Zai Lab And argenx Get Approval For Efgartigimod Alfa SC Injection For Generalized Myasthenia Gravis In China

7/16/24 1:13:51 AM ET

$ARGX

$ZLAB

Biotechnology: Biological Products (No Diagnostic Substances)

Health Care

Biotechnology: Pharmaceutical Preparations

Health Care

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First and only NMPA-approved subcutaneous (SC) injectable providing additional flexibility and optionality for gMG patients in China
Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study

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Company	Date	Price Target	Rating	Analyst
argenx SE $ARGX	11/1/2024	$515.00 → $650.00	Outperform → Neutral	Robert W. Baird
argenx SE $ARGX	11/1/2024		Mkt Perform → Outperform	William Blair
argenx SE $ARGX	10/10/2024	$605.00	Strong Buy	Raymond James
argenx SE $ARGX	10/4/2024		Buy → Hold	Deutsche Bank
argenx SE $ARGX	8/6/2024		Equal Weight → Overweight	Barclays
argenx SE $ARGX	7/25/2024		Hold → Buy	Deutsche Bank
argenx SE $ARGX	7/23/2024	$546.00	Perform → Outperform	Oppenheimer
argenx SE $ARGX	2/15/2024		Peer Perform	Wolfe Research

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Press Releases

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argenx Reports Third Quarter 2024 Financial Results and Provides Business Update
$573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its third quarter 2024 financial results and provided a business update. "We delivered significant patient impact with VYVGART over the quarter, expanding our gMG footprint and delivering inn
10/31/24 2:00:00 AM ET
$ARGX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Zai Lab Reports Positive Topline Data from Phase 3 Bridging Trial Evaluating KarXT for the Treatment of Schizophrenia in China
KarXT demonstrated a statistically significant 9.2-point reduction in PANSS Total score from baseline at Week 5 compared to placebo (p=0.0014) Trial also met all secondary endpoints, demonstrating statistically significant reductions in positive and negative symptoms of schizophrenia, as measured by the PANSS positive subscale, PANSS negative subscale and PANSS negative Marder factor score KarXT has a tolerable safety profile with no new or unexpected safety signals Based on these results, Zai is moving swiftly to submit New Drug Application (NDA) to China's National Medical Products Administration (NMPA) in early 2025 Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688)) today announced positive
10/29/24 7:30:00 AM ET
$ZLAB
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ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer
-- Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) -- Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy -- Zai Lab to host conference call and webcast to discuss data on October 24, 2024, at 8:30 a.m. ET, following presentation of the data at ENA Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC)
10/24/24 5:15:00 AM ET
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argenx Reports Third Quarter 2024 Financial Results and Provides Business Update
$573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its third quarter 2024 financial results and provided a business update. "We delivered significant patient impact with VYVGART over the quarter, expanding our gMG footprint and delivering inn
10/31/24 2:00:00 AM ET
$ARGX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer
-- Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) -- Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy -- Zai Lab to host conference call and webcast to discuss data on October 24, 2024, at 8:30 a.m. ET, following presentation of the data at ENA Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC)
10/24/24 5:15:00 AM ET
$ZLAB
Biotechnology: Pharmaceutical Preparations
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argenx to Report Third Quarter 2024 Financial Results and Business Update on October 31, 2024
October 24, 2024Amsterdam, the Netherlands – argenx ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 31, 2024 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2024 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation. Dial-in numbers: Belgium 32 800 50 201France
10/24/24 1:00:00 AM ET
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Leadership Updates

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Zai Lab Announces Dr. Harald Reinhart to Retire as Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases; Dr. Rafael Amado to be Appointed President, Head of Global R&D
Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) announced today that following a distinguished career, Harald Reinhart, M.D., President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases (NSAiID) of Zai Lab, will retire at the end of June, after which he will serve as a senior advisor for the Company. Rafael Amado, M.D., President, Head of Global Oncology Research and Development of Zai Lab, will expand his role and assume responsibility for all of the Company's Global R&D upon Dr. Reinhart's retirement. "Harald has devoted nearly 50 years to treating patients, first as a physician and later discovering and developing innovative therapies to bring to patients in
6/11/24 4:05:00 PM ET
$ZLAB
Biotechnology: Pharmaceutical Preparations
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argenx Announces Extraordinary General Meeting of Shareholders on February 27, 2023 to Appoint Steve Krognes as Non-Executive Director
January 16, 2023 Amsterdam, the Netherlands – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced an extraordinary general meeting of shareholders will be held at 12:00 PM CET on Monday, February 27, 2023 at the Hilton Amsterdam Schiphol at Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands.The shareholders and all other persons with meeting rights are invited to attend the extraordinary general meeting of shareholders. The formal notice of convocation (including information on attending the meeting in person or by proxy, requirements for notification and registration f
1/16/23 1:30:00 PM ET
$ARGX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Zai Lab Appoints Michel Vounatsos To Its Board of Directors
SHANGHAI and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that Michel Vounatsos has been appointed to its Board of Directors, effective January 7, 2023. Mr. Vounatsos brings to the Board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service at leading companies. His expertise includes significant commercial experience in China and worldwide in the areas of primary care and neuroscience. "We are delighted to welcome Michel Vounatsos to the Zai Lab Board of Directors," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "Michel has a wealt
1/9/23 7:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Zai Lab And argenx Get Approval For Efgartigimod Alfa SC Injection For Generalized Myasthenia Gravis In China

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$ARGX$ZLAB Insider Trading

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Chief Financial Officer Chen Yajing converted options into 920 units of American Depositary Shares and sold $7,645 worth of American Depositary Shares (301 units at $25.40), increasing direct ownership by 4% to 15,161 units (SEC Form 4)

Director Gaynor Richard sold $48,750 worth of American Depositary Shares (2,500 units at $19.50), decreasing direct ownership by 5% to 46,568 units (SEC Form 4)

Chief Legal Officer Edmondson Frazor Titus Iii converted options into 4,850 units of American Depositary Shares and sold $32,619 worth of American Depositary Shares (1,924 units at $16.95), increasing direct ownership by 11% to 28,872 units (SEC Form 4)

$ARGX$ZLAB SEC Filings

SEC Form 6-K filed by argenx SE

SEC Form 6-K filed by argenx SE

SEC Form 6-K filed by argenx SE

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argenx downgraded by Robert W. Baird with a new price target

argenx upgraded by William Blair

Raymond James resumed coverage on argenx with a new price target

$ARGX$ZLAB Press Releases

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argenx Reports Third Quarter 2024 Financial Results and Provides Business Update

Zai Lab Reports Positive Topline Data from Phase 3 Bridging Trial Evaluating KarXT for the Treatment of Schizophrenia in China

ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer

$ARGX$ZLAB Insider Purchases

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

Smiley Joshua L bought $64,200 worth of American Depositary Shares (3,000 units at $21.40), increasing direct ownership by 10% to 31,684 units (SEC Form 4)

Smiley Joshua L bought $62,490 worth of American Depositary Shares (3,000 units at $20.83), increasing direct ownership by 15% to 23,527 units (SEC Form 4)

Smiley Joshua L bought $119,600 worth of American Depositary Shares (4,000 units at $29.90), increasing direct ownership by 24% to 20,527 units (SEC Form 4)

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SEC Form SC 13G/A filed by Zai Lab Limited (Amendment)

SEC Form SC 13G/A filed by argenx SE (Amendment)

SEC Form SC 13G filed by Zai Lab Limited

$ARGX$ZLAB Financials

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argenx Reports Third Quarter 2024 Financial Results and Provides Business Update

ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer

argenx to Report Third Quarter 2024 Financial Results and Business Update on October 31, 2024

$ARGX$ZLAB Leadership Updates

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Zai Lab Announces Dr. Harald Reinhart to Retire as Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases; Dr. Rafael Amado to be Appointed President, Head of Global R&D

argenx Announces Extraordinary General Meeting of Shareholders on February 27, 2023 to Appoint Steve Krognes as Non-Executive Director

Zai Lab Appoints Michel Vounatsos To Its Board of Directors

$ARGX$ZLAB Market Insights

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Argenx shares are trading higher after the company reported better-than-expected Q2 GAAP EPS and sales.

For 2024 argenx Expects To Spend Less Than $2B On Expenses And Under $500M In Net Cash For Operations

argenx Q2 2024 GAAP EPS $0.45 Beats $(0.98) Estimate, Sales $489.428M Beat $439.217M Estimate

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