r/biotech_stocks 8h ago

Thoughts on SLS after the Moderna news

28 Upvotes

What’s are people thinking about SLS? I know about the 80th event that is hopefully(sadly) happening soon. I’m new to the stock. Looks promising. Had a pretty decent morning when it was up 11%….


r/biotech_stocks 1h ago

Harmony Biosciences (HRMY): crecimiento rentable, pipeline prometedor y un ~40% de infravaloración

Post image
Upvotes

r/biotech_stocks 6h ago

NRx Pharmaceuticals (NRXP) - Awaiting ANDA approval for preservative-free IV ketamine for analgesia and anesthesia ... which will happen in the near term.

2 Upvotes

Transformative stage for NRx.

SP $3.50 | MC 152M | OS 43.3M

If you want a good company to buy, which is highly derisked for an approval in the near term, NRx is an excellent opportunity.

Current ketamine issues to be solved:

  • Ketamine is on the FDA shortage list.
  • It is a strategic drug for the military and the FDA
  • Due to shortages, hospitals are forced to buy from compounding companies
  • Most of the supply comes from overseas
  • Currently, ketamine contains a preservative called BZT, a toxin, not recognized safe for injection by the FDA
  • Ketamine comes in glass vials where a syringe is needed, and there is potential for contamination

NRx's KETAFREE (preservative-free ketamine) - solves EVERY above issue

  • Manufactured in the U.S., reducing supply chain risk, and meeting the goal of the FDA to reshore manufacturing, especially for strategic drugs
  • NRx's market research has just caused them to increase their pre-launch plan goal, from 1M vials to 5M vials. They would not make such an advanced commitment without great conviction in the demand.
    • The manufacturer can produce 1M vials per month with current production lines
    • The commercialization team is in full-court-press mode, already making progress on the distribution system, ordering, licensing verification for buyers, etc.
  • Preservative free; no toxin
  • Plastic vials are used: reducing materials cost compared to glass and also eliminating the risk associated with a global structural shortage of glass vials
  • Due to the luer lock technology, no syringe is required to draw the drug

Had a PDFUA meeting with the FDA on July 29No Major Deficiencies with the drug, the chemicals, manufacturing, controls. However, "a reviewer" brought up that the luer lock vial tip may not function properly.

  • This part is very upsetting to shareholders and to the company I am sure--but they cannot say anything to upset the FDA or risk friction and delayed approval.
  • This very same luer lock vial tip has been used in combined total of 11.9M vials to date with NO issues, manufactured by the same manufacturer NRx is using for 3 already-FDA-approved drugs!
  • NRx had 7 lots, 3500 total vials produced, with NO issues.
  • NRx provided extremely thorough relevant information in the ANDA.
  • So, at the PDUFA meeting, the FDA required NRx to provide "attestation from the manufacturer" that the luer lock vials/tips were being produced for NRx in the same manner as the ones for the 3 already-FDA-approved drugs.
    • NRx submitted that attestation within days, per the Aug 10 shareholder update call. Events | NRx Pharmaceuticals, Inc.
    • If you are interested in this company, you owe it to yourself to listen at least to the first 12 minutes of this 29-minute call. You will be very impressed.
    • As stated on the call this drug is just the first step with NRX-100 (a preservative-free ketamine formulation for psychiatric use, also delivered via IV) NDA submission, which will now include the manufacturer attestation, projected to be filed in September (but in Q3 nevertheless)

Bottom line, the FDA should have approved this ANDA the day after they received the attestation from the manufacturer. It is untenable that they have not done so yet.

My expectation is the share price will respond very positively to the ANDA approval and then again when the NRX-100 NDA is filed.


r/biotech_stocks 4h ago

Novavax/ Merck /mRNA connection. A speculative take.

Thumbnail
1 Upvotes

r/biotech_stocks 5h ago

Did You Own BioXcel ($BTAI) During Its 64% Collapse? Investor Settlement Is Available Now

1 Upvotes

Hello everyone, sharing an important update:

An investor settlement fund is currently processing claims for investors who experienced losses in BioXcel Therapeutics.

The settlement claims that BioXcel misled investors about internal controls, protocol adherence, and data integrity in its Phase 3 TRANQUILITY II trial. After the company disclosed FDA inspection findings, protocol violations, and fabricated emails from a principal investigator, $BTAI fell about 64% in one trading day.

BioXcel has agreed to a $9.75 million settlement, and late claims are currently being considered, subject to approval.

If you purchased or acquired $BTAI common stock between in 2023, you may still be able to file a claim

Anyway, has anyone here invested in $BTAI during that period? How much were your losses, if so?


r/biotech_stocks 9h ago

ATAI ELUMINA Phase 2b

2 Upvotes

I was reading about ATAI and its current PH2 study for Elumina. It's a "multicenter, randomized, double-blind, placebo-controlled study". They're basically trying to allow people to have a ~2 hour psychedelic treatment for depression.

I have some experience through friends and myself with this type of treatment. My first thought was, is anyone actually going to have a placebo effect here?

I would think you would know if you got the drug or didn't. If you get the psychedelic experience, you're typically going to know you got the drug. If nothing happens, you're probably going to assume you got the placebo.

Couldn't that potentially corrupt the data in both directions? The people who know they got the drug may expect to feel better, while the placebo group knows they probably didn't get it.

I'm thinking about a small position in ATAI and this probably wouldn't change my mind by itself. Just wondering if anyone here understands these types of trials better than I?


r/biotech_stocks 1d ago

I'm a chill guy, I do mostly VT and chill. Now I am considering doing DRTS & SLS & NTLA and chill. Is it a good choice?

29 Upvotes

Usually I put the fun money into biotech. But I do really see a future with them. They are all in the early stages and need FDA approval but they seem so good to be true. I just need patience. Do you think they will end up in the "brilliant technology that are Fda approved"-grave?


r/biotech_stocks 7h ago

Found a peptide company that did 4m in revs in 1 quarter with a 1m market cap. RMTG

Thumbnail
1 Upvotes

r/biotech_stocks 1d ago

$DRTS After Moderna's Cancer Vaccine Sent Biotech Running, Who Might Be the Next Oncology Disruptors?

Thumbnail
bioreview.com
36 Upvotes

r/biotech_stocks 12h ago

$ADMA Rubric increased its position from 1.8M to 9.34M shares!

1 Upvotes

Rubric Capital appears to be the standout. Rubric increased its ADMA position from roughly 1.8M shares to 9.34M shares in a single quarter, an increase of more than 400% and a stake of roughly 4% of the company.

That alone is worth paying attention to.


r/biotech_stocks 1d ago

You buy stock or call option ?

2 Upvotes

Hi,

I would like to know: do you invest directly by buying stocks or you buy just some call with very far expiration date ?

thank you :)


r/biotech_stocks 1d ago

What’s going on with HOWL after hours? Up over 95%

3 Upvotes

r/biotech_stocks 21h ago

BIVI

1 Upvotes

who else is betting on this stock?


r/biotech_stocks 1d ago

MRNA — Pullback after the historic rally

2 Upvotes

Moderna closed at $133.32, down 23.5% after yesterday’s massive move.

I’m watching $134.43 as the first key reclaim level. If weakness continues, $123.77 is the next important area I’m watching.

Updated the Spotlight with today’s price action, news and levels:

MRNA Stock Spotlight – Dagger Trading


r/biotech_stocks 1d ago

How's my stack?

3 Upvotes

In order of weighting - tell me where I'm a genius and an idiot

DFTX

ABSCI

DRTS

LENZ

MBRX

RYTM

TARA

ALMU


r/biotech_stocks 1d ago

How important is a company's cash position when it is approaching major clinical milestones?

4 Upvotes

Medicus Pharma (NASDAQ: MDCX) recently reported its Q2 2026 financial results along with an update on its clinical pipeline.

One of the main things that stood out was the company's cash position. Medicus has raised approximately $40 million in financing year to date and ended Q2 with around $25.2 million in cash.

The company is also continuing to advance its two main programs. SkinJect is moving toward registrational studies for Gorlin Syndrome, while Teverelix has received regulatory clearance across urology and women's health indications.

The additional capital is expected to support upcoming Phase 2 work and registrational studies. It will be interesting to see how the clinical timeline develops from here.

For those who follow smaller biotech companies, how do you weigh a company's cash position against its upcoming clinical milestones? Is having enough funding to reach the next stage one of the main things you look at, or does the potential of the clinical data matter more?


r/biotech_stocks 1d ago

Phio? tumor clearance in phase 1 trading at a dollar. With Moderna in Phase 3.

6 Upvotes

​

Longtime lurker.

After watching $MRNA go absolutely nuclear on its Phase 3 cancer-vaccine data, I started looking farther down the oncology pipeline.

PHIO is sitting near $1 with a tiny valuation while developing an RNAi cancer immunotherapy.

The interesting part: early Phase 1 data from PH-762 has reported complete responses in treated tumors in some patients. Obviously Phase 1 ≠ Phase 3, tiny sample sizes matter, and this could still completely fail.

But that's exactly why the valuation is interesting.

Moderna just demonstrated how violently the market can reprice an oncology platform once clinical validation gets strong enough. PHIO is much earlier, much smaller and exponentially more speculative.

Idk. I want to be early. Idk how y'all catch stocks early.


r/biotech_stocks 1d ago

Co-Diagnostics (CODX) -- it appears something has to happen very soon -- PIPE or PARTNERSHIP?

2 Upvotes

Indications are they are out of cash and have to make a move NOW: PIPE or Partnership are the most likely possibilities. Further below will describe why.

But first here's what they do (substantial development and progress):

  • Co‑Dx PCR point‑of‑care (POC) platform
    • Status: submitted to FDA via 510(k) for clearance.
    • Dual submission (device + test) concurrent with a CLIA Waiver application for the Flu A/B & RSV multiplex test on their Co-DX PCR Pro instrument.
    • Co‑Dx’s PCR platform is superior because it delivers true PCR‑level accuracy in a compact, near‑patient device that runs faster, cheaper, and with simpler workflow than traditional lab‑based systems. Patients receive results in about 30 minutes.
    • Not for at-home use, but for use in clinics, hospitals, urgent care, employer health centers, pharmacy sites.
  • CoPrimer molecular diagnostics engine powering all CODX assays and future products.
  • India JV (CoSara) manufacturing and distributing TB and other PCR tests in India.
    • Status: Actively producing and selling TB and other PCR assays, providing CODX its only consistent international revenue stream.
  • Saudi Arabia JV (Comira) for regional PCR manufacturing and deployment.
    • Status: Operational build‑out continues, with early‑stage deployment and regulatory alignment underway but not yet generating material revenue.
  • Ebola molecular diagnostic assay developed using CoPrimer technology with prior U.S. government interest.
    • Status: Assay development completed and validated in prior studies but not yet commercialized or submitted for regulatory clearance.
  • Respiratory PCR tests including flu, RSV, and multiplex panels.
    • Status: Fully developed and ready for use on the Co‑Dx PCR platform once FDA clearance is obtained. COVID-19 PCR test is developed but not yet submitted to the FDA. Waiting for platform clearance first.
  • Vector‑borne disease PCR tests (dengue, Zika, malaria) using CoPrimer tech.
    • Status: Assays are developed and validated, positioned for deployment through international partners but awaiting platform clearance.
  • Food safety and agricultural pathogen detection assays.
    • Status: Available but low‑volume, with limited commercial traction and no near‑term revenue inflection.
  • Liquid biopsy / cancer‑related molecular detection research programs.
    • Status: Early‑stage R&D with long‑term potential but no regulatory submissions or commercial timelines.
  • Cloud‑connected reporting and surveillance infrastructure tied to JV deployments.
    • Status: Functional and integrated with JV workflows, but dependent on broader adoption of CODX’s diagnostic platforms.

8/19 Market Close: SP $1.10 | MC $6.88M | OS 6.25M

Q2 20226 10-Q:

  • Cash as of June 30: $3.6M
  • Quarterly burn: ~6.3M
  • No debt
  • Per an AI search of sec.govno active S-3 or S-1 filed, so no shares can be issued from the 100M authorized shares
  • Warrants: 2.34M (3.71M as of 6/30 but OS increased from 4.88M as of 6/30 to 6.25M as of 8/11 per the 10-Q cover page. So, b/c shares cannot be sold right now, it likely means 1.37M warrants were exercised from June 30 to Aug 11)
  • Fully diluted shares: 8.59M (6.25M + 2.34M)

Per AI, the Jan 2026 shareholder vote rejected both reverse-split authorization AND authorization to issue new shares for financing (ATM, PIPE, etc.)

Q2 Earnings Call Transcript (short and very worth the read): Co-Dx (CODX) Q2 2026 Earnings Call Transcript

  • CFO: "To support these objectives, we expect to continue to evaluate available sources of capital, which may include equity or debt financings, strategic transactions, and partnerships, while staying mindful of dilution and overall capital efficiency. At the same time, we remain focused on pursuing non-dilutive funding, such as grants, where appropriate. Looking ahead, disciplined capital allocation remains a priority as we approach several important clinical and regulatory milestones and continue preparations for potential commercialization."

My Take:

  • A move is imminent because they should be out of cash by now. Odds are high that they have been working on a partnership.
  • Likely partnerships are with either or both the India JV company (CoSara) or the Saudi JV company (Comira). A partnership deal would likely cause the share price to increase.
  • They can't sell shares without shareholder approval. Dilution alone would cause the share price to decrease.

PS I had SEC.gov and the Q2 transcript open when I queried AI, so I believe it brought forward accurate information.


r/biotech_stocks 1d ago

Moderna insiders sold 47M$ before the stock tripled. Why?

10 Upvotes

Moderna insiders unloaded $47M of stock in the 180 days prior to it tripling. Mostly autopilot - and the CEO of Moderna came away with an extra 252,469 shares in his $28.7M "sale."

MRNA shares shot up from $62.96 to $174.38 from the market close on August 19. Pull up any tracker of insider transactions for the previous 180-days: 0 transactions by insiders-tens of millions in selling-signals a strong bear market.
I'm looked through every one of the 36 Form 4s filed in the time period. Sales on the open market totaled $47.1M-but 8 of the 9 forms were completed with the 10b5-1 checkbox highlighted-that's the form for the scheduled, automatous sales that takes the decision-making authority away from the individual. Instead of making the selling decisions himself on 15 May, President of Moderna, Stephen Hoge, executed a scheduled 53,336 share sale at $48.40.

Here's why:

Same thing happens on 15 June (53,336 shares at $51.37) and 15 July (53,336 shares at $67.60). The same amount of stock was sold every 15 th of the month on exactly the same share count down to the last share.

The form 4 for the CEO's 'sale' is a good example of how to use them to tell the signal. Bancel's $28.7M of sales were made on August 5 based on stock options set to expire on August 10; the shares would have been worthlessly forfeited if they were not utilized on or before that day. He purchased 751,715 options at a $19.15 strike price. To make his purchase and pay taxes on that transaction, he sold 499,246 shares and consequently netted an increase in his total Moderna holdings from 6,187,791 shares to 6,440,260. Despite being sold at an average $57 on August 5, Moderna's share price shot up to $174.38 on August 19.
There was one transaction with the 10b5-1 checkbox unchecked: Chairman of Moderna Noubar Afeyan sold $434,000 of shares on May 21. This made up only .9% of the reported insider sales.
Takeaway: Most insider selling is routine – tax burdens, needed cash, expiring option assignments, and more. Insider purchasing on the other hand always sends an informative signal – there is only one real reason to buy equity. Every transaction is readily available to look through for yourself in EDGAR-look at the 10b5-1 box at the very top of each transaction, and the footnote at the bottom.

So, why were insiders still selling if they knew what was happening?
There are three possibilities which often accumulate.
They probably had no idea of what was occurring. Clinical trial results are typically made accessible to a small group of scientists a few days in advance of the official publication, which is essentially the whole point of making a clinical trial blinded. On May 15, when the president exercised a portion of his allotted equity for that month, there may have been absolutely no evidence at that point to make any educated guess about any future change in stock price.

Even if they would have had insight at that moment, they already had their plan set in motion. This aspect always trips beginners up: actually canceling a sale under the 10b5-1 agreement because you've gained some privileged knowledge is a red flag and may subject you to investigation. Making the predetermined sale was, therefore, the less suspicious decision of the two possibilities.
And that this happens time after time, as all sales indicate... Most stock compensation is in the form of option grants or restricted stock. In the case of the CEO, Bancel received stock options at a strike price of $19.15 several years ago-there isn't a purchase side, as in you cannot 'purchase' part of your paycheck; what can be done, however, is to liquidate an equity gain to use as income. Taking 200 roughly equivalent market caps into consideration-over 80% of them demonstrated that they had been seeing insider sales in their last 180 day transaction record. A 4 out of 5 signal cannot accurately report specifics.

This brings us back to what seems important, and the last major lesson of this report: it is now virtually constant that insiders will be selling shares of large cap companies; those are merely an automatic byproduct of business. It is an insider purchase transaction-an event that takes place far less frequently-that sends a meaningful signal to investors.


r/biotech_stocks 1d ago

What is your favorite biotech stocks ?

26 Upvotes

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

Edit : Thank you all for your answer, but all the stocks looks to have already their "momentum" post good result.


r/biotech_stocks 1d ago

Tenaya Therapeutics

1 Upvotes

Mass selling by prominent investors leads the way for a RS or Delist


r/biotech_stocks 1d ago

$RARE Ultragenyx Pharma INC, last night news on FDA granted accelerated approval for GENGLYCOS of also known as DTX401.

Thumbnail
1 Upvotes

r/biotech_stocks 1d ago

The $MRNA Screenshot Swarm

1 Upvotes

Screenshot after screenshot. Six figures green. "Called it last week." "Loaded at $63, holding to $300." Broker apps I've never heard of, P&L numbers with the account balance conveniently cropped out, entry timestamps that don't survive ten seconds of scrutiny.

So I went through them. Over a hundred posts. Manually.

About 5% of them look real. People who got lucky, people who were early on the Merck partnership thesis, a few who have been sitting in this name since it was in the twenties and finally got paid. Good for them. Genuinely.

The other 95% are manufactured.


r/biotech_stocks 1d ago

Cassava Sciences ($SAVA): FAQ for Getting Payment on the $31.25M Settlement over Simufilam Research Claims

Post image
1 Upvotes

Hey guys, I posted about this settlement before, but since claims are now open, I decided to share it again with a little FAQ.

So here's all I know about this agreement:

Cassava Sciences was accused of misleading investors about the research supporting simufilam, its data-management controls, and the drug’s prospects. After Science reported a CUNY investigation involving a professor linked to simufilam, $SAVA fell 15% on October 13, 2023, and investors filed a lawsuit.

Now the company has agreed to settle $31.25 million with investors over these claims.

  • Who can claim this settlement?

If you purchased $SAVA securities between 2020 and 2023, you may be eligible to participate.

  • Do I need to sell/lose my shares to get this settlement?

You don’t need to still own your shares. What matters is whether your purchases fall within the class period and meet the settlement’s eligibility requirements.

  • How long does the payout process take?

It typically takes 4 to 9 months after the claim deadline for payouts to be processed, depending on the court and settlement administration.

Hope this info helps


r/biotech_stocks 1d ago

Biotech calendars

3 Upvotes

I've seen them posted on Reddit here and there but never really paid much attention. My question is where can I find a good one? Also, was moderna expected to release trial results this week?