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Regulatory

BABA

Alibaba Group Holding Limited (NYSE:BABA) is undergoing a significant business transformation, including leadership changes within its core e-commerce unit, Taobao and Tmall Group. Trudy Dai Shan has relinquished her roles at several Alibaba subsidiaries to focus on Alibaba's primary e-commerce operations. Alibaba clarified that these changes are routine business registration adjustments at the subsidiary level. The company is also restructuring into six primary groups and spinning off its logistics network, Cainiao, for an IPO in Hong Kong. However, the overall market's performance and delay in Cainiao's listing have tempered the excitement surrounding this move.

Portfolio Pulse from Anusuya Lahiri

October 02, 2023 | 11:37 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

RCKT

The FDA has accepted Rocket Pharmaceuticals' Biologics License Application and granted priority review for RP-L201 gene therapy for severe leukocyte adhesion deficiency-I. The PDUFA date is set for March 31, 2024.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:13 am

CGEN

Compugen announced that the Japanese Patent Office has granted a patent for treating cancer with a triple combination of any anti-PVRIG antibody with any anti-TIGIT and anti-PD-1 antibody. This strengthens Compugen's patent portfolio and leadership in blocking three pathways of the DNAM-1 axis.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:04 am

APLS

Apellis Pharmaceuticals has received US FDA approval for its EMPAVELI Injector, a device designed to streamline self-administration of EMPAVELI (pegcetacoplan), a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH).

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 11:02 am