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ASMB

Assembly Biosciences has chosen ABI-6250 for IND-enabling studies for chronic Hepatitis D Virus infection. This is the second development candidate selected in 2023, following ABI-5366 for high-recurrence genital herpes.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 12:02 pm

SPHR

Shares of Sphere Entertainment rose in premarket trading following the successful debut of a U2 concert at their new arena in Las Vegas. The stock has risen about 79% through Friday's close.

Portfolio Pulse from Charles Gross

October 02, 2023 | 11:58 am

SHYF

Shyft Group (SHYF) has finalized an agreement with Rush Enterprises to sell and service Shyft's Blue Arc Class 3, 4, and 5 all-electric delivery vehicles. This partnership is expected to expand Shyft's reach and potentially increase its revenues.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:41 am

ARAY

Accuray Incorporated (ARAY) and Limbus AI have unveiled an online adaptive therapy solution for the Radixact System at the American Society for Radiation Oncology Annual Meeting. This solution is expected to enhance the precision and efficiency of radiation therapy treatments.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:40 am

ZVRA

Zevra Therapeutics has announced interim data from the Phase 2 trial of KP1077 for Idiopathic Hypersomnia, indicating that SDX (API of KP1077) is well-tolerated across all doses and both dosing regimens studied. Topline data from the completed trial is expected in the first half of 2024, with potential to initiate Phase 3 trial by the end of 2024.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:35 am

ALZN

Alzamend Neuro has indicated that the safety aspects of its AL001 development may qualify for a Section (505)(b)(2) NDA pathway, which could support FDA approval.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:30 am

ALZN

Alzamend Neuro has received FDA approval to proceed with a Phase IIA clinical trial of AL001, a next-generation lithium therapeutics drug candidate, for bipolar disorder patients.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:30 am

ALZN

Alzamend Neuro Inc (NASDAQ:ALZN) has received the FDA's approval to initiate a Phase 2A clinical study of AL001 for bipolar disorder type 1. The company expects the first patient to be dosed in Q1 2024. This will be the second indication for AL001, with the company planning to submit two more INDs by the end of 2023 for Major Depressive Disorder and PTSD. The company's CEO believes that if AL001, a next-generation lithium product, is developed, it could significantly improve current lithium-based treatments for bipolar disorder.

Portfolio Pulse from Vandana Singh

October 02, 2023 | 11:30 am

VTGN

Vistagen Therapeutics is planning to initiate a Palisade Phase 2 re-dosing trial in the second half of 2024, according to an 8K filing.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:21 am

VTGN

Vistagen Therapeutics plans to launch the Palisade-3 trial in the first half of 2024 and Palisade-4 in the second half of 2024. If successful, these trials, along with Palisade-2, may provide substantial evidence of the effectiveness of fasedienol, potentially leading to a U.S. New Drug Application for the acute treatment of anxiety in adults with SAD in the first half of 2026.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:20 am