Plantar fibromatosis

SpringWorks Therapeutics Announces Abstracts Accepted for Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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星期三, 四月 24, 2024
Decentralized finance, FDA, Cancer, Mutation, Safety, NDA, Plantar fibromatosis, Food, Nirogacestat, MEK, ASCO, Patient, Society, APC, Adenomatous polyposis coli, Annual general meeting, Therapy, Pharmaceutical industry

STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that data from the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31 to June 4, 2024. SpringWorks recently initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib in pediatric and adult patients with NF1-PN.

Key Points: 
  • STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that data from the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31 to June 4, 2024.
  • SpringWorks recently initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib in pediatric and adult patients with NF1-PN.
  • Additional data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid tumors were also accepted for presentation at ASCO, including an abstract describing the onset and resolution of ovarian toxicity for desmoid tumor patients treated with nirogacestat, as well as two additional sub-group analyses evaluating nirogacestat in desmoid tumor patients with poor prognostic factors and in those with adenomatous polyposis coli (APC) mutations.
  • “The Phase 2b ReNeu trial data are the cornerstone of our NDA for mirdametinib in NF1-PN, and we are very pleased that these data were accepted for an oral presentation at ASCO,” said Jim Cassidy, M.D., Ph.D., Chief Medical Officer of SpringWorks.

Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

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星期二, 四月 9, 2024
Eurostat, Diagnosis, Civil service commission, Plantar fibromatosis, Radiation, Gene, Growth, Sarcoma, Blood, Disease, Patient, Committee, Knowledge, Tissue, Regulation, Cancer, EMA, IRIS, Radiation therapy, European, Therapy, COMP, Aggressive fibromatosis, Safety, European Commission, GS, Pain, Marketing, Swelling, Medicine, Pharmaceutical industry

Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

Key Points: 


Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

Immunome Completes Acquisition of AL102, a Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala

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星期二, 三月 26, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Phase 1, Plantar fibromatosis, Food, Pharmaceutical industry

“We believe that AL102 can establish a new standard of care for the treatment of desmoid tumors.

Key Points: 
  • “We believe that AL102 can establish a new standard of care for the treatment of desmoid tumors.
  • In parallel, we are excited to advance our preclinical programs towards Phase 1 trials.”
    AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy.
  • AL102 is a potential once-daily oral treatment for desmoid tumors.
  • Data from clinical trials have shown AL102 may be more effective in treating desmoid tumors than OGSIVEO™ (nirogacestat), which recently became the first treatment approved for desmoid tumors by the U.S. Food and Drug Administration in November 2023.

SpringWorks Therapeutics Announces European Medicines Agency Validation for Marketing Authorization Application of Nirogacestat for the Treatment of Adults with Desmoid Tumors

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星期四, 二月 29, 2024
Progression-free survival, PFS, European Commission, EMA, Marketing, Orphan drug, MAA, European, Nirogacestat, Risk, Civil service commission, Therapy, European Medicines Agency, Plantar fibromatosis, Patient, Cancer, Pharmaceutical industry

STAMFORD, Conn., Feb. 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors.

Key Points: 
  • STAMFORD, Conn., Feb. 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors.
  • If approved, nirogacestat will be the first therapy to receive marketing authorization in the European Union (EU) for the treatment of desmoid tumors.
  • Nirogacestat previously received Orphan Drug designation from the European Commission for the treatment of soft tissue sarcoma.
  • “The validation of our marketing authorization application is an important step towards bringing nirogacestat to patients with desmoid tumors in the European Union who currently do not have an approved therapy,” said Saqib Islam, Chief Executive Officer of SpringWorks.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

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星期二, 二月 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Ayala Pharmaceuticals Announces Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors

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星期二, 二月 20, 2024
Progression-free survival, PFS, QOL, New Drug Application, Physician, Quality of life, Plantar fibromatosis, Patient, OTCQX, NDA, Nursing

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors.

Key Points: 
  • REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors.
  • ”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth Berlin, President and Chief Executive Officer of Ayala.
  • “There has been a high-level of enthusiasm from clinical trial investigators, support staff, and patients during the enrollment of RINGSIDE.
  • RINGSIDE has been designed as a registration study to support a New Drug Application (NDA) in desmoid tumors.

Immunome Recognizes Ayala Pharmaceuticals’ Announced Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors

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星期二, 二月 20, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Ayala, OTCQX, Plantar fibromatosis, Pharmaceutical industry

Immunome , Inc. (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, today recognized the announcement by Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors.

Key Points: 
  • Immunome , Inc. (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, today recognized the announcement by Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors.
  • Earlier this month, Immunome announced that it entered into a definitive asset purchase agreement with Ayala to acquire AL102 and related drug candidate AL101.
  • “We are pleased with the progress of the RINGSIDE trial,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome.
  • “The robust enrollment of the Phase 3 portion affirms our excitement for the potential of AL102.

Iterion Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of Tegavivint in Patients with Advanced Hepatocellular Carcinoma Who Have Failed One or More Systemic Treatments

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星期二, 二月 20, 2024
NCI, Neoplasm, WNT, FDA, Drug development, Overalls, Metastasis, National Cancer Institute, Death, Survival rate, Prevalence, Safety, Prognosis, Therapy, Plantar fibromatosis, Patient, Clinical trial, Transducin, Trial of the century, HCC, Cancer, Pharmaceutical industry

Unfortunately, key members of this pathway (including beta-catenin) have either been resistant to conventional drug development or plagued with off-target toxicities.

Key Points: 
  • Unfortunately, key members of this pathway (including beta-catenin) have either been resistant to conventional drug development or plagued with off-target toxicities.
  • Extensive pre-clinical study results across multiple tumor types suggest that TBL1 is a downstream target that is necessary for Wnt/beta-catenin-activated oncogenesis.
  • Tegavivint has demonstrated safety, clinical and pharmacodynamic activity in a Phase 1 clinical study of patients with desmoid tumors.
  • For more information about this Phase 1b/2a clinical trial of tegavivint in patients with advanced HCC, please visit www.ClinicalTrials.gov using the identifier NCT05797805.

Immunome To Acquire AL102, A Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals

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星期二, 二月 6, 2024
OTCQX, MRI, Patient, Prevalence, Pain, Aggressive fibromatosis, VWAP, Plantar fibromatosis, Fibromatosis, FDA, Biotechnology, Orphan, Food, Disability, Radiation, Cancer, NDA, Pharmaceutical industry

Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.

Key Points: 
  • Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.
  • AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy.
  • AL102 is a potential once-daily oral treatment for desmoid tumors.
  • A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala Pharmaceuticals, Inc. in connection with the transaction.

Immunome to Acquire AL102, a Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals

Retrieved on: 
星期二, 二月 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, OTCQX, MRI, Patient, Prevalence, Pain, Aggressive fibromatosis, VWAP, Plantar fibromatosis, Fibromatosis, FDA, Orphan, NDA, Food, Disability, Radiation, Cancer, Pharmaceutical industry

Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.

Key Points: 
  • Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.
  • AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy.
  • AL102 is a potential once-daily oral treatment for desmoid tumors.
  • A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala Pharmaceuticals, Inc. in connection with the transaction.