BRAF V600

XOMA Reports First Quarter 2024 Financial Results and Highlights Recent Activities

Retrieved on: 
Thursday, May 9, 2024
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EMERYVILLE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2024 financial results and highlighted recent activities.

Key Points: 
  • Earned $9 million milestone upon U.S. Food and Drug Administration’s approval of Day One’s OJEMDA™ (tovorafenib);
    EMERYVILLE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2024 financial results and highlighted recent activities.
  • XOMA receives 100 percent of the DSUVIA® economics until a threshold is achieved; thereafter, XOMA retains the 15 percent royalty associated with DSUVIA® commercial sales.
  • The 75 percent royalties from Department of Defense purchases and remaining milestone payments will be shared equally between XOMA and Talphera.
  • Dosed first patient in its Phase 3 trial of RZ358; XOMA earned a $5.0 million milestone associated with the event.

Day One Reports First Quarter 2024 Financial Results and Corporate Progress

Retrieved on: 
Monday, May 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.

FDA Roundup: April 26, 2024

Retrieved on: 
Friday, April 26, 2024
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On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.

Key Points: 
  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.
  • The FDA expects this firm to fully address the violations described in the warning letter.
  • This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.
  • This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.

XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Thursday, April 25, 2024
FDA, Glioma, NDA, Food, Economics, New Drug Application, BRAF, Patient, Therapy, LGG, BRAF V600, Pharmaceutical industry

EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 

Key Points: 
  • First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
    EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  • “This is an important milestone for XOMA and our royalty portfolio, but more importantly, it is a watershed event for children living with low-grade gliomas with BRAF alterations that have relapsed or progressed,” stated Owen Hughes, Chief Executive Officer of XOMA.
  • In March 2021, XOMA paid $13.5 million upfront to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, plus a share of potential event-based economics, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

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

Retrieved on: 
Tuesday, April 23, 2024
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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.

FORE Biotherapeutics to Present Nonclinical Data at the 2024 AACR Annual Meeting Supporting Superior Potency for Plixorafenib Compared with BRAF or Pan-Raf Inhibitors, When Combined with MEK Inhibition

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Safety, BRAF, Meki, Binimetinib, BRAF V600, Cell, MEK, Pharmaceutical industry

The data show nonclinical synergistic activity of plixorafenib when combined with MEK inhibition across all BRAF alterations tested.

Key Points: 
  • The data show nonclinical synergistic activity of plixorafenib when combined with MEK inhibition across all BRAF alterations tested.
  • In cells with BRAF V600 or non-V600 mutations or BRAF fusions, the combination of plixorafenib and binimetinib is most potent of the BRAF and pan-RAF inhibitors tested.
  • To date, plixorafenib has demonstrated encouraging efficacy and safety data from the phase 1/2a study; these nonclinical data help build the foundation for potential future development of plixorafenib in combination with a MEK inhibitor.
  • Poster Title: The paradox-breaker BRAF inhibitor plixorafenib (PLX8394; FORE8394) synergizes with MEK inhibitors (MEKi) in BRAF V600 and non-V600 alterations, with higher potency compared to early generation BRAFi and pan-RAFi

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024
BRAF, Cancer, Wuxi, TIL, Information, Melanoma, FDA, Food, U.S. FDA, BLA, PD-1, Interim, BRAF V600, Patient, Navy, Research, MEK, Pharmaceutical industry

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024
BRAF, Cancer, Wuxi, TIL, Information, Melanoma, FDA, Food, U.S. FDA, BLA, PD-1, Interim, BRAF V600, Patient, Navy, Research, MEK, Pharmaceutical industry

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024
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SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024
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"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.