FDA Approval for HYMPAVZI issued to PFIZER INC

Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74 Pfizer Inc. (NYSE:PFE) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk

Pfizer Inc. (NYSE:PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. Pfizer's dose-optimization studies of once-daily formulations of danuglipron (NCT06567327 and NCT06568731) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with appro

Pfizer Inc. (NYSE:PFE) announced today that its shareholders and the general public are invited to access its virtual 2025 Annual Meeting of Shareholders at 9:00 a.m. EDT on Thursday, April 24, 2025. Pfizer has designed the virtual Annual Meeting to ensure that its shareholders who participate will be afforded comparable rights and opportunities to participate as they would at an in-person meeting. Beginning today, shareholders can find additional information on accessing and registering for the virtual meeting at https://meetnow.global/PFE2025. On the day of the Annual Meeting, shareholders may begin logging into the virtual meeting platform at 8:45 a.m. EDT using either the control numbe

BofA Securities resumed coverage of Pfizer with a rating of Neutral and set a new price target of $29.00

Wolfe Research initiated coverage of Pfizer with a rating of Underperform and set a new price target of $25.00

Citigroup resumed coverage of Pfizer with a rating of Neutral and set a new price target of $30.00

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For Immediate Release: October 25, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to deter

Submission status for PFIZER INC's drug HYMPAVZI (ORIG-1) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 10/11/2024. Application Category: BLA, Application Number: 761369, Application Classification:

For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). “Today’s approval of Hympavzi pro

DexCom, Inc. (NASDAQ:DXCM), the global leader in glucose biosensing, today announced the appointment of Jon Coleman as chief commercial officer. In this role, Mr. Coleman will assume responsibility for Dexcom's global commercial organization, including global sales, marketing and customer experience. Mr. Coleman joins Dexcom with more than 30 years of global commercial leadership experience across multiple healthcare segments and channels. Mr. Coleman served as an executive officer of Masimo Corporation (NASDAQ:MASI), where he held roles of increasing responsibility across his fifteen-year tenure. This included serving as president of Masimo's commercial teams where he oversaw the consolid

Industry veteran in clinical development of oncology therapeutics, Dr. Jens Wurthner, PhD, joins as Chief Medical Officer Lead development candidate, FORX-428, a PARG inhibitor for solid tumors, maintains progress toward IND submission by mid-2025 FoRx Therapeutics AG, a Swiss-based company committed to discovering and developing innovative drugs targeting cancer-relevant DDR (DNA Damage Response) pathways, today announced that it has appointed Jens Würthner, MD PhD, as Chief Medical Officer. He is further strengthening FoRx Therapeutics' existing management team with CEO Tarig Bashir, CSO Frank Zenke, and Head of Chemistry Ulrich Lücking. Jens Würthner has 20+ years of clinical devel

Strengthening Board with Industry Veterans Gemini Bioproducts, LLC ("GeminiBio"), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Fort Lauderdale-based healthcare private equity firm, announced today the appointment of Michael Stella to its Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250218608576/en/Mike Stella, CEO of Ascend Advanced Therapies, joins the Board at GeminiBio to provide strategic leadership in the fields of cell and gene therapy contract development and manufacturing. (Photo: Business Wire) GeminiBio prov

Pfizer Inc. (NYSE:PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EDT on Tuesday, April 29, 2025. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's First Quarter 2025 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call. You can also listen to the conference

Pfizer Inc. (NYSE:PFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025 at 10:30 a.m. Eastern Standard Time. To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days. About Pfize

Full-Year 2024 Revenues of $63.6 Billion, Reflecting 7% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 12% Operationally Full-Year 2024 Reported(2) Diluted EPS of $1.41 and Adjusted(3) Diluted EPS of $3.11 Fourth-Quarter 2024 Revenues of $17.8 Billion, Reflecting 21% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 11% Operationally Fourth-Quarter 2024 Reported(2) Diluted EPS of $0.07 and Adjusted(3) Diluted EPS of $0.63 On Track to Deliver Overall Net Cost Savings of Approximately $4.5 Billion by End of 2025 from Ongoing Cost Realignment Program(4) Reaff

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