Shares Of Achieve Life Sciences Upgraded
Achieve Life Sciences Inc. (NASDAQ: ACHV) recently reported positive study results for a smoking cessation drug
Placebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, just about doubles the chances of quitting at 6 months. The meaning of this is that Achieve may have a first line treatment for smoking cessation at it's finger tips.
On September 27, 2018 Achieve a clinical-stage pharmaceutical company updated investors on results from a study of its version of a smoking cessation drug. Shares traded up on irregular volume that day. Investor interest being high enough that a small share offering transpired at a price per share higher than the going rate. As a side note, the share float remains small, hence Acheive shares will still enjoy fast movement with a bit more of the needed liquidity.
Achieve shares could value as high as Amarin Corporation plc (AMRN) shares in the not so distant future. This idea is based on the similar story concerning both companies. In Amarin's case it's Omega 3 product was already marketed before its positive trial results were announced, where Achieve is not marketing cytisine yet, however, a slightly different cytisine is marketed in some areas of the world giving a glimpse into potential marketability. Both companies are in niche areas and both companies have an improved version of the product compared to competitors. For Achieve it's a monumental undertaking to bring its FDA approved version of cytisine to the North American and Western European markets. Interestingly Rick Stewart was instrumental for both companies.
With a stable share price after profit taking and recent volume spike traders\investors have probably set Achieve on their watch lists for a while. An associated lower risk with a "long position" going forward exists with Achieve shares as compared to say, AMRN shares that are already up considerably in 2018. Both company stocks may have a higher revaluation coming, however, Achieve is not going to have nearly the downside risk. See the chart;
ACHV Achieve Life Sciences, Inc. daily Stock Chart
Despite a single hit piece article with questionable motive/agenda and quite possibly working for a special interest, the price target for Achieve shares has recently been raised to $12. See: price target. The article in question had no new information, only Achieve can release new information and recently positive news concerning cytisine has been released. Investors are right to question both timing and motive of an article suggesting a lower share valuation after positive news using the same fundamentals that existed before the news. Is someone interested in gathering shares in front of a pending larger run? Did the article intentionally fail to mention Acheive's improved financial situation after the completed capital raise for a reason?
Here's a thought: With the increase in cannabis use may come an increased smoking addiction. This makes Achieve's success all that much more important and may make Achieve an undiscovered cannabis play. Achieve's shares could become the first adjunct cannabis play. See the following; Will Legal Marijuana Lead To More People Smoking Tobacco? While the cannabis crowd may or may not jump in (wishful thinking) there is still real reason for going long in Achieve's stock.
To be specific, Achieve has been pursuing cytisine succinate salt as a new drug product formulation that should further enhance product stability along with a longer potency. Achieve has already received a United Kingdom patent (No. 2550241) on cytisine succinate salt. Further, Achieve is working to expand its intellectual property portfolio to help protect the potential value of the modified cytisine side of its operation. What Achieve is working on here is a next-generation cytisine molecule. The next generation molecule could be bigger than a smoking cessation drug alone. The potential uses could include indications such as alcohol addiction and potentially opioid addiction as well.
Prof. Tim Gallagher, Dean of the Faculty of Science and Professor of Organic Chemistry at the University of Bristol, said, "We can now move forward to explore the full potential of these modified cytisine ligands as therapeutic agents to help the millions of people who are battling nicotine and other addictions and was made possible through our partnership with Achieve".
Did trading volume recently surge to 49 million trades without reason? No, there exists a contemplation that Achieve is onto something big, it's called "Molecular Locksmithing" the use of precision chemical keys for biological locks at the receptor level. That's a whole lot of potential in the future for designing drugs.
Achieve's detractors, suggest cytisine is a natural nutritional supplement instead of medication and already available in other areas of the world. Unfortunately for those formulations already available, the majority of the health claims have not been evaluated using randomized clinical trials or formulated in the best proven standard dose. This isn't to say that nutrition has no effect on brain chemistry. It most certainly does. However, because research is limited in this area, it's difficult to determine the effectiveness and safety of nutritional additives let alone the real dose in the product. Acheive's drug is a modified cyctine ligand specifically targeting the a4ß2 nicotine receptor and going through FDA clinical trials. Sounds awfully familiar to the Amarin story as mentioned previously and Amarin persevered. Achieve's road is no less bumpy.
The competition for Acheive is Pfizer's Chantix. Revenue for Chantix was $647 million in 2014 and $997 million in 2017. Pfizer's drug comes with concerns that shouldn't plague Achieve's cytisine. In fact Achieve may have Pfizer's market share under threat; Pfizer (Chantix) vs Achieve (cytisine). Achieve stated that it sees a market worth $740 million in the near future that's not going anywhere.
At the time Chantix was the newest smoking cessation drug, debuting on the market back in 2006. It was the first prescription drug approved for smoking cessation by the U.S. Food and Drug Administration in nearly a decade and since GlaxoSmithKline’s antidepressant Zyban. Aside from those two drugs, there are only nicotine-replacement gums, lozenges and patches. But that’s it. The promise of treatments such as nicotine vaccines or other drugs had flamed out. Nothing new has come down the pike.
Enter Cytisine currently manufactured by Sopharma as Tabex. Achieve has an alliance with Sopharma with the idea of selling Tabex under its own brand in Western Europe and the United States. The brand name could potentially be called something like AchieveX. Achieve has an exclusive supply agreement with Sopharma who has agreed to produce cGMP-grade cytisine for Achieve's use. Sopharma will manufacture the specific pharmaceutical ingredient to Achieve's standard and produce finished tablets. Achieve plans on phase 3 studies in the United States in 2019. If Achieve's drug gets approved, it will have five years of U.S. market exclusivity as a novel drug under the 1984 Hatch-Waxman Act. After those 5 years it would be an established top line seller in the North American and Western European markets.
Sopharma with a minority stake in Achieve Life Sciences seems to be confident in Achieve's cytisine prospects for 2022 and beyond as it has announced plans to ramp up production.
While it's true Tabex can be imported to North America, it comes with a wait time of 9 working days or more depending on customs. This is something that prevents the not yet FDA approved version Cytisine drug from becoming a brand name in North America, let alone stocked on prescription shelves at the local Rite Aid or Walgreens. Achieve is diligently working to change all that.
While Tabex had been available in all former socialist countries in the 1960s, it was withdrawn from the market in those countries that joined the European Union. The reasons are unclear, but Sopharma acknowledges regulatory agencies like the FDA want a better understanding before approval can be granted. That's a big reason that they've partnered with Achieve.
Shares of Achieve traded as high as $5.25 after its last Cytisine update. At Ardent Biotech it's expected that shares will value to a higher area in the not so distant future. The recent volume was above and beyond past surges and likely not by chance. Trading spikes of this nature tend to reflect future sentiment that the stock will move higher in the not to distant future. Also, Achieve should have some upcoming catalysts per webcast.
Due to the sited reasons Ardent Biotech initiated a "BUY" rating and price projection of $17 for Acheive shares on October 10, 2018. This is the third upgrade in the last few months, Ladenburg Thalmann's upgrade to $12 being one of the others. Initially Ardent Biotech had upgraded to $15 a share.
Related: Achieve Life Sciences (ACHV) vs. Riot Blockchain (RIOT) Financial Survey. Story here
Ardent Biotech investment rating: B+
(Highest rating given for sub $5 stock)
Price per share at time of rating $2.70
To the best of Ardent Biotech's knowledge information presented above is true, however, each individual should conduct a thorough investigation of their own. At a minimum investors should contact the company themselves with questions that arise before investing. This site is not recommending anyone buy or sell a security. The opinions here are posted as part of Ardent Biotech's due diligence, however, remain only opinions. No investment advice is to be implied.
