FDA Approval for MARGENZA

12/20/20 4:31:01 PM ET

$MGNX

Biotechnology: Pharmaceutical Preparations

Health Care

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Biologic License Application (BLA): 761150
Company: MACROGENICS INC

Products on BLA 761150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MARGENZA	MARGETUXIMAB-CMKB	250MG/10ML(25MG/ML)	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2020	ORIG-1	Approval		N/A		Label is not available on this site.

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Recent Analyst Ratings for
$MGNX

Date	Price Target	Rating	Analyst
11/7/2024		Mkt Outperform → Mkt Perform	JMP Securities
8/1/2024		Buy → Neutral	BTIG Research
7/31/2024	$18.00 → $5.00	Buy → Neutral	B. Riley Securities
7/31/2024		Buy → Neutral	Guggenheim
5/10/2024	$24.00 → $8.00	Outperform → Market Perform	BMO Capital Markets
5/10/2024	$29.00 → $7.00	Buy → Hold	Stifel
5/10/2024		Buy → Hold	TD Cowen
4/26/2024	$25.00	Buy	B. Riley Securities

More analyst ratings

MacroGenics Provides Update on Corporate Progress, Third Quarter 2024 Financial Results
Strengthened financial position resulting from recently announced MARGENZA® transaction and previously announced receipt of milestone payment from Incyte related to advancement of ZYNYZ®ADAM9-directed ADC (MGC028) Investigational New Drug (IND) application submitted to FDA Conference call scheduled for today at 4:30 p.m. ET  ROCKVILLE, Md., Nov. 05, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended September
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MacroGenics Announces Date of Third Quarter 2024 Financial Results Conference Call
ROCKVILLE, MD, Oct. 29, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the third quarter of 2024 after the market closes on Tuesday, November 5, 2024. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, November 5, 2024, at 4:30 pm ET. Conference Call Information To participate via telephone, please register in advance via this link. Upon registration, all telephone participants will receive a
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MacroGenics Announces Appointment of Dr. Margaret Liu and Meenu Chhabra Karson to Board of Directors
ROCKVILLE, MD, Jan. 04, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced the appointment of Dr. Margaret A. Liu and Meenu Chhabra Karson to its Board of Directors, effective January 3, 2023. Dr. Liu will serve as a member of MacroGenics' Science and Technology Committee and Ms. Karson will serve as a member of the Company's Audit Committee. Following the appointment of Dr. Liu and Ms. Karson, MacroGenics' Board will comprise ten directors, nine of whom are independent. "We are delighted to have both Margaret and Meenu join Ma
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ROCKVILLE, MD, May 23, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced the appointment of William Heiden to its Board of Directors, effective May 22, 2022. Mr. Heiden will serve as Chair of the board and a member of the Audit Committee. Following the appointment of Mr. Heiden, the Board will comprise eight directors, seven of whom are independent. Mr. Heiden is replacing Paulo F. Costa as Chair. Mr. Costa served in the Chair position until his term as director expired on May 19, 2022. "We are delighted to have Bill join Macr
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MacroGenics to Participate in Upcoming Investor Conferences
ROCKVILLE, MD, Nov. 06, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences this month: Guggenheim Securities Healthcare Innovation Conference (Boston). MacroGenics' Chief Operating Officer, Eric Risser, will participate in a fireside chat on Tuesday, November 12, 2024, at 4:00pm ET. MacroGenics' management will also participate in one-on-one meetings. Stifel 2024 Healthcare Conference (New York). MacroGenics' Pre
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Strengthened financial position resulting from recently announced MARGENZA® transaction and previously announced receipt of milestone payment from Incyte related to advancement of ZYNYZ®ADAM9-directed ADC (MGC028) Investigational New Drug (IND) application submitted to FDA Conference call scheduled for today at 4:30 p.m. ET  ROCKVILLE, Md., Nov. 05, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended September
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FDA Approval for MARGENZA

Products on BLA 761150

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761150

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $MGNX

$MGNX Insider Purchases

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

Biotech Target N V bought $669,585 worth of shares (150,000 units at $4.46), increasing direct ownership by 2% to 9,929,963 units (SEC Form 4)

$MGNX SEC Filings

MacroGenics Inc. filed SEC Form 8-K: Leadership Update

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

SEC Form 10-Q filed by MacroGenics Inc.

$MGNX Insider Trading

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

President and CEO Koenig Scott gifted 53,265 shares and received a gift of 53,265 shares, closing all direct ownership in the company (SEC Form 4)

President and CEO Koenig Scott gifted 374,215 shares and received a gift of 374,215 shares, decreasing direct ownership by 35% to 703,413 units (SEC Form 4)

SEC Form 4 filed by Liu Margaret (Amendment)

$MGNX Financials

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$MGNX Large Ownership Changes

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MacroGenics Provides Update on Corporate Progress, Third Quarter 2024 Financial Results

MacroGenics Announces Date of Third Quarter 2024 Financial Results Conference Call

MacroGenics Announces Updated Efficacy & Safety Data from TAMARACK Phase 2 Study of Vobra Duo in mCRPC Patients at ESMO Congress 2024

FDA Approval for MARGENZA issued to MACROGENICS INC

FDA Approval for MARGENZA

MacroGenics Announces Leadership Transition

MacroGenics Announces Appointment of Dr. Margaret Liu and Meenu Chhabra Karson to Board of Directors

MacroGenics Announces Appointment of William Heiden to Board of Directors

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MacroGenics downgraded by BTIG Research

MacroGenics downgraded by B. Riley Securities with a new price target

SEC Form SC 13G filed by MacroGenics Inc.

Amendment: SEC Form SC 13G/A filed by MacroGenics Inc.

SEC Form SC 13G filed by MacroGenics Inc.

$MGNX Press Releases

Fastest customizable press release news feed in the world

MacroGenics to Participate in Upcoming Investor Conferences

MacroGenics Provides Update on Corporate Progress, Third Quarter 2024 Financial Results

MacroGenics Announces Leadership Transition

$MGNX Market Insights

Live Market Insights

Why Science Applications International Shares Are Trading Lower By 11%? Here Are Other Stocks Moving In Monday's Mid-Day Session

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