Clinical trial

Spectral AI Announces 2024 First Quarter Financial Results

Retrieved on: 
Tuesday, May 7, 2024
Sale, FDA, Administration, ELOC, ASPR, PBS, Burn, SWAT, Human services, FY, DFU, Trial of the century, Artificial intelligence, Development, Assessment, MDAI, RCSI, Spectral, Patient, Acquisition, Health, Marketing, Ulcer, Clinical trial, Avita Medical, Growth, Pharmaceutical industry

DALLAS, May 07, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2024 (“Q1 2024”) and provided an update on its ongoing business activities.

Key Points: 
  • DeepView AI®-Burn Devices Deployed in UK; Expect Commercial Revenue in 2H 2024
    DALLAS, May 07, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2024 (“Q1 2024”) and provided an update on its ongoing business activities.
  • “During the first quarter we continued to execute against our strategic priorities resulting in significant accomplishments across the enterprise,” said Peter M. Carlson, CEO of Spectral AI.
  • Completed enrollment in our DFU training study in the US with expected completion of our DFU validation study in 2H 2024.
  • Additionally, Spectral AI entered into a fixed price standby equity purchase agreement (“SEPA”) with a long-only investor that includes a $12.5 million prepaid advance (“Advances”).

Vigil Neuroscience Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 7, 2024
American Academy, Research and development, IGNITE, Publication, Research, TREM2, Microglia, Administration, Patient, Enrollment, Interim, Clinical trial, Completeness, Pharmaceutical industry

WATERTOWN, Mass., May 07, 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 first quarter ended March 31, 2024, and provided an update on recent progress.

Key Points: 
  • In addition, two posters highlighting the ILLUMINATE Natural History Study of ALSP and the mechanism of action for iluzanebart were also presented.
  • Next data readout from Phase 2 IGNITE clinical trial on track for third quarter of 2024: The Company is on track to report additional data from its Phase 2 clinical trial evaluating iluzanebart in ALSP in the third quarter of 2024.
  • Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2024 were $14.3 million, compared to $13.8 million for the same period in 2023.
  • Net Loss: Loss from operations for the first quarter ended March 31, 2024 were $19.9 million, compared to $19.8 million for the same period in 2023.

CytomX Therapeutics Announces Clinical Collaboration with Merck to Evaluate CX-801 in Combination with KEYTRUDA® (pembrolizumab)

Retrieved on: 
Tuesday, May 7, 2024
MSD, Cancer, Merck & Co., Patient, Renal cell carcinoma, Melanoma, Head, Clinical trial, Therapy, SAN, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US and Canada) for CytomX’s first-in-human Phase 1 clinical trial assessing the clinical activity of CX-801, a dually-masked interferon-alpha2b cytokine in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab).

Key Points: 
  • “Interferon-alpha-2b is a potent cytokine with demonstrated clinical activity against multiple cancer types, but its use has been limited by systemic toxicities.
  • CX-801 is designed to overcome these limitations to unlock the full potential of interferon in activating the immune tumor microenvironment.
  • “CytomX is excited to be entering into this agreement with Merck to utilize Keytruda in combination with CX-801.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Denali Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights

Retrieved on: 
Tuesday, May 7, 2024
FDA, Amyloid beta, Part, Total, PIPE, CDER, Transferrin receptor, Nerve, BBB, CSF, Biomarker, Gamma, Enzyme replacement therapy, Traffic barrier, Hunting, OTV, PTV, Food, MGH, IDS, Conference, MAPT, ALS, Therapy, Cerebrospinal fluid, SAN, MPS II, Hospital, Safety, AFL, SGSH, UC, Alpha-synuclein, LUMA, SNCA, Clinical trial, Glycogen storage disease, Neurodegenerative disease, MPS, COMPASS, Patient, Alfa, Acquisition, ETV, ATV, Hunter syndrome, Sanofi, Massachusetts General Hospital, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the first quarter ended March 31, 2024, and provided business highlights.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the first quarter ended March 31, 2024, and provided business highlights.
  • There was no collaboration revenue for the quarter ended March 31, 2024, compared to $35.1 million for the quarter ended March 31, 2023.
  • Total research and development expenses were $107.0 million for the quarter ended March 31, 2024, compared to $128.8 million for the quarter ended March 31, 2023.
  • General and administrative expenses were $25.2 million for the quarter ended March 31, 2024, compared to $27.1 million for the quarter ended March 31, 2023.

Y-mAbs Reports First Quarter 2024 Financial Results and Recent Corporate Developments

Retrieved on: 
Tuesday, May 7, 2024
Treasurer, Cancer, Investment, Dive (Belgian band), Abstract, Research, Yoy, Medicaid, WEP, Webcast, Comment, Employment, McCormick Place, Disassembler, Patient, Society, Toxicity, Clinical trial, Self-assembly, Therapy, Interest, Pharmaceutical industry

“On the commercial front, the first quarter of 2024 marked the highest quarter of U.S. demand for DANYELZA® (naxitamab-gqgk) since its initial launch.

Key Points: 
  • “On the commercial front, the first quarter of 2024 marked the highest quarter of U.S. demand for DANYELZA® (naxitamab-gqgk) since its initial launch.
  • License revenue for the quarter ended March 31, 2024 arose from the January 2024 acceptance of the Brazilian Medicines Market Regulation Chamber (“CMED”) price for DANYELZA.
  • Research and development expenses were $13.3 million for the quarter ended March 31, 2024, a decrease of 1% compared to $13.4 million for the quarter ended March 31, 2023.
  • Interest and other income was $0.4 million for the quarter ended March 31, 2024, as compared to $1.1 million for the quarter ended March 31, 2023.

X4 Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
Tuesday, May 7, 2024
Birth, FDA, Capsule, Myelokathexis, Research and development, Priority review, Safety, WHIM syndrome, Food, Security (finance), Conference call, WHIM, Research, Conference, Wart, Neutrophil, CIS, Patient, Society, EMA, Hypogammaglobulinemia, Infection, G-CSF, Interim, Immune system, Lymphocyte, Clinical trial, ID, European Medicines Agency, Pharmaceutical industry

BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.

Key Points: 
  • ET
    BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.
  • “Concurrent with this approval, we received a Rare Pediatric Disease Priority Review Voucher, which we intend to monetize.
  • X4 currently expects to seek approval from the European Medicines Agency (EMA) for mavorixafor in WHIM syndrome in late 2024/early 2025.
  • The live webcast will be accessible through the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com.

Verve Therapeutics Announces Dosing of First Patient in Heart-2 Phase 1b Clinical Trial Evaluating VERVE-102

Retrieved on: 
Tuesday, May 7, 2024
LDLR, Patient, Clinical trial, Risk, Safety, Woman, Pharmacokinetics, Blood, ASCVD, Gene, Moyamoya disease, Gene editing, RNA, PCSK9, Life, Ageing, Liver, CAD, Cardiovascular disease, Therapy, Asialoglycoprotein receptor, DSM-IV codes, Apolipoprotein, Sudden death, Pharmaceutical industry

BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that the first patient has been dosed with VERVE-102 in the Heart-2 Phase 1b clinical trial. The Heart-2 trial is enrolling adult patients with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD), two patient populations who require deep reductions of low-density lipoprotein cholesterol (LDL-C) levels in the blood for an extended period of time. Patients living with HeFH have an inherited disorder characterized by elevated blood levels of LDL-C starting early in life. Patients living with premature CAD experience cholesterol-driven blockage of coronary arteries early in life and are at high risk of further complications. A lack of durable control of LDL-C levels in both HeFH and premature CAD patients carries high lifetime risks for cardiovascular events, including heart attack and sudden death.

Key Points: 
  • Patients living with HeFH have an inherited disorder characterized by elevated blood levels of LDL-C starting early in life.
  • Patients living with premature CAD experience cholesterol-driven blockage of coronary arteries early in life and are at high risk of further complications.
  • “Dosing the first patient in the Heart-2 Phase 1b clinical trial for VERVE-102 is an important step in the continued progress of our pipeline,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve Therapeutics.
  • Clinical Trial Applications for the Heart-2 trial have been cleared in Canada and the United Kingdom.

uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, May 7, 2024
FDA, Phase, Safety, Food, Fabry disease, Research, Immunosuppression, Male, Hand, IRB, Conference, Information technology, RBC Capital Markets, Patient, ALS, Acquisition, CSL, POC, Clinical trial, Temporal lobe epilepsy, SOD1, Pharmaceutical industry

LEXINGTON, Mass. and AMSTERDAM, May 07, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2024 and highlighted recent progress across its business.

Key Points: 
  • ~ Clinical trial initiation for Fabry disease on track to begin in second quarter of 2024, followed by refractory mesial temporal lobe epilepsy and SOD1-ALS in third quarter of 2024 ~
    LEXINGTON, Mass.
  • and AMSTERDAM, May 07, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2024 and highlighted recent progress across its business.
  • We have obtained IRB approvals for initial sites, which are poised for imminent activation, and have also identified prospective patients.
  • The Company expects cash, cash equivalents and investment securities will fund operations into the second quarter of 2027.

Clinical Study Highlights Improvements to Gut Microbiome and Autism Spectrum Disorder Symptoms with Use of Custom Probiotics

Retrieved on: 
Tuesday, May 7, 2024
PGIA, Social Responsiveness Scale, ASU, Language, M-Systems, Arizona State University, Spectrum, Comprehension, Metagenomics, Health, Cognition, Thought, Trial of the century, Research, Speech, MTT, Diet, Probiotic, Caregiver, Genomics, Clinical trial, Quality of life, SAN, Dietary supplement

“Our research uncovered critical insight into the connection between precision nutrition – in the form of precision probiotics – and both gut health and autism spectrum disorder.

Key Points: 
  • “Our research uncovered critical insight into the connection between precision nutrition – in the form of precision probiotics – and both gut health and autism spectrum disorder.
  • The clinical research was conducted with the participation of 296 children and adults diagnosed with autism spectrum disorder and 123 age-matched neurotypical controls.
  • Behavioral and Autism Symptoms: Follow-up surveys revealed moderate improvement in thinking abilities, sensory experiences and overall autism-related symptoms among participants.
  • The next step is a randomized, double-blind and placebo-controlled study, which is needed to confirm the clinical study findings.

Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia

Retrieved on: 
Tuesday, May 7, 2024
Contract research organization, Brain, Traumatic brain injury, NCE, Common, Food and Drug Administration, Therapeutic Goods Administration, Food, Partnership, Science, TBI, Concussion, Incidence, Patient, CTE, Head Injuries, DSM-IV codes, Chronic traumatic encephalopathy, Clinical trial, European Medicines Agency, Traffic, Pharmaceutical industry

This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.

Key Points: 
  • This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.
  • An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated.
  • "Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical.
  • Michael Redmond, President of Oragenics, added, "Our collaboration with Avance Clinical during the Phase I trial was instrumental, and we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion."