FDA Approval for OGSIVEO issued to SPRINGWORKS THERAPEUTICS INC

11/27/23 5:34:04 PM ET

$SWTX

Biotechnology: Biological Products (No Diagnostic Substances)

Health Care

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New Drug Application (NDA): 217677
Company: SPRINGWORKS THERAPEUTICS INC

Products on NDA 217677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OGSIVEO	NIROGACESTAT	150MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

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Recent Analyst Ratings for
$SWTX

Date	Price Target	Rating	Analyst
11/20/2024	$60.00	Outperform	Evercore ISI
2/5/2024	$75.00	Buy	Guggenheim
12/1/2022	$45.00	Buy	BofA Securities
9/8/2021	$97.00 → $105.00	Overweight	JP Morgan
8/5/2021	$136.00 → $137.00	Buy	HC Wainwright & Co.

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$SWTX
Leadership Updates

Live Leadership Updates

SpringWorks Therapeutics Appoints Dr. Martin Mackay to its Board of Directors
STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company's Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. "Martin is a proven industry leader whose experience in developing and delivering novel treatments to patients in need is exceptional," said Saqib Islam, Chief Executive Officer of SpringWorks. "His expertise
7/29/24 6:30:11 AM ET
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Biotechnology: Biological Products (No Diagnostic Substances)
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SpringWorks Therapeutics Appoints Dr. Tai-An Lin as Chief Scientific Officer
STAMFORD, Conn., Sept. 11, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the appointment of Tai-An Lin, Ph.D., as its Chief Scientific Officer. Dr. Lin brings more than 25 years of biotechnology and global pharmaceutical experience in advancing drug discovery programs from target identification through early clinical trials across the therapeutic areas of oncology, immuno-oncology, and immunology. "Tai-An is a talented scientist with a strong track record of advancing innovative oncology programs from discovery
9/11/23 6:30:00 AM ET
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Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
SpringWorks Therapeutics Appoints Carlos Albán to its Board of Directors
STAMFORD, Conn., July 15, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the appointment of Carlos Albán to the Company's Board of Directors. Mr. Albán, who served as Vice Chairman and Chief Commercial Officer at AbbVie, Inc. ("AbbVie") until his retirement last year, brings over 30 years of experience in global commercial strategy and operations. "Carlos' success in building and leading global commercial organizations will be valuable as SpringWorks continues its planned transition into a commercial-stage compa
7/15/22 6:30:00 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
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$SWTX
Financials

Live finance-specific insights

SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
– Achieved $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the third quarter – – Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors highlight further reductions in tumor size, increase in ORR, sustained improvement in desmoid tumor symptoms, and consistent safety profile – – Granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN – – $498 million in cash, cash equivalents and marketable securities as of September 30, 2024; expected to fund the Company through profitability, which is anticipated in the first
11/12/24 6:30:21 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
SpringWorks Therapeutics to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024
STAMFORD, Conn., Oct. 22, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, November 12, 2024 to report its third quarter financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcast will be availa
10/22/24 7:00:14 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
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SpringWorks Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the second quarter of 2024 and provided an update
8/7/24 6:30:35 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
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Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Nov. 14, 2024 /PRNewswire/ -- USA News Group News Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American Medical Association is pointing out the alarming trend of rising cancer rates, especially with younger people. According to data released from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), a map shared by Newsweek showed that the prevalence of cancer varies significantly from state to state. Thankfully, there are plenty of new breakthroughs in the fight against cancer that the World Eco
11/14/24 8:00:00 AM ET
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SpringWorks Therapeutics to Participate in the Jefferies London Healthcare Conference
STAMFORD, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference, taking place in London, United Kingdom on Tuesday, November 19, 2024 at 10:30 a.m. ET. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company's website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks' website for a limited time following the conference. About SpringWorks Therapeutic
11/12/24 9:25:59 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
– Achieved $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the third quarter – – Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors highlight further reductions in tumor size, increase in ORR, sustained improvement in desmoid tumor symptoms, and consistent safety profile – – Granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN – – $498 million in cash, cash equivalents and marketable securities as of September 30, 2024; expected to fund the Company through profitability, which is anticipated in the first
11/12/24 6:30:21 AM ET
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care

FDA Approval for OGSIVEO issued to SPRINGWORKS THERAPEUTICS INC

Products on NDA 217677

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217677

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $SWTX

$SWTX SEC Filings

SEC Form 10-Q filed by SpringWorks Therapeutics Inc.

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

SEC Form 144 filed by SpringWorks Therapeutics Inc.

$SWTX Leadership Updates

Live Leadership Updates

SpringWorks Therapeutics Appoints Dr. Martin Mackay to its Board of Directors

SpringWorks Therapeutics Appoints Dr. Tai-An Lin as Chief Scientific Officer

SpringWorks Therapeutics Appoints Carlos Albán to its Board of Directors

$SWTX Insider Trading

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

Chief Scientific Officer Lin Tai-An covered exercise/tax liability with 2,324 shares, decreasing direct ownership by 8% to 26,965 units (SEC Form 4)

Chief Executive Officer Islam Saqib sold $1,988,033 worth of shares (49,000 units at $40.57), decreasing direct ownership by 4% to 1,063,368 units (SEC Form 4)

Chief Operating Officer Edris Badreddin sold $812,954 worth of shares (20,000 units at $40.65), decreasing direct ownership by 8% to 229,600 units (SEC Form 4)

$SWTX Financials

Live finance-specific insights

SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

SpringWorks Therapeutics to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024

SpringWorks Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights

$SWTX Analyst Ratings

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Evercore ISI initiated coverage on SpringWorks Therapeutics with a new price target

Guggenheim initiated coverage on SpringWorks Therapeutics with a new price target

BofA Securities initiated coverage on SpringWorks Therapeutics with a new price target

$SWTX Large Ownership Changes

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

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

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

$SWTX FDA approvals

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November 27, 2023 - FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors

FDA Approval for OGSIVEO issued to SPRINGWORKS THERAPEUTICS INC

Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon

SpringWorks Therapeutics to Participate in the Jefferies London Healthcare Conference

SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

$SWTX Market Insights

Live Market Insights

SpringWorks Therapeutics Has Completed The Submission Of A New Drug Application To The FDA For Mirdametinib For Pediatric And Adult Patients With Neurofibromatosis Type 1- Associated Plexiform Neurofibromas

SpringWorks Therapeutics Inc Says Termination Of License Deal Does Not Trigger Any Payment Obligations On Part Of Co/any Other Material Wind-Down Costs

SpringWorks Therapeutics Says Termination Does Not Affect Co's Rights To Continue Developing Or Commercializing Its Products Or Product Candidates; Expects That GSK Will Continue Ongoing Clinical Trials Under License Agreement

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