EGFR

Affimed Reports 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Research, EGFR, GVHD, NSCLC, Genentech, ASH, AML, PD, Disease, International, International Financial Reporting Standards, Patient, Webcast, EFS, EDT, CRS, Cancer, Record, Insurance, Trial of the century, Bank statement, Investment, Safety, Workforce, Roivant Sciences, PFS, IASB, Hodgkin lymphoma, Book, NK, HL, Cytokine release syndrome

MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.

Key Points: 
  • MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
  • Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 financial results and corporate developments.

Erasca Reports Fourth Quarter 2023 and Full Year 2023 Business Updates and Financial Results

Retrieved on: 
Wednesday, March 27, 2024
Administration, EGFR, Mutation, Index, Colorectal cancer, Cetuximab, Central nervous system, Novartis, Webcast, Patient, GBM, CNS, Neoplasm, Acquisition, G&A, Insurance, BRAF, NRAS, MEK, CRC, Melanoma, ASCO, ID, MTD, Research and development, Probability, Data, FDA, Outsourcing, FTD, Pharmaceutical industry

SAN DIEGO, March 27, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today provided business updates and reported financial results for the fiscal quarter and full year ended December 31, 2023.

Key Points: 
  • In addition, a strategic pipeline prioritization sharpened Erasca’s focus on existing programs that we believe have the highest probability of success for patients.
  • Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended December 31, 2023, compared to $29.4 million for the quarter ended December 31, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $9.1 million for the quarter ended December 31, 2023, compared to $8.7 million for the quarter ended December 31, 2022.
  • Erasca will hold a conference call and webcast on Thursday, March 28, 2024 at 8:30 am ET.

One Biosciences Welcomes Dr. Scott Braunstein and Dr. Vincent Miller to its Board of Directors

Retrieved on: 
Wednesday, March 27, 2024
Constellation, Single-cell analysis, Lung cancer, EGFR, Health, Biotechnology, Rachel Haurwitz, New Jersey Medical School, Foundation Medicine, Cornell University, University, Knowledge, American Cancer Society, Research, Esperion Therapeutics, Cancer, A.I, Medicine, Summit Health, Esperies, Therapy, Drug development, Partner, MorphoSys, JPMorgan Chase, Thomas Jefferson University Hospital

to identify a new generation of precision medicine targets and develop new treatments, today announced the appointments of Dr. Scott Braunstein, and Dr. Vincent Miller, to its Board of Directors.

Key Points: 
  • to identify a new generation of precision medicine targets and develop new treatments, today announced the appointments of Dr. Scott Braunstein, and Dr. Vincent Miller, to its Board of Directors.
  • Our proprietary discovery engine has identified its first promising targets, and we are preparing to start drug development activities in 2025.
  • Bolstering our Board with such seasoned leaders will be a key factor to success.”
    Dr. Scott Braunstein brings over 30 years of knowledge and experience gained in the biotechnology, pharmaceutical, and biotech portfolio management industries.
  • Dr. Braunstein is currently on the board at Trevena and Caribou Biosciences.

EpiBiologics Extracellular Protein Degraders Demonstrate Robust Preclinical Anti-tumor Activity and Survival Benefit

Retrieved on: 
Monday, April 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, EGFR, Survival, NSCLC, Colorectal cancer, Patient, Lung cancer, AACR, CRC, Therapy, Research fellow

EpiBiologics , a preclinical stage company advancing new bispecific antibody therapeutics for extracellular protein degradation, is presenting data today on its EpiTAC protein degraders in oncology demonstrating robust in vivo anti-tumor activity and survival benefit.

Key Points: 
  • EpiBiologics , a preclinical stage company advancing new bispecific antibody therapeutics for extracellular protein degradation, is presenting data today on its EpiTAC protein degraders in oncology demonstrating robust in vivo anti-tumor activity and survival benefit.
  • EpiTAC bispecific antibodies leverage cell-surface degrader receptors enriched in disease tissue to selectively degrade membrane and extracellular targets and address significant unmet needs.
  • “Our proof-of-concept data demonstrate that EpiTAC activity is greater than standard of care in multiple preclinical tumor models.
  • These data motivate us to develop new and clinically meaningful therapies,” said Shyra Gardai, Ph.D., Chief Scientific Officer of EpiBiologics.

Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024

Retrieved on: 
Monday, April 8, 2024
Penetrance, HER2, Mutagenesis, EGFR, Cell, Patient, CNS, Cancer, ENU, Human, Senior, TRK, AACR, Crizotinib, ROS1, Drug discovery, Vaccine

CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new preclinical data for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520). The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego. The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.

Key Points: 
  • The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego.
  • The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.
  • "Today's presentations continue to reinforce the differentiated profiles of our drug candidates," said Henry Pelish, Ph.D., Senior Vice President of Drug Discovery at Nuvalent.
  • These mutagenesis screens provide additional preclinical support for zidesamtinib's potential to drive deep and durable responses for patients with ROS1-driven cancers.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Retrieved on: 
Sunday, April 7, 2024
PART, EGFR, Mutation, BTD, NSCLC, Disease, Progression-free survival, Patient, Heel, Corr, NDA, Breakthrough, Non-Euclidean geometry, Doctor of Philosophy, CDE, Society, ESMO, Safety, ASCO, FDA, Annual general meeting, Food, Pharmaceutical industry

SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

Key Points: 
  • SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
  • This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1).
  • This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
  • Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.

Sequana Medical announces three month follow-up data from MOJAVE non-randomized cohort confirming dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR® therapy

Retrieved on: 
Monday, March 25, 2024
Cardiorenal syndrome, Congestion, Myocardial infarction, DSR, Brussels Stock Exchange, Liver disease, Partnership, RED, Patient, 2.0, Blood urea nitrogen, Cancer, Fluid, Heart, Heart failure, Furosemide, EGFR, Safety, DSMB, Overload, Hyponatremia, Hypertension, Pharmaceutical industry

These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.

Key Points: 
  • These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.
  • Unlike loop diuretics which, on average, have a negative impact on renal function and diuretic response, DSR has again demonstrated its potential to restore renal health and control of volume status.
  • Dramatic improvement in diuretic response and stable kidney function: During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics.
  • In January 2024, the independent DSMB approved the start of the randomized MOJAVE cohort following review of the safety data reported from the non-randomized cohort.

ProKidney Reports Full Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 21, 2024
Research, Health, Commercialization, Transplant, CKD, Risk, Patient, AHN, Kidney failure, Biostatistics, CBO, Business development, Overalls, Quality of life, Trial of the century, Kidney disease, CVS Health, Clinical trial, EGFR, Chronic kidney disease, Dialysis, Baxter International, Type, Pharmaceutical industry

WINSTON-SALEM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the year ended December 31, 2023.

Key Points: 
  • WINSTON-SALEM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the year ended December 31, 2023.
  • In November, the Company announced Dr. Bruce Culleton assumed the role of the CEO and joined the ProKidney board of directors.
  • Dr. Culleton joined ProKidney in July 2023 as Executive Vice President of Clinical Development and Commercialization.
  • Mr. Periera-Kamath had previously joined ProKidney in July 2023 as Vice President of Business Development & Innovative Solutions.