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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.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 12:02 pm

BTBT

NVDA

Bit Digital, Inc. (BTBT) has announced the launch of Bit Digital AI, a new business line providing infrastructure for AI workstreams. The company has signed a binding term sheet with a customer for GPU-accelerated workloads, with a contract worth up to $257M. Bit Digital has also agreed to purchase 1,056 NVIDIA HGX H100 GPUs and 132 FusionOne HPC from xFusion Digital Technologies Co., Ltd.

Portfolio Pulse from Happy Mohamed

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.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:54 am

JAZZ

Jazz Pharmaceuticals has announced new data that emphasizes the continued need for its low-sodium treatment option, Xywav® Oral Solution, and real-world, evidence-based approaches for individualized treatment in adults with narcolepsy.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:51 am

HYZN

Hyzon Motors has announced the commercial trial deployment of its first heavy rigid fuel cell electric waste collection truck to REMONDIS Australia. This marks a significant step in the company's expansion into the Australian market.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:37 am

AMST

Amesite Inc. (AMST) has announced a partnership with Wayne State University Graduate School to provide online professional development courses. The partnership aims to enhance the skills of professionals and students alike.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:37 am

SNSE

Sensei Biotherapeutics has presented a trial-in-progress poster for its Phase 1/2 clinical study of SNS-101 at ESMO 2023.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 11:36 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.

Portfolio Pulse from Benzinga Newsdesk

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.

Portfolio Pulse from Akanksha Bakshi

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