TKI

Black Diamond Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, August 11, 2023
Diamond, FGFR, MAP, Myenteric plexus, DNA, AACR, Central nervous system, PRS, GBM, Diarrhea, RECIST, Clinical trial, Cancer, MAPK, Black Diamond, BRAF, Mutation, TKI, G&A, Toxicity, Appetite, Lung cancer, Paronychia, CNS, Rash, Glioblastoma, II, M26 Modular Accessory Shotgun System, Development, State Administrative Expenses, RAS, Patient, Investment, EGFR, Stomatitis, Administration, Drug discovery, Nausea, Neoplasm, Poster, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, ORR, Food, Safety, Fatigue, RAF, Medical imaging, Pharmaceutical industry, Security (finance), Life insurance, NSCLC

and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
  • Black Diamond initiated a Phase 1 clinical trial for BDTX-4933 in select indications for patients harboring all-class BRAF or RAS mutations in the second quarter of 2023.
  • Net cash used in operations was $14.4 million for the second quarter of 2023 compared to $18.1 million for the second quarter of 2022.
  • Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents and investments.

Chondrosarcoma Market Outlook to 2032: Emerging Therapies and Market Access Drive Growth in the 7MM, Addressing Unmet Needs in Rare Bone Cancer Treatment - ResearchAndMarkets.com

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Wednesday, August 9, 2023
Health, Oncology, TKI, EU4, Ivosidenib, Disease, Radiation, Chondrosarcoma, USD, NCCN, Patient, IDH2, IDH1, United Kingdom, Dasatinib, Drug pipeline, Pharmaceutical industry, Epidemiology

It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.

Key Points: 
  • It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.
  • Chondrosarcoma Cases and Market Size: As per NCCN Guidelines, nearly 65% of chondrosarcoma cases are related to IDH1 or IDH2 mutations.
  • Limited Treatment Options: Conventional chondrosarcomas, the major subtype, are considered resistant to chemotherapy and radiation, resulting in limited treatment options.
  • Market Access and Reimbursement: Reimbursement of rare disease therapies like chondrosarcoma can be limited due to high costs and lack of specific approaches to evaluating rare disease drugs.

Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2023

Retrieved on: 
Wednesday, August 9, 2023
Biotechnology, Health, Science, Pharmaceutical, Research, Monoclonal antibody, US Food Sovereignty Alliance, Clinical trial, OS, Trae tha Truth, Quality of life, TKI, NSCLC, Immunotherapy, Lung cancer, PFS, ASCO, VEGF, Hair, American Society of Clinical Oncology, Patient, Investment, EGFR, Anemia, Annual general meeting, SMMT, Webcast, Knowledge, PD-1, FDA, Phase, Collaboration, Society, ORR, Pharmaceutical industry, Road, Security (finance), Cryptocurrency, Rare-earth element

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the second quarter and six months ended June 30, 2023.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the second quarter and six months ended June 30, 2023.
  • Summit intends to dose patients in the HARMONi-3 trial during the second half of 2023.
  • Net loss for the three and six months ended June 30, 2023 was $14.7 million and $557.1 million, respectively.
  • Operating cash outflow for the six months ended June 30, 2023 and 2022 was $42.4 million and $38.2 million, respectively.

QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT® (avapritinib) in gastrointestinal stromal tumors

Retrieved on: 
Monday, August 7, 2023
TKI, GIST, DNA, QIAGEN, QGEN, Stromal cell, Gastrointestinal tract, DSM-IV codes, Research fellow, Biotechnology, NGS, Mutation, Helix, Sarcoma, PDGFRA, Patient, Physician, Polymerase chain reaction, Medicine, Nested polymerase chain reaction, MDX, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, PCR, Food, Vaccine

The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.

Key Points: 
  • The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.
  • QIAGEN and Blueprint Medicines collaboratively developed the PDGFRA companion diagnostic assay.
  • QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics.
  • Furthermore, QIAGEN has recently announced a series of collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

ESMO 2023 | Ascentage Pharma to Present Results from Two Clinical Studies, including One Oral Presentation, at 2023 ESMO Congress

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Thursday, August 3, 2023
GIST, Mini, ESMO, Cancer, Hope, TKI, CHB, BCR-ABL, Oncology, NSCLC, European Society for Medical Oncology, Congress, Poster, Patient, Notifiable disease, Gastrointestinal stromal tumor, Hepatitis, Pharmaceutical industry

As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.

Key Points: 
  • As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.
  • This year, the ESMO Congress will take place on October 20 to October 24, local time, in Madrid, Spain.
  • "These presentations highlight Ascentage Pharma's robust capabilities in clinical development and global innovation, as well as our strong potential in solid tumors.
  • These two clinical studies to be presented at the ESMO Congress this year are as follows:

Clearside Biomedical Highlights Excellent Safety Profile of CLS-AX and Potential for Extended Duration of Effect in Data Presentation at the American Society of Retina Specialists 41st Annual Scientific Meeting

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Monday, July 31, 2023
Durability, Diabetes, Anti-VEGF, AMD, Pharming, Cohort, Aes, Eye, Clinical trial, TKI, Targeted therapy, Diabetic retinopathy, Retina, Inflammation, Extension, Șaeș, Melanoma, Patient, Physician, CST, Associate, Month, Biological effects of high-energy visible light, Vascular occlusion, Axitinib, Phase, Visual acuity, Society, ASRS, Safety, SCS, Pharmaceutical industry, MD

ALPHARETTA, Ga., July 31, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that safety and tolerability data from its recent OASIS clinical trial of CLS-AX (axitinib injectable suspension) were presented at the American Society of Retina Specialists (ASRS) 41st Annual Scientific Meeting. CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector®.

Key Points: 
  • CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector®.
  • The presentation, entitled, “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy” was delivered by Rahul N. Khurana, MD, FACRS, Northern California Retina Vitreous Associates.
  • “The safety profile for new potential treatments in development for wet AMD and other retinal diseases is of paramount importance to physicians and patients.
  • CLS-AX has demonstrated an excellent safety profile to date with no adverse events, and in particular, no inflammation,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.

Elevar Therapeutics Announces Publication of Phase 3 CARES 310 Study Results in The Lancet

Retrieved on: 
Tuesday, July 25, 2023
Camrelizumab, ACC, Hepatocellular carcinoma, Progression-free survival, Food, TKI, Adenoid cystic carcinoma, Prescription Drug User Fee Act, Patient, Sorafenib, PDUFA, PD-1, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCC, Pharmaceutical industry, Lancet

FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.

Key Points: 
  • FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.
  • The study assessed the combination of Elevar’s drug candidate rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).
  • “As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • With efficacy results generally consistent across all subgroups, the CARES 310 data suggested the combination confers a benefit in a global uHCC population.

Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma

Retrieved on: 
Monday, July 17, 2023
Hepatocellular carcinoma, Progression-free survival, NDA, TKI, PFS, Patient, Sorafenib, PDUFA, PD-1, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.

Key Points: 
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.
  • “Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • “With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy.
  • Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab

Retrieved on: 
Wednesday, July 12, 2023
TKI, Malignancy, Renji Hospital, RCC, Clinical trial, Hope, Nephrectomy, Immunotherapy, PFS, Kidney, Shanghai Jiao Tong University School of Medicine, Global Research, Chinese, Death, Development, SSE, Chinese Medical Journal, HIV disease progression rates, Patient, Risk, National Medical Products Administration, IMDC, Carcinoma, Diagnosis, Axitinib, ORR, Safety, Disease, Pharmaceutical industry

Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.

Key Points: 
  • Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.
  • This supplemental new drug application is mainly based on the RENOTORCH study (NCT04394975).
  • The safety profile of toripalimab in the study was consistent with known risks, and no new safety signals were identified.
  • Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences, expressed her enthusiasm regarding the acceptance of this application.

AVEO Oncology Announces Completion of Enrollment in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma

Retrieved on: 
Tuesday, June 27, 2023
Apoptosis, RCC, Bristol Myers Squibb, TKI, Immunotherapy, Harvard Medical School, NCCN, VEGF, Journal of the National Comprehensive Cancer Network, Patient, Data, LG Chem, Safety, Nivolumab, Dana–Farber Cancer Institute, Pharmaceutical industry

BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.

Key Points: 
  • BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.
  • The study is evaluating FOTIVDA® (tivozanib) in combination with OPDIVO® (nivolumab), Bristol Myers Squibb's anti-PD-1 immunotherapy.
  • There are currently no National Comprehensive Cancer Network® (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy.
  • The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment.