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Clinical Trial News

Axsome Therapeutics Reports Strong Q1 2024 Financial Results and Pipeline Advancements

  • Axsome Therapeutics reported Q1 2024 total net product revenue of $75 million, marking a 160% year-over-year growth, driven by strong performance of its marketed products.
  • The company advanced its neuroscience pipeline, with AXS-12 achieving positive Phase 3 results in narcolepsy and progress in trials for migraine, fibromyalgia, and Alzheimer's disease agitation.
  • Axsome is on track for NDA resubmission for AXS-07 (migraine) and NDA submission for AXS-14 (fibromyalgia) this quarter, with multiple Phase 3 trial results expected in 2024 and 2025.
  • The company's cash balance of $331.4 million is expected to fund operations into cash flow positivity, supporting continued commercial expansion and pipeline development.

Opdivo Fails to Meet Primary Endpoint in CheckMate-73L NSCLC Study

• Bristol Myers Squibb's CheckMate-73L study, evaluating Opdivo plus Yervoy following chemoradiotherapy, did not meet its primary endpoint of progression-free survival in unresectable stage III NSCLC. • The phase III trial compared Opdivo-based regimens to chemoradiotherapy followed by AstraZeneca’s Imfinzi in 925 patients with locally advanced non-small cell lung cancer. • No new safety signals were identified, with adverse events consistent with the known profiles of Opdivo and Yervoy, according to Bristol Myers Squibb. • Bristol Myers is conducting a thorough evaluation of the CheckMate-73L data, with plans to present the findings at an upcoming medical conference.

DLL3-Guided Therapies Show Promise in Small-Cell Lung Cancer Treatment

Recent advancements in DLL3-targeted therapies, including antibody-drug conjugates, bispecific T-cell engagers, and chimeric antigen receptor T-cell therapies, are offering new hope for patients with small-cell lung cancer (SCLC). Despite challenges, these therapies have demonstrated potential in improving clinical outcomes, with ongoing clinical trials exploring their efficacy and safety.

A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

NCT04429087RecruitingPhase 1
Boehringer Ingelheim
Posted 7/29/2020

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

NCT04885998CompletedPhase 1
Amgen
Posted 9/27/2021

Study of DLL3-CAR-NK Cells in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT05507593Unknown StatusPhase 1
Tianjin Medical University Cancer Institute and Hospital
Posted 9/1/2022

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

NCT04471727RecruitingPhase 1
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 12/14/2020

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

NCT06179069RecruitingPhase 1
Zai Lab (Shanghai) Co., Ltd.
Posted 1/23/2024

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

NCT05879978Active, Not RecruitingPhase 1
Boehringer Ingelheim
Posted 7/28/2023

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

NCT05740566Active, Not RecruitingPhase 3
Amgen
Posted 5/31/2023

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

NCT06211036RecruitingPhase 3
Amgen
Posted 6/5/2024

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395RecruitingPhase 1
Amgen
Posted 8/24/2022

A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

2023-506541-39-00Active, Not RecruitingPhase 1
Amgen Inc.
Posted 12/26/2017

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

NCT06117774RecruitingPhase 3
Amgen
Posted 2/20/2024

Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors

NCT05461287RecruitingPhase 1
Qilu Pharmaceutical Co., Ltd.
Posted 9/30/2022

DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

NCT06077500RecruitingPhase 1
Boehringer Ingelheim
Posted 2/14/2024

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

NCT05619744CompletedPhase 1
Hoffmann-La Roche
Posted 1/23/2023

A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC

NCT03392064SuspendedPhase 1
Amgen
Posted 9/10/2018

DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy

NCT05990738RecruitingPhase 1
Boehringer Ingelheim
Posted 2/14/2024

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

NCT05882058RecruitingPhase 2
Boehringer Ingelheim
Posted 10/13/2023

FDA Finalizes Guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates

• The FDA has finalized its guidance on clinical pharmacology considerations for antibody-drug conjugates (ADCs), providing a framework for drug developers focusing on the cytotoxic payload. • The guidance emphasizes bioanalytical methods, dosing strategies, exposure-response analysis, intrinsic patient factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs). • Key areas of interest include measuring ADC constituents and metabolites, conducting exposure-response analyses, and assessing intrinsic factors like renal or liver impairment. • The guidance also addresses QTc assessment for cardiac safety, drug-drug interaction risk, and dosing strategies to maximize the therapeutic index of ADCs.

Recursion Anticipates Phase 2 Data Readouts and Advances Platform Capabilities

  • Recursion expects to release Phase 2 data for REC-994 in Cerebral Cavernous Malformation in Q3 2024, with the SYCAMORE trial fully enrolled.
  • Preliminary Phase 2 data for REC-2282 in Neurofibromatosis Type 2 is anticipated in Q4 2024, with adult enrollment expected to complete in Q2 2024.
  • The company's BioHive-2 supercomputer nears completion, enhancing capabilities in constructing foundation models for biology and chemistry.
  • A multi-year agreement with Helix provides access to extensive genomic and health record data for AI model training and patient stratification.

Efficacy and Safety of Piwei Peiyuan Prescription in Treating Chronic Atrophic Gastritis

A clinical trial demonstrates the effectiveness and safety of Piwei Peiyuan Prescription, a Traditional Chinese Medicine, in treating Chronic Atrophic Gastritis (CAG), a precancerous condition of the stomach. The study highlights the prescription's ability to improve symptoms, enhance gastrointestinal motility, and promote mucosal repair, with minimal adverse reactions.

Intellia Therapeutics Reports First Quarter 2024 Financial Results and Operational Progress

Intellia Therapeutics, a leader in CRISPR-based gene editing therapies, announced its first quarter 2024 financial results and highlighted significant progress in its clinical trials, including rapid enrollment in the Phase 3 MAGNITUDE trial for ATTR amyloidosis with cardiomyopathy and plans for a new Phase 3 trial for hereditary ATTR amyloidosis with polyneuropathy. The company also reported a strong financial position with $953 million in cash.

Know Labs Presents Promising Clinical Data on Non-Invasive Glucose Monitoring Technology

  • Know Labs presented clinical study results at the AACE Annual Meeting, demonstrating the accuracy of its non-invasive glucose monitoring sensor.
  • The study involved individuals with diabetes and used venous blood as a reference, employing a machine learning model for data analysis.
  • Know Labs plans to conduct large-scale clinical trials with its KnowU™ wearable CGM to assess performance in real-world conditions and extreme glycemic ranges.
  • The company is advancing towards FDA clearance, with the goal of providing accessible and affordable real-time blood glucose information.

R3 Vascular Secures $87 Million in Series B Financing and Appoints New CEO

R3 Vascular Inc., a medical device company focused on developing bioresorbable scaffolds for peripheral arterial disease (PAD), has announced the completion of an $87 million Series B financing round. The funding, led by Deerfield Management, will support the ELITE FDA IDE pivotal trial of its MAGNITUDE® bioresorbable scaffold for below-the-knee PAD, alongside R&D, regulatory submissions, and manufacturing scale-up. Christopher M. Owens has been appointed as the new President and CEO, bringing over three decades of medical device industry experience to the role.

Acelyrin Provides Update on Clinical Programs and Business Strategy

• Acelyrin completed enrollment in the Phase 3 trial of izokibep for hidradenitis suppurativa, with top-line data expected in the third quarter of 2024. • Positive proof-of-concept data were reported for lonigutamab in thyroid eye disease, with a Phase 2b/3 trial planned for initiation in the second half of 2024. • The company anticipates completing enrollment in the Phase 2b/3 trial of izokibep for uveitis this month, with top-line data expected by year-end 2024. • Acelyrin reported a cash position of $678.5 million as of March 31, 2024, expected to fund operations into 2026, while also considering options to extend its cash runway.

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