Biomarker

EQS-News: Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Retrieved on: 
Wednesday, March 13, 2024

Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Key Points: 
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    The issuer is solely responsible for the content of this announcement.
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    Dr. Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, to lead collaboration
    BERKELEY, US – MAINZ, Germany – March 5, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.
  • In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
  • The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.

EQS-News: Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 13, 2024

The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS).

Key Points: 
  • The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS).
  • The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption.
  • Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
  • An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations .

NGM Bio Provides Recent Business Highlights and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024

--On February 26, 2024, announced that it had entered into the Agreement and Plan of Merger with Atlas Neon Parent, Inc., and Atlas Neon Merger Sub, Inc.--

Key Points: 
  • The combination of NGM707 and pembrolizumab was generally well-tolerated at all four doses (200, 600, 1200, 1800 mg) of NGM707.
  • Additional details can be found in NGM Bio’s recent filings with the United States Securities and Exchange Commission (SEC).
  • NGM Bio anticipates that the Offer and the Merger contemplated under the Merger Agreement will be consummated in the second quarter of 2024.
  • If the Merger is effected, NGM Bio’s common stock will be delisted from The Nasdaq Stock Market LLC and NGM Bio will be privately held.

BioVie Announces Pipeline Update and Near-Term Clinical Priorities

Retrieved on: 
Monday, March 11, 2024

CARSON CITY, Nev., March 11, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that its recently completed funding round provides opportunity to further the Company’s clinical priorities in Parkinson’s Disease (PD), Alzheimer’s Disease (AD), and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators. 

Key Points: 
  • The Company continues to explore longevity and aging in conjunction with external collaborators.
  • The trial targets enrolling 100-150 patients in a 6-month trial with the Part 3 (motor) score on the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as the primary endpoint.
  • Only one Phase 3 trial is potentially needed as BIV201 has already received Orphan and Fast Track designations.
  • BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete.

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points: 
  • We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
  • We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
  • At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
  • Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against GrafTech, Instacart, Cassava, and Amylyx and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, March 9, 2024

The Company sells and delivers a range of products in the food, alcohol, consumer health, pet care, and ready-made meals categories, in addition to others.

Key Points: 
  • The Company sells and delivers a range of products in the food, alcohol, consumer health, pet care, and ready-made meals categories, in addition to others.
  • The Company offers its services through a mobile application and website, while also providing software-as-a-service solutions to retailers.
  • In addition, the complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX

Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024

In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.

Key Points: 
  • In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.
  • Of these potential future payments, Ovid sold a 13% interest to Ligand Pharmaceuticals for $30 million in October 2023.
  • Financial runway: Ovid anticipates its cash runway will support operations and clinical development programs into the first half of 2026.
  • Ovid also anticipates several events for its current pipeline programs and clinical results for soticlestat from Takeda in 2024.

Acumen Pharmaceuticals Presents Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting

Retrieved on: 
Friday, March 8, 2024

CHARLOTTESVILLE, Va., March 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today presented cerebrospinal fluid (CSF) biomarker data from the sabirnetug (ACU193) Phase 1 INTERCEPT-AD trial in an oral presentation at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Lisbon, Portugal, and online. Acumen also presented a poster showcasing the method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody.

Key Points: 
  • Acumen also presented a poster showcasing the method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody.
  • Acumen’s sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration.
  • Positive topline results from 62 participants dosed in the Phase 1 INTERCEPT-AD trial (NCT04931459) were reported in July 2023 , and additional insights from exploratory analyses have further confirmed sabirnetug’s proof-of-mechanism and broad therapeutic potential as a next-generation treatment for early AD.
  • The novel assay configuration was tailored to selectively detect sabirnetug-AβO complex in CSF as a direct measure of target engagement, showing clear dose-related increases in target engagement across all cohorts.

Allarity Therapeutics Reports Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Friday, March 8, 2024

The Company's Interim Chief Executive Officer, Thomas Jensen, stated, “2023 was a year of remarkable achievements for Allarity Therapeutics as we made significant strides in advancing our DRP®-guided drug development.

Key Points: 
  • The Company's Interim Chief Executive Officer, Thomas Jensen, stated, “2023 was a year of remarkable achievements for Allarity Therapeutics as we made significant strides in advancing our DRP®-guided drug development.
  • Announced leadership changes and strategic advisory engagement:
    Appointment of co-founder Thomas H. Jensen as Interim Chief Executive Officer in December 2023.
  • With nearly two decades at Allarity Therapeutics, Jensen brings extensive experience and a deep understanding of the company’s DRP® to his new role.
  • Net Loss from Operations: Net Loss from Operations was $17.1 million for 2023, compared to $34 million for 2022.