AST

AST Named Chicago Top Workplace for Fifth Consecutive Year

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Wednesday, November 8, 2023
Professional Services, Data Management, Technology, Other Technology, Human Resources, Software, Internet, Trust, Workplace, Translation, AST, Interface (computing), Management

AST today announces its recognition as a Chicago Tribune Top Workplace for the fifth consecutive year.

Key Points: 
  • AST today announces its recognition as a Chicago Tribune Top Workplace for the fifth consecutive year.
  • "At AST, our people are our top priority," affirmed Justin Winter, AST's CEO.
  • AST prioritizes a diverse workplace, encouraging risk-taking, skills development, and career growth.
  • We are dedicated to continuously enhancing our workplace to ensure that AST remains a place where employees can build a long-term career," established Teresa Stanula.

STERIS Announces Financial Results for Fiscal 2024 Second Quarter

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Tuesday, November 7, 2023
BD, Steris, Growth, Customer, NYSE, Health care, Dental, STE, AST, Video game

Constant currency organic revenue (see Non-GAAP Financial Measures) increased 8% for the second quarter of fiscal 2024 as compared to the second quarter of fiscal 2023.

Key Points: 
  • Constant currency organic revenue (see Non-GAAP Financial Measures) increased 8% for the second quarter of fiscal 2024 as compared to the second quarter of fiscal 2023.
  • Adjusted net income (see Non-GAAP Financial Measures) for the second quarter of fiscal 2024 was $202.2 million or $2.03 per diluted share, compared with the previous year’s second quarter of $199.6 million or $1.99 per diluted share.
  • Dental second quarter revenue as reported declined 5% to $104.2 million compared with $109.6 million in the second quarter of fiscal 2023.
  • Reflecting lower volume, operating income was $24.5 million in the second quarter of fiscal 2024 compared with $28.1 million in the prior year’s second quarter.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

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Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors

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Friday, November 3, 2023
Massachusetts General Hospital, Hypertelorism, Patient, Lymphocytopenia, Incidence, PD, Myalgia, Trae tha Truth, Fatigue, Society for Immunotherapy of Cancer, AST, Fever, FACS, SITC, Immunotherapy, NK, Neoplasm, Webcast, Biopsy, Annual general meeting, IO, Chills, Tumor microenvironment, Safety, Lymphocyte, Cancer, Society, Therapy, ALT, Hospital, Hypoxia, Toxic leukoencephalopathy, Dietary supplement, Pharmaceutical industry

We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.

Key Points: 
  • We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.
  • Eight (8) patients were treated in Phase 2 monotherapy at a dose level of 1.4 mg/kg Q3W.
  • As of the data cutoff date, 20 patients were continuing treatment with XTX202 across the Phase 1/2 trial.
  • Based on the initial monotherapy data for XTX202, Xilio also plans to explore opportunities for strategic partnerships to evaluate XTX202 as a combination therapy.

Shattuck Labs to Present Topline Data from Phase 1 A/B Clinical Trial of SL-172154 in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS) Patients at the American Society of Hematology (ASH) 2023 Annua

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Thursday, November 2, 2023
Patient, MCP1, Aes, IRR, TP53, Bachelor of Medicine, Bachelor of Surgery, AST, Bone marrow, CD47, Azacitidine, Observation, Nausea, Clinical trial, Autoimmune disease, AZA, Safety, Cancer, Cellular, ALT, Combination therapy, Transplant, CD40, AML, Pharmaceutical industry

AUSTIN, Texas and DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced the presentation of topline data from the dose escalation portion of its Phase 1 A/B clinical trial of SL-172154 as monotherapy and in combination with azacitidine (AZA) in primarily R/R AML and HR-MDS patients. These data will be featured in a poster presentation at the 65th ASH Annual Meeting, which is being held both virtually and in San Diego, CA from December 9-12, 2023.

Key Points: 
  • “Response rates are historically low for heavily pretreated relapsed/refractory AML and HR-MDS patients.
  • Notably, preliminary data shows anti-leukemic effects detected in previously untreated TP53m-MDS and R/R AML patients.
  • In bone marrow, abundant staining of SL-172154 was observed, along with a dose-dependent increase in phagocytic cells within mature myeloid immune cell compartments.
  • Reduction in leukemic blasts was associated with an increase in mature myeloid and phagocytic cell phenotypes.

CymaBay Announces Publication of Two-year Safety and Efficacy Results of Seladelpar in Patients with Primary Biliary Cholangitis

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Wednesday, November 1, 2023
McWherter, Liver injury, Patient, University of Texas Southwestern Medical Center, AST, MD, Conditional sentence, Liver, Professor, ALP, PBC, Bilirubin, Vierling, Alkaline phosphatase, Cholestasis, Primary biliary cholangitis, University, Safety, Alimentary Pharmacology & Therapeutics, Therapy, ALT, Diagnosis, Liver disease, Pharmaceutical industry, DA, RJ, Y, PJ

Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar.

Key Points: 
  • Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar.
  • The objectives were to evaluate the long-term safety, tolerability, and efficacy of seladelpar at 5 mg and 10 mg once daily throughout 2-years.
  • In addition, ALP normalization was achieved in 23% and 42% in patients at one and two years, respectively.
  • In the study long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury in the second year of treatment.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

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Wednesday, November 1, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Survival, Patient, Colitis, Nephritis, Cholangiocarcinoma, Incidence, Hypothyroidism, Pneumonitis, NYSE, Food, Progression-free survival, Fatigue, Medicine, Itch, DOR, AST, Pembrolizumab, Cisplatin, Head, Gastrointestinal cancer, MRK, PFS, Fever, University of California, Bile, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV disease progression rates, Administration, Rash, Disease, Ascending cholangitis, Merck & Co., Risk, Immunotherapy, ORR, University, Anemia, RECIST, BTC, Hepatitis, Biliary tract, Lymphocyte, ALT, OS, Death, Toxicity, Hematopoietic stem cell transplantation, CI, Pharmaceutical industry, Vaccine, Merck

Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).

Gannex Published Phase I Data of ASC42, a Novel Farnesoid X Receptor Agonist on the Journal Drugs in R&D

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Monday, November 6, 2023
TC, PD, UDCA, Hepatology, Ursodeoxycholic acid, AST, Primary biliary cholangitis, PBC, Pharmacokinetics, Phase, American Association for Geriatric Psychiatry, NASH, GGT, Medicine, Non-alcoholic fatty liver disease, FXR, NAFLD, Obeticholic acid, Safety, ALT, Patient, OCA, Diagnosis, FGF19, New England, Pharmaceutical industry, Gannex

In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.

Key Points: 
  • In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.
  • On July 20, 2023, Gannex announced the completion of patient enrollment for Phase II clinical trial of ASC42 for PBC.
  • The Phase II clinical trial of Gannex's in-house developed farnesoid X receptor agonist ASC42 will be completed soon.
  • The topline data of the Phase II clinical trial are expected to be released by the end of 2023.

Freeline Presents Positive New Data from Phase 1/2 GALILEO-1 Trial of FLT201, Its Novel Gene Therapy Candidate, in Gaucher Disease at ESGCT 30th Annual Congress

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Wednesday, October 25, 2023
Bone pain, Research, Plasma, Clinical trial, AAV, DBS, Biomarker, AST, Congress, Liver, Cancer Treatment Centers of America, CEST, Cell, Enzyme replacement therapy, White blood cell, Tissue, Gene, Glucocerebrosidase, Blood, ESGCT, Gaucher's disease, Safety, European Society for Primary Immunodeficiencies, Lysosome, ALT, Pharmaceutical industry, Patient

LONDON, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced that new clinical data from its ongoing Phase 1/2 GALILEO-1 trial of FLT201, its adeno-associated virus (AAV) gene therapy candidate for Gaucher disease, show a substantial reduction of glucosylsphingosine (lyso-Gb1) levels in the blood of the first patient treated with FLT201. Lyso-Gb1 is a well-established biomarker of clinical response in Gaucher disease, with reductions in lyso-Gb1 correlating with positive clinical outcomes. These data are being highlighted in an oral presentation at the European Society of Gene & Cell Therapy (ESGCT) 30th Annual Congress held in Brussels, Belgium.

Key Points: 
  • Lyso-Gb1 is a well-established biomarker of clinical response in Gaucher disease, with reductions in lyso-Gb1 correlating with positive clinical outcomes.
  • These data are being highlighted in an oral presentation at the European Society of Gene & Cell Therapy (ESGCT) 30th Annual Congress held in Brussels, Belgium.
  • Reduction in lyso-Gb1 in the blood is strongly correlated with improvement in clinical outcomes in Gaucher disease.
  • The presentation entitled “Results from GALILEO-1, a First-In-Human Clinical Trial of FLT201 Gene Therapy in Patients with Gaucher Disease Type 1” is part of a session taking place from 14:30-16:30 CEST (8:30-10:30 a.m.

AST SpaceMobile to Provide Quarterly Business Update on November 14, 2023 and Provides Preliminary Financial Results for Third Quarter 2023

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Wednesday, October 25, 2023
Technology, Satellite, Aerospace, Manufacturing, Mobile, Wireless, Telecommunications, Eastern Time Zone, ASTS, AST, Public expenditure, GAAP, KPMG LLP, AST SpaceMobile, Bluebird, Bank statement, Webcast, Data-rate units, Total, KPMG, Rakuten, AT&T, Mobile phone, Cryptocurrency, Bank, Vodafone

The company is also providing its preliminary estimated financial results for the third quarter ended September 30, 2023.

Key Points: 
  • The company is also providing its preliminary estimated financial results for the third quarter ended September 30, 2023.
  • AST SpaceMobile will be accepting questions from retail and institutional shareholders and management will answer select questions relating to AST SpaceMobile’s business and financial results on the conference call.
  • The call will be accessible via a live webcast on the Events page of AST SpaceMobile’s Investor Relations website at https://ast-science.com/investors/ .
  • Our independent registered public accounting firm, KPMG LLP, has not reviewed, or performed any procedures with respect to these preliminary estimated financial results.