FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

4/24/24 12:52:43 PM ET

$DAWN

Biotechnology: Pharmaceutical Preparations

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New Drug Application (NDA): 218033
Company: DAY ONE BIOPHARMACEUTICALS INC

Products on NDA 218033

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OJEMDA	TOVORAFENIB	100MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218033

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2024	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

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Recent Analyst Ratings for
$DAWN

Date	Price Target	Rating	Analyst
10/9/2024	$32.00 → $33.00	Buy	Needham
8/1/2024	$11.00 → $24.00	Underperform → Buy	BofA Securities
4/24/2024	$30.00 → $33.00	Buy	Needham
4/25/2023	$34.00 → $9.00	Buy → Underperform	BofA Securities
2/8/2023	$40.00	Overweight	CapitalOne
2/3/2023		Perform	Oppenheimer
12/15/2022	$35.00	Buy	H.C. Wainwright
12/14/2022	$40.00	Buy	Needham

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Day One Announces Retirement of Dr. Samuel Blackman, Co-Founder and Head of Research & Development
Dr. Blackman's departure planned for end of 2024 Company's search for a new Head of R&D is ongoing BRISBANE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that Samuel Blackman, M.D., Ph.D, co-founder and Head of Research & Development (R&D) of the Company, will be retiring effective at the end of 2024. He will continue to serve as a strategic advisor and consultant while the Company seeks a new Head of R&D. "Sam's passion for pediatric oncology
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Day One Announces Two New Appointments to Board of Directors
BRISBANE, Calif., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN) ("Day One" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the appointments of Habib Dable and Dr. William Grossman to its Board of Directors. "We are excited to welcome Habib and Bill to our Board during this pivotal phase of our growth," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Their deep expertise and leadership in oncology will further strengthen our Board and will be a great asset as we prepare for the potential launch of ou
1/17/24 8:00:00 AM ET
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SOUTH SAN FRANCISCO, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the appointment of Garry Nicholson as chairman of its board of directors. Mr. Nicholson brings more than 30 years of pharmaceutical and biotech oncology experience and previously served as president of Pfizer Oncology where he led its global oncology franchise. Day One co-founder Julie Grant, who served as board chair since 2021, will continue to serve as a member of the board of directors. "Garry is an accompl
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Financials

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Day One Reports First Quarter 2025 Financial Results and Corporate Progress
OJEMDA™ (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDA™ (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2025 financial results and highlighted recent corporate achievemen
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BRISBANE, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Tuesday, May 6, 2025 at 4:30 p.m. ET to report financial results and discuss corporate progress for the first quarter 2025. Live audio of the webcast will be accessible on the Day One Investors & Media page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days
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Achieved Q4 2024 and full year 2024 OJEMDA™ (tovorafenib) net product revenues of $29.0 million and $57.2 million, respectively Ended 2024 with $531.7 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, February 25, 4:30 p.m. ET BRISBANE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its fourth quarter and full year 2024 financial results and highli
2/25/25 4:05:00 PM ET
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Press Releases

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Day One Reports First Quarter 2025 Financial Results and Corporate Progress
OJEMDA™ (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDA™ (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2025 financial results and highlighted recent corporate achievemen
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$DAWN
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BRISBANE, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Tuesday, May 6, 2025 at 4:30 p.m. ET to report financial results and discuss corporate progress for the first quarter 2025. Live audio of the webcast will be accessible on the Day One Investors & Media page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days
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$DAWN
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Day One Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Progress
Achieved Q4 2024 and full year 2024 OJEMDA™ (tovorafenib) net product revenues of $29.0 million and $57.2 million, respectively Ended 2024 with $531.7 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, February 25, 4:30 p.m. ET BRISBANE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its fourth quarter and full year 2024 financial results and highli
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April 30, 2024 - FDA Roundup: April 30, 2024
For Immediate Release: April 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patriz
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FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC
Submission status for DAY ONE BIOPHARMACEUTICALS INC's drug OJEMDA (ORIG-1) with active ingredient TOVORAFENIB has changed to 'Approval' on 04/23/2024. Application Category: NDA, Application Number: 218033, Application Classification: Type 1 - New Molecular Entity
4/24/24 12:52:43 PM ET
$DAWN
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

Products on NDA 218033

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218033

Original Approvals or Tentative Approvals

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

New insider Merendino Lauren claimed ownership of 28,552 shares (SEC Form 3)

COO, CFO AND SECRETARY York Charles N Ii converted options into 16,875 shares and sold $52,278 worth of shares (4,370 units at $11.96), increasing direct ownership by 5% to 252,638 units (SEC Form 4)

GENERAL COUNSEL Dubow Adam converted options into 12,086 shares and sold $55,580 worth of shares (4,646 units at $11.96), increasing direct ownership by 23% to 39,602 units (SEC Form 4)

$DAWN Leadership Updates

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Day One Announces Retirement of Dr. Samuel Blackman, Co-Founder and Head of Research & Development

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$DAWN Financials

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Needham reiterated coverage on Day One Biopharmaceuticals with a new price target

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$DAWN Press Releases

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Day One Reports First Quarter 2025 Financial Results and Corporate Progress

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Ai Day1 Llc bought $14,978,327 worth of shares (1,475,454 units at $10.15) (SEC Form 4)

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Amendment: SEC Form SC 13G/A filed by Day One Biopharmaceuticals Inc.

Amendment: SEC Form SC 13G/A filed by Day One Biopharmaceuticals Inc.

SEC Form SC 13G filed by Day One Biopharmaceuticals Inc.

$DAWN SEC Filings

SEC Form 10-Q filed by Day One Biopharmaceuticals Inc.

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

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FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

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