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Ivy Brain Tumor Center Announces Promising Data for Niraparib in Phase 0/2 Glioblastoma Clinical Trial

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금요일, 11월 17, 2023

Phoenix, AZ, Nov. 17, 2023 (GLOBE NEWSWIRE) -- The Ivy Brain Tumor Center at Barrow Neurological Institute announces promising results from a Phase 0/2 trial of niraparib in patients with newly diagnosed glioblastoma with unmethylated MGMT.

Key Points: 
  • Phoenix, AZ, Nov. 17, 2023 (GLOBE NEWSWIRE) -- The Ivy Brain Tumor Center at Barrow Neurological Institute announces promising results from a Phase 0/2 trial of niraparib in patients with newly diagnosed glioblastoma with unmethylated MGMT.
  • Glioblastoma is an incurable malignant brain tumor and MGMT-unmethylated glioblastoma is the most common and fastest-recurring variant, comprising more than 60 percent of all glioblastoma tumors.
  • In the Phase 0 component of the study, patients exposed to niraparib demonstrated high drug concentrations in brain tumor tissue.
  • These presentations represent a broader portfolio of pharmacodynamic and pharmacokinetic-driven clinical trials, utilizing industry-supported drug development to test new-in-class therapies for brain tumor patients.

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: 
목요일, 11월 16, 2023

"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.

Blackford and contextflow Announce Commercial Partnership to Bring Comprehensive Chest CT Detection Software to Healthcare Providers

Retrieved on: 
목요일, 11월 16, 2023

EDINBURGH, Scotland, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Blackford, the pioneering strategic AI platform and solutions provider, and contextflow today announced a commercial partnership to bring contextflow’s ADVANCE Chest CT solution to healthcare professionals.

Key Points: 
  • EDINBURGH, Scotland, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Blackford, the pioneering strategic AI platform and solutions provider, and contextflow today announced a commercial partnership to bring contextflow’s ADVANCE Chest CT solution to healthcare professionals.
  • Blackford provides healthcare professionals access to an extensive portfolio of medical AI solutions designed to drive clinical efficiency and improve patient outcomes.
  • By integrating contextflow’s advanced detection technology into the Blackford platform, Blackford can offer healthcare providers a powerful tool for detecting ILD, COPD and lung cancer on chest CTs.
  • Our partnership with Blackford will accelerate the adoption of this much-needed AI, increasing its accessibility to radiologists and patients alike.”

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
화요일, 11월 14, 2023

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
화요일, 11월 14, 2023

SAN DIEGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Next steps for Cohort A:
    Plan to report the outcome from the interim futility analysis in the fourth quarter of 2023.
  • Held a positive Type-B clinical meeting with FDA in the third quarter of 2023.
  • Next steps for Cohort B:
    Expect to commence enrollment for Cohort B in the fourth quarter of 2023.
  • Revenues for the third quarter of 2023 were approximately $6.2 million compared with approximately $1.6 million for the third quarter of 2022.

Dr. Alan Kivitz to Chair XBiotech’s Natrunix Program in Rheumatoid Arthritis

Retrieved on: 
화요일, 11월 14, 2023

is now Lead Investigator & Study Chairman for its clinical research program for Natrunix in Rheumatoid Arthritis.

Key Points: 
  • is now Lead Investigator & Study Chairman for its clinical research program for Natrunix in Rheumatoid Arthritis.
  • The company has now enrolled about 33% of the 210 patients it is recruiting for a Phase II, Double-Blind, Placebo-Controlled, Randomized study, examining Natrunix in combination with methotrexate for the treatment of Rheumatoid Arthritis.
  • I am excited to be part of a clinical trial program studying a novel approach to RA.”
    Dr. Kivitz has had a prodigious medical career treating arthritis and rheumatic diseases.
  • Dr. Kivitz has authored over 500 research articles, abstracts, and clinical studies relating to osteoarthritis, osteoporosis and rheumatoid arthritis and has lectured on his findings around the world.

SAB Biotherapeutics Announces Q3 2023 Financial Results and Provides Company Updates

Retrieved on: 
화요일, 11월 14, 2023

SIOUX FALLS, S.D., Nov. 14, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today reported financial results for the third quarter ended October 31, 2023, and provided a company update.

Key Points: 
  • “The third quarter of 2023 was a pivotal growth point for SAB as we advance SAB-142, our T1D immunotherapy.
  • The full proceeds, when funded, are expected to fund the company through 2026 and through topline Phase 2 results.
  • Russell P. Beyer, former EVP and Chief Financial Officer, departed the Company effective October 27, 2023.
  • The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.

Belite Bio Reports Third Quarter 2023 Operational Highlights and Financial Results

Retrieved on: 
화요일, 11월 14, 2023

ET

Key Points: 
  • ET
    SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its financial results for the three-months ended September 30, 2023, and provided a general business update.
  • “We made meaningful progress in the quarter advancing our clinical trials for Tinlarebant and are excited by our results,” said Dr. Tom Lin, Chairman and CEO of Belite Bio.
  • Third Quarter 2023 Financial Results:
    Cash: As of September 30, 2023, the Company had $54.5 million in cash.
  • Belite Bio will host a webcast on Tuesday, November 14, 2023, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update.

Molecular Templates, Inc. Reports Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
월요일, 11월 13, 2023

The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.
  • Revenues for the third quarter of 2023 were $6.8 million, compared to $4.2 million for the same period in 2022.
  • Total research and development expenses for the third quarter of 2023 were $7.6 million, compared with $22.0 million for the same period in 2022.
  • Total general and administrative expenses for the third quarter of 2023 were $4.3 million, compared with $5.9 million for the same period in 2022.

Clearside Biomedical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
월요일, 11월 13, 2023

ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • Other Income: Other income for the third quarter of 2023 was $0.4 million, compared to $0.2 million for the third quarter of 2022.
  • Other Expense: Non-cash interest expense for the third quarter of 2023 was $2.6 million, compared to $1.3 million in the third quarter of 2022.
  • Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.