FDA Approval for HYMPAVZI issued to PFIZER INC

10/15/24 2:57:27 PM ET

$PFE

Biotechnology: Pharmaceutical Preparations

Health Care

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Biologic License Application (BLA): 761369
Company: PFIZER INC

Products on BLA 761369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYMPAVZI	MARSTACIMAB-HNCQ	300MG	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2024	ORIG-1	Approval		N/A; Orphan	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761369Orig1s000ltr.pdf

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Recent Analyst Ratings for
$PFE

Date	Price Target	Rating	Analyst
11/15/2024	$25.00	Underperform	Wolfe Research
10/25/2024	$30.00	Neutral	Citigroup
10/17/2024	$32.00	Mkt Perform	Bernstein
8/7/2024		Neutral → Outperform	Daiwa Securities
3/22/2024		Buy → Hold	Argus
2/23/2024	$36.00	Buy	Guggenheim
1/4/2024	$32.00	Outperform → Market Perform	TD Cowen
10/20/2023	$36.00 → $34.00	Neutral	UBS

More analyst ratings

$PFE
Market Insights

Live Market Insights

European Commission Approves Pfizer's DURVEQTIX, A One-Time Gene Therapy For Adults With Hemophilia B
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients.Pfizer Inc. (NYSE:PFE) today announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX® (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to v
7/25/24 10:52:38 AM ET
$PFE
Biotechnology: Pharmaceutical Preparations
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Pfizer's Options: A Look at What the Big Money is Thinking
Financial giants have made a conspicuous bearish move on Pfizer. Our analysis of options history for Pfizer (NYSE:PFE) revealed 21 unusual trades. Delving into the details, we found 42% of traders were bullish, while 47% showed bearish tendencies. Out of all the trades we spotted, 3 were puts, with a value of $296,355, and 18 were calls, valued at $1,032,173. Expected Price Movements Taking into account the Volume and Open Interest on these contracts, it appears that whales have been targeting a price range from $25.0 to $35.0 for Pfizer over the last 3 months. Analyzing Volume & Open Interest Looking at the volume and open interest is an insightful way to conduct due diligence on a stock.
7/25/24 10:46:09 AM ET
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Biotechnology: Pharmaceutical Preparations
Health Care
Sangamo Stock Spikes As Pfizer Partnership Meets Goal In Late-Stage Study
Sangamo Therapeutics Inc (NASDAQ:SGMO), which developed a treatment in collaboration with Pfizer Inc (NYSE:PFE), received a boost to its stock price after struggling with liquidity issues. At last check Wednesday, Sangamo was up more than 36.2%, trading at 55 cents per share. Both companies released results from the Phase 3 AFFINE study of giroctocogene fitelparvovec, an investigational gene therapy for adult patients with moderately severe to severe hemophilia A. The AFFINE study achieved its primary objective. Also Read: Second Death – Pfizer Reports Young Boy’s Death After One Year Of Gene Therapy Treatment In Muscle Wasting Disorder Trial. Following a single 3e13 vg/kg dos
7/24/24 12:10:52 PM ET
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Biotechnology: Pharmaceutical Preparations
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Biotechnology: Biological Products (No Diagnostic Substances)

$PFE
Financials

Live finance-specific insights

Pfizer Reports Strong Third-Quarter 2024 Results And Raises 2024 Guidance
Third-Quarter Performance Driven by Focused Commercial Execution and Robust Double-Digit Revenue Growth Across Product Portfolio Raises Full-Year 2024 Revenue Guidance(1) to a Range of $61.0 to $64.0 Billion and Raises Adjusted(2) Diluted EPS Guidance to a Range of $2.75 to $2.95 Third-Quarter 2024 Revenues of $17.7 Billion, Representing 32% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(3), Revenues Grew 14% Operationally Third-Quarter 2024 Reported(4) Diluted EPS of $0.78 and Adjusted(2) Diluted EPS of $1.06 On Track to Deliver Net Cost Savings of At Least $5.5 Billion from Previously Announced Cost Reduction Initiatives At Least $4 B
10/29/24 6:45:00 AM ET
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ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024
Studies from OPERA and Trio cohorts provide further real-world evidence supporting CAB LA for PrEP's high effectiveness and adherence in preventing HIV acquisition Patient-reported results for CAB LA for PrEP in the PILLAR implementation study showed a reduction in stigma and anxiety – common challenges associated with daily oral PrEP ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP)
10/16/24 7:01:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Pfizer Declares Fourth-Quarter 2024 Dividend
Board of Directors approves quarterly cash dividend of $0.42 per share Pfizer Inc. (NYSE:PFE) today announced that its board of directors declared a $0.42 fourth-quarter 2024 dividend on the company's common stock, payable December 2, 2024, to holders of the Common Stock of record at the close of business on November 8, 2024. The fourth-quarter 2024 cash dividend will be the 344th consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients' Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery
10/9/24 4:30:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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$PFE
FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

October 25, 2024 - FDA Roundup: October 25, 2024
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
10/25/24 2:48:21 PM ET
$PFE
Biotechnology: Pharmaceutical Preparations
Health Care
FDA Approval for HYMPAVZI issued to PFIZER INC
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:
10/15/24 2:57:27 PM ET
$PFE
Biotechnology: Pharmaceutical Preparations
Health Care
October 11, 2024 - FDA Approves New Treatment for Hemophilia A or B
For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). “Today’s approval of Hympavzi pro
10/11/24 2:12:15 PM ET
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Biotechnology: Pharmaceutical Preparations
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$PFE
Leadership Updates

Live Leadership Updates

Pfizer Announces New Chief Scientific Officer and President, Research & Development
Chris Boshoff to lead all Research and Development functions including Oncology Oncology Unit end-to-end structure to remain intact, reporting to Boshoff Roger Dansey to become Interim Chief Oncology Officer and Johanna Bendell to join Pfizer as Oncology Chief Development Officer Pfizer Inc. (NYSE:PFE) today announced that after a comprehensive internal and external selection process, the company is appointing Chris Boshoff, M.D., PhD, as Chief Scientific Officer and President, Research & Development effective January 1, 2025. Dr. Boshoff, who most recently served as Chief Oncology Officer and Executive Vice President, will succeed Dr. Mikael Dolsten whose departure from Pfizer wa
11/20/24 6:45:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Tim Buckley Elected to Pfizer's Board of Directors
Pfizer Inc. (NYSE:PFE) today announced the election of Mortimer ("Tim") J. Buckley to its Board of Directors, effective immediately, following a lengthy and comprehensive search that began in May 2024. Mr. Buckley, age 55, was also appointed to and will join the Governance and Sustainability Committee and the Audit Committee of Pfizer's Board. Following the appointment of Mr. Buckley, the Board will comprise 14 directors, 13 of whom are independent. Mr. Buckley served as Chairman and Chief Executive Officer at Vanguard from 2018 until his retirement in 2024. Previously he was Vanguard's Chief Investment Officer, overseeing the company's internally managed stock, bond and money market portf
10/15/24 6:45:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Rocket Pharmaceuticals Announces Appointment of Mikael Dolsten, M.D., Ph.D., to Board of Directors
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced the appointment of Mikael Dolsten, M.D., Ph.D., as an independent director to its Board of Directors. Dr. Dolsten is an accomplished industry executive with extensive global pharmaceutical management experience. "As an industry-leading pharmaceutical executive, I am very pleased to welcome Mikael to our Board of Directors," said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharma. "His research and development experience will help advance our leading scientific capabilities and
9/10/24 7:00:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Press Releases

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Zai Lab and Pfizer Announce Strategic Collaboration on the Novel Antibacterial Drug XACDURO® (Sulbactam-Durlobactam)
Zai Lab (("Zai Lab", NASDAQ:ZLAB, HKEX: 9688)) and Pfizer (("Pfizer", NYSE:PFE) announced today a strategic collaboration for the novel antibacterial drug XACDURO® (sulbactam-durlobactam) in mainland China. Pfizer's affiliated companies will be exclusively authorized to undertake and perform certain commercialization activities for XACDURO® in mainland China. Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer's affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China. The period of collaboration is for the imported product through Novem
11/21/24 4:00:00 AM ET
$PFE
$ZLAB
Biotechnology: Pharmaceutical Preparations
Health Care
Pfizer Announces New Chief Scientific Officer and President, Research & Development
Chris Boshoff to lead all Research and Development functions including Oncology Oncology Unit end-to-end structure to remain intact, reporting to Boshoff Roger Dansey to become Interim Chief Oncology Officer and Johanna Bendell to join Pfizer as Oncology Chief Development Officer Pfizer Inc. (NYSE:PFE) today announced that after a comprehensive internal and external selection process, the company is appointing Chris Boshoff, M.D., PhD, as Chief Scientific Officer and President, Research & Development effective January 1, 2025. Dr. Boshoff, who most recently served as Chief Oncology Officer and Executive Vice President, will succeed Dr. Mikael Dolsten whose departure from Pfizer wa
11/20/24 6:45:00 AM ET
$PFE
Biotechnology: Pharmaceutical Preparations
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European Commission Approves Pfizer's HYMPAVZI™ (marstacimab) for the Treatment of Adults and Adolescents with Severe Hemophilia A or B Without Inhibitors
In the EU, HYMPAVZI is the first once-weekly subcutaneous treatment approved for eligible people living with severe hemophilia B and the first to be administered via a pre-filled pen or syringe for people living with severe hemophilia A or B HYMPAVZI's approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with se
11/20/24 4:00:00 AM ET
$PFE
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for HYMPAVZI issued to PFIZER INC

Products on BLA 761369

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761369

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $PFE

$PFE Insider Trading

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SEC Form 4 filed by Chairman & CEO Bourla Albert

SEC Form 4 filed by Executive Vice President Johnson Rady A

SEC Form 4 filed by Executive Vice President Johnson Rady A

$PFE Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

Wolfe Research initiated coverage on Pfizer with a new price target

Citigroup resumed coverage on Pfizer with a new price target

Bernstein initiated coverage on Pfizer with a new price target

$PFE Market Insights

Live Market Insights

European Commission Approves Pfizer's DURVEQTIX, A One-Time Gene Therapy For Adults With Hemophilia B

Pfizer's Options: A Look at What the Big Money is Thinking

Sangamo Stock Spikes As Pfizer Partnership Meets Goal In Late-Stage Study

$PFE Financials

Live finance-specific insights

Pfizer Reports Strong Third-Quarter 2024 Results And Raises 2024 Guidance

ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024

Pfizer Declares Fourth-Quarter 2024 Dividend

$PFE SEC Filings

SEC Form 10-Q filed by Pfizer Inc.

Pfizer Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

Pfizer Inc. filed SEC Form 8-K: Leadership Update, Financial Statements and Exhibits

$PFE FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

October 25, 2024 - FDA Roundup: October 25, 2024

FDA Approval for HYMPAVZI issued to PFIZER INC

October 11, 2024 - FDA Approves New Treatment for Hemophilia A or B

$PFE Leadership Updates

Live Leadership Updates

Pfizer Announces New Chief Scientific Officer and President, Research & Development

Tim Buckley Elected to Pfizer's Board of Directors

Rocket Pharmaceuticals Announces Appointment of Mikael Dolsten, M.D., Ph.D., to Board of Directors

$PFE Press Releases

Fastest customizable press release news feed in the world

Zai Lab and Pfizer Announce Strategic Collaboration on the Novel Antibacterial Drug XACDURO® (Sulbactam-Durlobactam)

Pfizer Announces New Chief Scientific Officer and President, Research & Development

European Commission Approves Pfizer's HYMPAVZI™ (marstacimab) for the Treatment of Adults and Adolescents with Severe Hemophilia A or B Without Inhibitors

$PFE Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

Director Gottlieb Scott bought $28,240 worth of shares (1,000 units at $28.24), increasing direct ownership by 11% to 10,000 units (SEC Form 4)

Gottlieb Scott bought $79,401 worth of shares (3,000 units at $26.47), increasing direct ownership by 50% to 9,000 units (SEC Form 4)

$PFE Large Ownership Changes

This live feed shows all institutional transactions in real time.

SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

SEC Form SC 13D filed by Pfizer Inc.

SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

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