ITT

IMUNON Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Jeudi, mars 28, 2024
Transfer, Ovarian cancer, Immunotherapy, Patient, Lung, Vaccine, Good manufacturing practice, Sale, CMC, IND, Bangladesh Technical Education Board, IPR, Investment, Clinical trial, Neoplasm, Research, Primate, DNA, NOL, MD Anderson Cancer Center, Trial of the century, ITT, Safety, MRD, Interim, Silicon Valley Bank, Vaccination, Food, CMOS, Elsevier, CD8, Drug discovery, SVB, CRS, University, Death, SARS-CoV-2, Earnings call, Lassa mammarenavirus, PFS, Immunoglobulin G, FDA, OS, CD4, Temperature, Progression-free survival, COVID-19, Mouse, Messenger, Human, Wistar Institute, Hospital

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024

Retrieved on: 
Mardi, mars 26, 2024
Neuroprotection, OhioHealth, VIVA, LINC, EPS, Stroke, NSPR, Carotid artery stenosis, Clinical trial, PMA, ITT, TEL

TEL AVIV, Israel and MIAMI, March 26, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

Key Points: 
  • TEL AVIV, Israel and MIAMI, March 26, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
  • Chris Metzger, M.D., System Vascular Chief at Ohio Health, and lead investigator of the C-Guardians trial
    Marvin Slosman, chief executive officer of InspireMD, stated, “At last year’s VIVA and VEITH conferences in November, Dr. Metzger, principal investigator for the C-GUARDIANS trial, presented positive 30-day follow-up data from the trial which demonstrated a DSMI1 rate of just 0.95% in the Intent-To-Treat (ITT) analysis population, and 0.63% in the per-protocol (PP) analysis population.
  • We are very excited to announce today that an abstract of the 12-month outcomes data from this important trial has been accepted for presentation at the upcoming LINC 2024 conference, which is among the most influential and widely attended meetings focused on vascular intervention.
  • We are optimistic that the results will show a similar level of neuroprotection, which may support a Premarket Approval Application (PMA) later this year and allow us to prepare for a commercial launch of CGuard Prime in the U.S. in the first half of 2025, if approved.”

LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep at Late-Breaking Session at American College of Cardiology 2024

Retrieved on: 
Lundi, avril 8, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Week, Temperature, Cardiovascular disease, PCSK9, CVD, ADAS, FH, Patient, Travel, Female, Refrigeration, OLE, MBBS, Marketing, European Medicines Agency, American College, Therapy, Liberation, ITT, Safety, Food, ACC, Apolipoprotein B, Apolipoprotein, Pharmaceutical industry

Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.

Key Points: 
  • Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.
  • Of 478 participants in the base LIBerate-HeFH trial, 421 (88%) continued into the OLE trial: 281 patients on Lerodalcibep and 140 on placebo.
  • All participants received open-label Lerodalcibep 300 mg in a subcutaneous 1.2 mL once-monthly dose starting immediately upon completion of the base trial.
  • After 48 weeks of OLE treatment, mean % LDL-C reductions with Lerodalcibep from baseline in the base trial was 48.5% (ITT population).

Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints

Retrieved on: 
Mardi, mars 19, 2024
DREAM, OSA, Annual report, ODI, Patient, PSG, Mont-Saint-Guibert, IDE, AHI, Euronext, ITT, Oxygen, Obstructive sleep apnea, Pharmaceutical industry

The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.

Key Points: 
  • The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.
  • Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5.
  • “DREAM is a pivotal, multicenter, international study of Genio, a next generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable.
  • A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: DREAM Results Webcast .

ITT Nominates Christopher O’Shea for Election to Board of Directors

Retrieved on: 
Mardi, avril 2, 2024
Automotive Manufacturing, Aerospace, Manufacturing, Transport, Automotive, Building Systems, Logistics, Supply Chain Management, Commercial Building & Real Estate, Construction & Property, Mining, Minerals, Oil, Gas, Public Relations, Investor Relations, Natural Resources, Energy, Communications, General Automotive, Engineering, Chemicals, Plastics, Electricity, Growth, Centrica, ITT, ITT Inc., Management

April 2, 2024-- ITT Inc. (NYSE: ITT ) today announced the nomination of Christopher O’Shea for election to its Board of Directors at the company’s upcoming 2024 annual meeting of shareholders.

Key Points: 
  • April 2, 2024-- ITT Inc. (NYSE: ITT ) today announced the nomination of Christopher O’Shea for election to its Board of Directors at the company’s upcoming 2024 annual meeting of shareholders.
  • “We are honored at the prospect of having Chris join the ITT Board of Directors.
  • Mr. O’Shea’s election to the Board will be effective May 15, 2024 pending shareholder approval at the company’s 2024 annual meeting of shareholders.
  • The Board intends to appoint Mr. O’Shea to the company’s Audit Committee, effective at the time of his election.

ITT Announces ~$11 Million Investment for Expanded Pump Testing Capabilities in Germany, India and Saudi Arabia to Support Growth and Large Project Awards

Retrieved on: 
Jeudi, mars 21, 2024
Other Transport, Manufacturing, Transport, Automotive, Building Systems, Architecture, Mining, Minerals, Other Energy, Construction & Property, Utilities, Oil, Gas, Natural Resources, Energy, Other Manufacturing, General Automotive, Machinery, Engineering, Machine Tools, Metalworking & Metallurgy, Chemicals, Plastics, Carbon, Growth, Investment, IP, Industrial processes, ITT Inc., ITT

The investments at IP facilities in Obernkirchen, Germany, Vadodara, India and Dammam, Saudi Arabia will increase ITT’s power capacity in pump, motor and control systems testing, enabling the company to locally test larger, more complicated pump packages.

Key Points: 
  • The investments at IP facilities in Obernkirchen, Germany, Vadodara, India and Dammam, Saudi Arabia will increase ITT’s power capacity in pump, motor and control systems testing, enabling the company to locally test larger, more complicated pump packages.
  • The investments are expected to be completed in the third quarter of 2024.
  • At ITT’s Goulds Pumps sites in Saudi Arabia and India, the investments will support future growth as part of ITT’s ‘in region, for region’ strategy.
  • “These strategic investments will further enhance our capabilities and customer experience and continue to differentiate ITT from the competition,” said Luca Savi, ITT’s Chief Executive Officer and President.

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Jeudi, mars 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

Watts Water Technologies Elects Kenneth Napolitano to Its Board of Directors

Retrieved on: 
Mercredi, mars 13, 2024
Commercial Building & Real Estate, Construction & Property, Other Energy, Urban Planning, Utilities, Oil, Gas, Building Systems, Energy, Residential Building & Real Estate, Heat, Strategic planning, ITT Inc., Senior, Xylem Inc., Water quality, Water, ITT, Chairperson, Safety, Retirement, Management

Watts Water Technologies, Inc. (NYSE: WTS) today announced the election of Kenneth Napolitano as a member of the Board of Directors.

Key Points: 
  • Watts Water Technologies, Inc. (NYSE: WTS) today announced the election of Kenneth Napolitano as a member of the Board of Directors.
  • Mr. Napolitano was also appointed by the Board to serve as a member of the Governance and Sustainability Committee of the Board of Directors.
  • Xylem is a global designer, manufacturer and equipment and service provider for water and wastewater applications which spun off from ITT Corporation in 2011.
  • Watts Water companies and brands offer innovative plumbing, heating, and water quality solutions to control the efficiency, safety, and quality of water within commercial, residential, and industrial applications.

10xBio Announces Data from Interim Analysis of Phase 2b Clinical Trial Showing Superior Efficacy of Novel Drug for Submental Body Contouring

Retrieved on: 
Lundi, mars 11, 2024
CSFS, PSFS, Biotechnology, Elective surgery, Bruise, Patient, SAN, Abdomen, American Academy, MD, Clinician, Clinical trial, American Academy of Dermatology, Erythema, ITT, FAAD, Pain, AAD, FDA, Organic acid, Edema, Annual general meeting, Pharmaceutical industry

SAN DIEGO, March 11, 2024 /PRNewswire/ -- 10xBio, LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today promising initial clinical trial results on its novel injectable drug for submental body contouring, 10XB101. An innovative alternative to other fat removal options, 10XB101 provides superior efficacy, fewer side effects, enhanced patient tolerability and shorter treatment intervals.

Key Points: 
  • SAN DIEGO, March 11, 2024 /PRNewswire/ -- 10xBio , LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today promising initial clinical trial results on its novel injectable drug for submental body contouring, 10XB101.
  • An innovative alternative to other fat removal options, 10XB101 provides superior efficacy, fewer side effects, enhanced patient tolerability and shorter treatment intervals.
  • "10XB101 has the appropriate product-market fit to capture the tremendous opportunity for submental contouring.
  • In addition, its attributes hold promise for potential expansion to other body contouring applications, such as treatment of the abdomen and flanks."

G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Mercredi, février 28, 2024
G1 Therapeutics, Breast cancer, Carboplatin, Research, PIN, SCLC, Telephone, Update, J. P. Morgan, DMC, Food, Growth, SACT, G1, Trilaciclib, Hospital, ADC, OS, Conjugation, GAAP, Event, Therapy, Webcast, Patent, Patient, Acceleration, Clinical trial, Survival, Oncology, ITT, Pharmaceutical industry

G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.

Key Points: 
  • G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.
  • Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022.