Castration

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.

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, Platinum, INN, Risk, HER2, Leukopenia, Heartburn, Woman, BRCA, Man, Nausea, DNA, Cancer, Neoplasm, Mutation, Pancreatic cancer, ADP, Prostate, Anatomy, Cell division, Cough, IIA, Diarrhea, Prostate cancer, HRD, Fatigue, Breast cancer, ATC, Platelet, Pancreas, Prednisone, Disease, Genome, Abdomen, Testosterone, PARP, Neutrophil, Bevacizumab, Appetite, Human, Anemia, Patient, Medical Subject Headings, Peritoneum, International, FIGO, Tubing (recreation), Neutropenia, Language, Castration, Dizziness, Thrombocytopenia, BRCA1, Gene, Tablet, Select, Time, Vomiting, Ovary, Prednisolone, X-ray, Ovarian cancer, Headache, BRCA2, European Medicines Agency, Indigestion, Periodic breathing, Birth control

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Prednisolone, European Commission, Liver, Agency, Survival, CYP17, INN, Woman, Docetaxel, Fracture, ATC, Male, Hormone, Hypersensitivity, International, Cough, Man, European, Prednisone, Disease, Language, Prostate cancer, Cerebral edema, Eating, Castration, Cancer, Urinary tract infection, Neoplasm, Testosterone, Prostate, Abiraterone acetate, European Medicines Agency, Food, Tablet, Growth, Select, Anatomy, Medicine, IIA, Hypokalemia

Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

PDS Biotech Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Well, Neck, Annual general meeting, DNA, Cervical cancer, Castration, ICI, PSA, ADC, Patient, Research, Lymph, E pluribus unum, Neoplasm, Cytokine, Cancer, Pembrolizumab, Oncology, Doctor of Philosophy, OS, Burtness, Webcast, Safety, Fourth grade, Food, Head, International, Radiation, PDS, Infection, Society, SOC, PDSB, KOL, Opinion, National Cancer Institute, IL12, Recurrence, CRT, CD8, Ferret, Nivolumab, Squamous-cell carcinoma, Biomarker, Standard works, HDAC, Clinical trial, NCI, FDA, Biotechnology, Vaccine, Prostate cancer, Immunotherapy, Survival, TH1, Prostate-specific antigen, Cetuximab, HPV, Docetaxel, Pharmaceutical industry, Medical imaging, Birth control, H1N1

The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.

Key Points: 
  • The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.
  • PDS Biotech anticipates initiation of VERSATILE-003 in Q1 2024.
  • PDS Biotech’s cash balance as of September 30, 2023 was approximately $54.3 million.
  • PDS Biotech believes that, with initiating the VERSATILE-003 Phase 3 clinical trial in the first quarter of 2024, its available cash resources will sustain operational and research and development endeavors into the third quarter of 2024.

Panbela Provides Business Update and Reports Q3 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Pancreatic cancer, MSN, Acquisition, Safety, Oncology Drug Advisory Committee, Therapy, Castration, Data monitoring committee, Exercise, Clinical trial, Sanofi, Patient, DSMB, Intellectual property, Research, ODAC, Patent, DFMO, Doctor of Philosophy, CPP, PBLA, Eflornithine, Pharmaceutical industry

MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.

Key Points: 
  • MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.
  • The independent Data Safety Monitoring Board (DSMB) of the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial.
  • The aggregate gross proceeds from the exercise of the existing warrants totaled approximately $1.9 million, before deducting financial advisory fees.
  • Third Quarter ended September 30, 2023 Financial Results
    General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022.

Merus Announces Financial Results for the Third Quarter 2023 and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, Research, NSCLC, Biomarker, Pembrolizumab, Betta, Castration, HIV disease progression rates, Cetuximab, Partnership, NRG1, Cancer, Drug design, PSA, ESMO, Head, Prostate cancer, Abstract (summary), Pancreatic cancer, ORR, Douglas BTD Destroyer, Safety, PDAC, Patient, EAP, Eli Lilly and Company, Congress, ADT, Clinical trial, CT, Oncology, European Society for Medical Oncology, Toxic leukoencephalopathy, FDA, Lilly, CD3, Aes, HER2, Afatinib, RECIST, Lung cancer, MET, BLA, FTD, Mutation, EGFR, Pharmaceutical industry, Life insurance, Vaccine, Medical imaging, Telescope, Bank, Tutoring, Birth control, CRPC, HNSCC, Incyte, Meru Networks

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the third quarter and provided a business update.

Key Points: 
  • In the planned trial, patients will be randomized to petosemtamab monotherapy or investigators’ choice of single agent chemotherapy or cetuximab.
  • Merus also continues to enroll patients with previously untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in combination with Keytruda®.
  • Initial safety data from this single arm cohort may support the initiation of a first-line registration trial with this combination.
  • 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 Announces Business Update Conference Call

Retrieved on: 
Monday, October 16, 2023
Memorial, Cetuximab, Abstract, NSCLC, ORR, HNSCC, Aes, BLA, PDAC, Memorial Sloan Kettering Cancer Center, EGFR, Safety, Lung cancer, Causality, Abstract (summary), Mutation, Interim, Principal, FDA, ESMO, RECIST, Webcast, Cancer, Neck, Head, European Society for Medical Oncology, Castration, Prostate cancer, EAP, NRG1, HER2, PD-1, Patient, Toxicity, Pharmaceutical industry, Cryptocurrency, Vaccine, Computer data storage, Platinum, Meru Networks

ET

Key Points: 
  • ET
    UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 15, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that it will host a conference call to discuss a business update on Monday, October 16, 2023 at 7:30 a.m.
  • Merus also continues to enroll patients with previously untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in combination with Keytruda®.
  • Merus plans to report initial interim safety and efficacy data from this cohort in the first half of 2024.
  • Merus will hold a conference call and webcast for investors on October 16, 2023 at 7:30 a.m.

PDS Biotech Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
Vaccine, Survival rate, Docetaxel, Biotechnology, International, ICI, Progression-free survival, PDSB, CMC, Survival, Infection, Research, Castration, ASCO, National Cancer Institute, Cytokine, American Society of Clinical Oncology, PDS, Patient, HPV, Webcast, FDA, Pembrolizumab, NCI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, Safety, Prostate cancer, Pharmaceutical industry, Cryptocurrency, Chemistry

PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, will discuss its financial results for the quarter ended June 30, 2023 and provide a business update on its conference call today.

Key Points: 
  • PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, will discuss its financial results for the quarter ended June 30, 2023 and provide a business update on its conference call today.
  • We are excited about the NCI’s abstract acceptance at the upcoming Cytokines 2023 annual meeting.
  • The higher net loss this quarter was primarily due to costs incurred in connection with our research and development programs.
  • The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Merus Announces Financial Results for the Second Quarter 2023 and Provides Business Update

Retrieved on: 
Monday, August 7, 2023
PDAC, Travel, CRPC, RECIST, Oncology, European Society for Medical Oncology, Patient, EGFR, National Medical Products Administration, Eli Lilly and Company, Prostate cancer, Disease, EAP, Afatinib, Mutation, ADT, Research, Lung cancer, Biologics license application, Drug design, CPS, MET, PD-1, FDA, PD-L1, Safety, Pancreatic cancer, Neoplasm, AACR, CD3, HER2, ESMO, Cancer, American Association for Cancer Research, BTD, NSCLC, IP, NRG1, Castration, Lilly, Depreciation, Pembrolizumab, ORR, Partnership, Betta, Clinical trial, OS, Cetuximab, FTD, Bank, Pharmaceutical industry, Medical imaging, Cryptocurrency, HNSCC, Incyte, Meru Wind Power Station

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the second quarter and provided a business update.

Key Points: 
  • In April, Merus provided an interim clinical update at the American Association for Cancer Research (AACR) Annual Meeting 2023.
  • Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.
  • The Company plans to provide an initial clinical data update from the expansion cohorts, and a further clinical development strategy update in the second half of 2023.
  • In July 2023, Merus achieved a milestone and expects a payment of $2.5 million related to the advancement of this program in the third quarter of 2023.

Zenocutuzumab (Zeno) granted second Breakthrough Therapy Designation by the U.S. Food & Drug Administration

Retrieved on: 
Wednesday, July 5, 2023
Pancreatic cancer, Partnership, EAP, CRPC, Afatinib, Cancer, Lung cancer, BTD, Medicine, NSCLC, NRG1, Castration, Patient, FDA, Abstract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, BLA, Food, Safety, Prostate cancer, Pharmaceutical industry, Meru Networks

UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 05, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC), following progression with prior systemic therapy. This designation for Zeno follows BTD for the treatment of patients with NRG1+ pancreatic cancer, following progression with prior systemic therapy or in patients who have no satisfactory alternative treatment options recently announced on June 30, 2023, Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy announced in January 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer announced in July 2020.

Key Points: 
  • (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC), following progression with prior systemic therapy.
  • As of June 1, 2023, more than 175 patients with NRG1+ cancer have been treated with Zeno monotherapy.
  • Further, Merus is evaluating Zeno in combination with androgen deprivation therapy (enzalutamide or abiraterone) in castration resistant prostate cancer (CRPC), irrespective of NRG1+ status.
  • Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.