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Regulatory

FDMT

4D Molecular Therapeutics (4DMT) has secured the European Medicines Agency (EMA) Priority Medicines designation for its clinical-stage genetic medicine, 4D-150, for the treatment of Wet Age-Related Macular Degeneration (AMD). This follows positive interim Phase 1 PRISM clinical data for 4D-150, which demonstrated encouraging safety, tolerability, and clinical activity profile.

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October 23, 2023 | 12:02 pm

KZIA

Kazia Therapeutics has presented selected clinical data from its ongoing Phase 1 clinical trial evaluating EVT801 in patients with advanced solid tumours. The data was presented at a scientific conference.

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October 23, 2023 | 11:54 am

MRUS

Merus N.V. has announced interim clinical data from its Phase 1/2 eNRGy trial and early access program of Zeno. The results show a 37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients, and a 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients. The company expects to have sufficient clinical data by 1H24 to support potential BLA submissions.

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October 23, 2023 | 11:33 am

ALZN

Alzamend Neuro Inc (NASDAQ:ALZN) has submitted an investigational new drug (IND) application to the FDA for a Phase IIA clinical study of AL001 for the treatment of major depressive disorder (MDD). AL001 is a novel lithium-delivery system that could deliver the benefits of marketed lithium salts while mitigating associated toxicities. The company aims to start a Phase IIA study following the FDA's approval. ALZN shares are down 0.55% at $0.20 premarket.

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October 23, 2023 | 11:31 am

ALZN

Alzamend Neuro has indicated that the safety aspects of its AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval. This could potentially expedite the approval process for the drug.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:30 am

ALZN

Alzamend Neuro has submitted an Investigational New Drug (IND) application for a Phase IIA clinical trial of its lithium therapeutics drug candidate AL001 in patients with major depressive disorder.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:30 am

VERV

Verve Therapeutics has received clearance from the FDA for its Investigational New Drug application for VERVE-101 in patients with heterozygous familial hypercholesterolemia. This has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:22 am

ONCY

Oncolytics Biotech has achieved success criteria for efficacy in the third-line colorectal cancer cohort of the Phase 1/2 GOBLET study.

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October 23, 2023 | 11:07 am

UNCY

Unicycive Therapeutics is planning to file a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) using the 505(b)(2) regulatory pathway. This pathway allows Unicycive to reference the currently approved drug, Fosrenol.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:04 am

EGRX

Eagle Pharmaceuticals has been granted a unique J-Code and pass-through status for BARHEMSYS by the Centers for Medicare & Medicaid Services (CMS).

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 10:59 am