FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

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

$DAWN

Biotechnology: Pharmaceutical Preparations

Health Care

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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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$DAWN
Financials

Live finance-specific insights

Day One Reports Third Quarter 2024 Financial Results and Corporate Progress
Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 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 its third quarter 2024 financial results and highlighted recent corporate achievements. "Our third quarter results demonstrate continued patient demand
10/30/24 4:01:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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Day One to Report Third Quarter 2024 Financial Results Wednesday, October 30, 2024
BRISBANE, Calif., Oct. 16, 2024 (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 Wednesday, October 30, 2024 at 4:30 p.m. ET to report financial results and discuss corporate progress for the third quarter 2024. 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
10/16/24 8:30:00 AM ET
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Day One Reports Second Quarter 2024 Financial Results and Corporate Progress
Achieved $8.2 million in OJEMDATM (tovorafenib) net product revenues in initial 2 months of launch Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. for approximately $111 million upfront in cash and equity investment at a premium Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Company to host conference call and webcast today, July 30, 8:00 a.m. Eastern Time
7/30/24 7:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Press Releases

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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
11/20/24 4:30:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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Day One to Participate in the Piper Sandler 36th Annual Healthcare Conference
BRISBANE, Calif., Nov. 18, 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 management will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3 at 3:00 p.m. EST. A live webcast of the discussion will be available by visiting the Events & Presentations section of the Day One Investors & Media page. An archived replay of the webcast will be available for 30 days following the live event. About Day One Biopharmaceutica
11/18/24 8:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Day One Reports Third Quarter 2024 Financial Results and Corporate Progress
Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 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 its third quarter 2024 financial results and highlighted recent corporate achievements. "Our third quarter results demonstrate continued patient demand
10/30/24 4:01:00 PM ET
$DAWN
Biotechnology: Pharmaceutical Preparations
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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
11/20/24 4:30:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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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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Day One Appoints Garry Nicholson as Chairman of the Board of Directors
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
9/12/22 8:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Why Indivior Shares Are Trading Higher; Here Are 20 Stocks Moving Premarket
Shares of Indivior PLC (NASDAQ:INDV) rose sharply in today's pre-market trading after the company posted better-than-expected second-quarter results and announced an accelerated $100 million share repurchase program. Indivior reported quarterly earnings of 44 cents per share which beat the analyst consensus estimate of 14 cents per share. The company reported quarterly sales of $299.00 million which beat the analyst consensus estimate of $296.05 million. Indivior shares jumped 14.5% to $12.46 in pre-market trading. Here are some other stocks moving in pre-market trading. Gainers Psyence Biomedical Ltd. (NASDAQ:PBM) rose 157.4% to $1.00 in pre-market trading after the company
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Ipsen And Day One Earlier Announced Exclusive Ex U.S. Licensing Agreement To Commercialize Tovorafenib For The Most Common Childhood Brain Tumor
Ipsen ((Euronext: IPN, OTC:IPSEY) and Day One Biopharmaceuticals (NASDAQ:DAWN) (Day One), announced today a new global partnership outside the U.S. for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma (pLGG), the most common form of childhood brain cancer, i and any future indications developed by Day One. Under the terms of the agreement, Ipsen will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S. Day One will receive an upfront payment of approximately $111 million, which includes approximately $71 million in cash as well as a $40 million equity investment at a premium and up to approx
7/25/24 6:10:04 AM ET
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Ipsen And Day One Enter Ex-U.S. Licensing Deal For Pediatric Brain Cancer Drug Tovorafenib
Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for most common childhood brain tumor, pediatric low-grade glioma (pLGG), and any future indications OJEMDA™ (tovorafenib) is the first FDA-approved treatment for relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or V600 mutation, following the pivotal Phase II trial, FIREFLY-1 Day One receives approximately $111 million upfront in cash and equity investment with up to approximately $350 million in milestone payments and double-digit tiered royalties Ongoing Phase III trial, FIREFLY-2, is evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF-altered low-grad
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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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April 26, 2024 - FDA Roundup: April 26, 2024
For Immediate Release: April 26, 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
4/26/24 3:10:22 PM ET
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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

Chat with this insight

Recent Analyst Ratings for $DAWN

$DAWN Financials

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Day One Reports Third Quarter 2024 Financial Results and Corporate Progress

Day One to Report Third Quarter 2024 Financial Results Wednesday, October 30, 2024

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$DAWN Large Ownership Changes

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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 Press Releases

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

Day One to Participate in the Piper Sandler 36th Annual Healthcare Conference

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

Day One Announces Two New Appointments to Board of Directors

Day One Appoints Garry Nicholson as Chairman of the Board of Directors

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

Day One Biopharmaceuticals upgraded by BofA Securities with a new price target

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

$DAWN SEC Filings

SEC Form 8-K filed by Day One Biopharmaceuticals Inc.

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

$DAWN Insider Purchases

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

$DAWN Insider Trading

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CHIEF EXECUTIVE OFFICER Bender Jeremy sold $139,420 worth of shares (10,554 units at $13.21) and converted options into 19,999 shares, increasing direct ownership by 10% to 108,377 units (SEC Form 4)

HEAD OF R&D Blackman Samuel C. converted options into 8,686 shares and sold $29,142 worth of shares (2,206 units at $13.21), increasing direct ownership by 0.61% to 1,064,015 units (SEC Form 4)

GENERAL COUNSEL Dubow Adam converted options into 8,399 shares and sold $41,810 worth of shares (3,165 units at $13.21), increasing direct ownership by 19% to 32,162 units (SEC Form 4)

$DAWN Market Insights

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Ipsen And Day One Earlier Announced Exclusive Ex U.S. Licensing Agreement To Commercialize Tovorafenib For The Most Common Childhood Brain Tumor

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$DAWN FDA approvals

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April 30, 2024 - FDA Roundup: April 30, 2024

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FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

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