Afatinib

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

Retrieved on: 
Wednesday, February 28, 2024

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.

Delta-Fly Pharma Inc.: Notice of Initiation of Phase III Pivotal comparative clinical trial of DFP-14323

Retrieved on: 
Friday, February 2, 2024

And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.

Key Points: 
  • And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.
  • Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
  • We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.
  • Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.

EGFR Tests Market Forecasts to 2033: Comprehensive Analysis of Size, Share, Regulatory Landscape and Global Trends - ResearchAndMarkets.com

Retrieved on: 
Friday, December 22, 2023

The "EGFR Tests Market Size by Segments, Share, Regulatory, Reimbursement and Forecast to 2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "EGFR Tests Market Size by Segments, Share, Regulatory, Reimbursement and Forecast to 2033" report has been added to ResearchAndMarkets.com's offering.
  • The model includes EGFR Immunohistochemistry Tests, EGFR Sanger Sequencing Tests, EGFR Nucleic Acid Amplification Tests (NAATs), and EGFR Other Tests (EGFR ISH and Mass Array tests).
  • Key Inclusions of the market model are:
    Currently marketed EGFR Tests and evolving competitive landscape:
    Insightful review of the key industry trends.
  • Global, Regional and Country level market specific insights:
    Qualitative market specific information is available with global trends further broken down into regional trends.

Improving Survival Rates: Biotech Innovations in Pancreatic Cancer Treatment

Retrieved on: 
Wednesday, November 29, 2023

VANCOUVER, BC, Nov. 29, 2023 /PRNewswire/ -- USA News Group  -  According to the European Cancer Information System (ECIS), new cancer cases and deaths are on the rise in the EU. Sadly, this is a trend that's happening in North America too, especially among young people. Perhaps the most concerning are the incidences of pancreatic cancer, which while only being the 4th most common cause of death, remains one of the lowest survival rates among all cancers. Despite the dire odds, several biotech developers are working diligently to find treatments to enhance the chances of those who've been unlucky enough to contract pancreatic cancer. Among the top developers putting out promising results with new treatments are Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Exelixis, Inc. (NASDAQ:EXEL), Mirati Therapeutics, Inc. (NASDAQ:MRTX), Eli Lilly and Company (NYSE:LLY), and POINT Biopharma Global Inc. (NASDAQ:PNT).

Key Points: 
  • Perhaps the most concerning are the incidences of pancreatic cancer, which while only being the 4th most common cause of death, remains one of the lowest survival rates among all cancers.
  • Despite the dire odds, several biotech developers are working diligently to find treatments to enhance the chances of those who've been unlucky enough to contract pancreatic cancer.
  • Late last year, favourable data from trials involving pelareorep in treating pancreatic cancer led to the FDA rewarding it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • By mid-2023, the Pancreatic Cancer Action Network (PanCAN) selected pelareorep for their pivotal Phase 3 trial , called Precision Promise.

Improving Survival Rates: Biotech Innovations in Pancreatic Cancer Treatment

Retrieved on: 
Wednesday, November 29, 2023

VANCOUVER, BC, Nov. 29, 2023 /PRNewswire/ -- USA News Group  -  According to the European Cancer Information System (ECIS), new cancer cases and deaths are on the rise in the EU. Sadly, this is a trend that's happening in North America too, especially among young people. Perhaps the most concerning are the incidences of pancreatic cancer, which while only being the 4th most common cause of death, remains one of the lowest survival rates among all cancers. Despite the dire odds, several biotech developers are working diligently to find treatments to enhance the chances of those who've been unlucky enough to contract pancreatic cancer. Among the top developers putting out promising results with new treatments are Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Exelixis, Inc. (NASDAQ:EXEL), Mirati Therapeutics, Inc. (NASDAQ:MRTX), Eli Lilly and Company (NYSE:LLY), and POINT Biopharma Global Inc. (NASDAQ:PNT).

Key Points: 
  • Perhaps the most concerning are the incidences of pancreatic cancer, which while only being the 4th most common cause of death, remains one of the lowest survival rates among all cancers.
  • Despite the dire odds, several biotech developers are working diligently to find treatments to enhance the chances of those who've been unlucky enough to contract pancreatic cancer.
  • Late last year, favourable data from trials involving pelareorep in treating pancreatic cancer led to the FDA rewarding it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • By mid-2023, the Pancreatic Cancer Action Network (PanCAN) selected pelareorep for their pivotal Phase 3 trial , called Precision Promise.

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

Retrieved on: 
Thursday, November 2, 2023

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 Financial Results for the Second Quarter 2023 and Provides Business Update

Retrieved on: 
Monday, August 7, 2023

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

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.

Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer

Retrieved on: 
Thursday, June 29, 2023

(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+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.

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+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.
  • This designation for Zeno follows a 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 on January 7, 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer on July 27, 2020.
  • 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 Announces Financial Results for the First Quarter 2023 and Provides Business Update

Retrieved on: 
Thursday, May 4, 2023

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 04, 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 first quarter and provided a business update.

Key Points: 
  • In April, Merus provided an interim clinical update at the AACR Annual Meeting 2023.
  • Merus plans to provide an update in Q3 2023 on the potential registrational path for this program.
  • In April, Merus provided a pre-clinical presentation of MCLA-129 in comparison with amivantamab at the AACR Annual Meeting 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.