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Biopharma's Phase 2b/3 Alzheimer's Disease Trial Approved to Continue

Source: Streetwise Reports

 

April 8, 2021 (Investorideas.com Newswire) Anavex Life Sciences' study, its drug's mechanism of action and the company's upcoming catalysts are covered in a Dawson James Securities report.


In an April 5 research note, Dawson James Securities analyst Jason Kolbert reported that the Independent Data Safety Monitoring Board (DSMB) greenlighted Anavex Life Sciences Corp. (AVXL:NASDAQ) to continue, without changes, its Phase 2b/3 Alzheimer's disease study of ANAVEX2-73.

Kolbert pointed out that the biopharma's lead drug candidate ANAVEX2-73 activates the sigma-1 receptor (SIGMAR1). SIGMAR is believed to help remove misfolded proteins from neural cells and restore homeostasis, thereby helping the cells survive.

"The implications here could have an impact across a wide range of neurodegenerative diseases from Alzheimer's to Parkinson's and niche orphan diseases such as Rett's syndrome, which may represent a 'fast path' to establish proof of concept around the sigma 1 agonism," wrote Kolbert.

The analyst also noted that the Phase 2b/3 study "includes prespecified SIGMAR1 gene expression as endpoints using [the] Alzheimer's Disease Assessment Scale–cognition and [the] Alzheimer’s Disease Cooperative Study–activities of daily living as primary endpoints."

The company completed 92% enrollment of this 450-patient study. Topline data for the trial are expected in H1/22, as are topline data from two additional trials. They are AVATAR in Rett's syndrome and the Phase 1 ANAVEX3-71 in frontotemporal dementia.

As for additional 2021 catalysts, Anavex Life Sciences plans to initiate three additional clinical trials. They are the ANAVEX2-73 imaging-focused Parkinson's disease study, a Phase 2/3 Fragile X study and a Phase 2/3 study "for the treatment of a new, rare disease indication," he wrote.

Dawson James has a Buy rating and a $19 per share target price on Anavex Life Sciences, the stock of which is now trading at about $15.38 per share.

Disclosure:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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Disclosures for Dawson James Securities, Anavex Life Sciences Corp., April 5, 2021

The Firm does not make a market in the securities of the subject company(s). The Firm has NOT engaged in investment banking relationships with AVXL in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has NOT received any other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of March 31, 2021, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm's investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

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