Day One

Morningstar Announces Agenda for 2024 Morningstar Investment Conference

Retrieved on: 
Wednesday, March 13, 2024
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Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today announced the agenda for its 36th annual Morningstar Investment Conference , set to convene Wednesday, June 26, through Thursday, June 27, 2024, exclusively in-person at a new venue, Chicago’s Navy Pier.

Key Points: 
  • Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today announced the agenda for its 36th annual Morningstar Investment Conference , set to convene Wednesday, June 26, through Thursday, June 27, 2024, exclusively in-person at a new venue, Chicago’s Navy Pier.
  • “We are reimagining our conference this year to coincide with Morningstar’s 40th anniversary,” said Kunal Kapoor, chief executive officer at Morningstar.
  • More information about the Morningstar Investment Conference, including the full agenda, hotel accommodations, continuing-education credits, and an FAQ is available here .
  • Morningstar is pleased to implement several accessibility measures at the Morningstar Investment Conference.

Day One Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Progress

Retrieved on: 
Monday, February 26, 2024
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BRISBANE, Calif., Feb. 26, 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 its fourth quarter and full year 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • “We have a monumental year ahead of us at Day One with the upcoming PDUFA date for tovorafenib,” said Jeremy Bender, Ph.D., chief executive officer of Day One.
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
  • In November 2023, Nature Medicine published the registrational Phase 2 FIREFLY-1 trial results investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pediatric low-grade glioma (pLGG).
  • In the fourth quarter of 2023, Day One continued its commercial preparedness for the approval and launch of tovorafenib with the hiring of 18 sales representatives in the U.S.

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Monday, October 30, 2023
FDA, Ageing, PDUFA, Food, Glioma, Regulation of tobacco by the U.S. Food and Drug Administration, Caregiver, Neoplasm, New Drug Application, NDA, Day One, Patient, BRAF, Pharmaceutical industry

The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

Key Points: 
  • The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
  • The FDA is not currently planning to hold an advisory committee meeting to discuss the application.
  • For the vast majority of patients in the relapsed setting, there is no standard of care and no approved therapy.
  • Updated data was recently disclosed when the Company announced the completion of its rolling NDA submission on September 11, 2023.

Day One Reports First Quarter 2023 Financial Results and Corporate Progress

Retrieved on: 
Monday, May 1, 2023
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BRISBANE, Calif., May 01, 2023 (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 its first quarter 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • The company remains in position to initiate the submission of the NDA as early as the second quarter of 2023.
  • R&D Expenses: Research and development expenses were $27.8 million for the first quarter of 2023 compared to $15.0 million for the first quarter of 2022.
  • G&A Expenses: General and administrative expenses were $18.0 million for the first quarter of 2023 compared to $12.7 million for the first quarter of 2022.
  • Day One will present two posters at the 2023 American Society of Pediatric Oncology/Hematology (ASPHO) Conference May 10-13, 2023, focused on the pLGG burden of illness and healthcare utilization data.

SOUTHERN CALIFORNIA BANCORP REPORTS NET INCOME OF $8.2 MILLION FOR THE FIRST QUARTER

Retrieved on: 
Tuesday, April 25, 2023
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Southern California Bancorp reported net income of $8.2 million for the first quarter of 2023, or $0.44 per diluted share, compared to net income of $1.4 million, or $0.08 per diluted share in the first quarter of 2022, and $8.5 million, or $0.46 per diluted share in the fourth quarter of 2022.

Key Points: 
  • Southern California Bancorp reported net income of $8.2 million for the first quarter of 2023, or $0.44 per diluted share, compared to net income of $1.4 million, or $0.08 per diluted share in the first quarter of 2022, and $8.5 million, or $0.46 per diluted share in the fourth quarter of 2022.
  • Net income for the first quarter of 2023 was $8.2 million, or $0.44 per diluted share, compared with net income of $8.5 million, or $0.46 per diluted share in the fourth quarter of 2022.
  • Pre-tax, pre-provision income (non-GAAP) for the first quarter was $11.4 million, a decrease of $902 thousand or 7.3% from the prior quarter.
  • Net interest income for the first quarter of 2023 was $24.9 million, compared to $25.3 million in the prior quarter.

Day One Beverages Unveils New Slim Can Design

Retrieved on: 
Monday, March 20, 2023
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VENICE BEACH, Calif., March 20, 2023 /PRNewswire/ -- Natural CBD sparkling water and wellness brand Day One Beverages has announced an exciting refresh to the design of their classic CBD Sparkling Waters. The consumer-loved sparkling waters are now available in Slim Can form to heighten consumer experience and make the benefits of RTD CBD increasingly more accessible.

Key Points: 
  • VENICE BEACH, Calif., March 20, 2023 /PRNewswire/ -- Natural CBD sparkling water and wellness brand Day One Beverages has announced an exciting refresh to the design of their classic CBD Sparkling Waters .
  • The consumer-loved sparkling waters are now available in Slim Can form to heighten consumer experience and make the benefits of RTD CBD increasingly more accessible.
  • Day One's new redesign provides a heightened alcohol-free indulgence, with the look and feel of a hard seltzer, but made with real fruit juice, no added sugar and zero-calories.
  • Our new design choices reflect the initiatives we're taking to improve consumer experience with Day One, without compromising our affordability and efficacy, " shares Chris Clifford, Founder & CEO of Day One Beverages.

Rookie Joey Cifuentes III notches first Bassmaster Elite Series win on Lake Seminole

Retrieved on: 
Monday, February 27, 2023
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BAINBRIDGE, Ga., Feb. 26, 2023 /PRNewswire/ -- Despite enduring several painful losses, Arkansas rookie Joey Cifuentes III held on to sack up a final-round limit of 18 pounds, 7 ounces and win the Gamakatsu Bassmaster Elite at Lake Seminole with a four-day total of 85-2.

Key Points: 
  • BAINBRIDGE, Ga., Feb. 26, 2023 /PRNewswire/ -- Despite enduring several painful losses, Arkansas rookie Joey Cifuentes III held on to sack up a final-round limit of 18 pounds, 7 ounces and win the Gamakatsu Bassmaster Elite at Lake Seminole with a four-day total of 85-2.
  • "I knew I had a cushion, but I didn't think it was going to take that much weight to do it."
  • Cifuentes entered the final round with slightly more than a 4-pound advantage over the red-hot Rivet, who won last week's season opener at Lake Okeechobee.
  • As the tournament advanced, Cifuentes noticed that his most consistent action came in areas where two to three trees clustered.

Day One Announces Topline Data from Pivotal Phase 2 FIREFLY-1 Trial Demonstrating Meaningful Responses with Tovorafenib (DAY101) in Recurrent or Progressive Pediatric Low-Grade Glioma

Retrieved on: 
Sunday, January 8, 2023
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Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023.

Key Points: 
  • Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023.
  • The primary endpoint of the FIREFLY-1 trial is overall response rate (ORR) by Response Assessment for Neuro-Oncology (RANO) criteria as assessed by blinded independent central review.
  • The trial is being conducted in collaboration with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and is designed to support the potential regulatory approval of tovorafenib.
  • The global, Phase 3, registrational FIREFLY-2/LOGGIC clinical trial is evaluating once-weekly monotherapy tovorafenib in newly-diagnosed patients with pLGG harboring a known activating RAF alteration.

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

Retrieved on: 
Monday, September 12, 2022
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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.

Key Points: 
  • 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 accomplished leader in the development and commercialization of new cancer therapies and we are thrilled to welcome him as chairman of our board of directors, said Jeremy Bender, Ph.D., chief executive officer of Day One.
  • Mr. Nicholson currently serves as chairman of the board of directors for G1 Therapeutics and as a board member for Tmunity Therapeutics and NextCure.
  • Day One is an innovative company dedicated to advancing new cancer therapies for people of all ages and I could not be more excited to join its board of directors as chairman, said Mr. Nicholson.

Day One Reports Second Quarter 2022 Financial Results and Corporate Progress

Retrieved on: 
Thursday, August 4, 2022
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SOUTH SAN FRANCISCO, Calif., Aug. 04, 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 financial results for the second quarter of 2022 and highlighted recent corporate achievements.

Key Points: 
  • Day One anticipates releasing topline results for the full FIREFLY-1 pivotal study population in the first quarter of 2023.
  • Day One expects to dose the first patient in FIREFLY-2/LOGGIC trial in the third quarter of 2022.
  • R&D Expenses: Research and development expenses were $22.6 million for the second quarter of 2022 compared to $9.9 million for the second quarter of 2021.
  • G&A Expenses: General and administrative expenses were $14.2 million for the second quarter of 2022 compared to $5.5 million for the second quarter of 2021.