Market is Excited About Alzheimer’s Companies - Upcoming Catalysts To Watch
- BPIQ
- Jun 24, 2021
- 5 min read
Updated: Aug 19, 2021
Summary
Biotech companies continue to focus on Alzheimer’s disease with some promising early clinical data this year.
There have been huge runups in some Alzheimer-focused biotech companies this year.
FDA approval of Biogen's drug Aduhelm on less than stellar data has increased the chances of eventual approval of other Alzheimer's and dementia drug candidates
There are a number of key Alzheimer’s readouts ahead from key biotech stocks to watch.
To see a more comprehensive version of this article with stocks and catalysts to watch and to access our full database and tools sign up for a free account or lock in our current discounted pricing. Learn more here.
Want to get catalyst events and stocks to watch sent directly to your inbox each week? sign up for our free weekly newsletter
Alzheimer's Stocks To Watch
Alzheimer’s disease (AD) is one of our biggest health challenges for society today and a huge focus for biotech companies. It is a progressive, multi-factorial disease and the most common cause of primary neurodegenerative dementias. AD incidence in the U.S. is approximately 5 million (See Alzheimer’s disease: pathogenesis, diagnostics, and therapeutics). There are no commercially available therapies to address the underlying biological cause of AD’s progressive cognitive decline. Thus, developing new drugs to treat AD is a huge unmet medical need.
Table 1 lists Alzheimer’s biotech companies and their clinical stage Alzheimer’s drug candidate(s), from our BPIQ database of virtually all publicly traded biotech companies with market caps under $5 billion. Our list is intended to focus on drugs from companies whose share price is most likely maximally impacted by clinical trial results and includes a small fraction of the total agents in clinical trials for AD, which was recently listed at 126 agents (Alzheimer's disease drug development pipeline: 2021). Fortunately, promising early results this year for some of these Alzheimer’s drug candidates have given renewed hope for meaningful breakthroughs in this horrible disease and have propelled the valuation and thus stock price, of the sponsor companies (Table 1).
It is noteworthy that TNXP, with a market cap of ~$400M has average volume that is almost 5x that of the next closest Alzheimer’s company in our database. This could be from it’s sudden popularity in message boards and communities like Reddit earlier in the year (See Tonix, Biolase Join Penny Stocks Surge After Reddit Touts article). TNXP has been cleared for clinical trials by the FDA, but a trial has not yet begun (BPIQ subscribers, See TNX-102 in Alzheimer’s IQ card). It is noteworthy that TNXP is testing many indications for TNX-102, several of which are in active clinical trials (See FIG. 1). TNX-102 is a multifunctional agent that antagonises a number of receptors, including the 5-HT2A, α1-adrenergic and histamine H1 receptors (BPIQ subscribers, See TNX-102 in Alzheimer’s IQ card).
Table 1. Alzheimer’s Drug Candidates for Biotech Companies*
*Biotech companies with valuations between $100M and $5B
FIG. 1 TNXP pipeline from BPIQ.com
ANVS and SAVA are both up over 1000% this year, on encouraging data that showed not only slowing the progression of symptoms, but some possible reversal (e.g. see our prior article https://bit.ly/3oEH5vD). It is noteworthy that positive (or likely negative) news can move many of the Alzheimer’s companies, not just the reporting company. For example, SAVA’s positive clinical trial update on February 2 of this year (See press release: Cassava Sciences’ Simufilam Improves Cognition and Behavior in Alzheimer’s Disease in Interim Analysis of Open-label Study) appeared to move many of the other Alzheimer’s companies by more than 10% (See Table 1 Stock moves 1/31-2/8/21).
Of course caution is warranted for these Alzheimer’s drug candidates because historically, Alzheimer’s has been a graveyard for mid to late-stage drug candidates (See Review). Alzheimer’s drugs have been in the spotlight recently because earlier this month Biogen gained accelerated approval for its drug Aduhelm (FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease) for treating Alzheimer's disease (See Aduhelm label). However, this came with considerable controversy and actually against the recommendation of an FDA Advisory Committee, because of mixed late-stage clinical trial results for the drug (FDA’s Decision to Approve New Treatment for Alzheimer’s Disease). Released FDA records have confirmed that the agency relaxed their requirements as part of the accelerated approval based on a surrogate endpoint (amyloid reduction) rather than a full approval because of the mixed clinical trial data balanced against the desperate needs of Alzheimer’s patients (“FDA releases fresh details on internal debate over controversial Alzheimer’s drug“ Washington Post 6/22/21).
Current Alzheimer’s drug candidates of small/mid-cap biotech companies are quite diverse. They are directed against many different targets and include both biologics and small molecules (Table 2). The vast majority of the clinical assets are in Phase 2 or Phase 3, with ADMS as the only company we identified thus far in our database that derives revenue from a currently approved Alzheimer’s drug, Namzaric (See Namzaric.com). It is our understanding that ADMS gets licensing revenue from Allergan, who commercialized this drug It is also noteworthy that Namzaric’s label includes the specific clarifying statement: ”There is no evidence that NAMZARIC prevents or slows the underlying disease process in patients with Alzheimer's disease” (Namzaric label).
Table 2. Alzheimer’s Drug Candidate Details from pipeline search on bpiq.com
Three of these Alzheimer’s companies are on our June/July Big-Mover stocks to watch list because of important near-term catalyst events. For a discussion of these companies/events and a much deeper look at these and other Alzheimer’s companies and readouts in our database, see our forum post for subscribers here (requires BPIQ subscription - see HERE for free 30-day trial no credit card required) and lock in introductory price under $20/month while it lasts).
If you are serious about investing in biotech stocks BPIQ is the research companion that will take you to the next level.
Save yourself time by accessing our database of over 550 companies, 1,800+ of their drug assets, and tools including: Catalyst Calendar, Big Movers, Company Pipelines, and more!
P.S. We are currently running a sale - lock in the price before it's gone
See what our members are saying about us:
Mike from United States
“Really loving the site over the competitor... like the layout and speed over the competition...like the individual pages for each drug/treatment”
Carl from United States
“I like your service. I haven’t seen anyone else doing something similar...nothing like this available for retail.”
Essey from Canada
“Love what you’re doing, this website is awesome.”
James from United States
Great site and I see it’s a family run business, great job.”
This article will likely be updated from time to time
Article History:
Last updated 6/26/21 with addition of summary bullet re: Biogen's approval
This article is NOT investment, tax, or legal advice. Please use this as a starting point for your detailed diligence and consult professional advisers before making investment decisions.
Comments