannot be treated with an HHI.

News for Regeneron Pharmaceuticals Stock (REGN)