Insmed, a biotech company with one approved drug and a very promising pipeline, in the last 13 months saw its stock going up by a factor of no less than 4x – plus 300%! There were two key events each propelling the stock decisively higher. Both were updates on ongoing clinical trials only. I am saying deliberately “only”, because it is not even a given that biotechs surge so much after drugs get approved by the FDA, yet, here it happened twice following just updates to clinical trials. The reason: Insmed’s assets are very promising with each potentially achieving blockbuster status (> 1 bn. USD is sales, both potentially multi-billions). Is it now time to jump onto this precious opportunity? My Premium PLUS members will soon receive my latest stock idea with a much more attractive setup.

Summary and key takeaways from today’s Weekly
– Insmed is a relatively unknown company, despite having an almost 20 bn. USD market cap.
– The company has one approved drug, but what is interesting is the massive pipeline.
– Insmed holds potential multi-billion dollar assets. Unfortunately, much success seems to be already priced into the stock.

Since May 2024, the relatively unknown biotech company Insmed (ISIN: US4576693075, Ticker: INSM) made huge waves on two occasions. It has only 7.5k followers on Seeking Alpha (see here) and on twitter it hasn’t been shown in my timeline so far which is usually a good sign. 🙂

During the previous nine years since 2015, the stock had its ups (and downs), too. But the long-term chart looks almost like a flat line compared to what happened thereafter. Following the announcement and presentation of the results of ongoing clinical trials, the stock doubled practically from nowhere in May 2024. Despite subsequent dilution through raised equity, the stock continued to climb higher.

The next twelve months saw a rather boring side-ways move (with ups and downs).

Then, last week, Insmed striked again. Another clinical update and the stock until today is up by another 50% – from the higher baseline – making it a cool four-bagger in not even a full 13 months.

Insmed has truly precious assets with the potential for blockbuster treatments each.

Some could even be generating peak sales of several multi billions. With the story being in the early innings, could this be a major home run?

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A biotech to have an eye on

Insmed was founded in 1988, initially with the goal to develop diabetes drugs. Today, it is sailing in an entirely different direction as a result of business combinations. Around the dotcom bubble, Insmed went public through a reverse merger (it merged into a company of the name Celtrix Pharmaceuticals).

In 1997 and in parallel, the company Transave was founded to develop inhaled drugs for the treatment of lung diseases. In 2000, Transave developed an inhaled antibiotic which set the key milestone for the later approval of Insmed’s first drug.

In 2010, Insmed combined with Transave (retaining the name Insmed) to acquire the latter’s late-stage candidate which was approved in 2018 by the FDA.

You can read more about the company’s history here.

This first approved drug has the name ARIKAYCE.

ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting (not responding to standard treatments or therapies). A “Plan-B” treatment so to speak.

Approvals in the EU and Japan followed.

MAC is a rare bacterial lung infection, often in people with weakened lungs. It’s dire for those with advanced cases, is progressive and can even be deadly if untreated.

Currently, Insmed plans to submit a supplementary new drug application (sNDA, application for the approval of another treatment with the same drug) to the FDA for ARIKAYCE in all patients with MAC lung disease in the US in H2 of 2026.

Accordingly, sales are going up nicely with more to be expected.

Per year-end 2024, sales reached 363 mn. USD. ARIKAYCE sales grew by 23% in the first quarter of 2025 and the goal for this year is to achieve 405–425 mn. USD (growth of 11–17%).

ARIKAYCE marked a significant pipeline-to-commercial transition, driven by unmet needs in rare pulmonary (lung) disorders on which Insmed is now specializing.

But the Big Bang is the pipeline. It targets rare diseases with high unmet needs that have the potential to become blockbusters each.

• ARIKAYCE: The above discussed potential expansion for all MAC patients
• Brensocatib: a pill that reduces inflammation and helps calm overactive immune responses in the lungs. It’s aimed at a condition called non-cystic fibrosis bronchiectasis. FDA approval is pending (decision by 12 August 2025). It may also address other diseases with separate trials ongoing.
• Treprostinil Palmitil Inhalation Powder (TPIP): A once-daily inhaled drug. Strong Phase IIb trial results were announced last week (see here) for pulmonary arterial hypertension (PAH). Phase III planned (after discussion with the FDA, likely to start in early-2026). Phase III planned separately for a related disease of the name PH-ILD by late 2025.
• More early-stage research: Includes among others a few gene therapies.

You see, Insmed has a full pipeline, targeting several indications.

In chronological order, key dates are 12 August 2025 for the potential approval of Brensocatib, followed by the clinical update on ARIKAYCE for the targeted expansion to treat all MAC lung disease patients later this year. Then, we’ll also likely hear about TPIP for PH-ILD and the expected start of its Phase III trials still in 2025.

2026 is setting up to be not less exciting.

Back the envelope and from what I researched so far, Brensocatib alone could be a 5 bn. USD sales machine. If approved, it’ll be the first specific treatment of its kind. And the 5 bn. number is for bronchiectasis alone. There are even higher estimates of up to 8 bn. USD – one drug and just one treatment. It is being tested for two other indications currently, potentially making this a 10+ bn. drug.

A possible extension of ARIKAYCE would quickly shoot up sales past a full billion USD. From the information below, sourced from the current annual report, Insmed reaches currently only a fraction of the estimated patient population coping with MAC.

I’ve also found it curious and interesting alike that Japan has a higher estimated case number than the US with only about 35% of the latter’s population, just as a side note.

My attentive paid-members will likely have had an aha-moment while going through the pipeline notes above. Yes indeed, PAH and PH-ILD are diseases my members are familiar with from my exclusive reports about United Therapeutics (ISIN: US91307C1027, Ticker. UTHR) and Liquidia (ISIN: US53635D2027, Ticker: LQDA).

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There’s a reason why I am mentioning PAH and PH-ILD as well as UTHR and LQDA so prominently. Namely:

On 10 June 2025, a week ago as of writing, UTHR and LQDA both dropped like stones.

United closed the day 15% lower and Liquidia even by 17%, both under high volume. Temporarily, the intraday swings were higher with LQDA for example being down by more than 20% in reaction to Insmed’s clinical update.

Again, this was just an update – but a powerful one.

The reason why UTHR and LQDA dropped so heavily is that TPIP is setting up to become the new best-in-class treatment. TPIP would need to be administered only once daily via a dry powder inhaler, similar to UTHR’s and LQDA’s offerings regarding the form of administration. But UTHR’s and LQDA’s current drugs need to be taken more frequently and TPIP impressed with the improvements for PAH patients.

TPIP’s higher efficacy and once-daily convenience suggest an edge, though Phase III results are needed to confirm superiority. This will take us likely into around 2027 – for the results, not the potential approval which would take another 10–12 months.

If all goes well and the FDA approves TPIP, Insmed will join the market towards the end of this decade. Not tomorrow and not next year.

And this does not discuss anything from UTHR’s and LQDA’s pipelines.

The main fear that from my view has been priced in is that LQDA which received its approval just last month could have issues in gaining enough traction and momentum before Insmed’s TPIP arrives. Regarding United Therapeutics, TPIP would obviously heavily challenge the current crown jewel.

But this is just a very shortened overview, only to show that Insmed has potentially very sharp weapons in its quiver.

Coming back to Insmed and assuming all goes well, what potential could the stock have? We can see it is up by 56% over the last twelve months with the big jump having occurred last week.

If you look closer, you’ll notice the company has a market cap of 19.3 bn. USD and is shorted with a short interest of 9.2%.

Both are significant numbers. The short interest is signaling skepticism.

Insmed raised 750 mn. USD in capital after the recent surge of its stock to fund its pipeline expansion, including gene therapies and TPIP’s Phase III trials, but also of course in preparation for the potential launch of Brensocatib. The additional 7.8 mn. shares will beef up total share count to ~180 mn. pieces. But there are also more dilutive options available, hence the 19.3 bn. USD market cap fits.

If you remember from above, Insmed is currently planning to generate 405–425 mn. USD in sales in 2025. This is very little against an almost 20 bn. USD market capitalization. Hence, lots of, I mean LOTS OF success is already expected and accordingly priced into the stock of Insmed. Which does not automatically mean that the stock could not go higher.

The company is heavily investing in its pipeline and commercialization efforts. As a result, Insmed has never posted a positive bottom line, with losses becoming bigger and bigger even.

Share count went up significantly to finance this adventure.

There’s also some debt on the balance sheet, but net debt is currently almost zero, hence I’ll leave it with that. The new equity will likely be sufficient to commercialize Brensocatib to have a second sales-generating pillar.

But you will likely have read between the lines my mixed feelings about this case.

I like the pipeline and the story. It seems to be a very compelling setup with plenty of opportunities to bring even several blockbusters to the market. It is hard to estimate what peak sales Insmed could achieve as it depends on the success of the clinical trials, potential delays, the pending FDA decision regarding Brensocatib and of course the roll-out process itself.

Even if we assume 10 bn. USD or 12 bn. USD. When will that be the case? Could be by the end of this decade. What about profitability or potential competition? These are questions I have currently no or at least insufficient answers for. Also, how will the stock react to potential setbacks, as no biotech has a 100% hit rate over several attempts?

But what is clear: very, very much seems to be already priced in.

I do not like that. That’s why Insmed remains on my watchlist only. I do not want to chase this train that is already full-steam on the road.

What is absolutely possible, though, is that one of the big boys knocks on the door and acquires Insmed. This would make perfect sense for conglomerates that need to replenish their pipelines with promising assets, having more financial firepower to bring them to market.

I have other good news, though.

This is evidenced not just by what management says, but also a few more aspects express, adding massive substance. Among others, an experienced high-level executive turned down a much higher-paid job from one of the biggest names to join this movement. He is quoted with “this is the best asset” he has ever seen in this space.

But there’s more to it.

If I am correct, this could be a hit, making even Insmed standing in the rain. The company is also approaching late-stage Phase III trials for two indications. If only one gets approved, that’s already an underserved and growing multi-billion dollar market. Not sheer phantasy as the company is partnering with (and is financially supported by) an unknown privately-held market leader.

On Friday, you’ll find out. Join my Premium PLUS membership – most of my paid-readers decide for my full package – and I’ll send you an exclusive email as soon as my latest report is out.

Conclusion

Insmed is a relatively unknown company, despite having an almost 20 bn. USD market cap.

The company has one approved drug, but what is interesting is the massive pipeline.

Insmed holds potential multi-billion dollar assets. Unfortunately, much success seems to be already priced into the stock.

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