Biomarker

Vaxxinity Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 27, 2024
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CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
  • We also seek to advance UB-311, our anti-Aβ Alzheimer’s candidate, as we resume dialogue with regulatory authorities and partners.
  • General and administrative expenses were $3.4 million and $7.7 million for the three months ended December 31, 2023, and 2022, respectively.
  • General and administrative expenses were $22.4 million and $28.4 million for the years ended December 31, 2023, and 2022, respectively.

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

Retrieved on: 
Wednesday, March 27, 2024
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FORT WORTH, Texas , March 27, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Key Points: 
  • “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines.
  • The updated safety and efficacy data are based on the cutoff date of March 8, 2024.
  • The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.
  • The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

XORTX Announces New Clinical Advisory Board Member

Retrieved on: 
Wednesday, March 27, 2024
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CALGARY, Alberta, March 27, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA WKN: A3UNZ), a biopharmaceutical company focused on developing innovative therapies to treat autosomal dominant polycystic kidney disease (“ADPKD”), is pleased to announce that Dr. Ronald Perrone has joined the Company’s Clinical Advisory Board.

Key Points: 
  • CALGARY, Alberta, March 27, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA WKN: A3UNZ), a biopharmaceutical company focused on developing innovative therapies to treat autosomal dominant polycystic kidney disease (“ADPKD”), is pleased to announce that Dr. Ronald Perrone has joined the Company’s Clinical Advisory Board.
  • Dr. Allen Davidoff stated, “We are excited that Dr. Ron Perrone has agreed to join XORTX’s Clinical Advisory Board.
  • Dr. Perrone brings substantial medical and professional experience as a thought leader, combined with clinical experience treating patients with ADPKD and kidney disease.
  • We are privileged to have Dr. Perrone join our esteemed Clinical Advisory Board alongside current members, Dr. Petter Bjornstad, Dr. Richard Johnson, Dr. Federico Maese, Dr. Anjay Rostogi and Dr. Charles Edelstein.

Tellbio’s Technology Demonstrates that Analysis of Circulating Tumor Cells Can Predict Survival Among Patients with Metastatic Castration-Resistant Prostate Cancer Receiving Radium-2230

Retrieved on: 
Wednesday, March 27, 2024
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ANDOVER, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- TellBio, Inc., a development-stage medical technology company focused on revolutionizing the detection of cancer metastasis through its unique and proprietary circulating tumor cell (CTC) technology, the TellDx CTC System, announces the publication of data that shows the promise of CTCs as a prognostic biomarker for patients with prostate cancer receiving novel therapies such as radium-223. The paper, “Circulating and Imaging Biomarkers of Radium-223 Response in Metastatic Castration-Resistant Prostate Cancer,” was published in JCO Precision Oncology (DOI 10.1200/PO.23.00230).

Key Points: 
  • The paper, “Circulating and Imaging Biomarkers of Radium-223 Response in Metastatic Castration-Resistant Prostate Cancer,” was published in JCO Precision Oncology (DOI 10.1200/PO.23.00230 ).
  • “Radium-223 is a valuable treatment option for patients with mCRPC, but better biomarkers are needed to identify patients most likely to benefit from therapy.
  • Additionally, imaging assessment in patients with bone-predominant disease has also been limited in patients receiving radium-223.
  • Upon controlling for known prognostic markers, PSA and tAP, the presence of baseline CTC AR-V7 expression was most predictive of OS among patients receiving radium-223.

argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease

Retrieved on: 
Wednesday, March 27, 2024
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“We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.

Key Points: 
  • “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
  • “Consistent with our indication selection strategy, we confirmed our IgG biology hypothesis with these data, and now have a demonstrated clinical effect across multiple efficacy scales to support proof-of-concept.
  • Sjogren’s disease can be debilitating, predominantly affects women, and given its heterogeneous nature, is often misdiagnosed with its symptoms poorly understood.
  • Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

Retrieved on: 
Tuesday, March 26, 2024
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The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).

Key Points: 
  • The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).
  • The DECODE study showed that clinicians using the HeartFlow Plaque Analysis changed their management decisions for 66% of patients compared to CCTA alone across various patient presentations and disease stages.
  • “We believe real-world prospective data from the new DECIDE Registry will empower clinicians with enhanced patient insights leveraging HeartFlow Plaque Analysis to improve patient outcomes.
  • The primary endpoint for this registry will highlight change in medical management after HeartFlow Plaque Analysis compared to after CCTA alone.

Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2023 and Business Highlights

Retrieved on: 
Tuesday, March 26, 2024
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We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.

Key Points: 
  • We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.
  • We also expect to initiate a subcutaneous bioavailability study in mid-2024, to extend the product profile and offer administration optionality for patients.
  • Dr. Doherty brings decades of neuroscience-focused research and clinical development expertise to Acumen, from discovery through drug approval.
  • Net loss for the year ended December 31, 2023 was $52.4 million, compared to a net loss of $42.9 million for the year ended December 31, 2022.

Cognition Therapeutics Reports Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
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PURCHASE, N.Y., March 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. Management will host a live webcast conference call at 8:00am ET to review 2023 accomplishments. Details of the call are provided below.

Key Points: 
  • ET -
    PURCHASE, N.Y., March 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Cognition scientists published two manuscripts and made 11 presentations at medical and scientific congresses in 2023, advancing the understanding of its foundational science and clinical implications.
  • “We achieved a number of critical clinical objectives in 2023,” said Lisa Ricciardi, Cognition’s president and CEO .
  • Management will host a conference call and live webcast to discuss Cognition’s financial results today at 8:00 a.m.

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

Retrieved on: 
Tuesday, March 26, 2024
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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.

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

Retrieved on: 
Tuesday, March 26, 2024
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The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.

Key Points: 
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • However, in response, Cassava denied the allegations in the Citizen Petition and instead touted the effectiveness of simufilam and the efficacy of the Company's research programs.
  • On this news, Cassava's stock price fell $2.68 per share, or 15.28%, to close at $14.86 per share on October 13, 2023.
  • For more information on the InMode class action go to: https://bespc.com/cases/INMD