AST

HistoIndex Presents Advancements in AI-powered Stain-free Tissue Imaging for NASH Clinical Trials at EASL Congress 2023

Retrieved on: 
Wednesday, June 21, 2023
Photon, Abstract, EASL, Non-alcoholic fatty liver disease, PM, Drug development, University, TPE, CET, NASH, Hepatocellular carcinoma, Pathology, Intelligence, Research, ELF, Congress, Fibrosis, Gold, Hepatology, Patient, Algorithm, CEST, Artificial intelligence, ALT, Diagnosis, NAFLD, Entrepreneurship, AI, Digital, Mortality, AST, SHG, University of Oxford, Medical imaging, Medical device

SINGAPORE, June 21, 2023 /PRNewswire/ -- HistoIndex today announced that the Company, alongside its collaborators, will present new data on its novel stain-free tissue imaging technology using clinically validated artificial intelligence (AI) algorithms at the EASL Congress, taking place June 21-24, 2023. The data demonstrate how HistoIndex's stain-free Second Harmonic Generation/Two-Photon Excitation (SHG/TPE) imaging and AI technologies can be used in preclinical through late-stage clinical development to quantify and analyze morphological features of liver biopsy samples across Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD). HistoIndex's patented imaging technology and methodologies will be featured in 14 accepted abstracts, including one oral presentation by Dr. Timothy J. Kendall.

Key Points: 
  • HistoIndex's patented imaging technology and methodologies will be featured in 14 accepted abstracts, including one oral presentation by Dr. Timothy J. Kendall.
  • The studies presented at the EASL Congress demonstrate the successful application of SHG/TPE imaging technology combined with AI analysis in multiple clinical trials focused on NASH and NAFLD.
  • In contrast to manual assessments of stained tissue biopsies and categorical scoring systems, HistoIndex's approach eliminates variability and enhances the accuracy of diagnosis.
  • HistoIndex is participating in the EASL Congress 2023 in Vienna and will be hosting a brunch meeting on 23rd June 2023 from 10.30 am – 12 pm CET to discuss the use of stain-free digital pathology and AI as endpoints in NASH clinical trials.

AST SpaceMobile Confirms 4G Capabilities to Everyday Smartphones Directly From Space

Retrieved on: 
Wednesday, June 21, 2023
Satellite, Technology, Aerospace, Manufacturing, Telecommunications, Mobile, Wireless, Networks, Smart Communications, Digital divide, AT&T, AST SpaceMobile, Telecom Argentina, Bell Canada, Nokia, Rakuten, Verizon (mobile network), AT, Internet, Indosat, Smartfren, Telephone, Human, TIM, History, Vodafone, RAN, Millicom, Data-rate units, ASTS, Telefónica, Saudi Telecom Company, Africell, AST, News, Rakuten Mobile Park Miyagi, Vodacom, Mobile phone, American Tower, Telstra, Etisalat by e&

Space-based cellular communications at 4G speeds using unmodified smartphones is another world first telecommunications achievement by AST SpaceMobile.

Key Points: 
  • Space-based cellular communications at 4G speeds using unmodified smartphones is another world first telecommunications achievement by AST SpaceMobile.
  • View the full release here: https://www.businesswire.com/news/home/20230621154227/en/
    Engineers conducted download speed tests in Hawaii during June using multiple everyday, off-the-shelf smartphones.
  • On April 25, AST SpaceMobile announced it had completed the first-ever space-based voice calls using everyday unmodified smartphones.
  • Vodafone, Rakuten, American Tower, Samsung NEXT and Bell Canada are also investors in AST SpaceMobile.

Finch Announces Reverse Stock Split of Common Stock

Retrieved on: 
Friday, June 9, 2023
Transfer, Intellectual property, Shareholder, Bangladesh Securities and Exchange Commission, Finch, CUSIP, Security (finance), FNCH, AST, Book

The reverse stock split is intended to increase the per share trading price of Finch’s common stock to enable Finch to satisfy the minimum price requirement for continued listing on the Nasdaq Global Select Market.

Key Points: 
  • The reverse stock split is intended to increase the per share trading price of Finch’s common stock to enable Finch to satisfy the minimum price requirement for continued listing on the Nasdaq Global Select Market.
  • The reverse stock split affects all issued and outstanding shares of Finch’s common stock uniformly and will not alter any stockholder’s percentage interest in Finch’s equity, except to the extent that the reverse stock split results in some stockholders receiving cash in lieu of any fractional shares.
  • The par value of Finch’s common stock will remain unchanged at $0.001 per share after the reverse stock split.
  • There will be no change in the authorized number of shares of common stock or preferred stock after the reverse stock split.

Intercept Announces New Data Showing Potential of Fixed-Dose Combination of OCA and Bezafibrate to Normalize Multiple Biomarkers in PBC to be Featured in Podium Presentation at EASL Congress 2023

Retrieved on: 
Wednesday, June 7, 2023
Intercept, EASL, Research and development, Bezafibrate, Therapy, Serum, PBC, Alanine transaminase, Obeticholic acid, Safety, GGT, Aes, ALP, Biomarker, Alkaline phosphatase, Congress, Development, Primary biliary cholangitis, Patient, Data, Intercept Pharmaceuticals, Itch, OCA, Randomness, UDCA, Effect, ALT, European Association for the Study of the Liver, FDA, AST, Interim analysis, Pharmaceutical industry, Medical imaging, Liver

MORRISTOWN, N.J., June 07, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced initial results from a planned interim analysis of its ongoing Phase 2 study 747-213, an active comparator trial demonstrating the therapeutic potential of the combination of obeticholic acid (OCA) and bezafibrate vs. bezafibrate monotherapy on serum biomarkers in primary biliary cholangitis (PBC). These data are part of a larger analysis that will be presented at 08:45 CEST on Friday, June 23 at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria.

Key Points: 
  • Safety was assessed by monitoring of adverse events (AEs) and laboratory values.
  • “Multiple real-world studies have demonstrated improved transplant-free survival of OCALIVA (obeticholic acid) following improvements in a specific combination of biomarkers.
  • We are encouraged by the best-in-class potential of our novel combination to build on this evidence with rapid biochemical responses that have predicted improved clinical outcomes.
  • “Results from a Planned Interim Analysis of a Randomized, Double-Blind, Active-Controlled Trial Evaluating the Effects of Obeticholic Acid and Bezafibrate on Serum Biomarkers in Primary Biliary Cholangitis” Abstract #2495

Destra Multi-Alternative Fund Declares June 2023 Distribution

Retrieved on: 
Friday, June 9, 2023
Professional Services, Finance, Transfer, DRP, Marketing, Calendar, Investment Company Act of 1940, Financial adviser, DMA, Capital gain, Indian stock exchange, Fund, AST, Investment, NYSE, Common, Life insurance, Financial services

On June 9, 2023, Destra Multi-Alternative Fund (the “Fund” or “DMA”), a closed-end fund traded on the New York Stock Exchange under the symbol DMA, declared a distribution of $0.0526 per share for the month of June 2023.

Key Points: 
  • On June 9, 2023, Destra Multi-Alternative Fund (the “Fund” or “DMA”), a closed-end fund traded on the New York Stock Exchange under the symbol DMA, declared a distribution of $0.0526 per share for the month of June 2023.
  • The record date for the distribution is June 20, 2023, and the payable date is June 30, 2023.
  • Based on the Fund’s current share price of $5.54 (as of its close on June 7, 2023), the distribution represents an annualized distribution rate of approximately 11.39% (calculated by annualizing the distribution amount and dividing it by the current market price).
  • The distribution rate should not be considered the yield or total return on an investment in the Fund.

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Tuesday, June 6, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, MSD, Cytomegalovirus, Neutropenia, Male, Pimozide, Aciclovir, IV, AE, Culture, Alkaloid, Simvastatin, Aes, Myopathy, Valganciclovir, MRK, HSCT, Immunotherapy, Merck & Co., Hypertension, Incidence, Ergotism, Diarrhea, Drug, Patient, Leukopenia, Blood, CMV, Kidney, Ciclosporin, ALT, Transplant, Rhabdomyolysis, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, NYSE, Food, Safety, Disease, Medical device, Vaccine, Pharmaceutical industry, Merck

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Key Points: 
  • PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
  • Increased pimozide concentrations due to concomitant administration of PREVYMIS may lead to QT prolongation and torsades de pointes.
  • Study drug was initiated between Day 0 and Day 7 post-kidney transplant and continued through Week 28 (~200 days) post-transplant.
  • The most common primary reasons for transplant were congenital cystic kidney disease (17%), hypertension (16%), and diabetes/diabetic nephropathy (14%).

AST Awarded $49M PICSSS Contract from the U.S. Department of Energy

Retrieved on: 
Tuesday, June 6, 2023
Science, Computer Support Services, RDD, AST, Multimedia, NE, Office of Nuclear Energy, Office of Inspector General, U.S. Department of Health and Human Services, DOE, Consultant, U.S. Department of Energy, Office of Inspector General, Management, Nursing

BRIDGEPORT, W.Va., June 6, 2023 /PRNewswire/ -- Allegheny Science & Technology (AST), a woman-owned energy and technology solutions firm, has been awarded a five-year contract valued at $49M.

Key Points: 
  • BRIDGEPORT, W.Va., June 6, 2023 /PRNewswire/ -- Allegheny Science & Technology (AST), a woman-owned energy and technology solutions firm, has been awarded a five-year contract valued at $49M.
  • The Program Information Collection System and Support Services (PICSSS) contract provides essential support for the U.S. Department of Energy's (DOE) Office of Nuclear Energy's (NE) portfolio worth almost $15B.
  • With the PICSSS contract appointment, AST will support the DOE's mission-critical research, development, demonstration, and deployment (RDD&D) programs while providing real-time project progress and milestone data.
  • Utilizing scientists, consultants, and subject matter experts, AST delivers innovative solutions that drive clean, affordable, and sustainable energy technologies for its clients.

Live from ASCO 2023 | Ascentage Pharma Releases Updated Data Showing APG-2449's Potential as a New Treatment for Drug-Resistant NSCLC

Retrieved on: 
Tuesday, June 6, 2023
PRS, PD, Diarrhea, Cohort, American Society of Clinical Oncology, DCR, Cancer, Trae tha Truth, Pharmacokinetics, Sun, TKI, CHB, NSCLC, Lung cancer, Sun Yat-sen University Cancer Center, Female, ASCO, Vomiting, ORR, Drug resistance, Patient, Annual general meeting, Nausea, ALT, FAK, Poster, Principal, Notifiable disease, AST, Society, Landing slot, SD, Hepatitis, PR, Safety, ALK, Pharmaceutical industry

Among these results, the updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK.

Key Points: 
  • Among these results, the updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK.
  • Developed by Ascentage Pharma, APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development.
  • "We believe that FAK inhibition could be a new treatment strategy for patients with NSCLC resistant to second-generation ALK inhibitors."
  • Appendix: The four posters on Ascentage Pharma's four lead drug candidates, including APG-2449, presented at this year's ASCO Annual Meeting.

Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

Retrieved on: 
Sunday, June 4, 2023
IRC, Hypophosphatemia, Progression-free survival, Conference call, Human, Neoplasm, Telephone, Arm, DOR, New Drug Application, NDA, BRAF, Mutation, Head, Research, Medicine, CPK, CSR, PFS, ASCO, Vomiting, Wild Arms 2, Independent Review Committee, American Society of Clinical Oncology, Patient, Maculopapular rash, Anemia, Annual general meeting, Webcast, Ageing, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, ORR, AST, Food, Safety, Fatigue, Pharmaceutical industry, Medical imaging, Cryptocurrency, Conference

BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced new data from the registrational Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib (DAY101). These data were shared in an oral presentation today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In addition, the Company announced that it has initiated a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).

Key Points: 
  • These data were shared in an oral presentation today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • In addition, the Company announced that it has initiated a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).
  • "Based on the strength of the safety and efficacy data we’ve observed to date, we believe tovorafenib has a compelling clinical profile.
  • The rolling submission allows Day One to submit portions of the regulatory application and have them reviewed by the FDA on an ongoing basis.

Latest Vitrakvi® (larotrectinib) Subgroup Analyses at ASCO 2023 Showcase Long-Term Efficacy and Safety Profile in Adult and Pediatric Patients with NTRK Gene Fusion Cancer, Across Solid Tumors

Retrieved on: 
Friday, June 2, 2023
General Health, Pharmaceutical, Health, Oncology, Hypersensitivity, DTC, IRC, Central nervous system, NGS, Trae tha Truth, Lung cancer, Mutation, NTRK1, CNS, ASCO, Bayer, Food and Drug Administration Amendments Act of 2007, American Society of Clinical Oncology, Dor, Myalgia, Patient, Data, NTRK, Anemia, Annual general meeting, Disease, Anaplastic thyroid cancer, ALT, ATC, FDA, AST, Society, NTRK2, Thyroid cancer, ORR, TC, Food, Safety, TRK, Pharmaceutical industry

The data was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.

Key Points: 
  • The data was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.
  • Patients should be selected for therapy based on a Food and Drug Administration (FDA)-approved test.
  • The results encourage wider adoption of next-generation sequencing (NGS) testing for identifying patients with solid tumors harboring NTRK gene fusions, including lung cancer.
  • Vitrakvi was evaluated in updated subgroup analyses of patients (n=30; data cut-off July 20, 2022) with TRK fusion thyroid cancer (TC).