CSF1R

Vigil Neuroscience Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Research, Administration, CSF1R, TREM2, MRI, Data analysis, PD, CSF, Magnetic resonance imaging, Patient, Biomarker, Microglia, Osteopontin, Fluid mechanics, IGNITE, Investment, Clinical trial, Pharmacokinetics, Interim, Research and development, Data, FDA, AFL, Pharmaceutical industry

WATERTOWN, Mass., March 26, 2024 (GLOBE NEWSWIRE) --  Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent progress.

Key Points: 
  • “Among our many recent milestones, the most significant for Vigil was the positive data readout from our ongoing Phase 2 IGNITE trial and ILLUMINATE Natural History Study.
  • We are also pleased to have enrolled 20 patients in our IGNITE trial, exceeding our target of 15 patients.
  • Cash Position: Cash, cash equivalents, and marketable securities were $117.9 million as of December 31, 2023, compared to $133.6 million as of September 30, 2023.
  • The increase year-over-year was primarily attributable to increases in headcount-related costs and professional service fees to support the Company’s growth.

Vigil Presents Poster on Impacts of Misdiagnosis and Genetic Testing on Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) Patient Journey at ACTRIMS 2024

Retrieved on: 
Thursday, February 29, 2024
CSF1R, ALSP, Genetic testing, Approximation error, Neurodegenerative disease, Life, Multiple sclerosis, Patient, Disease, Senior counsel, Diagnosis, Microglia, Research, Medical device

WATERTOWN, Mass., Feb. 29, 2024 (GLOBE NEWSWIRE) --  Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today presented a poster detailing the impact of misdiagnosis and the importance of genetic testing at the 2024 ACTRIMS Forum being held in West Palm Beach, Florida, from February 29 – March 2.

Key Points: 
  • “We continue to hear from members of the ALSP community that the path to an accurate diagnosis can be difficult, indirect, and time consuming.
  • As with many rare diseases, the misdiagnosis of ALSP can be a significant and persistent challenge to overcome.
  • It also showed that when considering genetic testing, access to approved treatments may be a motivator for patients, family members, and clinicians.
  • A structured patient journey workshop was hosted as a means of better understanding life with ALSP, including the impact of misdiagnosis and barriers to genetic testing.

Vigil Neuroscience Provides 2023 Year-in-Review and Highlights Upcoming 2024 Milestones

Retrieved on: 
Wednesday, January 3, 2024
Leukoencephalopathy, Senior counsel, Conference, European Commission, Food, MRI, Medicine, IND, CSF1R, FDA, Civil service commission, Clinical trial, Investigational New Drug, IGNITE, TREM2, AFL, CNS, SAD, Neurodegenerative disease, Biomarker, Pathology, Completeness, Genetic testing, Patient, Diagnosis, Safety, Microglia, Magnetic resonance imaging, Pharmaceutical industry

WATERTOWN, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today provided a 2023 year-in-review and outlined key milestones anticipated in 2024. The Company also today announced that it has extended its projected cash runway into the second half of 2025.

Key Points: 
  • ET -
    WATERTOWN, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today provided a 2023 year-in-review and outlined key milestones anticipated in 2024.
  • “2023 marked a year of persistent advancement and landmark achievements for the Company,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil.
  • “Most notably, we were the first company to demonstrate clinical data supporting TREM2 agonism as a potential therapeutic approach in neurodegenerative disease.
  • “We enter 2024 well-positioned to achieve our planned value-driving milestones across our development pipeline,” concluded Dr. Magovčević-Liebisch.

Vigil Neuroscience Reports Positive Interim Data from Phase 2 IGNITE Proof-of-Concept Clinical Trial Evaluating Iluzanebart (VGL101) as a Treatment for ALSP and from Ongoing Natural History Study ILLUMINATE

Retrieved on: 
Thursday, November 16, 2023
Safety, Magnetic resonance imaging, Pathology, Disease, Clinical trial, TREM2, Patient, Medicine, FDA, Microglia, Caregiver, NHS England, Neurodegenerative disease, Osteopontin, Mayo Clinic, MRI, Biomarker, UCL Institute of Ophthalmology, IGNITE, HIV disease progression rates, AFL, Dietary supplement, Medical imaging, Communications satellite, Pharmaceutical industry, Vigil, CSF1R, Neurology, ALSP

"The positive interim results from our Phase 2 IGNITE trial represent the first clinical data reported from an interventional study in patients with ALSP and reaffirm our belief in the potential of iluzanebart as a novel treatment option.

Key Points: 
  • "The positive interim results from our Phase 2 IGNITE trial represent the first clinical data reported from an interventional study in patients with ALSP and reaffirm our belief in the potential of iluzanebart as a novel treatment option.
  • Key Highlights from Phase 2 IGNITE Interim Data:
    Favorable safety and tolerability profile, including no hematologic adverse events.
  • We believe the quality and consistency of the interim data further support the continuation of IGNITE without modification.
  • Interim Montreal Cognitive Assessment (MoCA) and Cortical Basal Ganglia Functional Scale data support use as clinical endpoints in ALSP at 12 months.

Gossamer Bio to Host Webcast to Discuss Latest Seralutinib Open-Label Extension Data on December 18, 2023

Retrieved on: 
Wednesday, December 13, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Webcast, PAH, Patient, GOSS, Pulmonary hypertension, Orthostatic hypertension, CSF1R

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that it will host a public conference call and webcast for investors and analysts on Monday, December 18, 2023 at 8:30 am ET to discuss the latest seralutinib clinical data from the ongoing TORREY Phase 2 Open-Label Extension Study in PAH patients.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that it will host a public conference call and webcast for investors and analysts on Monday, December 18, 2023 at 8:30 am ET to discuss the latest seralutinib clinical data from the ongoing TORREY Phase 2 Open-Label Extension Study in PAH patients.
  • Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, specifically designed to be delivered via dry powder inhaler for the treatment of pulmonary hypertension.
  • The live audio webcast may be accessed through the “Events / Presentations” page in the “Investors” section of the Company's website at www.gossamerbio.com .
  • Alternatively, the conference call may be accessed through the following:
    A replay of the audio webcast will be available for 30 days on the “Investors” section of the Company's website, www.gossamerbio.com .

Vigil Neuroscience Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 7, 2023
FDA, Research, Data analysis, Research and development, AD, IGNITE, Half-life, Genetic testing, Event, Food, European Commission, Publication, European Medicines Agency, Microglia, CSF1R, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, R, HCP, ANA, Approximation error, Civil service commission, Growth, Caregiver, PK, KOL, Medicine, EMA, TREM2, Patient, Administration, Investigational New Drug, Pharmaceutical industry, Cryptocurrency, IND, ALSP

WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2023, and provided an update on recent progress.

Key Points: 
  • In September, we also proudly introduced our oral small molecule TREM2 agonist candidate, VG-3927, with the opening of our IND.
  • Cash Position: Cash, cash equivalents, and marketable securities were $133.6 million as of September 30, 2023, compared to $150.2 million as of June 30, 2023.
  • General and Administrative (G&A) Expenses: G&A expenses for the third quarter ended September 30, 2023, were $6.9 million, compared to $4.8 million for the same period in 2022.
  • Net Loss: Loss from operations for the third quarter ended September 30, 2023, were $20.5 million, compared to $17.5 million for the same period in 2022.

Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT

Retrieved on: 
Monday, October 30, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Week, IRR, TGCT, Neoplasm, ITT, CSF1R, Leiden University Medical Center, Caregiver, Medicine, Stiffness, ORR, RECIST, Part, Safety, Cancer, Patient, Pharmaceutical industry

“TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.

Key Points: 
  • “TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.
  • Success across both the primary and all key secondary endpoints in MOTION underscores vimseltinib’s ability to help TGCT patients feel and function better.
  • “The totality of data shown today demonstrate the potential for vimseltinib to offer a new and differentiated treatment option for patients with TGCT.
  • The open-label Part 2 portion of MOTION, in which patients from both the vimseltinib and placebo arms receive treatment with vimseltinib, remains ongoing.

Deciphera Pharmaceuticals Announces Third Quarter 2023 Financial Results

Retrieved on: 
Monday, October 30, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Week, KIT, TGCT, ITT, CSF1R, ORR, GIST, INSIGHT, Cancer, Tenosynovial giant cell tumor, Patient, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • “QINLOCK achieved another record quarter of product revenue with continued strength in commercial demand,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals.
  • Cost of Sales: Cost of sales were $1.3 million in the third quarter of 2023 compared to cost of sales of $3.3 million for the third quarter of 2022.
  • Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET.

Gossamer Bio Announces Addition of Rainer Zimmermann, MD, as VP of Medical Affairs

Retrieved on: 
Tuesday, October 3, 2023
Research, General Health, Radiology, Professional Services, Pharmaceutical, Clinical Trials, Science, Legal, Cardiology, Biotechnology, Finance, Health, Medical Affairs Bureau, University, GOSS, PAH, Rainer, Bio, Nasiriyah Heart Center, University of Giessen, Actelion, Pulmonary hypertension, Gossamer, MD, Patient, Tadalafil, Entrepreneurship, Johnson & Johnson, Orthostatic hypertension, University of Oxford, Pharmaceutical industry, CSF1R

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that Rainer Zimmermann, MD, has joined the Company as Vice President of Medical Affairs.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced that Rainer Zimmermann, MD, has joined the Company as Vice President of Medical Affairs.
  • Dr. Zimmermann brings more than 23 years of experience within the PAH/PH space, most recently having served as the Global Medical Lead, Medical Affairs, Pulmonary Hypertension, at Johnson & Johnson Innovative Medicine.
  • “We are thrilled to have Rainer join us at such a critical juncture for the seralutinib program.
  • For nine years, Dr. Zimmerman oversaw the clinic for children with PAH/PH at the Heart Center, University of Giessen, Germany.

Vigil Neuroscience Presents VGL101 Complete Phase 1 Data and Phase 2 IGNITE Trial Design at the 2023 American Neurological Association Annual Meeting

Retrieved on: 
Monday, September 11, 2023
PD, American Neurological Association, Half-life, IGNITE, Pharmacokinetics, SAD, Biomarker, Publication, MRI, Data analysis, Magnetic resonance imaging, TREM2, Data, Patient, ANA, MAD, Microglia, CSF, CSF1R, Safety, Pharmaceutical industry, Generic drug, Medical imaging, ALSP

WATERTOWN, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced the complete data analysis from its VGL101 Phase 1 single and multiple ascending dose (SAD and MAD) healthy volunteer trial in a poster presentation at the 2023 American Neurological Association (ANA) Annual Meeting. In addition, the Company presented a poster highlighting the study design for its ongoing IGNITE Phase 2 clinical trial.

Key Points: 
  • In addition, the Company presented a poster highlighting the study design for its ongoing IGNITE Phase 2 clinical trial.
  • “The dataset from the VGL101 Phase 1 healthy volunteer trial is very encouraging and further validates our development strategy for the ongoing IGNITE Phase 2 trial in ALSP.
  • “We are committed to achieving further milestones for VGL101, including the interim data readout from IGNITE in the fourth quarter of 2023.
  • In a separate poster at the ANA Annual Meeting, the Company presented the trial design for its ongoing Phase 2 IGNITE trial.