U.S. FDA

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

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木曜日, 5月 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

Sofwave Medical Reports First Quarter 2024 Financial Results and Business Highlights

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木曜日, 5月 9, 2024
Sale, FDA, Pulse, Innovation system, Growth, U.S. FDA, Pure, SAN, Tourism

SAN CLEMENTE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, reported financial results for the first quarter of fiscal year 2024, for the period ended March 31, 2024, and recent business highlights.

Key Points: 
  • First quarter revenue of $13.2M, +27% year-over-year growth; IFRS gross margin of 75.2%
    First quarter pulse recurring revenue of $4.7M, +118% year-over-year growth
    IFRS and non-IFRS operating loss narrowed to -$1.0M and -$0.4M, respectively; company approaching breakeven
    SAN CLEMENTE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, reported financial results for the first quarter of fiscal year 2024, for the period ended March 31, 2024, and recent business highlights.
  • First Quarter Revenue of $13.2M; representing 27% year-over-year growth
    IFRS Operating Loss: $1.0M; down from $3.7 million in first quarter of 2023; *Non-IFRS Operating Loss: $0.4M
    Cash and Cash Equivalents as of March 31, 2024: $23.1M, Cash used in the first quarter of 2024 of $1.3M down from $3.0M in the first quarter of 2023.
  • Mr. Louis Scafuri, Sofwave CEO, commented, “We continue to experience significant tailwinds for our disruptive technology and unique business model, as demonstrated by the 27% top-line growth generated in the first quarter of 2024.
  • Of significance, recurring pulse sales are an increasingly significant contributor to our strong financial results, with recurring pulse sales representing more than one third of our total first quarter revenue.

X4 Pharmaceuticals Announces $125 Million Capital Infusion from $105 Million Sale of Priority Review Voucher and $20 Million Drawdown from Existing Loan Facility

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木曜日, 5月 9, 2024
Sale, FDA, PRV, WHIM syndrome, Food, WHIM, U.S. FDA, Patient, Immune system, Pharmaceutical industry

BOSTON, May 09, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed purchaser for $105 million and that it has drawn an additional tranche of $20 million under its existing loan facility with Hercules Capital, Inc. (NYSE: HTGC). Both transactions result from the U.S. Food and Drug Administration (FDA) approval of the company’s first product, XOLREMDI™ (mavorixafor), in late April.

Key Points: 
  • Both transactions result from the U.S. Food and Drug Administration (FDA) approval of the company’s first product, XOLREMDI™ (mavorixafor), in late April.
  • Under the Rare Pediatric Disease program, the FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
  • The term loan facility with Hercules Capital provides for up to $115 million of term loans in the aggregate, available to be funded in multiple tranches, and is in an interest-only period until July 2027.
  • The $105 million of gross funds received from the sale of the PRV and the $20 million drawn from the existing loan facility add to the $82 million in cash, cash equivalents, restricted cash, and short-term marketable securities reported as of March 31, 2024.

Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update

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木曜日, 5月 9, 2024
FDA, Fast Track, Research, Rett syndrome, Trial of the century, Partnership, Doctor of Philosophy, Conference call, CNS, Procedure, Frontotemporal dementia, EDGAR, Food, Orphan drug, European Medicines Agency, Brain, RWE, MECP2, Drug development, RNA-Seq, Conference, Publication, Pharmacokinetics, U.S. FDA, Marketing authorisation, DSM-IV codes, Patent, Real, RNA, Human, Therapy, Treatment, EMA, Alzheimer's disease, Central nervous system, Clinical trial, Medicine, Marketing, ADAS, Centralisation, Pharmacology, European, Patient, Expanded access, Caregiver, Webcast, Interim, Bank statement, Pharmaceutical industry

NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental and neuropsychiatric disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended March 31, 2024.

Key Points: 
  • Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 month trial is expected in the second half of 2024.
  • General and administrative expenses for the quarter of $2.8 million compared to $2.9 million for the comparable quarter of fiscal 2023.
  • Research and development expenses for the quarter of $9.7 million compared to $11.3 million for the comparable quarter of fiscal 2023.
  • The financial information for the fiscal quarter ended March 31, 2024, should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com .

Prime Medicine Presents Preclinical Data Demonstrating Ability of PM359 to Efficiently, Reproducibly and Durably Correct Causative Mutation of Chronic Granulomatous Disease (CGD)

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水曜日, 5月 8, 2024
FDA, Process, Chronic granulomatous disease, Mutation, Mouse, Cell, CGD, Food, Hematology, Life, U.S. FDA, IND, Neutrophil, NADPH, Patient, Society, Immunology, Stem cell, Fungus, Health, NCF1, Pharmaceutical industry

CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, today reported new preclinical data demonstrating the ability of its ex vivo Prime Editing program, PM359, to correct a common disease-causing mutation of chronic granulomatous disease (CGD). The data will be presented today at an oral presentation during the American Society of Cell & Gene Therapy 27th Annual Meeting in Baltimore. Prime Medicine recently announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for PM359 for the treatment of CGD.

Key Points: 
  • The data will be presented today at an oral presentation during the American Society of Cell & Gene Therapy 27th Annual Meeting in Baltimore.
  • Prime Medicine recently announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for PM359 for the treatment of CGD.
  • Prime Medicine is advancing an ex vivo Prime Editing program, PM359, that aims to correct the predominant mutation in NCF1 in CGD patient CD34+ hematopoietic stem cells (HSCs) and restore NADPH oxidase function.
  • In today’s presentation at ASGCT, Prime Medicine highlighted data from a series of in vivo non-clinical studies using human CGD patient CD34+ HSCs.

Creyon Bio to Present Clinical Data on Rapid AI-Enabled Engineering of Oligonucleotide-Based Medicines at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting

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火曜日, 5月 7, 2024
FDA, Brain, University, Rady, Seizure, Hope, Safety, AI, Asos, Health, Partnership, Trial of the century, Cell, Artificial intelligence, U.S. FDA, Entrepreneurship, Disease, Engineering, Attention, Family, Gene, Society, MRI, Locked nucleic acid, Pediatrics, TNPO2, CSF, Central nervous system, Drug development, GMP, DSM-IV codes, Annual general meeting, Associate, Behavior, LNA, Cerebrospinal fluid, SAN, Baltimore Convention Center, OBM, Pharmaceutical industry

SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., May 07, 2024 (GLOBE NEWSWIRE) -- Creyon Bio, Inc. ("Creyon"), a clinical stage drug development company that engineers Oligonucleotide-Based Medicines (OBMs) with industry-leading efficiency creating novel, best-in-class gene-centric medicines to treat rare and common diseases, today announced encouraging clinical data highlighting the use of its custom designed data set paired with artificial intelligence (AI) to rapidly engineer an investigational antisense oligonucleotide (ASO) therapy. Within one year of project initiation in partnership with The TNPO2 Foundation, Creyon developed a novel allele-selective Locked Nucleic Acid (LNA) treatment candidate for an ultra-rare and severe neurological disease caused by a single nucleotide variant in the Transportin-2 (TNPO2) receptor, and an investigator-initiated clinical trial received approval to dose a patient. Initial data from this trial demonstrate that the investigational treatment successfully reduced seizures, restored developmental milestones, and was well-tolerated over nine months. Creyon will share these results during an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting in Baltimore on Friday, May 10, 2024, between 5:15-5:30 p.m. EDT in Room 307-308 of the Baltimore Convention Center.

Key Points: 
  • Initial data from this trial demonstrate that the investigational treatment successfully reduced seizures, restored developmental milestones, and was well-tolerated over nine months.
  • Creyon will share these results during an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting in Baltimore on Friday, May 10, 2024, between 5:15-5:30 p.m. EDT in Room 307-308 of the Baltimore Convention Center.
  • “We developed predictive models that guide our molecular engineering from the outset and help mitigate potential safety concerns.
  • “Inflammatory reactions to oligonucleotide therapies have caused serious adverse reactions in other early clinical-stage therapies delivered directly to the central nervous system.

Atossa Therapeutics Announces Support of New Breast Cancer Screening Guidelines

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火曜日, 5月 7, 2024
Mortality, Breast, Woman, USPSTF, U.S. FDA, Atossa, Patient, Breast cancer screening, Diagnosis, Health, Therapy, Breast cancer, Medical imaging

SEATTLE, May 07, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced its support of new guidelines released by the U.S. Preventive Services Task Force (USPSTF) recommending that women begin breast cancer screening starting at age 40.

Key Points: 
  • SEATTLE, May 07, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced its support of new guidelines released by the U.S. Preventive Services Task Force (USPSTF) recommending that women begin breast cancer screening starting at age 40.
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • The change to the recommended age comes in response to rising breast cancer rates among younger women and racial disparities in breast cancer diagnosis and mortality.
  • Atossa Therapeutics recognizes the significance of these improved guidelines in empowering both healthcare providers and patients to make informed decisions regarding breast cancer screening and treatment.

T2 Biosystems Announces First Quarter 2024 Financial Results

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月曜日, 5月 6, 2024
FDA, ASPR, International, Research, ECCMID, U.S. FDA, ATM, Panel, Blood culture, CRG, Acinetobacter baumannii, Infection, Journal, Growth, Sepsis

LEXINGTON, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced unaudited financial and operational results for the first quarter ended March 31, 2024.

Key Points: 
  • LEXINGTON, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced unaudited financial and operational results for the first quarter ended March 31, 2024.
  • Advanced the T2Resistance Panel toward U.S. FDA 510(k) submission, expected to occur during the third quarter of 2024.
  • “Looking ahead, we plan to launch T2Lyme Panel and file the FDA submission for the T2Resistance Panel during the third quarter of 2024.
  • The Company raised $2.2 million in net proceeds through ATM sales in the first quarter of 2024.

Day One Reports First Quarter 2024 Financial Results and Corporate Progress

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月曜日, 5月 6, 2024
FDA, Brain, BRAF V600, Day One, Investment, Food, Research, Insurance, Conference, U.S. FDA, MEK, Prescription, ASCO, BRAF, Patient, Society, Clinical trial, Annual general meeting, Food and Drug Administration, Ageing, Pharmaceutical industry

BRISBANE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2024 financial results and highlighted recent corporate achievements.

Key Points: 
  • Results from the FIRELIGHT-1 Phase 1b and next steps are expected in the second half of 2024.
  • Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2026.
  • R&D Expenses: Research and development expenses were $40.2 million for the first quarter of 2024 compared to $27.8 million for the first quarter of 2023.
  • G&A Expenses: General and administrative expenses were $26.6 million for the first quarter of 2024 compared to $18.0 million for the first quarter of 2023.

Anumana’s ECG-AI™ Algorithms Honored with 2024 MedTech Breakthrough Award for “Best New Technology Solution-Cardiology”

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木曜日, 5月 9, 2024
Health, Technology, Health Technology, Software, Artificial Intelligence, Cardiology, Medtech, FDA, Mortality, Mayo Clinic, Pulmonary hypertension, AI, Therapy, Cardiac amyloidosis, Research, ECG, U.S. FDA, Patient, Disease, Hyperkalemia, LEF, Algorithm, Prevalence, Heart failure, Medical device

Anumana, Inc ., a leading AI-driven health technology company and portfolio company of nference , announced today it has received the 2024 MedTech Breakthrough Award for Best New Technology Solution in the Cardiology category.

Key Points: 
  • Anumana, Inc ., a leading AI-driven health technology company and portfolio company of nference , announced today it has received the 2024 MedTech Breakthrough Award for Best New Technology Solution in the Cardiology category.
  • Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI LEF represents a paradigm shift in ECG interpretation.
  • “At Anumana, we are committed to developing evidence-based AI algorithms that empower clinicians to uncover diseases earlier and improve patient outcomes,” said Maulik Nanavaty, CEO of Anumana.
  • “We are honored to be recognized by MedTech Breakthrough for our efforts in developing and implementing our cutting edge clinically validated AI algorithms that enhance ECG interpretation.