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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.

Regeneron recently failed to earn approval for an important candidate. The biotech company should get over this regulatory hump eventually.

Is Regeneron Stock a Buy After a Regulatory Blow?

LOS ANGELES, CA / ACCESSWIRE / July 7, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Regeneron Pharmaceuticals, Inc. ("Regeneron" or "the Company") (NASDAQ:REGN) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors with Losses In Excess of $100,000 to Contact the Firm

The Food and Drug Administration didn't approve Regeneron's higher-dose version of Eylea. Regeneron isn't concerned, as the decision wasn't a result of any issues relating to the drug's safety or efficacy.

Is Regeneron's Stock in Trouble After This FDA Rejection?

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The 3 Best Biotech Stocks to Buy In July

Regeneron (REGN) declines 13% in the last three months due to regulatory setback for 8 mg dose strength of aflibercept and competition for lead drug.

Regeneron (REGN) Loses 13% in Three Months: What Lies Ahead?

LOS ANGELES, CA / ACCESSWIRE / July 1, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Regeneron Pharmaceuticals, Inc. ("Regeneron" or "the Company") (NASDAQ: REGN) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / June 30, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Regeneron Pharmaceuticals, Inc. ("Regeneron" or "the Company") (NASDAQ:REGN) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

TARRYTOWN, N.Y., June 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2023 financial and operating results on Thursday, August 3, 2023, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Regeneron to Report Second Quarter 2023 Financial and Operating Results and Host Conference Call and Webcast on August 3, 2023

Regeneron's high-dose version of Eylea was rejected by the FDA this week due to manufacturing issues. Wall Street thinks this setback will delay the drug's approval by no more than three months.

Why Regeneron Pharmaceuticals Stock Dipped This Week

LOS ANGELES--(BUSINESS WIRE)---- $REGN #REGN--The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors to Contact the Firm.

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) shares plummeted by nearly 9% in after-hours trade on Tuesday after the US Food and Drug Administration (FDA) declined to approve a higher-dose version of the company's eye disease treatment. The rejected dosage was an 8-milligram injection of Eylea, intended for patients with wet age-related macular degeneration (wAMD), the primary cause of blindness among the elderly, as well as two other common eye diseases associated with diabetes.

Regeneron drops as US FDA declines to approve higher-dose version of its eye disease treatment

Regeneron (REGN) receives a completed response letter for the application seeking approval of aflibercept 8 mg for treating several retinopathic indications. The stock falls 9% following the news.

Regeneron (REGN) Gets CRL for Aflibercept 8 mg Drug, Shares Fall

Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler."

Regeneron shares fall after FDA rejects high-dose eye disease treatment

The Food and Drug Administration rejected a high-dose version of Regeneron's eye drug Eylea on Tuesday, leading REGN stock to crumble.

Regeneron Stock Crumbles After FDA Rejects Its Next Blockbuster Contender

The Food and Drug Administration rejected its application for approval of a new, higher-dose version of eye disease treatment Eylea.

Regeneron Stock Slumps After FDA Decision Delays Blockbuster Release

Regeneron Pharmaceuticals Inc. REGN, -1.34% said Tuesday that the U.S. Food and Drug Administration issued a complete response letter for the biologics license application for a higher-dose version of Eylea for treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The complete response letter, which indicates that the FDA has decided not to approve an application in its present form, was issued solely due to an ongoing review of inspection findings at a third-party filler and did not identify any issues with the treatment's efficacy or safety, trial design, labeling or manufacturing, Regeneron said in a release Tuesday.

Regeneron's high-dose Eylea not approved by FDA

The U.S. Food and Drug Administration on Tuesday declined to approve a higher-dose version of Regeneron Pharmaceuticals' blockbuster treatment Eylea, the company said, marking a blow in the drugmaker's plans to defend the eye drug against a fast-gaining rival.

US FDA declines to approve Regeneron high-dose Eylea

89% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years Of those assigned to a 16-week dosing regimen at baseline, 83% maintained ≥16-week dosing intervals through two years Many patients met the extension criteria for even longer dosing intervals, including 43% for ≥20-week intervals and 27% for 24-week intervals Visual gains and safety of aflibercept 8 mg remained consistent with the established profile of EYLEA ® (aflibercept) 2 mg Injection TARRYTOWN, NY, June 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced top-line, two-year (96 weeks) data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema (DME). During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met.

Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema

No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL

FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-party Filler

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN ) Goldman Sachs 44th Annual Global Healthcare Conference June 14, 2023 11:40 AM ET Company Participants Ryan Crowe - VP, IR Bob Landry - EVP & CFO Marion McCourt - EVP & Head of Commercial Conference Call Participants Salveen Richter - Goldman Sachs Salveen Richter Great. Good morning, everyone.

Regeneron Pharmaceuticals Inc. (REGN) Presents at Goldman Sachs 44th Annual Global Healthcare Conference (Transcript)

Microsoft

Regeneron has important regulatory milestones to hit in the next year. Microsoft's diversified business and growth opportunities bode well for its future.

2 Stocks to Buy No Matter What Happens in June and Beyond

Regeneron Pharmaceuticals, Inc. has potential to receive FDA approval of higher dosing of 8 mg of EYLEA, which has been set with an FDA target action date of June 27, 2023. The additional indication in preterm infants with retinopathy of prematurity makes it the fifth retinal disorder in which EYLEA has been approved for. Dupixent is another solid drug in the pipeline, where Regeneron and its collaboration partner recorded global net sales increase of 37% to $2.49 billion.

Regeneron: Solid Investment Based On Continued EYLEA Expansion

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN ) Jefferies Global Healthcare Conference Call June 7, 2023 8:30 AM ET Company Participants Ryan Crowe - Vice President, Investor Relations Bolanle Akinlade - Senior Vice President, Clinical Development, Immunology & Inflammation Brook Jennings - Vice President, Commercial Dermatology Conference Call Participants Akash Tewari - Jefferies Akash Tewari Good morning, everyone. For those who just got back from ASCO, I feel sorry for you, I am exhausted as well.

Regeneron Pharmaceuticals, Inc. (REGN) Jefferies Global Healthcare Conference (Transcript)

Moderna

Novavax

The biotechnology sector has seen better days. From the heady days of the pandemic when companies were racing to develop a vaccine against Covid-19, the industry is now enduring a hangover as both demand and sales decline.

3 Biotech Stocks to Sell in June Before They Crash and Burn

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN ) TD Cowen 4th Annual Oncology Innovation Summit May 30, 2023 12:30 PM ET Company Participants Izzy Lowy - SVP, Solid Organ Oncology Development Andres Sirulnik - SVP, Translational & Clinical Sciences, Hematology Ryan Crowe - VP, IR Conference Call Participants Tyler Van Buren - TD Cowen Tyler Van Buren All right. We'll give it a couple of seconds for everyone to join.

News for Regeneron Pharmaceuticals Stock (REGN)