...as already announced, there will be another biotech gamble from my direction in January.

@Tenbagger2024
@Dividendenopi
@Multibagger
@Klein-Anleger

Today, completely by chance, I read news about $AQST read. An application for approval is currently being submitted to the FDA, with a decision date of 31.01.2026.

The FDA has pointed out "deficiencies in the application". Share price reaction today: -38%!

No clear indication of the problem, so it is difficult to assess the ultimate impact. However, the application has not been rejected (which I consider positive for the time being) and the review is continuing. According to the FDA, a decision will not be made before the deadline that has already been set.

The company is, of course, desperately waiting for a clearer statement from the FDA, but has already signaled that it wants to clear up any ambiguities or questions during the review, i.e. by the decision date.

In principle (although the details are different), this scenario reminded me very much of the scenario at $FBIO some time ago. I looked at the key facts about the company and the preparation that is the subject of the application is, in my view, really something special.

Specifically, it is Anaphylm, a sublingual film (to be placed under the tongue) for the treatment of severe allergic reactions. The special thing about it: while epinephrine currently has to be injected by syringe for allergic shocks $AQST has packed a life-saving dose of epinephrine into a self-dissolving gel platelet, which releases the necessary epinephrine via the mouth without the need for fluids.

In my opinion, this offers considerable advantages for emergencies. Easy storage (unrefrigerated, even in hospitals etc.), easy handling for really anyone (even untrained helpers etc., I wouldn't know where or how to hammer it into someone with allergic shock and an emergency pen in their pocket muss🤷🏼‍♂️), lighter, smaller, easier to handle etc....

Long story short: For me, it is not a completely absurd scenario that it is rather errors in the application with regard to the design of the application than doubts about the efficacy that play a role here (why else would one continue to review and not reject directly, does the FDA do this often enough?)

In my view, two scenarios can occur here:

• If approved, potential peak sales of up to 700 million US dollars (2035e) beckon.

• If it is rejected, the share price could fall further, but in my opinion the price currently already includes a worst-case scenario.

I therefore have the feeling that the market reaction is currently exaggerated here too and have entered the stock today with the same "play money" size at $AQST as I did with $FBIO at the time.

I didn't hit the daily low perfectly, but of course a little more research and consideration was still necessary.

The same applies here: absolute high-risk, high-reward gambling, only imitate if you have looked into it yourself, weighed up the opportunities and risks for yourself and, in the worst case, can write off the invested capital without financial ruin.

For number crunchers, here again are the key financials and, as recently, the chart for a quick overview:

• Around USD 120 million in cash at the end of 2025 - enough to cover all approval and launch costs.

Valuation:

• Market capitalization: 757.64 million US dollars
• Revenue growth in 2024: 13.8%
• Expected decline in sales in 2025: -21.8% (due to delays at Anaphylm to date)

As announced in my previous post, here is something special and niche from the biotech sector.

It's about $FBIO . Who please (?!), you're probably wondering.

Let me give you a brief overview, especially with regard to what could provide a massive push in the short term.

Let me say in advance that this is absolute high-risk, high-reward gambling, not a buy recommendation and, as always, DYOR applies.

Now to the facts:

$FBIO is active in the development, approval and commercialization of innovative therapies in dermatology, oncology & rare diseases. As is not uncommon in the biotech sector, the company operates primarily through subsidiaries.

Currently, only dermatological products are marketed.

The game changer for $FBIO could be the preparation CUTX-101 as the first therapy against the rare Menkes' disease (I'll spare you the details of the disease, that's more for doctors, pharmacologists etc., if you're interested, you can of course research it for yourself😉). A corresponding application for approval has been pending with the FDA for some time. License fees and milestone payments of up to USD 129 million are linked to this active ingredient. To put this into perspective: the current market cap of $FBIO is approx. 135 million dollars!!!

Now to the really interesting part:

As part of the approval application, the responsible subsidiary received a Complete Response Letter (rejection) from the FDA in September 2025.

This was based solely on manufacturing problems - not on the efficacy or safety of the drug. Market approval is therefore still quite realistic. The market reaction to the rejection: approx. 30% share price loss on 30.09.2025.

It was pretty much at this point that I entered the market with a small position.

The sell-off seemed absolutely exaggerated to me and, given the share price performance over the last few months, the market also assessed it that way in retrospect.

Why should $FBIO be interesting right now?

Well, the responsible subsidiary resubmitted the application to the FDA in mid-December 2025, and the FDA subsequently set the decision date for January 14, 2026, i.e. next week.

Should approval be granted $FBIO considerable short-term upside potential (my estimate here is >100% from the current level, if you look at milestone payments, license fees etc. and the current market cap in relation).

The share is currently approx. 73% up for me, I will definitely stay on board until the decision is made, but will hedge profits in advance with a stop loss if necessary.

At the present time $FBIO in my opinion only something for very risk-averse investors who are interested in event-driven investing.💥

For the number crunchers among you, here is a brief summary of the key financials (which didn't really play a role for me in this trade from the outset😉):

• Cash balance: USD 86.22m (Q3 2025) - solid liquidity base for short-term capital requirements. If approval fails, further dilution through capital measures is very likely.

• Debt: Significantly reduced, debt/equity from 334.1% (2024) to 122.3% (Q3 2025).

• Earnings situation: Losses, negative EBITDA, but strong EPS trend (growth of 94.1% LTM).

Maybe something for the hardcore traders @Multibagger and @Klein-Anleger 😎

This or something similar could be my personal headline for 02.01.2026.

In addition to receiving my letter of congratulations on passing my probationary period after changing jobs last summer, it was of course another savings plan day.

In addition to the investments worth the equivalent of €1,375 to be collected there every month (€25 in $ATAI has not yet gone through due to the relocation to the USA, so I'm curious to see whether the NASDAQ-listed securities are still eligible for the savings plan😅), a further €1,000 has found its way into the market and thus into my portfolio.

In this case, it was not a "quick 1-2 new positions between the holidays" action like a few days ago (the days were really crazy to say the least with the price movements of some stocks with rather thin volumes), but a targeted increase in some of my existing positions, which were of course already provided with a savings plan.

I have done the same thing from time to time in recent months with the previously smaller savings plan positions in my portfolio, and this time was no exception.

This time, I increased the positions in equal parts:

$BNTX (-0,29 %)

$ANET (-1,67 %)

$FTNT (+0,77 %)

$BA. (+0,28 %)

Overall, I am quite satisfied with my current portfolio structure, but I will sit down from time to time during the course of the year and review existing positions, check my investment theses and probably also simply take profits on stocks that are more "bets" than long-term investments for me ($BITF (-4,6 %) , $HIVE (-3,99 %) , $REKR (-7,9 %) , $FBIO and one or two in the rare earth/critical raw materials sector).

A few new positions may then be added, but the aim here is clearly to liquidate positions first (where appropriate) and only then to open further positions.

How are you doing? How did your first trading day of the year go? Do you also have one or more of the stocks mentioned in your portfolio? How do you feel about them?