FDA Approval for BKEMV issued to AMGEN INC

5/28/24 4:35:29 PM ET

$AMGN

Biotechnology: Biological Products (No Diagnostic Substances)

Health Care

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Biologic License Application (BLA): 761333
Company: AMGEN INC

Products on BLA 761333

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BKEMV	ECULIZUMAB-AEEB	300MG/30ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761333

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2024	ORIG-1	Approval		N/A		Label is not available on this site.

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Recent Analyst Ratings for
$AMGN

Date	Price Target	Rating	Analyst
11/15/2024		Peer Perform	Wolfe Research
11/14/2024	$335.00	Neutral	Citigroup
10/17/2024	$380.00	Outperform	Bernstein
10/14/2024	$320.00 → $333.00	Buy → Hold	Truist
9/27/2024	$405.00	Overweight	Cantor Fitzgerald
8/7/2024	$320.00 → $335.00	Overweight → Equal Weight	Wells Fargo
5/3/2024	$230.00 → $300.00	Underweight → Equal Weight	Barclays
5/3/2024		Mkt Perform → Outperform	William Blair

More analyst ratings

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Market Insights

Live Market Insights

Market Whales and Their Recent Bets on AMGN Options
Deep-pocketed investors have adopted a bullish approach towards Amgen (NASDAQ:AMGN), and it's something market players shouldn't ignore. Our tracking of public options records at Benzinga unveiled this significant move today. The identity of these investors remains unknown, but such a substantial move in AMGN usually suggests something big is about to happen. We gleaned this information from our observations today when Benzinga's options scanner highlighted 12 extraordinary options activities for Amgen. This level of activity is out of the ordinary. The general mood among these heavyweight investors is divided, with 58% leaning bullish and 33% bearish. Among these notable options, 3 are puts
7/25/24 11:06:31 AM ET
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Amgen Says Currently Assessing Global IT Outage Impact And Working To Recover Impacted Systems As Quickly As Possible
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7/19/24 2:02:37 PM ET
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EXCLUSIVE: Weight-Loss Duopoly Breaks As Eli Lilly, Novo Plummet; 'Market Won't Be Dominated By Just 2 Players'
GLP-1 market leaders Eli Lilly and Company (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO) faced a significant selloff on Thursday, as new weight-loss drugs from rival pharmaceutical companies began threatening the dominance of their flagship products, Zepbound and Wegovy. Shares of Eli Lilly plummeted by 6.3%, marking their worst daily performance since March 2021. In the last two sessions, they have dropped by over 10%, registering the worst two-day downside since March 2020. Similarly, shares of Dutch pharmaceutical giant Novo Nordisk A/S fell 4%. Chart: Eli Lilly’s Worst Session In Over Three Years Image: Benzinga Pro Weight-Loss Market Sees New Entrants “This week is a pr
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AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT
Howard Chang, M.D., Ph.D., Joins as Senior Vice President of Research and Chief Scientific Officer THOUSAND OAKS, Calif., Nov. 20, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Howard Chang, M.D., Ph.D., will join the company as senior vice president of Research, effective Dec. 16, 2024. Chang will also assume the title and responsibility of serving as Amgen's chief scientific officer, reporting to Jay Bradner, M.D., executive vice president of Research and Development. "Howard is one of our generation's foremost physician-scientists, with expertise in human genetics and a profound ability to distill complex disease biology into clarified targets," Bradner said. "Leading Rese
11/20/24 4:00:00 PM ET
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AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024
MITIGATE Phase 3 Study Results Reinforce Promise of UPLIZNA® as the First Potential Treatment tor IgG4-RD Phase 4 AGILE Data Support Shortening KRYSTEXXA® Infusion Time THOUSAND OAKS, Calif., Nov. 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheumatology (ACR) Convergence 2024 conference in Washington, D.C., Nov. 14-19, 2024. New data showcase reduction in disease activity by UPLIZNA® (inebilizumab-cdon) in Immunoglobulin G4-Related Disease (IgG4-RD) and support shorter infusion times for KRYSTEXXA® (pegloticase) co-administered with weekly oral methotrexate 15 mg. "T
11/14/24 4:00:00 PM ET
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AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA
THOUSAND OAKS, Calif., Nov. 13, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today issued the following statement on the MariTide (maridebart cafraglutide, formerly AMG 133) Phase 1 data. "As previously stated, Amgen does not see an association between the administration of MariTide and bone mineral density changes. The Phase 1 study results do not suggest any bone safety concern or change our conviction in the promise of MariTide. We look forward to sharing the Phase 2 topline data later this year." Amgen Forward-Looking StatementsThis communication contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of histo
11/13/24 5:00:00 AM ET
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Financials

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AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT
Howard Chang, M.D., Ph.D., Joins as Senior Vice President of Research and Chief Scientific Officer THOUSAND OAKS, Calif., Nov. 20, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Howard Chang, M.D., Ph.D., will join the company as senior vice president of Research, effective Dec. 16, 2024. Chang will also assume the title and responsibility of serving as Amgen's chief scientific officer, reporting to Jay Bradner, M.D., executive vice president of Research and Development. "Howard is one of our generation's foremost physician-scientists, with expertise in human genetics and a profound ability to distill complex disease biology into clarified targets," Bradner said. "Leading Rese
11/20/24 4:00:00 PM ET
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024
MITIGATE Phase 3 Study Results Reinforce Promise of UPLIZNA® as the First Potential Treatment tor IgG4-RD Phase 4 AGILE Data Support Shortening KRYSTEXXA® Infusion Time THOUSAND OAKS, Calif., Nov. 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheumatology (ACR) Convergence 2024 conference in Washington, D.C., Nov. 14-19, 2024. New data showcase reduction in disease activity by UPLIZNA® (inebilizumab-cdon) in Immunoglobulin G4-Related Disease (IgG4-RD) and support shorter infusion times for KRYSTEXXA® (pegloticase) co-administered with weekly oral methotrexate 15 mg. "T
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AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA
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11/13/24 5:00:00 AM ET
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Replay Appoints Arun Balakumaran M.D., Ph.D as Chief Medical Officer
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FDA Approval for BKEMV issued to AMGEN INC

Products on BLA 761333

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761333

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $AMGN

$AMGN 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 Amgen

Citigroup initiated coverage on Amgen with a new price target

Bernstein initiated coverage on Amgen with a new price target

$AMGN Market Insights

Live Market Insights

Market Whales and Their Recent Bets on AMGN Options

Amgen Says Currently Assessing Global IT Outage Impact And Working To Recover Impacted Systems As Quickly As Possible

EXCLUSIVE: Weight-Loss Duopoly Breaks As Eli Lilly, Novo Plummet; 'Market Won't Be Dominated By Just 2 Players'

$AMGN SEC Filings

SEC Form 10-Q filed by Amgen Inc.

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

SEC Form 10-Q filed by Amgen Inc.

$AMGN Press Releases

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$AMGN Insider Trading

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

AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT

AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024

AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA

SVP, Business Development Khosla Rachna covered exercise/tax liability with 212 shares, decreasing direct ownership by 2% to 8,383 units (SEC Form 4)

VP, Finance & CAO Busch Matthew C. covered exercise/tax liability with 189 shares, decreasing direct ownership by 4% to 4,770 units (SEC Form 4)

Director Ishrak Omar was granted 221 shares, increasing direct ownership by 5% to 5,081 units (SEC Form 4)

$AMGN FDA approvals

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

FDA Approval for REPATHA issued to AMGEN INC

FDA Approval for PAVBLU issued to AMGEN INC

FDA Approval for REPATHA issued to AMGEN INC

$AMGN Large Ownership Changes

This live feed shows all institutional transactions in real time.

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

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

SEC Form SC 13D filed by Amgen Inc.

$AMGN Insider Purchases

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

SEC Form 4: Amgen Inc converted options into 33,603,948 shares and bought $29,999,985 worth of shares (1,764,705 units at $17.00)

$AMGN Financials

Live finance-specific insights

AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT

AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024

AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA

$AMGN Leadership Updates

Live Leadership Updates

Replay Appoints Arun Balakumaran M.D., Ph.D as Chief Medical Officer

AMGEN APPOINTS MICHAEL V. DRAKE TO BOARD OF DIRECTORS

Blade Therapeutics Appoints Bassem Elmankabadi, M.D., as Senior Vice President of Clinical Development

Recent Analyst Ratings for
$AMGN

$AMGN
Analyst Ratings

$AMGN
Market Insights

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$AMGN
Press Releases

$AMGN
Insider Trading

$AMGN
FDA approvals

$AMGN
Large Ownership Changes

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Financials

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Leadership Updates