Genta (company)

IceCure Medical Files Appeal with U.S. FDA Requesting a Review of its De Novo Classification for ProSense® in Early-Stage Breast Cancer

Retrieved on: 
Wednesday, November 15, 2023
Classification, Woman, Genta (company), De novo, Food, Luminal, Freezing, CFR, Breast cancer, Patient, European, FDA, Marketing, Neoplasm, ICE3, Medical device, Pharmaceutical industry

IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.

Key Points: 
  • IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.
  • On September 20, 2023, IceCure announced that the FDA denied its De Novo request.
  • Per the FDA's guidelines, IceCure expects a response to its appeal by the end of January 2024.
  • Outside of the U.S., ProSense® is approved for early-stage breast cancer in numerous countries, including in the European Union, Brazil, and China.

Tango Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Wednesday, November 8, 2023
Research, Breast, PRMT5, NSCLC, GBM, Cancer, Pembrolizumab, Georgetown University, Safety, SITC, Preclinical development, Head, Annual general meeting, University of California, San Diego Performance-Based Skills Assessment, USP1, Biotechnology, Genta (company), Lead, University, Therapy, Patient, Society for Immunotherapy of Cancer, Neuro-oncology, MTA, SNO, Conference, RCOR1, Immunotherapy, Clinical trial, MTAP, Nervous tissue, FDA, IND, Prostate cancer, Fast Track, Pharmacokinetics, STK11, Third Rock Ventures, Drug discovery, Collaboration, Carcinoma, Jannik Madum Andersen, Glioblastoma, FTD, Mutation, PARP, Pharmaceutical industry, Vaccine, Birth control, Petroleum, Arms industry, Biology

For TNG462, we dosed the first patient in the phase 1/2 trial in July 2023.

Key Points: 
  • For TNG462, we dosed the first patient in the phase 1/2 trial in July 2023.
  • Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, November 1-5, 2023, San Diego, CA
    In November 2023, Tango scientists presented preclinical data highlighting the potential of TNG260 in STK11-mutant cancers.
  • AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 11-15, 2023, Boston, MA
    In October 2023, Tango scientists presented five posters highlighting preclinical data from the precision oncology pipeline and synthetic lethality discovery platform.
  • The year-to-date increase is the result of out-licensing a program to Gilead for $5.0 million during the second quarter of 2023.

TC BioPharm Announces Streamlined Efficiencies and Reduces Overhead with Selection of Single Global CRO for Clinical Trials

Retrieved on: 
Thursday, November 2, 2023
Knowledge, Genta (company), Holding, FTRE, Data management, PLC, Database, Contract research organization, Cancer, Fine chemical

EDINBURGH, Scotland, Nov. 2, 2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, announced today that it has selected of Fortrea (FTRE) as the Company's Contract Research Organization (CRO) for global trials, including ACHIEVE and ACHIEVE2.

Key Points: 
  • EDINBURGH, Scotland, Nov. 2, 2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, announced today that it has selected of Fortrea (FTRE) as the Company's Contract Research Organization (CRO) for global trials, including ACHIEVE and ACHIEVE2.
  • The trials, in the UK and US respectively, will be managed by Fortrea on an ongoing basis, creating a vertically integrated clinical trial program which allows for increased operational efficiencies, resulting in better data management and review as well as value creation.
  • TC BioPharm expects to generate cash savings through the creation of these efficiencies by consolidating CRO services under a single entity.
  • We appreciate Fortrea taking on these exciting trials with us and look forward to data read outs in 2024."

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Retrieved on: 
Thursday, June 22, 2023
American Diabetes Association, Diabetes, Topcon, Eye, Food and Drug Administration, Clinical trial, DR, Paratriathlon, Doctor of Philosophy, MDR, Patient, European, Diabetic retinopathy, LOS, Diagnosis, Genta (company), AI, FDA, ADA, Food, Regulation, Medical device, Telescopic sight, Pharmaceutical industry, Medical imaging

The regulatory clearance of the EyeArt v2.2.0 system makes it the first and only AI system that is FDA-cleared for use with multiple retinal cameras by different manufacturers.

Key Points: 
  • The regulatory clearance of the EyeArt v2.2.0 system makes it the first and only AI system that is FDA-cleared for use with multiple retinal cameras by different manufacturers.
  • This clearance builds upon the EyeArt system's launch in August 2020 as the first and only AI technology to be cleared by the FDA to detect both more than mild and vision-threatening DR.
  • In the European Union, the EyeArt system is the first and only AI system approved under MDR Class IIb to detect DR, age-related macular degeneration, and glaucomatous optic nerve damage, in a single test.
  • Eyenuk will showcase the newly-cleared EyeArt system at the 83rd Annual Scientific Sessions of the American Diabetes Association ( ADA 2023 ) on June 23–26 in San Diego, CA.

Check-Cap Announces Review of Strategic Alternatives and Reduction in Workforce

Retrieved on: 
Tuesday, June 6, 2023
Workforce, Disclosure, CHEK, FDA, Genta (company), Sale

ISFIYA, Israel, June 6, 2023 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) today announced that following a review of its business, resources and capabilities, it is exploring strategic alternatives focused on maximizing stockholder value.

Key Points: 
  • ISFIYA, Israel, June 6, 2023 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) today announced that following a review of its business, resources and capabilities, it is exploring strategic alternatives focused on maximizing stockholder value.
  • As part of this process, the Company has engaged Ladenburg Thalmann & Co. Inc. as an advisor to the Company in this process.
  • Strategic alternatives being evaluated include the sale of all or part of the Company, licensing, merger or reverse merger.
  • In addition, the Company's Board of Directors has approved a reduction in its workforce by approximately 90 percent, to reduce the Company's cash burn, after which the Company expects to have eight remaining employees.

Soleno Therapeutics Completes Enrollment in Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome

Retrieved on: 
Wednesday, May 3, 2023
Prader–Willi syndrome, Therapy, File, Genta (company), NDA, Patient, Rare, PWS, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

REDWOOD CITY, Calif., May 03, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has completed enrollment in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS). The U.S. Food and Drug Administration (FDA) previously acknowledged that data from the study has the potential to support a New Drug Application (NDA) submission for DCCR.

Key Points: 
  • REDWOOD CITY, Calif., May 03, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has completed enrollment in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS).
  • “We are pleased that enrollment in the randomized withdrawal period of Study C602 is now complete,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.
  • We continue to expect top-line results in the third quarter of 2023.”
    The randomized withdrawal period of Study C602 is a multi-center, randomized, double-blind, placebo-controlled study of DCCR that enrolled 77 patients with PWS at 17 sites in the U.S. and 5 sites in the U.K.
  • The randomized withdrawal period consists only of patients previously enrolled in Study C602, with 93% of the total 83 patients participating, which was inline with expectations.

SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer's Disease and Agitation

Retrieved on: 
Tuesday, May 2, 2023
Edinburgh, CMAI, Central nervous system, Delirium, Alzheimer's disease, Pittsburgh Sleep Quality Index, Hypotension, Disease, Tolerability, Deficit spending, Falls, Appetite, Agitation, TEL, Dementia, MD, Mini–Mental State Examination, AD, Edinburgh Feeding Evaluation in Dementia Scale, Genta (company), Pharmaceutical industry, Medical imaging, Safety, Patient

TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment.

Key Points: 
  • TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment.
  • The Company is expecting to receive the final trial results in the upcoming weeks.
  • On November 7, 2022, the Company announced positive interim results from the open label trial, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability and efficacy trends of twice daily oral administration of SCI-110.
  • The interim results summarize the data from the first eight patients who completed the trial as per protocol.

BioLineRx Announces Publication in Nature Medicine of its GENESIS Phase 3 Clinical Trial Data Evaluating Motixafortide and G-CSF in Stem Cell Mobilization for Autologous Transplantation in Multiple Myeloma

Retrieved on: 
Monday, April 17, 2023
Nature Medicine, Multiple myeloma, Survival, Clinical trial, Bone marrow, HSCT, CD34, Stem cell, TEL, GENESIS, ASCT, Patient, Granulocyte colony-stimulating factor, HSPC, TASE, G-CSF, Genta (company), Safety, Pharmaceutical industry

TEL AVIV, Israel, April 17, 2023 /PRNewswire/ --  BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced the publication of data from the Company's GENESIS Phase 3 clinical trial in the peer-reviewed journal Nature Medicine.  The international GENESIS trial evaluated the safety and efficacy of the Company's lead investigational candidate motixafortide plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF for the mobilization of hematopoietic stem cells in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).

Key Points: 
  • The international GENESIS trial evaluated the safety and efficacy of the Company's lead investigational candidate motixafortide plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF for the mobilization of hematopoietic stem cells in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).
  • The clinical trial found that all primary and secondary endpoints were achieved with a statistical significance of p
  • These data highlight the potential of motixafortide plus G-CSF, if approved, to enhance the treatment options for clinicians and patients with multiple myeloma undergoing ASCT."
  • "We look forward to continuing the development of motixafortide with the aim of advancing care for patients with multiple myeloma."

Galectin Therapeutics Reports 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 30, 2023
Insurance, Database, Cirrhosis, Esophageal varices, Therapy, NASH, Liver disease, Clinical trial, Research, Liver transplantation, GALT, Data monitoring committee, Patient, Annual report, Liver, Pembrolizumab, Liver failure, Genta (company), Safety, Cryptocurrency, Pharmaceutical industry

NORCROSS, Ga., March 30, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2022.

Key Points: 
  • NORCROSS, Ga., March 30, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2022.
  • From the beginning of December until the end of February, we randomized more than 5 patients per week, notwithstanding the holiday season.
  • “We look forward to managing this trial and obtaining interim analysis results from the Phase 2b portion in the fourth quarter of 2024.
  • The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSD

Retrieved on: 
Wednesday, February 15, 2023
Connective tissue, Insurance, Dizziness, Genta (company), PTSD, Safety, Patient, Neck, Research, Neuro, Sympathetic nervous system, Hallucination, Contract research organization, FDA, Nausea, Pharmacokinetics, Pharmaceutical industry

Psycheceutical​​ ​is planning to conduct the clinical trials in ​​Australia.

Key Points: 
  • Psycheceutical​​ ​is planning to conduct the clinical trials in ​​Australia.
  • The first in-human, Phase I clinical trial with iNGENū is studying 20 people, each dosed with a single application of NeuroDirect™ ketamine.
  • iNGENū is an industry-leading, full-service CRO providing end-to-end services for companies like ours developing psychedelic drugs.
  • Together, we’re committed to discovering new psychedelic therapies for mental health disorders and central nervous system diseases,” said Psycheceutical CEO Chad Harman.