Have you looked at biotech stocks lately? Wall Street darlings like Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ), Amgen Inc. ( AMGN ), and many other healthcare and biotech stocks have been demolished in recent trading sessions. Even the well-diversified iShares Biotechnology ETF (Are You Getting The Returns You Want? Invest alongside the Financial Prophet's All-Weather Portfolio (2023 47% return) and achieve optimal results in any market.The Daily Prophet Report provides crucial information before the o ...

FDA Review and Dupixent's Potential in CSU - The FDA has accepted the resubmission of the supplemental biologics license application (sBLA) for Dupixent to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older who are inadequately controlled by H1 antihistamines [1] - The target action date for the FDA decision is April 18, 2025, and if approved, Dupixent would be the first targeted therapy for CSU in a decade [1] - The resubmitted sBLA includes new pivotal data from Study C of the LIBERTY-CUPID phase 3 clinical program, which confirmed Dupixent significantly reduced itch and hive activity in patients with uncontrolled CSU [2] Clinical Data and Safety Profile - Study C, part of the LIBERTY-CUPID phase 3 program, met its primary and key secondary endpoints, showing Dupixent's efficacy in reducing itch and urticaria activity [2] - Safety results across all LIBERTY-CUPID phase 3 studies were consistent with Dupixent's known safety profile, with injection site reactions and COVID-19 infection being the most common adverse events (≥5%) compared to placebo [3] Market and Regulatory Landscape - More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines, highlighting a significant unmet medical need [4] - Dupixent has already been approved for CSU in Japan and the United Arab Emirates and is under regulatory review in the EU [6] - Globally, more than 1,000,000 patients are currently being treated with Dupixent across various indications, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps [8] Dupixent's Mechanism and Development - Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways, which are key drivers of type-2 inflammation [7] - The Dupilumab development program, a collaboration between Sanofi and Regeneron, has studied over 10,000 patients across more than 60 clinical trials for various chronic diseases driven by type-2 inflammation [9] - Dupilumab is also being investigated in phase 3 studies for other conditions, such as chronic pruritus of unknown origin and bullous pemphigoid [10] Company Overview - Regeneron is a leading biotechnology company focused on developing life-transforming medicines for serious diseases, with a strong pipeline in allergic and inflammatory diseases, cancer, and rare diseases [11] - Sanofi is a global healthcare company dedicated to improving lives through innovative treatments and vaccines, with a focus on sustainability and social responsibility [14]

TARRYTOWN, N.Y., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: • Jefferies London Healthcare Conference at 11:00 a.m. BST (6:00 a.m. ET) on Tuesday, November 19, 2024 • Piper Sandler 36th Annual Healthcare Conference at 9:30 a.m. ET on Thursday, December 5, 2024 The sessions may be accessed from the "Investors & Media" page of Regeneron's website at https://investor.regeneron.com/events-and-presentations. Replays and transc ...

Core Insights - Dupixent (dupilumab) has been approved by the European Medicines Agency as the first and only treatment for eosinophilic esophagitis (EoE) in children aged one to eleven years, addressing a significant unmet medical need in this population [1][3][5] Summary by Sections Approval and Indication - The approval of Dupixent is based on phase 3 clinical trial data demonstrating that 68% of children treated with Dupixent achieved histological disease remission at 16 weeks, compared to only 3% in the placebo group [3][7] - Dupixent is indicated for children who weigh at least 15 kg and are inadequately controlled by or intolerant to conventional therapies [1][3] Clinical Study Details - The EoE KIDS study included two parts: Part A evaluated Dupixent's efficacy over 16 weeks, while Part B provided a 36-week extended treatment period [7][8] - Key outcomes from Part A showed an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline, alongside significant improvements in endoscopic findings and disease severity [3][8] Safety Profile - The safety profile of Dupixent in the EoE KIDS study was consistent with its known profile in older populations, with common adverse reactions including injection site reactions and conjunctivitis [4][10] - In children aged one to eleven, adverse events observed more frequently with Dupixent included COVID-19, nausea, injection site pain, and headache [4][10] Market Context - Eosinophilic esophagitis is a chronic disease that can severely impact a child's ability to eat, leading to nutritional challenges during critical growth periods [6][5] - Dupixent's approval represents a significant advancement in treatment options for pediatric patients who previously had no specifically approved therapies for EoE [3][5] Company Background - Dupixent is developed jointly by Sanofi and Regeneron, with a focus on treating various diseases driven by type-2 inflammation [12][14] - The drug has received regulatory approvals in over 60 countries for multiple indications, with more than 1,000,000 patients currently treated globally [11][12]

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year Dupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucial TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced ...

Regeneron (NASDAQ: REGN ) released a strong financial report for the third quarter. We saw double the success in exceeding the total earnings per share and quarterly revenue. However, the market reacted to this report with a 9.2% drop in the quote on the dayI am a qualified economist specializing in economic theory and I have been investing and trading since 2005. Since 2018, I have been investing in US equities. Until 2022, I was part of TopStepTrader, having passed the combine for a funded trader. I am a ...

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum. Shares of Regeneron (NASDAQ: REGN ) lost nearly a third of their value ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q3 2024 Earnings Conference Call October 31, 2024 8:30 AM ET Company Participants Ryan Crowe - SVP, IR and Strategic Analysis Leonard Schleifer - Board Co-Chair, Co-Founder, President and CEO George Yancopoulos - Board Co-Chair, Co-Founder, President and Chief Scientific Officer Marion McCourt - EVP, Commercial Chris Fenimore - SVP, Finance and CFO Conference Call Participants Taylor Hanley - JPMorgan Tyler Van Buren - TD Cowen Brian Abrahams - RBC Capital Marke ...

Regeneron (REGN) reported $3.72 billion in revenue for the quarter ended September 2024, representing a year-over-year increase of 10.7%. EPS of $12.46 for the same period compares to $11.59 a year ago.The reported revenue represents a surprise of +1.31% over the Zacks Consensus Estimate of $3.67 billion. With the consensus EPS estimate being $11.75, the EPS surprise was +6.04%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determ ...

Regeneron Pharmaceuticals, Inc. (REGN) reported better-than-expected third-quarter results despite lower sales from its lead drug, Eylea. Revenues climbed 11% to $3.72 billion, driven by growth in Eylea HD sales, profits from blockbuster asthma drug Dupixent and oncology drug Libtayo. The top line beat the Zacks Consensus Estimate of $3.67 billion.Higher revenues drove the bottom line as well. Adjusted earnings per share (EPS) of $12.46 beat the Zacks Consensus Estimate of $11.75 and were up 8% from the yea ...