Standard of care

Psyence Biomedical’s Subsidiary, Psyence Australia, Receives Human Research Ethics Committee (HREC) Approval to Initiate Phase IIb Study

Retrieved on: 
Wednesday, March 6, 2024
Anxiety, Palliative care, Caregiver, Research, Quality of life, Terminal, Standard of care, Adjustment disorder, Contract research organization, World Health Organization, Patient, Clinical trial, Diagnosis, PBM, Psychotherapy, Adjustment, Nursing

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.

Key Points: 
  • NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.
  • The study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context.
  • Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENū Pty Ltd ("iNGENū"), to design and execute the clinical trial.
  • Psyence anticipates enrolling the first patient in Q2 2024 and expects the primary endpoint results to be available in 2025.

Bionano Reports Fourth Quarter and Full-Year 2023 Results and Provides Revenue Outlook for 2024

Retrieved on: 
Tuesday, March 5, 2024
SAN, Doctor of Philosophy, Research, FDA, Data collection, Growth, Overalls, Sale, Genomics, NGS, DSM-IV codes, Standard of care, IRB, Bone marrow, GAAP, Medicare, First Step, Genome, Data analysis, Symposium, OGM, Met, Publication, Comment, SOC, DNA, Cancer, Workflow, Video game

Total revenue for the fourth quarter of 2023 was $10.7 million, an increase of 30% compared to the fourth quarter of 2022.

Key Points: 
  • Total revenue for the fourth quarter of 2023 was $10.7 million, an increase of 30% compared to the fourth quarter of 2022.
  • GAAP gross margin for the fourth quarter of 2023 was 23%, which was slightly higher than the 22% GAAP gross margin reported for the fourth quarter of 2022.
  • Fourth quarter 2023 GAAP operating expense was $27.4 million, compared to $39.3 million in the fourth quarter of 2022.
  • Fourth quarter 2023 non-GAAP operating expense was $27.3 million, compared to $30.6 million in the fourth quarter of 2022.

Dyne Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, March 5, 2024
Therapy, Myotonia, Central nervous system, Research, DYN, Dystrophin, Safety, DMPK, DMD, Exercise, Standard of care, Conference, DM1, Eteplirsen, Muscular Dystrophy Association, Fatigue, Myotonic dystrophy, Patient, Clinical trial, PMO, Male, G&A, MDA, Episcopal conference, Pharmaceutical industry

WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2023 and recent business highlights.

Key Points: 
  • (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2023 and recent business highlights.
  • Net loss: Net loss for the quarter ended December 31, 2023 was $66.6 million, or $1.09 per basic and diluted share.
  • This compares with a net loss of $38.8 million, or $0.74 per basic and diluted share, for the quarter ended December 31, 2022.
  • Net loss for the year ended December 31, 2023 was $235.9 million, or $3.95 per basic and diluted share.

Zymeworks to Present Preclinical Data on Antibody-Drug Conjugate and Multispecific Platforms at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024
Therapy, CD28, San Diego Convention Center, Zymeworks, Abstract, Standard of care, Vaccine

Strong preclinical activity across multiple FRα-expressing indications for ZW191, a FRα-targeting antibody-drug conjugate

Key Points: 
  • Strong preclinical activity across multiple FRα-expressing indications for ZW191, a FRα-targeting antibody-drug conjugate
    VANCOUVER, British Columbia, March 05, 2024 (GLOBE NEWSWIRE) --  Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced acceptance of five abstracts for poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place at the San Diego Convention Center in San Diego, CA from April 5-10, 2024.
  • “Our team is especially excited to participate in AACR this year to highlight some recent advancements in the development of our next generation antibody-drug conjugate and multispecific antibody therapeutics,” said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks.
  • “Five abstracts being accepted underscores the strong progress we continue to make in advancing multiple development programs based on our proprietary engineering platforms and integrated technologies.”
    Title: TriTCE Co-Stim: A next generation trispecific T cell engager platform with integrated CD28 costimulation, engineered to improve responses in the treatment of solid tumors

MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8

Retrieved on: 
Tuesday, March 5, 2024
Senior, Randomized controlled trial, RAA, Teaching, EST, Diabetes, MannKind Corporation, ABC, A1C, Standard of care, Conference, ATTD, University, MDI, Patient, Insulin, Automation, Clinical trial, T1D, Pharmaceutical industry

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “With ABC and this trial, we used a higher initial conversion dose for inhaled insulin than in our current label.
  • In the ABC study, this conversion dose produced significantly lowered post-prandial glucose levels that peaked 30 minutes sooner than standard of care.
  • More information on the study is available at: ClinicalTrials.gov(NCT05904743) .

89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, February 29, 2024
Liver, SAN, FGF21, EMA, Research, AASLD, FDA, Research and development, Cirrhosis, Standard of care, Hepatitis, Safety, European Medicines Agency, Administration, Patient, Fibrosis, NASH, Pharmaceutical industry

SAN FRANCISCO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • ENLIGHTEN-Fibrosis is expected to enroll non-cirrhotic patients with fibrosis stage F2-F3 and ENLIGHTEN-Cirrhosis is expected to enroll NASH patients with compensated cirrhosis (F4).
  • ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis are expected to initiate in the first and second quarter of 2024, respectively.
  • Completed follow-on offering in the fourth quarter of 2023 for $172.5 million in gross proceeds.
  • The foregoing financial information is unaudited and subject to change, and actual results may vary from the foregoing.

Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
CRDF, SAN, Research, Investment, Cancer, Bev, FOLFIRI, PLK1, Bevacizumab, Standard of care, Clinical Cancer Research, Interim, Safety, Patient, SOC, Pharmaceutical industry

New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.

Key Points: 
  • New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.
  • Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • Full Year 2023 Financial Results:
    As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024.

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

Retrieved on: 
Thursday, February 29, 2024
NRAS, CRDF, SAN, MD, FDA, Cancer, Bev, PLK1, Standard of care, FACP, Patient, Suggestion, SOC, Phase, Mutation, Pharmaceutical industry

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.

Key Points: 
  • Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment.
  • The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
  • “The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting.
  • We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
    In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.

Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024
Fast Track, HCV, BID, Patient, Week, Research, Infection, Tax, Doctor of Philosophy, NS5A, FDA, Food, Security (finance), SVR4, Kinetics, Immunodeficiency, Hospital, Standard of care, Viral, Cirrhosis, Interim, Prevalence, Safety, COVID-19, Contraindication, Death, Administration, Atea, Bemnifosbuvir, Risk, DSMB, Second generation, Development, Ageing, SOC, SVR, Viral load, Pharmaceutical industry

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • Enrollment of the remainder of this study is ongoing with topline results anticipated in the second half of 2024,” continued Dr. Sommadossi.
  • Final results from the 60 patient lead-in cohort confirmed a 98% SVR4 rate across GT from 58 of 59 patients.
  • Final SVR12 results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024.
  • Cash, Cash Equivalents and Marketable Securities: $578.1 million at December 31, 2023 compared to $646.7 million at December 31, 2022.

BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Tuesday, February 27, 2024
Human services, Oxygen, Gelsolin, Incidence, Sepsis, ICU, Inflammation, Randomness, Safety, Quality of life, Șaeș, Causality, Drive, Administration, Infection, Nursing care plan, Therapy, Patient, Standard of care, Trauma, Efficacy, Mortality, Plasma, Pharmaceutical industry

Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.

Key Points: 
  • Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.
  • The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
  • In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions.