Can this company achieve what hasn’t been done in 20 years?

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Everyone is aware of tobacco / cigarette companies and their stocks. For many investors, these are absolute core investments for their stability and high dividends. Against all negativity and a shrinking pool of smokers, tobacco companies managed to survive and thrive. Almost a year ago, my Premium PLUS members received an exclusive report from me with an idea with ties to this sector — but from an entirely different viewpoint. I am making this case public now, discussing the rollercoaster that’s behind us, but also what’s ahead of us.

Summary and key takeaways from today’s Weekly
– In this weekly, I am discussing one of my stock ideas that I published for my Premium PLUS members about a year ago.
– Achieve Life Sciences is a very interesting, but also compelling case with multi-bagger potential.
– If you like such ideas — and what to receive them before everyone else (if at all) — join Premium (PLUS).

When talking about smoking, vaping, heated smoking, chewing tobacco, nicotine intake without tobacco (SNUS, modern oral, pouches, or whatever the names), practically everyone automatically thinks of the usual suspects.

Altria (ISIN: US02209S1033, ticker: MO), British American Tobacco (ISIN: GB0002875804, ticker: BATS), Philip Morris (ISIN: US7181721090, ticker: PM), and, after pausing for a second, Imperial Brands (ISIN: GB0004544929, ticker: IMB) come to most minds instantly.

There was a great window of opportunity to allocate these stocks a few years ago.

I had my finger on the trigger to write a member-exclusive research report about Imperial Brands with the thesis that it will be a winner in the cost-of-living crisis due to its lower-cost offerings amid a record spread (price difference) between premium and non-premium cigarettes.

This was absolutely correct — unfortunately, I missed on this in a big way…

Fast forward a few months, I found another idea to play the sector, at least indirectly. I wrote a report about Achieve Life Sciences (ISIN: US0044685008, ticker: ACHV) for my Premium PLUS members. The company can achieve something that has not been done for now exactly 20 years — to bring a new smoking cessation drug to the US market. Many people want to quit smoking, but fail. With or without available drugs.

Achieve Life Sciences has a realistic and good shot to change that.


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The best “tobacco stock” to buy now?

I must admit that whenever I think about it, despite always having the plan to look forward and not to live in the past, I get annoyed to have missed this great opportunity in tobacco stocks which are strongly up over the last 18–24 months, even excluding juicy dividends.

It had not much to do with playing the next generation devices as a growth story, but simply banking on a winner in the cost-of-living crisis, spurred by high inflation rates.

Being right is fine, but not participating is either bad luck or just a missed opportunity.

As I cannot change that anymore and new opportunities arrive sooner or later — assuming one opens both eyes and ears — it’s best to search for new attractive ideas.

source: PublicDomainPictures On Pixabay

And this is how I stumbled over Achieve Life Sciences.

To make it clear from the beginning, this is not your typical defensive tobacco stock that you can tuck away. It is possible this turns into a big loss, because it depends on the FDA’s decision to approve — or not — its drug candidate Cytisinicline for the treatment of smoking cessation.

On 20 June 2026, the PDUFA date (prescription drug user fee act), we will know it.

Chances are good for Achieve Life Sciences to strike big. Smoking cessation therapies are urgently needed to tackle this huge underserved public health crisis that is causing health issues and accordingly burdensome costs for the healthcare system. An estimated 40–50 million Americans or about 15% of the population, are smoking and / or vaping. Some even both in parallel.

Current smoking cessation options do not work properly and are off-patent.

The last approved drug was Pfizer’s (ISIN: US7170811035, ticker: PFE) varenicline, sold under the name Chantix — this was in 2006 (see here). But it comes with serious side effects and was even temporarily taken off the market in 2021 due to contamination issues. The other available options show strong side effects, too, often leading to premature quitting.

For vaping, which is a relatively modern form of tobacco consumption, there is not even any single approved treatment.

And here comes Achieve into play.

source: Achieve Life Sciences investor presentation, see here

Achieve says America has 29 million cigarette smokers and 17 million vape users (e-cigarettes). With a rate of less than 10%, successful quitting is hard to achieve.

Cytisinicline comes with a significantly stronger safety profile AND higher success / lower pre-mature quitting rates. This is why I believe this could be the winning formula for a blockbuster — for the company, but also for shareholders, as Cytisinicline, if approved, would be the only patented drug.

Just for comparison, Chantix in 2018 generated sales of close to a billion USD (see here), after hefty price increases. In 2019 it reached its peak sales of 1.1 billion USD (see here), before it went off-patent the subsequent year. So, why should a what it looks like better drug not aim for sales of this magnitude — not even counting inflation? But it gets better.

The PDUFA date in June is set for the treatment of smoking cessation for cigarettes.

In parallel, Achieve is in late-stage trials for the treatment of vaping cessation. In this latter market, as said above, it would even be the first and only treatment option, if approved. Potential for an even bigger franchise, if vaping continues to grow so strongly.

source: Achieve Life Sciences investor presentation, see here

There’s a realistic chance that Achieve even handles two billion-dollar treatments at some point in time. This is not my base case scenario I am planning with — just a thought experiment to show the potential. Of course this is something to be watched closely on an ongoing basis.

So, the setup is that Achieve would enter the cigarette smoking cessation market as the only branded and patented option — bringing a much more favorable safety and success profile with it. And having a good chance to become the prescribed standard of care in a (multi) billion-dollar market.

Here is the safety profile versus Chantix, showing less frequent side effects.

source: Achieve Life Sciences investor presentation, see here

Efficacy, respectively tolerability and odds to quit smoking successfully have shown to be significantly higher compared to placebo use in the clinics.

source: Achieve Life Sciences investor presentation, see here

That’s why chances are good, Achieve gets its drug candidate Cytisinicline approved this summer.

There are no guarantees and risks always remain.

But there have been worse drugs approved and sold, so why not Cytisinicline?

Since 07 February 2025, my Premium PLUS members are aware of this case.

It is definitely a higher-risk, but also much-higher reward idea. My research has led me to believe that this is not a 50/50 coin flip, but that indeed Achieve Life Sciences has a strong setup.

If approved, Cytisinicline will be the first smoking-cessation drug approved since 2006. Incredible, but true.

(Download my full report by clicking on the cover —>)

A few words on how this drug works.

The drug’s main ingredient, Cytisinicline, is plant-based (instead of chemical, better tolerated by the gastrointestinal system) and structurally similar to nicotine. When taken in, it binds to the nicotine receptors in the brain, stimulating the nicotine-like pleasure — without the addiction and side effects profile.

It has been in use in Europe already for decades (!!) to support smoking cessation and even as tobacco and cigarette replacement in war times when cigarettes were rare. It is derived from the seeds of the Laburnum tree, also called golden rain (“Goldregen“ in German).

So, it’s not a moonshot, as there’s serious precedent.

These trees grow predominantly in the mountains of Southern Europe (Bulgaria). The Bulgarian company Sopharma (ISIN: BG11SOSOBT18, ticker: SFA) has control over these resources as well as the supply chain and distribution in Europe. The therapy is approved in countries like Poland, Austria or Germany, and in many other markets.

In other words, this is a long-proven and well-known treatment.

Achieve obtained a license for the US under a slightly adjusted formulation it owns the intellectual property for. Patent protection for Cytisinicline is until at least 2037.

Cytisinicline has a higher success rate to quit smoking and a more favorable safety profile. Competing drugs are known for their severe side effects together with high discontinuation rates.

When looking at the stock chart, the story does not look promising at first sight.

source: tikr

That’s why it is important to do one’s homework properly.

One reason why ACHV stock is trading so low is that the company needed to raise equity multiple times to stay afloat. This led to dilution, holding the stock back.

But there was another reason.

In late-2023 Achieve wanted to submit its new drug application. However, the FDA surprisingly demanded more long-term data which crashed the stock as it prolonged the application process and Achieve needed more cash.

My members and I entered this case in February of last year.

With a market cap of only around 100 mn. USD back then, this was clearly a smaller capitalized idea of mine. But the potential reward still is extreme, assuming Cytisinicline becomes a blockbuster with at least 1 billion USD in sales – which is not unrealistic.

I told my Premium PLUS members that Achieve will need more capital down the road, so another bigger equity raise should be planned with. We knew that it would come, it was obvious from the numbers. And it happened last summer, when Achieve simultaneously announced to having submitted its NDA — but also the surprisingly-timed capital raise. So a piece of good and one of bad news all at once?

The result was a ~50% dilution (!), sending the stock down roughly 40% the next day.

source: tikr

If you think I am crazy enough to let my members and myself dealing with such extreme volatility — yes, I am indeed.

The reason is, I understand this case.

I told my members in an update that this raise, as painful as it might be, puts the company financially on more solid footing, enabling us to look forward towards the next twelve months.

It was not a failure, but a gigantic opportunity to load up.

As you can see above, the crash didn’t last for long. ACHV stock started to move up over the next weeks and months — until there was a huge spike in October, when the stock jumped 40%, again in one day. The reason this time was that the company achieved from the FDA a voucher for its vaping cessation efforts.

source: Achieve Life Sciences, see here

In brief, this is a newly launched program from the FDA that gives priority review access for exclusively chosen therapies where there are special circumstances like under-supply or a strongly underserved medical need — like for smoking, respectively in this case vaping cessation therapies.

This priority voucher reduces the FDA’s decision time from almost a year to just a few months, strongly lowering the cash burn and shortening the time-to-market period.

One of the most important things I pointed my members towards was Achieve’s full market cap, not its stock price. We have seen above how shares developed, making this case look goofy. But the big picture, the entire market cap, is telling us something entirely different.

This case is credible — and the market is rewarding it.

Financing is just part of the game.

source: tikr

While smart investors on social media celebrate loser stocks with declining share prices and share counts, we did the opposite.

We have a higher share count from capital raises AND a higher price per share over time, resulting in a massively higher market cap. The company is growing. We started at ~100 million USD, Achieve is approaching now 300 million USD. Of course, shareholders got diluted.

But this company is becoming bigger, nearing approval and commercialization.

Per last count and as of writing, we are up ~54% per share, i.e. including the hefty dilution. The rest is straightforward. If one is okay with the risk and reward profile of this pick, the upside is still very decent. The first big move has been made.

The rest is now waiting for 20 June 2026.

My Premium PLUS members will receive updates, when something important happens. More details and timely assessments are likewise member-exclusive.

If you like such stock ideas — and want to receive frequent updates on top — the best you can do now is to join Financial-Engineering as a Premium (PLUS) member.

My picks provenly beat the market through serious fundamental analysis. This weekly showed you one such case my members receive from me.

Conclusion

In this weekly, I am discussing one of my stock ideas that I published for my Premium PLUS members about a year ago.

Achieve Life Sciences is a very interesting, but also compelling case with multi-bagger potential.

If you like such ideas — and what to receive them before everyone else (if at all) — join Premium (PLUS).

By becoming a Premium or Premium PLUS Member, you get instant access to all my already published research reports as well as several updates.

Likewise, you qualify for eight, respectively four more exclusive reports with my best investment ideas plus updates on the featured businesses over the next twelve months.