Zymeworks Says FDA Has Cleared Investigational New Drug Application For ZW191

7/22/24 6:02:30 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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ZW191 is the Company's novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor (TOPO1i) antibody-drug conjugate (ADC).

The Company expects to file applications seeking regulatory authorization to initiate clinical studies for ZW191 in non-US jurisdictions in the second half of 2024.

ZW191 is the first of three ADC molecules incorporating the Company's proprietary ZD06519 payload designated for clinical development, with IND filings for ZW220 (NaPi2b ADC) and ZW251 (GPC3 ADC) on schedule for 2025.

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Recent Analyst Ratings for
$ZYME

Date	Price Target	Rating	Analyst
11/1/2024	$12.00	Overweight → Equal Weight	Wells Fargo
3/21/2023	$12.00	Overweight	Wells Fargo
1/4/2023	$10.00 → $8.00	Neutral	H.C. Wainwright
12/20/2022	$7.70 → $11.00	Hold → Buy	Jefferies
11/1/2022	$40.00 → $8.00	Buy → Neutral	H.C. Wainwright
10/21/2022	$8.00	Outperform → Mkt Perform	SVB Leerink
10/4/2022	$45.00 → $9.00	Overweight	Wells Fargo
5/5/2022	$14.00	Neutral → Buy	Guggenheim

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$ZYME
Press Releases

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Zymeworks Provides Corporate Update and Reports Third Quarter 2024 Financial Results
First patient dosed in Phase 1 clinical trial evaluating ZW171 in advanced mesothelin (MSLN)-expressing cancers Preclinical data presented on ZW220 and ZW251 at EORTC-NCI-AACR conferenceOur partner Jazz Pharmaceuticals presented new and updated clinical data at ESMO 2024 on zanidatamab highlighting its potential for the treatment of multiple HER2-positive (HER+) indicationsZymeworks to host in-person and virtual R&D day in New York City on December 12, 2024The Company has completed the initial $30 million of its Share Repurchase Program for 2,545,402 shares at an average price per share of $11.79 as of October 31, 2024Reported $374.9 million in cash resources as of September 30, 2024, which
10/31/24 4:05:00 PM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
Health Care
Zymeworks Announces Participation in Upcoming Investor Conferences
VANCOUVER, British Columbia, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that management will participate in the following upcoming investor conferences: UBS Global Healthcare Conference: Zymeworks' management will participate in one-on-one meetings on November 12 in Rancho Palos Verdes, CA.Stifel 2024 Healthcare Conference: Zymeworks' management will participate in one-on-one meetings and a fireside chat on November 19 at 4:10 pm Eastern Time (ET) in New York, NY.Jefferies London
10/29/24 6:00:00 AM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
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Zymeworks Presents New Preclinical Data on Antibody-Drug Conjugate Programs at EORTC-NCI-AACR Conference
Presentations highlight key preclinical data that support investigational new drug application (IND) submissions for ZW220 in 1H and ZW251 in 2H in 2025 VANCOUVER, British Columbia, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced new preclinical data for Zymeworks' antibody-drug conjugate (ADC) candidates ZW220 and ZW251 in presentations at the European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR)
10/25/24 6:00:00 AM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
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Zymeworks Provides Corporate Update and Reports Third Quarter 2024 Financial Results
First patient dosed in Phase 1 clinical trial evaluating ZW171 in advanced mesothelin (MSLN)-expressing cancers Preclinical data presented on ZW220 and ZW251 at EORTC-NCI-AACR conferenceOur partner Jazz Pharmaceuticals presented new and updated clinical data at ESMO 2024 on zanidatamab highlighting its potential for the treatment of multiple HER2-positive (HER+) indicationsZymeworks to host in-person and virtual R&D day in New York City on December 12, 2024The Company has completed the initial $30 million of its Share Repurchase Program for 2,545,402 shares at an average price per share of $11.79 as of October 31, 2024Reported $374.9 million in cash resources as of September 30, 2024, which
10/31/24 4:05:00 PM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
Health Care
Zymeworks to Report Third Quarter 2024 Financial Results and Host Conference Call on October 31, 2024
VANCOUVER, British Columbia, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that management will report its third quarter 2024 financial results after market close on October 31, 2024. Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on October 31, 2024 at 4:30 pm Eastern Time (ET). The event will be webcast live with dial-in details and webcast replays available on Zymeworks' website at https:/
10/10/24 6:30:00 AM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
Health Care
Zymeworks Provides Corporate Update and Reports Second Quarter 2024 Financial Results
Reported $395.9 million in cash resources as of June 30, 2024, which when combined with certain anticipated regulatory milestone payments provides projected cash runway into 2H 2027Priority Review of the Biologics License Application (BLA) granted for zanidatamab as second-line (2L) treatment for HER2-positive biliary tract cancers (BTC) in the United States with target action date of November 29, 2024The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for zanidatamab in 2L BTCZanidatamab BLA acceptance in China triggering $8 million milestone payment under the terms of Zymeworks' Asia-Pacific license and collaboration agreement with BeiGeneOur partner
8/1/24 4:05:00 PM ET
$ZYME
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$ZYME
Leadership Updates

Live Leadership Updates

Augurex Life Sciences Corp. Names Healthcare Leader Neil Klompas to Succeed Co-Founder Dr. Norma Biln as President and CEO
Veteran life sciences executive Mr. Neil Klompas to assume role of President and CEO Co-Founder and outgoing CEO Dr. Norma Biln to helm research and new product development and remain Chair of the Board of Directors Augurex Life Sciences Corp., a world leader in the early diagnosis of autoimmune diseases and a pioneer in the field of 14-3-3η based diagnostics, today announced the appointment of Mr. Neil Klompas as President and Chief Executive Officer. Mr. Klompas will succeed Augurex's Co-founder Dr. Norma Biln, who has served as President and CEO since the Company began operations in 2008. Dr. Biln will continue to be an integral part of the company transitioning into the interim r
8/6/24 7:00:00 AM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
Health Care
Zymeworks Appoints Leone Patterson as Chief Business and Financial Officer
VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced the appointment of Leone Patterson as Executive Vice President, and Chief Business and Financial Officer, effective September 1, 2024. "After an extensive search, we are delighted to have Leone Patterson join us at this exciting time as we plan for our next stage of growth and development at Zymeworks," said Kenneth Galbraith, Chair and CEO of Zymeworks. "She brings more than 20 years of public company biotec
7/25/24 4:30:00 PM ET
$ZYME
Biotechnology: Pharmaceutical Preparations
Health Care
Zymeworks Announces Appointment of Dr. Neil Gallagher to its Board of Directors
VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced the appointment of Dr. Neil Gallagher to its board of directors effective April 2, 2024. "Dr. Gallagher is the sixth director to join our board of directors in the past twelve months as we continue to refresh and strengthen the Board governance and oversight required for the next stage of the Company's development and growth," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "His exp
3/28/24 6:00:00 AM ET
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Zymeworks Says FDA Has Cleared Investigational New Drug Application For ZW191

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$ZYME SEC Filings

SEC Form 10-Q filed by Zymeworks Inc.

Zymeworks Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure, Financial Statements and Exhibits

SEC Form DEFA14A filed by Zymeworks Inc.

$ZYME Press Releases

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Zymeworks Provides Corporate Update and Reports Third Quarter 2024 Financial Results

Zymeworks Announces Participation in Upcoming Investor Conferences

Zymeworks Presents New Preclinical Data on Antibody-Drug Conjugate Programs at EORTC-NCI-AACR Conference

$ZYME Large Ownership Changes

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SEC Form SC 13D filed by Zymeworks Inc.

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

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

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Zymeworks Provides Corporate Update and Reports Third Quarter 2024 Financial Results

Zymeworks to Report Third Quarter 2024 Financial Results and Host Conference Call on October 31, 2024

Zymeworks Provides Corporate Update and Reports Second Quarter 2024 Financial Results