Day One

BrightSpring Health Services Announces Onco360® Was Selected as National Pharmacy Partner for OJEMDA™

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월요일, 5월 20, 2024
Insurance, Day One, Patient, Health care, Brain, FDA, Pharmacy, Health, Cancer, LGG, BRAF, BRAF V600, Central nervous system, Pharmaceutical industry

LOUISVILLE, Ky., May 20, 2024 (GLOBE NEWSWIRE) -- BrightSpring Health Services (“BrightSpring” or “BrightSpring Health Services”) (NASDAQ: BTSG) is proud that its company, Onco360®, one of the nation’s largest independent oncology pharmacies, is being selected as a pharmacy partner by Day One Biopharmaceuticals for OJEMDA™, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.

Key Points: 
  • LOUISVILLE, Ky., May 20, 2024 (GLOBE NEWSWIRE) -- BrightSpring Health Services (“BrightSpring” or “BrightSpring Health Services”) (NASDAQ: BTSG) is proud that its company, Onco360®, one of the nation’s largest independent oncology pharmacies, is being selected as a pharmacy partner by Day One Biopharmaceuticals for OJEMDA™, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.
  • LGG is the most common central nervous system tumor in children, representing 30% of pediatric brain tumors.
  • BRAF is the most commonly altered gene in pediatric LGG, as 75% of patients have BRAF alterations.
  • We’re proud to partner with Day One Biopharmaceuticals to become a specialty provider for OJEMDA™,” said Benito Fernandez, Chief Commercial Officer at Onco360®.

Day One Reports First Quarter 2024 Financial Results and Corporate Progress

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월요일, 5월 6, 2024
FDA, Brain, BRAF V600, Day One, Investment, Food, Research, Insurance, Conference, U.S. FDA, MEK, Prescription, ASCO, BRAF, Patient, Society, Clinical trial, Annual general meeting, Food and Drug Administration, Ageing, Pharmaceutical industry

BRISBANE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2024 financial results and highlighted recent corporate achievements.

Key Points: 
  • Results from the FIRELIGHT-1 Phase 1b and next steps are expected in the second half of 2024.
  • Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2026.
  • R&D Expenses: Research and development expenses were $40.2 million for the first quarter of 2024 compared to $27.8 million for the first quarter of 2023.
  • G&A Expenses: General and administrative expenses were $26.6 million for the first quarter of 2024 compared to $18.0 million for the first quarter of 2023.

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

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화요일, 4월 23, 2024
Neuro-Oncology (journal), First grade, FDA, Society, University, BRAF V600, Day One, Hospital, Acne, Safety, Food, Biopharmaceutical, Conference call, Nausea, Insurance, Conference, Research, Webcast, Viral, Speech, Fatigue, Human, Disease, BRAF, Vomiting, Patient, Medicine, Headache, Event, Rash, Constipation, Diagnosis, Head, Neoplasm, Upper respiratory tract infection, PRS, Xeroderma, Fever, Caregiver, Ageing, Pharmaceutical industry

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.

Key Points: 
  • With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.
  • “We are very proud that our first approved medicine addresses this serious and life-threatening disease of childhood and adolescence.
  • BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration.
  • “This is a tremendous moment not only for Day One, but also for the broader pediatric brain tumor community.

Morningstar Announces Agenda for 2024 Morningstar Investment Conference

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수요일, 3월 13, 2024
Professional Services, Business, Other Professional Services, Finance, Asset Management, Consulting, Day One, GTM, Conference, FAQ, TCW Group, FTX, Sensory overload, CRD, Research, Eddie C. Brown, Artificial intelligence, BlackRock, McCormick Place, AlphaSimplex Group, Morningstar, Inc., Adviser, Machine learning, Marketing, Navy, Financial adviser

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

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월요일, 2월 26, 2024
BRAF, Pfizer, Research, New Drug Application, Doctor of Philosophy, MD, Investment, FDA, Food, Priority review, Day One, Event, Patient, Medicine, Clinical trial, Nature Medicine, NDA, Head, Ageing, MEK, Pharmaceutical industry

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)

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월요일, 10월 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

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월요일, 5월 1, 2023
Rituximab, Bevacizumab, Society, Drug development, Capecitabine, New Drug Application, Roche, Neogene, Food and Drug Administration, Clinical trial, NDA, Cancer, MAPK, SNO, MBA, MEK, CMO, CCO, Doctor of Philosophy, ASCO, Research and development, Pakistan Society of Neuro-Oncology, Goldman Sachs, Development, American Society of Clinical Oncology, MD, Patient, Investment, Pediatrics, Roivant Sciences, Annual general meeting, Webcast, FDA, Conference, Day One, ASPHO, D, Pharmaceutical industry, Nursing, Medical imaging, Video game, Genentech, Research

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

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화요일, 4월 25, 2023
Exercise, Borrowing base, Insurance, OTC Markets Group, Fed, Federal Reserve Bank of St. Louis, FHLB, ALL, Tax, FDIC, Sale, ICS, Federal Home Loan Banks, Federal Reserve responses to the subprime crisis, Tangibility, Federal Reserve, CECL, Insured Cash Sweep, SBA, Day One, Bank, BCAL, ACL, Environment, Video game, Security (finance), Cryptocurrency, Airline, Real estate

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

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월요일, 3월 20, 2023
CBD, Water, RTD, Grapefruit, Drink, Day One, Social media, Soft drink

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

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월요일, 2월 27, 2023
Fujita, Bass, Revo, Tree, Lake Seminole, Cifuentes, Pressure, Day One, Survival Sunday, Tawe Phoenix Boat Club, Cobb, Flint River, ABU Garcia, Movement, Berkley, Water, Wool, Shipbuilding, Silviculture, Hunting, Whaling, Trapping, Airline, Lake Okeechobee

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.