Efficacy

Positive Results for Patients with Non-obstructive Hypertrophic Cardiomyopathy Treated with Ninerafaxstat in the Phase 2 IMPROVE-HCM Trial Presented During a Late-Breaking Clinical Trial Session at ACC.24

Retrieved on: 
Monday, April 8, 2024
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BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and functional capacity by enhancing cellular energetics, today announced that results from the Phase 2 IMPROVE-HCM clinical trial, evaluating ninerafaxstat in patients with symptomatic nHCM, were presented in a late-breaking clinical trial session at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24) and published in the Journal of the American College of Cardiology (JACC).

Key Points: 
  • “We are pleased with the IMPROVE-HCM clinical trial results presented today at ACC and simultaneously published in JACC, confirming the importance of these results for patients living with nHCM,” said Anne Prener, M.D., Ph.D., president and chief executive officer of Imbria Pharmaceuticals.
  • “Based on these positive results, we plan to initiate the Phase 3 FORTITUDE-HCM clinical trial in patients with symptomatic nHCM later this year.
  • Most treatment emergent adverse events (AEs) were self-limiting and mild to moderate in severity occurring in 24 ninerafaxstat treated patients (70.6%) vs. 20 patients on placebo (60.6%).
  • improved) from 31.2 to 30.9 in the ninerafaxstat treated group and worsened from 32.7 to 34.3 in the placebo group.

EVLV Class Action Alert: Robbins LLP Reminds Investors of Lead Plaintiff Deadline in Evolv Technologies Holdings, Inc. Class Action

Retrieved on: 
Friday, April 5, 2024
Gun, Weapon, Risk, SAN, School, Light, LLP, Efficacy, Complaint, Artificial intelligence, Person

For more information, submit a form , email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.

Key Points: 
  • For more information, submit a form , email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • The Allegations: Robbins LLP is Investigating the Allegations that Evolv Technologies Holdings, Inc. (EVLV) Overstated the Efficacy of its Products
    On or around July 19, 2021, Evolv went public through a SPAC merger with Newhold Investment Corp.
  • What Now: You may be eligible to participate in the class action against Evolv Technologies Holdings, Inc. Shareholders who want to serve as lead plaintiff for the class must file their papers with the court by May 24, 2024.
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

Retrieved on: 
Friday, April 5, 2024
IOV, Tao, Medicine, Savolitinib, VEGFR, Immunotherapy, Patient, MMAE, ERK, Relapse, Neoplasm, University, Huachung University, Cisplatin, Lymphoid leukemia, Lymphoma, Chongqing Medical University, Cholangiocarcinoma, Tyrosine-protein kinase SYK, Classification, Efficacy, MET, ADC, Cardiotoxicity, Nanjing Medical University, Non-receptor tyrosine kinase, Safety, Ferroptosis, Macrophage, Pancreatic cancer, Dual role, National Taiwan University Hospital, GPR34, Oncology, Guangzhou Medical University, MD Anderson Cancer Center, Daratumumab, HCM, NPM1, MLL, 301 Hospital, Acute leukemia, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024

Retrieved on: 
Thursday, April 4, 2024
Symantec Endpoint Protection, CLL, Safety, RT, Patient, EBMT, NHL, Euronext, Efficacy, Abstract, CD19, Pharmaceutical industry

ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.

Key Points: 
  • ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.
  • The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study.
  • GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
  • “We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.

Milestone® Pharmaceuticals to Present Data on Etripamil at the American College of Cardiology and European Heart Rhythm Association Annual Conferences

Retrieved on: 
Monday, April 1, 2024
FACC, Weill Cornell Medicine, Professor, Safety, NewYork-Presbyterian Hospital, Paroxysmal attack, Paroxysmal supraventricular tachycardia, Efficacy, RAPID, American College, Sinus rhythm, Hospital, Division, Signs and symptoms, Conversion, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at two upcoming cardiology conferences this month.

Key Points: 
  • MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at two upcoming cardiology conferences this month.
  • The company will deliver oral and poster presentations at the American College of Cardiology annual meeting (ACC24) , to be held April 6-8th in Atlanta, Georgia, and a poster presentation at the annual meeting of the European Heart Rhythm Association (EHRA) , to be held April 7-9th in Berlin, Germany.
  • The presentations will be available following the embargo at https://MilestonePharma.com .
  • Multi-Center, Open-Label Study of the Efficacy and Safety of Etripamil Nasal Spray Self-Administered For Multiple Episodes of Symptomatic Supraventricular Tachycardia Without Supervision (Phase 3, NODE-303)
    James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital
    Symptom-prompted, Self-administered Intranasal Etripamil for Termination of Paroxysmal Supraventricular Tachycardia in the RAPID Study: Relationship Among Etripamil-Induced Reduction in Tachycardia Rates, Conversion to Sinus Rhythm, and Improvement in Patient Symptoms
    James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital
    Characterising paroxysmal supraventricular tachycardia episodes by patient-perceived episode duration, symptoms, and severity: longitudinal patient-reported outcomes
    David Bharucha, M.D., Ph.D., FACC, Chief Medical Officer of Milestone Pharmaceuticals, Inc.

BrainsWay Announces Positive Results in Late-Life Depression Post-Marketing Analysis

Retrieved on: 
Thursday, March 28, 2024
Depression, Deep, Brainsway, Medicine, Safety, MDD, Patient, Ageing, TMS, Journal, Doctor of Philosophy, DSM-IV codes, Efficacy, Mixed anxiety–depressive disorder, Atrophy, Scalp, FDA, Pharmaceutical industry

The post-marketing study demonstrated real-world outcomes for older adults (60-91 years of age) suffering from major depressive disorder (MDD).

Key Points: 
  • The post-marketing study demonstrated real-world outcomes for older adults (60-91 years of age) suffering from major depressive disorder (MDD).
  • In the study, data was analyzed from 247 depression patients at 16 clinical sites in this age group who had been treated with BrainsWay’s proprietary H1 Coil.
  • The outcomes were comparable to those reported in a post-marketing analysis of over 1,350 patients published in 2023.
  • This can make it challenging for certain non-invasive technologies to reach the brain areas involved in depression,” said Colleen Hanlon, PhD, Vice President of Medical and Clinical Affairs at BrainsWay.

Investor Notice: Robbins LLP Informs Investors of Class Action Filed Against Evolv Technologies Holdings, Inc. f/k/a Newhold Investment Corp.

Retrieved on: 
Tuesday, March 26, 2024
Gun, Weapon, Risk, SAN, School, Light, LLP, Efficacy, Complaint, Artificial intelligence, Person

SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Evolv Technologies Holdings, Inc. (NASDAQ: EVLV) securities between June 28, 2021 and March 13, 2024.

Key Points: 
  • SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Evolv Technologies Holdings, Inc. (NASDAQ: EVLV) securities between June 28, 2021 and March 13, 2024.
  • The Allegations: Robbins LLP is Investigating the Allegations that Evolv Technologies Holdings, Inc. (EVLV) Overstated the Efficacy of its Products
    On or around July 19, 2021, Evolv went public through a SPAC merger with Newhold Investment Corp.
  • Prior to the SPAC Merger, Newhold traded on the NASDAQ under the ticker symbol “NHIC”.
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

Robbins LLP Urges Evolv Technologies Holdings, Inc. (EVLV) Stockholders with Large Losses to Contact the Firm for Information about the Evolv Technologies Holdings, Inc. Class Action

Retrieved on: 
Tuesday, April 9, 2024
Class Action Lawsuit, Professional Services, Legal, Gun, Weapon, Risk, School, Light, LLP, Efficacy, Complaint, Artificial intelligence, Person

Evolv describes itself as a “leader in Artificial Intelligence (“AI”)-based weapons detection for security screening."

Key Points: 
  • Evolv describes itself as a “leader in Artificial Intelligence (“AI”)-based weapons detection for security screening."
  • For more information, submit a form , email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • The Allegations: Robbins LLP is Investigating the Allegations that Evolv Technologies Holdings, Inc. (EVLV) Overstated the Efficacy of its Products
    On or around July 19, 2021, Evolv went public through a SPAC merger with Newhold Investment Corp.
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.

Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Retrieved on: 
Saturday, April 6, 2024
Biotechnology, Pharmaceutical, Health, Mental Health, BMY, Circulatory system, Head, SIRS, Schizophrenia, Xanomeline, Assessment, Patient, Bristol Myers Squibb, MD, Positive, Efficacy, Congress, Prolactin, Clinical trial, Safety, PANSS, FDA, Schizophrenia International Research Society, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
  • Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
  • In the interim analysis, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.
  • In long-term trials, KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.