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Sunday, May 07, 2017 8:00:44 PM
While the shorts continue their in-vein (perhaps this was AF was tweeting about) efforts to beat down on Anavex Life Sciences Corp. (NASDAQ:AVXL), the company continues to hold it’s own in the markets. At last count, Anavex traded for a little over $5.82 (pre market on Tuesday), representing a close to 45% premium on the company’s year open price.
The company just announced what we see as major news, and we’re going to use this news as an excuse to take another look at Anavex, its near term catalysts and – on the back of the recent announcement – see how the latest news plays into our thesis.
Before we get into the latest action, then, let’s quickly bring newer readers up to speed. This one’s a development stage biotech and its primary focus is on neurodegenerative and CNS conditions. The lead indication (we’ll get to this in more detail shortly) is Alzheimer’s – a notoriously difficult to treat population – and the lead asset with which it’s targeting said population is called ANAVEX-273.
The core of the company’s science is something called the sigma-1 receptor and the last time we covered this stock we tried to make a case as to why this receptor is potentially so important. In short, and to avoid repetition, our argument was rooted in the idea that neurodegenerative conditions (Alzheimer’s, Parkinson’s etc.) have a common initiation point. From these initiation points, various inputs contribute to them resulting in different diseases, but there’s a shared root that sets the ball rolling. If this is the case, the targeting of this initiation point could be the key to unlocking treatments across this spectrum of conditions.
Anavex believes that the sigma-1 receptor is this common point.
That sounds too good to be true, and we think this is why the company’s price is currently under-representative of its true value. There’s a large body of evidence (and not just that collected by Anavex) that supports this common initiation point theory, however, and Anavex is building on this evidence with its lead assets.
So, the lead – as mentioned – is 273 in Alzheimer’s, and the latest data derives from a successful phase IIa investigation in this population. Again, when this data hit press, the shorts attacked it as insufficient to warrant advance; this is nonsense. The drug will move into phase III and the study will try to replicate the clinical benefit seen across a large patient population of Alzheimer’s sufferers. If it’s successful, and the data we’ve seen so far suggests there’s a good chance of success in expansion, then the stock will run. Not just because of the Alzheimer’s indication, but because a clinical benefit readout in Alzheimer’s would hint strongly at a clinical benefit in Parkinson’s, and further, will support the sigma-1 single initiation theory.
Which brings us to the latest news.
Anavex just announced the hiring of Dr. Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. On its own, this would be good news. It suggests the company feels it’s going to be in a position to put 273 toe to toe with the FDA at a point not too far down the line, and this reinforces the company’s confidence in a successful pivotal. What makes it even better news, however, is the fact that Dr. Fadiran has 24 years of regulatory experience within the FDA. He’s personally dealt with, and made recommendations on, hundreds of NDAs, INDs, BLAs etc., and to have him guiding the Anavex team on its path to commercialization with 273, and the company’s deeper pipeline, is invaluable.
So what’s next?
We’re looking for any insight into the initiation of a pivotal study as driving this one near term. If the company can get a protocol in place with the FDA, and can execute according to this protocol to get things moving in phase III, it’s going to start attracting speculative volume and gaining strength accordingly.
Let's see what they say about the patent once gets released.
Recent AVXL News
- ZenaTech, Inc. (NASDAQ: ZENA) To Commence Trading Today • InvestorsHub NewsWire • 10/01/2024 11:00:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024 • GlobeNewswire Inc. • 09/03/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
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