BAL

bioAffinity Technologies Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Medical Devices, Surgery, FDA, Genetics, Clinical Trials, Biotechnology, Radiology, Pharmaceutical, Health, Oncology, Research, Lung cancer, Growth, CFO, Laboratory developed test, Form, Patient, Accounting, Bronchoalveolar lavage, Sale, Acquisition, Cancer, CPA, CAP, Insurance, MBA, Lung, BAL, BIAF, Bronchoscopy, LDT, Optimism, Medicare, Calendar, Marketing, CMS, Physician, Pharmaceutical industry

Revenue for the fourth quarter of 2023 was approximately $2.2 million, up from no revenue for the prior-year period.

Key Points: 
  • Revenue for the fourth quarter of 2023 was approximately $2.2 million, up from no revenue for the prior-year period.
  • Research and development expenses were $432,000 for the fourth quarter of 2023, compared with $429,000 for the comparable period in 2022.
  • Selling, general and administrative expenses were $2.2 million for the fourth quarter of 2023, compared with $1.2 million for the comparable period in 2022.
  • Net loss for the fourth quarter of 2023 was $2.4 million, compared with a net loss of $1.7 million for the comparable period in 2022.

Agenus Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, BOT, Colitis, Inc., Colorectal cancer, PD, RECIST, IST, Partnership, RAS, Patient, MSI, FOLFIRINOX, BMS, Melanoma, MSS, BAL, Cancer, CRC, NLM, TIGIT, Liver disease, Pharmaceutical industry

Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.
  • “In 2023, Agenus made significant advances across our BOT/BAL development program.
  • $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442 in December 2023.
  • For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share.

GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

Retrieved on: 
Monday, March 4, 2024
Oxygen, IPF, Idiopathic disease, Serum, Doctor of Philosophy, Blood, Homeostasis, Idiopathic pulmonary fibrosis, Inflammation, Vital signs, Safety, Health care, BAL, Biomarker, Pharmacokinetics, Patient, NKT, Natural killer T cell, Bronchoalveolar lavage, NIHR, Movement, GRI, CTA, Immune system, Pharmaceutical industry

LA JOLLA, CA, March 04, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.

Key Points: 
  • The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices.
  • The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
  • “We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621.
  • We are focused on driving this program forward and generating important data readouts this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

bioAffinity Technologies News Update

Retrieved on: 
Wednesday, February 21, 2024
Oncology, Health, Biometrics, Health Technology, General Health, Biotechnology, BIAF, American Thoracic Society, Medicine, Sputum, Research, Fluid, Cole, Conference, Chronic obstructive pulmonary disease, Nursing care plan, Lung, BAL, ATS, Human, Associate, Patient, Lung cancer, Bronchoalveolar lavage, COPD, Evidence-based practice, Pharmaceutical industry

bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.

Key Points: 
  • bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.
  • Lung Innovations Network’s multidisciplinary team focuses on affordable, innovative and individualized care by incorporating new technologies and research into an evidence-based practice.
  • National Sales Director Dallas Coleman announced that Cole Koeppen has joined bioAffinity Technologies as Pulmonary Sales Executive for CyPath® Lung in North Texas.
  • Bansal’s experience as both clinician and researcher demonstrates his commitment to innovative healthcare and the best possible outcome for his patients,” bioAffinity Technologies President and CEO Maria Zannes said.

Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population

Retrieved on: 
Monday, January 22, 2024
Oncology, Health, Infectious Diseases, Research, Science, Biotechnology, Patient, Neoplasm, Microsatellite, MSS, MSI-H, IST, DFS, BAL, Delays, Pathologic, Observational study, Rated R, Colorectal cancer, CRC, Diagnosis, BOT, Inc., Medical imaging

Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.

Key Points: 
  • Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.
  • "BOT/BAL's potential impact on colorectal cancer is groundbreaking.
  • BOT/BAL Eliminates Circulating Tumor DNA (ctDNA): patients in the NICHE-1 study were tested for ctDNA, a biomarker closely associated with long-term Disease-Free Survival (DFS).
  • Neoadjuvant BOT/BAL in both MSS and MSI-H CRC resulted in marked tumor regression and robust immune cell infiltration in a very short interval.

BAL Promotes John Hamill to Partner at its New York Office

Retrieved on: 
Wednesday, January 24, 2024
KIND, Learning, Volunteering, Political science, Law, BAL, Angelina Jolie, AILA, Columbia University, American Immigration Lawyers Association, Lead, Thomson Reuters, Nursing

DALLAS and NEW YORK, Jan. 24, 2024 /PRNewswire/ -- BAL, the award-winning innovative corporate immigration law firm, announced today the promotion of John Hamill to partner. His legal expertise and commitment to making a positive difference in people's lives makes him a strong addition to the firm's esteemed group of partners.

Key Points: 
  • DALLAS and NEW YORK, Jan. 24, 2024 /PRNewswire/ -- BAL , the award-winning innovative corporate immigration law firm, announced today the promotion of John Hamill to partner.
  • As leader of the New York office, John oversees corporate immigration programs for clients in the pharmaceutical, banking, finance and consumer goods industries.
  • John joined BAL in 2018 as an associate in the New York office.
  • "I am humbled to continue leading and learning alongside my colleagues as we guide the immigration process for our clients, their employees and families," said John Hamill, partner at BAL.

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Retrieved on: 
Thursday, January 4, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Overview, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, Pemphigus, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

GRI Bio Commences Patient Enrollment in Phase 2a Biomarker Study Evaluating Lead Program GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”)

Retrieved on: 
Tuesday, December 5, 2023
BAL, Movement, Natural killer T cell, Bronchoalveolar lavage, IPF, Blood, Doctor of Philosophy, Pharmacokinetics, Serum, Oxygen, Biomarker, Interim, GRI, Safety, Vital signs, NKT

LA JOLLA, CA, Dec. 05, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the initiation of patient enrollment in the Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. Patient dosing is expected imminently. Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.

Key Points: 
  • Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • “The start of enrollment marks another important step forward for GRI as we continue to execute our clinical development plans for our lead program, GRI-0621.
  • We are pleased to meet this significant milestone and remain focused on the successful execution of this Phase 2a study.

GRI Bio (NASDAQ: GRI) Announces FDA Clearance of IND for Lead Program GRI-0621, a Type 1 Invariant NKT (“iNKT”) Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”)

Retrieved on: 
Monday, November 27, 2023
BAL, Food, IND, Movement, Natural killer T cell, Bronchoalveolar lavage, IPF, Blood, Doctor of Philosophy, Serum, Pharmacokinetics, Oxygen, Biomarker, Interim, GRI, Safety, NKT, Vital signs, Sales

LA JOLLA, CA, Nov. 27, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (“IND”) application for GRI-0621 for the treatment of IPF. The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end.

Key Points: 
  • The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end.
  • “Clearance of our IND application for GRI-0621 represents a significant milestone for the Company and for our innovative pipeline of NKT cell modulators.
  • Our team has worked tirelessly to meet our planned milestones and I am proud of the continued progress made.
  • Click here to watch a brief video from the GRI Bio management team discussing the IND clearance and the meaning of this milestone for the Company’s GRI-0621 development program.