EGFR

Merus Announces Financial Results for the Fourth Quarter and Full Year 2023 and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024
Cetuximab, Research, Castration, PRS, Intellectual property, Patient, Pancreatic cancer, HNSCC, EAP, Eli Lilly and Company, CRPC, Drug design, BLA, FTD, HER2, MET, Congress, Afatinib, Partnership, NSCLC, CD3, EGFR, ESMO, BTD, Betta, CRC, AACR, Safety, Biomarker, RECIST, Clinical trial, Oncology, Prostate cancer, Neoplasm, FDA, Pembrolizumab, Lung, Disease, Travel, Pharmaceutical industry

Merus also continues to evaluate patients with untreated advanced PD-L1+ HNSCC treated with petosemtamab 1500 mg in combination with pembrolizumab.

Key Points: 
  • Merus also continues to evaluate patients with untreated advanced PD-L1+ HNSCC treated with petosemtamab 1500 mg in combination with pembrolizumab.
  • Merus plans to report initial interim efficacy and safety data from this cohort in the second quarter of 2024.
  • Merus achieved a milestone and received a payment of $2.5 million related to the advancement of this program in the third quarter of 2023.
  • Merus also achieved an additional milestone of $1 million for candidate nomination in the fourth quarter of 2023.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

Retrieved on: 
Wednesday, February 28, 2024
Neoplasm, RMB, SHPL, Net, EZH2, Growth, FC, Tax, Follicular lymphoma, FX, Fast Track, TCFD, Ethics, Marketing, RCC, Health, CER, Sintilimab, ITP, Disclosure, Plasma protein binding, Lancet, MET, Completeness, D-19, Paclitaxel, Met, NDA, NSCLC, EGFR, NRDL, Atopic dermatitis, ESG, CRC, PD-1, Completion, Phases of clinical research, Task force, Half-life, Chills, Potential, Breakthrough therapy, NMPA, Investment, FGFR, Research, PFS, AstraZeneca, EMA, ADS, Annual report, ASCO, FDA, Carbon accounting, VEGFR, Lung, COVID-19, Alopecia areata, PMDA, Lilly, Patient, Cancer, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

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

Retrieved on: 
Tuesday, February 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.

Janux Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Friday, March 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Head, Cancer, Incidence, Neck, EGFR, Investment, Colorectal cancer, PSMA, Renal cell carcinoma, Șaeș, FINANCIAL, Therapy, Liver disease, Patient, PSA, RECIST, IP, FUTURE, CRS, Infrared spectroscopy correlation table, Prostate cancer

“2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.

Key Points: 
  • “2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.
  • RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
    Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024.
  • Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.
  • FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:
    Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

Alnylam Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Therapy, Blood pressure, DBP, Amlodipine, Roche, Month, Safety, Glomerular filtration rate, ABPM, Trial of the century, Cardiology, Indapamide, AGT, Hypertension, American College, SBP, EGFR, Patient, Angiotensin, DB, Alnylam Pharmaceuticals, Medication, RNA interference, Pharmaceutical industry

Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.

Key Points: 
  • Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives.
  • “We are thrilled that a single dose of zilebesiran achieved clinically significant, additional reductions in systolic blood pressure when administered to patients who are not adequately controlled with commonly prescribed antihypertensives,” said Simon Fox, Ph.D., Vice President, Zilebesiran Program Lead at Alnylam.
  • “These KARDIA-2 results, showing durable additional levels of blood pressure reduction on top of what is achieved by standard of care first-line antihypertensives with an encouraging safety profile, reinforce our confidence in zilebesiran’s differentiated profile.
  • The primary endpoint is the change from baseline in mean SBP at Month 3, assessed by 24-hour ABPM.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

Janux Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for PSMAxCD3-TRACTr JANX007 in mCRPC and EGFRxCD3-TRACTr JANX008 in Solid Tumors

Retrieved on: 
Monday, February 26, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, NSCLC, Head, Incidence, Neck, EGFR, Toxicity, TCE, Colorectal cancer, SCCHN, RCC, Prostate, PSMA, Renal cell carcinoma, CRC, Lung, PR, Glioma, Interim, Lung cancer, Safety, Breast, Therapy, Liver disease, Patient, PSA, RECIST, Cytokine release syndrome, CD28, CRS, PD-L1, Cancer

“These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors.

Key Points: 
  • “These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors.
  • JANX007 is in a Phase 1a clinical trial in subjects with advanced or metastatic prostate cancer (mCRPC).
  • As of February 12, 2024, 23 subjects were treated with JANX007 in the dose escalation portion of the Phase 1a clinical trial.
  • Based on this safety profile, we are continuing in the dose escalation and optimization portion of the trial for JANX008.

Bayer Receives U.S. FDA Breakthrough Therapy Designation for BAY 2927088 for Non-Small Cell Lung Cancer Harboring HER2 Activating Mutations

Retrieved on: 
Monday, February 26, 2024
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, NSCLC, EGFR, Neoplasm, Physician, Food, MIT, Harvard University, Breakthrough, Broad Institute, HER2, Safety, Bayer, Pharmacokinetics, Patient, Lung cancer, Mutation, Breakthrough therapy, ERBB2, TKI, Pharmaceutical industry

Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

Key Points: 
  • Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.
  • The Breakthrough Therapy designation is supported by preliminary clinical evidence from the Phase I, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR.
  • “Early clinical evidence suggests that BAY 2927088, our investigational novel oral tyrosine kinase inhibitor, has the potential to benefit patients with NSCLC harboring a HER2 mutation that have progressed on a prior systemic therapy and currently have no other approved treatment available,” said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division.
  • “This Breakthrough Therapy designation is a significant milestone in our relentless efforts to develop innovative therapies for the treatment of lung cancer characterized by specific genomic markers.

Janux Therapeutics to Host Virtual Event Discussing Updated Clinical Data for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008

Retrieved on: 
Tuesday, February 20, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Head, Neck, EGFR, Colorectal cancer, Prostate, PSMA, Renal cell carcinoma, Lung, Glioma, Breast, Lung cancer, Safety, Therapy, Clinical trial, CD28, PD-L1, Vaccine

Specifically, the company will provide clinical efficacy and safety updates to report on progress towards identifying doses for expansion studies with JANX007, and on early dose escalation data for JANX008.

Key Points: 
  • Specifically, the company will provide clinical efficacy and safety updates to report on progress towards identifying doses for expansion studies with JANX007, and on early dose escalation data for JANX008.
  • The company anticipates providing an update on identifying doses to be evaluated in expansion cohorts for JANX007 in 2H 2024.
  • Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with mCRPC.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Year Ended December 31, 2023

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, NSCLC, Paranal Observatory, Cohort, EGFR, Research, Neoplasm, Forecasting, Immunotherapy, ASCO, Investment, FDA, SITC, Table, PD-1, SMMT, Society, Annual general meeting, IPR, Lung cancer, GAAP, VEGF, The Wall Street Journal, Tumor microenvironment, Webcast, Patient, Phase, Trial of the century, Summit, TKI, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the fourth quarter and year-ended December 31, 2023.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the fourth quarter and year-ended December 31, 2023.
  • Summit received the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan.
  • In exchange for these rights, Summit made an upfront payment of $500 million in 2023.
  • Non-GAAP R&D expenses were $22.4 million for the fourth quarter of 2023, as compared to $4.4 million for the same period of the year period.