Streetbeat News

Regulatory

INMB

INmune Bio, Inc. (NASDAQ:INMB) has received approval from the U.K. Medicines and Healthcare Products Regulatory Agency to expand its ongoing Phase 2 trial of XPro in patients with early Alzheimer's disease to the U.K. The trial is also enrolling patients in Australia and Canada. In a prior Phase I trial, INmune Bio met all primary and secondary endpoints, with patients showing significant reductions in neuroinflammation and improvements in axonal integrity and synaptic function.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:03 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has been granted a new U.S. patent for C4-Carboxylic Acid-Substituted Tryptamine Derivatives, which includes EB-373, a new chemical entity psilocin prodrug. The patent provides Enveric with intellectual property rights for compositions and methods for tryptamine-derived prodrugs. This strengthens Enveric's intellectual property portfolio and distinguishes its tryptamine-based prodrugs from similar compounds being developed for the treatment of mental health disorders.

Portfolio Pulse from Happy Mohamed

September 05, 2023 | 12:03 pm

WVE

Wave Life Sciences has submitted its first clinical trial application for WVE-006 in Alpha-1 Antitrypsin Deficiency. The company expects to initiate dosing in 4Q 2023 and deliver AAT protein restoration data in 2024.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:32 am

CYBN

Cybin Inc. (NYSE:CYBN), a clinical-stage biopharmaceutical company, has been granted a US patent for deuterated tryptamine compounds and pharmaceutical compositions thereof, with exclusivity until 2041. The patent covers deuterated 5-methoxy-dimethyltryptamine analogs in the company's pre-clinical deuterated tryptamine portfolio and strengthens Cybin's position in the development of potential therapeutics for the treatment of mental health conditions.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:31 am

BCDA

Biocardia has announced interim efficacy results for its Phase 3 CardiAMP Cell Therapy Heart Failure Trial. The first-tier, all-cause death at 12 months was 5.6%, compared to 5.3% in the control group, a difference that was not statistically significant (P = 0.42).

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:20 am

HSDT

Helius Medical Technologies has received formal notice of its compliance with all applicable Nasdaq listing criteria.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:14 am

QURE

uniQure N.V. (NASDAQ:QURE) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for AMT-260, a gene therapy candidate for refractory mesial temporal lobe epilepsy (MTLE). AMT-260 uses an AAV9 vector to deliver two engineered miRNAs designed to degrade the GRIK2 gene and suppress the aberrant expression of glutamate receptor subtype GLUK2, which is believed to trigger seizures in patients with refractory MTLE.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:06 am

ELDN

Eledon Pharmaceuticals has initiated the Phase 2 Bestow trial for Tegoprubart, a drug aimed at preventing organ rejection in kidney transplant patients. The first participant has been dosed.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:05 am

AUTL

Autolus Therapeutics plc (NASDAQ:AUTL) has announced the publication of data from its AUTO1/22 Phase 1 study in Pediatric B-cell Acute Lymphoblastic Leukemia in the journal Blood. The study was previously presented at the European Society for Blood and Marrow Transplantation in April.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:04 am

BHVN

Biohaven has announced data from an exploratory electroencephalogram biomarker study of BHV-7000, confirming CNS activity. The company also announced the completion of once-daily formulation development and plans to initiate Phase 3 pivotal studies.

Portfolio Pulse from Benzinga Newsdesk

September 05, 2023 | 11:03 am