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 PRESS RELEASE

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatm...

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps TARRY...

Jonathan Moreland
  • Jonathan Moreland

InsiderInsights Weekly Report: May 11, 2024

InsiderInsights Ratings of Companies with Open-Market Form 4 Purchases; Sales Filed at the SEC on the date above. We separate the real investment intelligence from the noise. Saving you time, and improving your research process

 PRESS RELEASE

Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Lev...

Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness within 24 Weeks and Initial Hearing Improvements in a Second Child at 6 Weeks Preliminary data detailed in an ASGCT oral presentation include results for one of the youngest children in the world to receive a gene therapy for genetic deafness Ongoing Phase 1/2 CHORD trial is currently enrolling infants and children in the U.S., UK and Spain TARRYTOWN, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the investigatio...

 PRESS RELEASE

Regeneron Announces Investor Conference Presentations

Regeneron Announces Investor Conference Presentations TARRYTOWN, N.Y., May 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: RBC Capital Markets Global Healthcare Conference at 9:00 a.m. ET on Tuesday, May 14, 2024Jefferies Global Healthcare Conference at 8:30 a.m. ET on Wednesday, June 5, 2024Goldman Sachs 45th Annual Global Healthcare Conference at 8:00 a.m. ET on Tuesday, June 11, 2024 The sessions may be accessed from the "Investors & Media" page of Regeneron's website at . Replays and transcripts of the web...

 PRESS RELEASE

Pfizer Announces New Chief Strategy and Innovation Officer

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that Andrew Baum, M.D., will join the company as Chief Strategy and Innovation Officer, Executive Vice President. Dr. Baum will be a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla. He joins Pfizer from Citi, where he served as Head of Global Healthcare, Managing Director Equity Research. Prior to joining Citi in 2011, Dr. Baum covered European Pharmaceuticals at Morgan Stanley for 14 years and earlier in his career was a practicing physician at the Royal Nation...

 PRESS RELEASE

Regeneron Reports First Quarter 2024 Financial and Operating Results

Regeneron Reports First Quarter 2024 Financial and Operating Results First quarter 2024 revenues decreased 1% to $3.15 billion versus first quarter 2023; excluding RonapreveTM(a)(b), revenues increased 7%First quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 24% to $3.08 billion versus first quarter 2023First quarter 2024 U.S. net sales for EYLEA® HD and EYLEA® were $1.40 billion, including $200 million from EYLEA HDFirst quarter 2024 Libtayo® global net sales increased 45% to $264 million versus first quarter 2023First quarter 2024 GAAP diluted EPS of $6.27 and non-GA...

Cleveland-Cliffs Inc: 2 directors

Two Directors at Cleveland-Cliffs Inc bought 85,000 shares at between 16.761USD and 16.995USD. The significance rating of the trade was 84/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors ov...

 PRESS RELEASE

Pfizer Reports First-Quarter 2024 Results

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2024 and raised its Adjusted(3) diluted EPS guidance while maintaining all other components of its 2024 financial guidance(6). The first-quarter 2024 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at . EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “We delivered strong performance in our non-COVID product portfolio in the first quarter of 2024, including...

 PRESS RELEASE

FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic ...

NEW YORK & COPENHAGEN, Denmark--(BUSINESS WIRE)-- (NYSE: PFE) and (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. "Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief...

 PRESS RELEASE

EYLEA® HD (aflibercept) Injection 8 mg Presentations at ARVO Reinforce...

EYLEA® HD (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Sustained and Clinically Meaningful Outcomes in Serious Retinal Diseases Long-term data and subgroup analyses from pivotal EYLEA HD clinical program continue to demonstrate durable efficacy and consistent safety in patients with wet age-related macular degeneration and certain diabetic eye diseases TARRYTOWN, N.Y., April 29, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of positive long-term results and subgroup analyses from the pivotal clinical program of E...

 PRESS RELEASE

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicin...

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago. More than 50 abstracts, including 11 oral presentations, will be presented from Pfizer’s broadened portfolio of approved and pipeline therapies across the company’s key tumor areas and core scientific modalities, including small molecules, antibody-drug conjugates (ADCs) and bispecific antibodies. “We are excited to participate in our first ASCO A...

 PRESS RELEASE

U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a ...

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. BEQVEZ is a one-time treatment that is designed to ena...

 PRESS RELEASE

Regeneron and Mammoth Biosciences Collaborate to Pursue Next-Generatio...

Regeneron and Mammoth Biosciences Collaborate to Pursue Next-Generation CRISPR-Based Gene Editing for Multiple Diseases Mammoth’s proprietary ultracompact CRISPR-based gene editing platform and Regeneron’s proprietary delivery technologies set to advance in vivo programs in multiple tissue and cell types Mammoth to receive $100 million total upfront payment and equity investment from Regeneron at signing TARRYTOWN, N.Y., April 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Mammoth Biosciences, Inc., today announced a collaboration to research, develop and...

 PRESS RELEASE

Pfizer Declares Second-Quarter 2024 Dividend

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.42 second-quarter 2024 dividend on the company’s common stock, payable June 14, 2024, to holders of the Common Stock of record at the close of business on May 10, 2024. The second-quarter 2024 cash dividend will be the 342nd consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the stan...

 PRESS RELEASE

Regeneron to Showcase Progress in Advancing Novel Investigational Trea...

Regeneron to Showcase Progress in Advancing Novel Investigational Treatment Approaches for a Broad Range of Solid Tumors and Blood Cancers at ASCO Oral presentation will feature new data for investigational REGN7075, an EGFRxCD28 costimulatory bispecific with the potential to enhance the treatment of certain advanced solid tumors in combination with Libtayo® (cemiplimab-rwlc) 17 presentations to highlight Regeneron's investigational pipeline including checkpoint inhibitors, CD3 bispecifics and CD28 costimulatory bispecifics TARRYTOWN, N.Y., April 24, 2024 (GLOBE NEWSWIRE) -- Reg...

 PRESS RELEASE

Regeneron to Highlight Advances in Genetic Medicine Research at Americ...

Regeneron to Highlight Advances in Genetic Medicine Research at American Society of Gene and Cell Therapy (ASGCT) Oral presentations include updated results from clinical study of otoferlin gene therapy DB-OTO demonstrating restoration in children with profound genetic hearing loss Additional presentations cover progress in novel genetic medicine delivery systems and immune response modulation TARRYTOWN, N.Y., April 22, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new and updated data across its genetic medicines portfolio will be pres...

 PRESS RELEASE

European Commission Approves Pfizer’s EMBLAVEO® for Patients with Mult...

NEW YORK--(BUSINESS WIRE)-- . (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. “For healthcare teams treating patients with ...

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