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
11/13/2025	$30.00	Sector Outperform	Scotiabank
4/22/2025	$24.00	Neutral	Cantor Fitzgerald
12/10/2024	$29.00	Neutral	BofA Securities
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

More analyst ratings

FDA Approval for HYMPAVZI issued to PFIZER INC

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

$PFE

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $PFE alert in real time by email

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
11/13/2025	$30.00	Sector Outperform	Scotiabank
4/22/2025	$24.00	Neutral	Cantor Fitzgerald
12/10/2024	$29.00	Neutral	BofA Securities
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

More analyst ratings

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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Pfizer Invites Public to View and Listen to Webcast of December 16 Conference Call with Analysts to Provide Full-Year 2026 Financial Guidance

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 8:00 a.m. EST on Tuesday, December 16, 2025. The purpose of the call is to provide Pfizer's full-year 2026 financial guidance. To view and 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. Participants are advised to register in advance of the conference call. You can also listen to the conference call by dialing either 800-456-4352 in the United States and Canada or 785-424-1086 outside of the United States

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Arvinas Announces Data Presentations from the Vepdegestrant (ARV-471) Clinical Development Program at the 2025 San Antonio Breast Cancer Symposium (SABCS)

NEW HAVEN, Conn., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE:PFE) as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast canc

11/24/25 7:00:00 AM ET

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U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer

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Pfizer Invites Public to View and Listen to Webcast of December 16 Conference Call with Analysts to Provide Full-Year 2026 Financial Guidance

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11/12/25 10:00:00 AM ET

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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

Crush Q1 2026 with the Best AI Superconnector

Recent Analyst Ratings for $PFE

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

Crush Q1 2026 with the Best AI Superconnector

Recent Analyst Ratings for $PFE

$PFE Insider Trading

SEC Form 4 filed by Chairman & CEO Bourla Albert

SEC Form 4 filed by Chairman & CEO Bourla Albert

SEC Form 4 filed by Chairman & CEO Bourla Albert

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Scotiabank initiated coverage on Pfizer with a new price target

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Director Blaylock Ronald E bought $499,072 worth of shares (19,457 units at $25.65), increasing direct ownership by 236% to 27,707 units (SEC Form 4)

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)

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$PFE FDA approvals

$PFE SEC Filings

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

SEC Form 8-K filed by Pfizer Inc.

SEC Form 424B5 filed by Pfizer Inc.

SEC Form 424B3 filed by Pfizer Inc.

$PFE Press Releases

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Pfizer Invites Public to View and Listen to Webcast of December 16 Conference Call with Analysts to Provide Full-Year 2026 Financial Guidance

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Recent Analyst Ratings for
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Recent Analyst Ratings for
$PFE

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Insider Trading

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Analyst Ratings

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FDA approvals

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SEC Filings

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Leadership Updates