Trial of the century

atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024
Depression, Headache, Atypical depression, Data analysis, Patient, Aes, Trial of the century, Nausea, TRD, Treatment, Safety, Vomiting, Pharmaceutical industry

The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.

Key Points: 
  • The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.
  • Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.
  • Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response2 in 55% of patients on the day after dosing.
  • The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year.

Palisade Bio Reports Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 27, 2024
Research, Ulcerative colitis, Exercise, Initiate, Average cost, Patient, Internet, UC, PDE4, Insurance, Trial of the century, IBD, Medicine, Completeness, Inflammatory bowel disease, Therapy, FDA, Autoimmunity, Physician, Consultant, Pharmaceutical industry

Carlsbad, CA, March 27, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a pre-clinical biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today reported its financial results for the full year 2023 and provided a corporate update.

Key Points: 
  • “2023 was a transformative year for Palisade Bio as we strategically shifted into the autoimmune, inflammatory, and fibrotic disease space, with the focus on our precision medicine approach in inflammatory bowel disease,” commented J.D.
  • “As a result of the progress made by our development team, we are on track to launch the Phase 1 study of PALI-2108 by the end of 2024.
  • Summary of Financial Results for the Year Ended December 31, 2023
    As of December 31, 2023, the Company had cash, cash equivalents and restricted cash of $12.5 million.
  • Net operating loss was $13.1 million for the year ended December 31, 2023 compared to $15.7 million for the year ended December 31, 2022.

ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, OSA, Interest, Growth, Food and Drug Administration, Insurance, Trial of the century, News, Investment, Oxygen saturation (medicine), Depreciation, Obstructive sleep apnea, FDA, Marketing, RPM, Food, Pharmaceutical industry

Generated record revenues of $7.8 million for the fourth quarter and $27.7 million for the fiscal year 2023, a 35% increase compared to $5.8 million for the fourth quarter 2022 and 43% increase compared to $19.4 million for fiscal year 2022.

Key Points: 
  • Generated record revenues of $7.8 million for the fourth quarter and $27.7 million for the fiscal year 2023, a 35% increase compared to $5.8 million for the fourth quarter 2022 and 43% increase compared to $19.4 million for fiscal year 2022.
  • I am proud of the 2023 results, and I look forward to building upon this momentum during 2024.”
    Financial Results for the Fourth Quarter and Year Ended December 31, 2023
    Revenues increased to $7.8 million for the fourth quarter ended December 31, 2023.
  • Fourth quarter 2023 sales and marketing expense reflects a modest increase compared to the quarter ended September 2023, and an increase of $1.0 million, or 40%, compared to the quarter ended December 2022.
  • Fourth quarter 2023 general and administrative expenses reflect an increase of $0.5 million, or 16%, compared to the quarter ended September 2023, and a decrease of $1.7 million, or 30%, compared to the quarter ended December 2022.

Biora Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Absorption, Ulcerative colitis, Plasma, Aviation, Comparison, Disease, Partnership, SAN, Patient, Capital structure, Trial of the century, Investment, Clinical trial, Therapy, Antibody, Pharmacokinetics, Blood, SAD, Dicarboxylic acid, Peptide

SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood
    SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • “We are thrilled by the results from the single ascending dose (SAD) portion of our clinical trial for BT-600.
  • During 2023, Biora reduced its outstanding notes by more than $80 million, resulting in a 75% reduction in net debt.
  • Comparison of Full-Year Ended December 31, 2023 and 2022
    Operating expenses were $67.1 million for the year ended December 31, 2023, compared to $62.1 million for the year ended December 31, 2022.

Aptose Reports Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 26, 2024
Indian stock exchange, Absorption, Plasma, Exercise, Hanmi Pharmaceutical, AML, BID, Patient, APS, SAN, Venetoclax, G1, VEN, FLT3, EHA, LUX, Acute myeloid leukemia, Trial of the century, TUS, TSX, Hanmi, Azacitidine, G3, Pharmaceutical industry

This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.

Key Points: 
  • This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.
  • Total gross proceeds from the public offering were approximately $9.7 million before deducting underwriting costs, placement agent commissions and other offering-related expenses.
  • Private Placement – On January 31, 2024, Aptose closed a US $4 million private placement of common shares with strategic partner Hanmi Pharmaceutical.
  • Luxeptinib G3 Evaluation Completed – During 2023 and early 2024, clinical evaluation of the new generation 3 (G3) formulation of luxeptinib (LUX) was completed.

GTG Global Collaborations and Innovation Update

Retrieved on: 
Tuesday, March 26, 2024
Breast cancer, Health, General practice, Professor, BRCA, Public, Public health, Disease, GTG, Risk, Patient, PRS, Research, ASX, Breast, Mammography, University, Royal Melbourne Hospital, Trial of the century, WHI, Risk assessment, Sonneborn–Berger score, Council, Biobank, Publication, Clinical trial, Cancer, CLIA, Medical research, Colorectal cancer, University of Melbourne, Government, UK Biobank, Pharmaceutical industry

MELBOURNE, Australia, March 26, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a global leader in genomics-based tests in health, wellness and serious disease, is pleased to highlight a summary of the Company’s commitment to innovation.

Key Points: 
  • MELBOURNE, Australia, March 26, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a global leader in genomics-based tests in health, wellness and serious disease, is pleased to highlight a summary of the Company’s commitment to innovation.
  • GTG is one of the co-co-principal investigators of this trial led by Professor Jon Emery.
  • GTG regards adding new expanded risk assessment tests to the company’s portfolio as a critical step in improving patient care.
  • Leveraging this approach GTG is expanding the portfolio with the following new tests:
    Leveraging the BRCA-modifier research projects GTG will develop a test that incorporates high penetrant pathogenic variant risk with PRS.

SELLAS Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study

Retrieved on: 
Tuesday, March 26, 2024
Corporation, Toxicity, SLS, Survival, AML, Committee, Biomarker, GPS, Death, BIW, Enrollment, MD, Date, Trial of the century, Doctor of Science, Safety, IDMC, Pharmaceutical industry

The Company will host a webinar to discuss the data and the REGAL update today at 8:15 am ET.

Key Points: 
  • The Company will host a webinar to discuss the data and the REGAL update today at 8:15 am ET.
  • “We are extremely grateful to the patients, their families, and investigators who have helped us achieve this significant milestone.
  • Additionally, we are pleased to share that the Steering Committee has reviewed the study as of the March 1, 2024, cutoff date.
  • Dr. Stergiou continued: “We are extremely excited to share positive topline data from the Phase 2a trial of SLS009 in AML patients resistant to venetoclax combination therapies.

Intravacc announces positive data of first in human intranasal OMV based vaccine for SARS-CoV-2

Retrieved on: 
Tuesday, March 26, 2024
Conference, Immunoglobulin A, Female, Aes, FIH, SARS-CoV-2, Volunteering, Trial of the century, Male, OMV, Vaccination, Safety, Vaccine, Immunoglobulin G, Administration

The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.

Key Points: 
  • The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.
  • In a randomized, double-blinded, placebo and OMV controlled study, 36 healthy 18-55 year-old, male and female volunteers, received two intranasal doses, 3 weeks apart.
  • Dr. Dinja Oosterhoff, Intravacc’s VP of Research & Development, stated:
    “This FIH intranasal vaccine study marks a significant milestone for Intravacc’s flagship OMV based vaccine platform.
  • Now Intravacc is also developing an intranasal vaccine for Gonorrhea targeting the FIH in Q4 2025.

Qnovia, Inc. Announces the Appointment of Four New Members to its Scientific Advisory Board

Retrieved on: 
Tuesday, April 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Tobacco, Clinical Trials, Retail, Disease, Cardiovascular Research, Society, IND, Psychology, Therapy, Senior counsel, Population health, School, Dean (education), Partnership, Nicotine, Policy, Smoker, Behavior, NIH, Brown University, Trial of the century, University, SAB, Pharmacology, Homelessness, San Francisco General Hospital, UCSF, Public, Cancer, MD, Publication, Heated tobacco product, Hospital, Juul, FDA, Alpert Medical School, Pregnancy, Chair, Public health, University of Kansas, Cardiology, CTA, Mortality, Louisiana State University, Doctor of Philosophy, MHRA, Smoking, Toxicology, Division, Brown, Social science, Pharmaceutical industry

“We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.

Key Points: 
  • “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.
  • Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial.
  • We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year.
  • He also served a three-year term on the Board of the Society for Research on Nicotine and Tobacco.

Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Azacitidine, VTX, Phase, Wake Forest University, Patient, Trial of the century, Survivor, Acute myeloid leukemia, Cancer, AML, Pharmaceutical industry

Accordingly, we can start the Phase I/II combo-study very soon.

Key Points: 
  • Accordingly, we can start the Phase I/II combo-study very soon.
  • The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML.
  • This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML.
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