Streetbeat News

Regulatory

SLS

SELLAS Life Sciences has received positive feedback from the FDA regarding its Chemistry, Manufacturing, and Controls (CMC) plans for Galinpepimut-S (GPS), aligning with FDA requirements and expectations for a Biologics License Application (BLA). This regulatory alignment is a crucial step in the approval process for GPS.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:51 pm

MBOT

Microbot Medical Inc. (MBOT) has announced the successful completion of the Electromagnetic Compatibility (EMC) testing, a part of the Verification and Validation (V&V) process for its LIBERTY Robotic Surgical System. This step is crucial for the Investigational Device Exemption (IDE) submission to the FDA, which is required to start clinical trials in the US. The company is committed to completing additional V&V testing soon, aiming to begin its first clinical trial.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:50 pm

LGVC

LGVCU

LGVCW

LAMF Global Ventures Corp. I has announced the extension of the deadline to complete its initial business combination from November 16, 2023, to December 16, 2023. This is the first of potentially six one-month extensions allowed under the company's amended and restated memorandum and articles of association.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:27 pm

VNOM

Viper Energy has filed a prospectus with the SEC for the proposed resale of up to 9 million shares of Class A common stock by selling stockholders. This filing indicates that current shareholders may be looking to sell a significant number of shares.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:09 pm

MBRX

Moleculin Biotech, Inc. has provided a preliminary update on its recent clinical activities and outlined expected near-term milestones for its clinical development pipeline. The update includes progress on various clinical trials and anticipated key events that could influence the company's future direction and investor sentiment.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:06 pm

ALGS

Aligos Therapeutics presented clinical and nonclinical data at the AASLD Liver Meeting 2023, showing that its drug ALG-055009 has a favorable risk-benefit profile. This could potentially impact the company's stock as investors react to the positive news regarding the drug's development.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 1:05 pm

ALZN

Alzamend Neuro has indicated to Benzinga that the safety aspects of its AL001 development could be eligible for a 505(b)(2) New Drug Application (NDA) pathway with the FDA, which may streamline the approval process.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 12:31 pm

ALZN

Alzamend Neuro has submitted an IND application for a Phase IIA clinical trial for its drug candidate AL001, aimed at treating Post-Traumatic Stress Disorder (PTSD). This submission marks a significant step for the company in the development of next-generation lithium therapeutics.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 12:30 pm

ROIV

Roivant Sciences plans to announce further clinical results for its two drugs, 1402 and brepocitinib, in the last quarter of the year.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 12:12 pm

ABOS

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) has secured a $50.0 million credit facility with K2 HealthVentures. The facility includes a first tranche of $30.0 million, already funded, and a second tranche of up to $20.0 million available upon request and lender approval. The term loan matures on November 1, 2027, with a possible extension to 2028 upon meeting certain milestones. Details will be disclosed in the upcoming quarterly report.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 12:08 pm