Toxicity

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2023

Retrieved on: 
Thursday, March 28, 2024
Narcolepsy, Toxicity, Administration, Development, ASH, ABR, Haemophilia, Part, APC, Tumor microenvironment, Observation, Volunteering, Trial of the century, CD47, Investment, Society, Bleeding, CNTA, ATM, Safety, OX2R, Sleep, Person, Pharmaceutical industry

“This is an exciting and pivotal time for Centessa,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.

Key Points: 
  • “This is an exciting and pivotal time for Centessa,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.
  • Cash, Cash Equivalents and Short-term Investments: $256.5 million as of December 31, 2023, which includes approximately $6.2 million in net proceeds through ATM sales in the fourth quarter ended December 31, 2023.
  • General & Administrative Expenses: $12.3 million for the fourth quarter ended December 31, 2023, compared to $13.8 million the fourth quarter ended December 31, 2022, and $53.7 million for the full-year 2023 compared to $55.2 million for the full-year 2022.
  • Net Loss Attributable to Ordinary Shareholders: $36.8 million for the fourth quarter ended December 31, 2023, compared to $43.2 million for the fourth quarter ended December 31, 2022, and $151.1 million for the full-year 2023 compared to $216.2 million for the full-year 2022.

Omega Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Strategic Update

Retrieved on: 
Thursday, March 28, 2024
HCC, Research, Epigenomics, Toxicity, Obesity, Cell death, Growth, Burns, Gene expression, Novo Nordisk, NSCLC, AASLD, Appetite, OMEGA, DCR, Patient, Lung, Tissue, Cohort, CXCL9, CXCL10, Omega, G&A, Cancer, Messenger, Lung cancer, Human, Life expectancy, Liver regeneration, DLT, Fibrosis, Thermogenesis, Therapy, MYC, Liver, Pharmacokinetics, Hepatitis, CXCL11, LNP, Pharmaceutical industry

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.

Key Points: 
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022.
  • Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022.
  • The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.

Matinas BioPharma Reports 2023 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, March 27, 2024
Malignancy, Colitis, Survival, BioNTech, Patient, Lung, City, Standard of care, Quality of life, Fungal infection, Aspergillosis, Nationwide, Clinical trial, Bone marrow, Melanoma, Aspergillus fumigatus, Therapy, Human, Psoriasis, Partnership, World Health Organization, Coccidioides, Safety, Clutch (eggs), University, Kidney, Amphotericin B, Neoplasm, Research, Data monitoring committee, Infection, Skin, Vanderbilt University Medical Center, Hospital, Immunodeficiency, FDA, Critical, Element, Toxicity, IL-17A, Brain, Conference call, Conference, Johns Hopkins, Nephrotoxicity, Docetaxel, Serum, Inflammation, Mouse, Mortality, Fusarium, Bangladesh Technical Education Board, Pharmaceutical industry

BEDMINSTER, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports 2023 financial results and provides a business update.

Key Points: 
  • Aspergillus fumigatus is also included in the FDA qualified designation list of pathogens that pose a serious and life-threatening risk.
  • Revenue for 2023 was $1.1 million, which was generated from the Company’s research collaborations with BioNTech SE and Genentech Inc.
  • Cash, cash equivalents and marketable securities as of December 31, 2023 were $13.8 million compared with $28.8 million as of December 31, 2022.
  • Matinas will host a conference call and webcast today beginning at 4:30 p.m. Eastern time.

Allarity Therapeutics Makes Strategic Pivot to Focus Solely on Accelerating Stenoparib Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer

Retrieved on: 
Wednesday, March 27, 2024
Toxicity, Ovarian cancer, BRCA, Mirvetuximab soravtansine, Partnership, Patient, Neoplasm, Cancer, Merck, Doctor of Philosophy, Olaparib, WNT, Niraparib, Jiangsu Hengrui Medicine, PARP, Therapy, Safety, Platinum, Interim, Rucaparib, Pharmaceutical industry

This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.

Key Points: 
  • This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.
  • In addition, stenoparib is unique in its mechanism of action, inhibiting PARP as well as the novel cancer target, tankyrase.
  • Tankyrase inhibition would restrain the WNT pathway, which is commonly upregulated not only in ovarian cancers but in many other solid cancers.
  • Given the unique, dual mechanism of action for stenoparib—coupled with its favorable safety profile—stenoparib may represent the next-generation alternative in the evolving market for advanced ovarian cancer patients.

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

Retrieved on: 
Tuesday, March 26, 2024
Research, Toxicity, Central nervous system, PIN, Administration, Immunotherapy, Emax, Science, Patient, AstraZeneca, Food and Drug Administration, Biomarker, G&A, Plaque, Chemistry, Therapy, Neurogranin, Safety, ABOS, Research and development, Plasma protein binding, Food, Pharmaceutical industry

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.

Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Hepatitis, KPMG, GNI, Cirrhosis, Patient, Chronic obstructive pulmonary disease, Sale, Coagulopathy, Ernst & Young, Idiopathic pulmonary fibrosis, Fibrosis, Therapy, COPD, Marketing, Partnership, Arthur Andersen, Audit committee, SAN, Safety, CVR, CHB, Fatty liver disease, Prevalence, Pharmacy, Hospital, Research, Acquisition, TGF, Pirfenidone, GAAP, Toxicity, Inflammation, Accounting, Entecavir, Loss, Orthostatic hypertension, IPF, Partner, NASH, Category 1, Pharmaceutical industry

Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.

Key Points: 
  • Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.
  • In October 2023, Gyre (formerly known as Catalyst Biosciences, Inc. (“Catalyst”)) completed the previously announced business combination with GNI Group Ltd. (“GNI”) and related entities.
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Appen Launches Solution for Enterprises to Customize Large Language Models (LLMs)

Retrieved on: 
Tuesday, March 26, 2024
Toxicity, Synthetic media, Benchmarking, Learning, RAG, ASX, AI, LLM, Quality, Collection, Sales

KIRKLAND, Wash., March 26, 2024 (GLOBE NEWSWIRE) -- Appen Limited (ASX: APX), a leading provider of high-quality data for the AI lifecycle, announced the launch of new platform capabilities that will support enterprises customizing large language models (LLMs).

Key Points: 
  • KIRKLAND, Wash., March 26, 2024 (GLOBE NEWSWIRE) -- Appen Limited (ASX: APX), a leading provider of high-quality data for the AI lifecycle, announced the launch of new platform capabilities that will support enterprises customizing large language models (LLMs).
  • The solution supports internal teams who are attempting to leverage generative AI within the enterprise.
  • The steps include:
    Model selection: Appen's platform connects directly to any model, enabling you to evaluate existing models, test new models, and conduct comprehensive benchmarking.
  • For almost three decades, Appen has excelled in the collection and preparation of high-quality, large volumes of data with global reach- exactly the data that is required to train large language models and get accurate, consistent outputs.

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, March 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

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.