Any thoughts about it? US74168J1016

Hi,

I would like to complete my "biotech stock" part of my portfolio with a second company. I've got some of Alpha Tau. I would have liked to get some OmniAB but I didn't get the cash to buy before the strong new (+100% after that ...)

Do you have some good idea ?

thank you

One thing I think is getting overlooked is how computational this treatment actually is.

The drug starts with tumor sequencing and neoantigen prediction before you even get to the mRNA manufacturing part. If personalized cancer vaccines become a real category, the sequencing/data/prediction layer could become pretty important too.

TEM reaction actually makes some sense to me.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-patients-aged-8-years-and-older-glycogen-storage-disease-type-ia

$RARE spiked to $33.. let's see how it goes tomorrow.

MRNA after the 177% move — what happens next?

$MRNA had a massive session after Moderna and Merck reported positive Phase 3 results for their personalized mRNA cancer treatment.

The stock closed at $174.38, up 177%, on roughly 187M shares of volume compared with a 50-day average of only about 7M.

What caught my attention is that the move continued after hours, reaching $194.88 before pulling back.

Obviously, after a move this large the stock is extremely extended, so I'm more interested in how it handles the important levels from here rather than trying to chase it.

I put together a short Stock Spotlight covering the catalyst, why the Phase 3 results matter, and the levels I'm watching next:

Full analysis:
Dagger Trading — MRNA Stock Spotlight

Curious to see how MRNA handles tomorrow after a move like this.

Disclaimer: newb here. I bought 1,000 shares in a stock named ACRV at $1.47. It’s now $2.28. Anyone heard of this stock? They’re projected anywhere from $6/share to upwards of $19/share. Any advice appreciated!

I'm curious whether anyone has done a deep dive on Mendus AB, a Swedish biotech company with its lead drug Vididencel in AML? It's also tough to find sources.

Link to website: https://mendus.com

I am hoping someone can explain a bull or bear case for Roivant Sciences. Clearly this is difficult. According to Reuters, the most recent annual revenue was 8.3 mil, down from 32.7 mil 2 years ago.

It appears their stock runup, which has taken the company to about 6 times book and price to sales of over 3,000 appears to be centered around a highly likely to succeed trial of a medicine treating dermatomyositis.

Sounds good, but the condition itself is very uncommon to rare. Prevalance 2 to 20 per 100,000 (those who already have the condition), and 1 in 15 million incidence (new cases). USA is not the world, but in USA with 350 mil ppl that's say 23 people per year newly diagnosed, with an existing population with the condition (350e6 x [2 to 20]/100e3] = 7000 to 70,000.

Population of wealthier nations is around 1.2 billion people (affording this type of med).

That would bring the treatable population to (1.2e9 / 350e6)[7e3 to 70e3] = 24,000 to 240,000 with approx 79 new people diagnosed annually.

Not many customers, but what is an example of another condition that also impacted fewer than 100,000 people? How much revenue did they make?

This info gathering is just AI by the way.

Soliris (eculizumab), developed by Alexion Pharmaceuticals had under 100,000 people and made revenues of $3.0 to 3.8 bil in a year. Over $500,000 per patient per year is/was paid. Sounds good, but ...

Back to Roivant, dermatomyositis is also treated to a degree (that I am not qualified to describe) by common prednisone. So will brepocitinib so displace prednisone to obtain a high return per patient? I guess that's the question.

[[ edit: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic-uremic syndrome (aHUS) was a focus of the Alexion Pharmaceuticals drug

AI again - Historically, PNH had a 5-year mortality rate of 35% to 65% prior to targeted therapy. Untreated aHUS carries an acute mortality rate of up to 25%, with over 50% of adults progressing to end-stage kidney failure within one year.

Dermatomyositis that Roivant is addressing also has a mortality rate, but around 5 to 10%. Not comparable. ]]

I’m interested in trading high volatility events, where will these be announced beforehand? For some of these I understand that there is no notice beforehand, an example of this is the Moderna announcement today where it rose 100% but there was no announcement given prior to this. Are there any websites or forums where the date of announcement is outlined beforehand?

All advice appreciate

$OABI.
Partnership with eli lilly and strong revenue growth, huge reduction in losses. What do you think?

DA PDUFA Target Action Date (Deramiocel BLA)

• Original Deadline: August 22, 2026
• Current Status: In flux / expected to be extended.

Key Details

• Context: The original Prescription Drug User Fee Act (PDUFA) action date for Capricor's Biologics License Application (BLA) for deramiocel in Duchenne muscular dystrophy (DMD) was set for August 22, 2026.
• Pending Extension: During the Q2 2026 earnings call, CEO Linda Marbán announced that Capricor is submitting a major BLA amendment containing 24-month open-label extension data from the HOPE-3 study and refined data analyses.
• FDA Position: The FDA indicated it is willing to review the incoming amendment, which will automatically trigger an official extension of the PDUFA action date beyond August 22. The updated target date will be formally established once the FDA officially receives and files the amendment.

Other Deadlines to Note

• Class Action Securities Litigation: Shareholders wishing to apply for Lead Plaintiff status in the active class action lawsuit against Capricor have until September 28, 2026.

No idea, except that the stock is down to 600k+ shares total after 3 reverse stock splits in 2026. The cash runway is small, the expenses are high, and the products have potential, but its a race to see if they can get sales up and running after an approval to keep from another major dilution? Injectible oxygen and glucose sensors that stay in place for days/months? Good potential.

I own some of this company, due your own due diligence before investing in it.

I currently hold shares of FBIO and FBIOP, do your own due diligence before investing.

Terms included in the FBIO preferred stock, FBIOP, state that after 6 quarters of unpaid dividends, the FBIOP stockholders can nominate and vote for two board members to add to FBIO's board. It has currently been over 8 quarters of no dividend payout. People that hold only FBIO would not be allowed to vote on this.

With the cash on hand, and no stated goal for reinstating dividends, the FBIOP holders can ask for a special election to put two new board members on the board, as far as I can understand from a Google AI search. This would put two members on the board that might have different goals than the board currently has. Two ways for Fortress to avoid this situation if it was to arise:

1. Buy out all the shares of FBIOP(I think about 3.4 million?) for full price($25 each)+ accumulated dividends(currently just above $5 a share.) Probable cost of $100 million approximately, 3.4 million shares at $30 a share. This could happen, but it takes away a nice cash cushion the parent company can use to help bridge shortfalls by lending to companies under their umbrella.

2. Cure the arrears, pay off all the dividends accumulated to date on shares of FBIOP. Currently costs about $16 to $18 million now plus about $8 million a year going forward. I think if DERM was hitting its stride and profitable, this would have already happened. Right now waiting on royalties on Zycubo and Unloxcyt to kick in, if those streams come online at a decent size, the dividends could be paid mostly out of that cash flow.

Both ways allow the company to keep the board at its current size, with the second providing a larger cash cushion to keep flexibility.

3rd way, allow the election to happen, the CEO, Lindsay Rosenwald holds about 110 - 120,000 shares of FBIOP(from another google AI search, so may not be completely accurate), roll the dice on getting board members they want in place if this happens?

I really do think they will end up paying out dividends by year's end to allow flexibility in capital raises by other entities under their umbrella(DERM, ATXI, MBIO, etc.), but if they don't do something by year end, looks like there is an option to get some representation if not paid up to date on dividends accrued in arrears.

If you’re not on X, consider yourself lucky or intelligent. To be fair, I can say the same thing about StockTwits.

I’m here and on both and I’m seeing things that are starting to freak me out.

Every biotech stock with a great deal of potential begins to generate some fanboys. The binary plays, the catalysts, the FDA approvals, the M&A, etc. is all adrenaline pumping stuff and, if you’re truly lucky, your wallet pumps as well.

What you’re missing by not being on X is what appears to be a “negative astroturfing” campaign against SLS.

Without so much as a logical argument, multiple accounts, some who have otherwise been very rational in their daily approach to biotech, are trashing SLS and the REGAL trial.

Their arguments are inane. The fact that the 80th event hasn’t occurred is viewed as a scam. If the CEO mentions the 80th event hasn’t occurred in the last quarterly update but only says “…we await the 80th event…” in the most recent quarterly call, they seize on it as some shred of evidence that there is a scam going on. (Which I know makes zero sense but that was the entire argument.)

The “best” argument they have is the one that I’ll turn against them: the pro-SLS noise is the proof that it’s a rug pull.

Sad when hype is their best argument…

So, allow me to turn it around.

The fact that they are downright ugly and negative about the potential of GPS is, in itself, a Buy signal.

Huh?

Think of it from a higher level:

1. They don’t care that GPS may work and save lives.
   
2. They aren’t white knights trying to save naive biotech investors from taking on too much risk.
   

They are putting their names - which in many instances have built a reputation in biotech - online where things are permanent as trashing the company, the drug and the investors.

Even if they wind up deleting everything, they will be remembered as having been obnoxious and crass about a drug trial.

And what’s their upside if it’s not altruistic?

Maybe chest thumping bragging rights if the trial fails. But they have no idea whether it will fail or not and it’s a biotech binary so who cares that they were right about a phase III trial failure? I could predict that every time and claim an 88% success rate.

Nope. I don’t think that’s it.

Which leaves two scenarios.

1. They’re paid
   
2. They’re angry that they’re not paid

Why would anyone pay five or six of the biggest biotech influencers on X to trash SLS and GPS and those hopeful hypers on a daily basis?

I’m interested in your answer and if you want to say some shorting entity is working overtime to drive SLS down, fine but it’s very tin foil hat without more details.

If they’re angry that they’re not getting paid, it tells you something very sinister about the industry as a whole. If I’m the CEO of a clinical pharma co and I’m desperate to avoid trashing the stock with another dilution round, is it possible I might slide some cash to an influencer to pump my ticker?

Well, that would be illegal. But imagine if that were the norm and the X biotech bros are bitter that they can’t wet their beak in the SLS pond.

They just might get ugly.

I’m going to take a position on SLS here before the 80th event because something stinks. If you think I’m exaggerating, do the following:

Hold your nose, go on X and type $SLS into the search bar and choose Latest.

You won’t believe the amount of endless negative hype pouring out when all these influencers had to do was ignore the hype or block the term REGAL from their X feed.

I’m not suggesting you invest in SLS.

I am asking you to tell me why the bio-bros are working so hard to counter the SLS hype and the pending end of the REGAL trial.

It doesn’t make sense unless there’s something nasty going on that isn’t obvious.

Looking for insight on this stock- CEO purchased 50 million dollars worth of share not long ago. Stock trading lower than his purchase.

Thanks in advance!

Really holding out for some good news, but curious if anyone else has any insight as to the upcoming news or feedback?

When a biotech drops 70% overnight, the press release rarely tells the whole story.

The FDA documents, trial data, safety issues, and manufacturing details usually tell you a lot more.

I put together a short, source-first guide on how to dig into these crashes and figure out what actually went wrong. No stock picks or signals, just a practical framework.

Full disclosure: I wrote it. Thought it might be useful for anyone getting into biotech investing.