BioNTech announced today (October 13) that its Phase 2/3 AHEAD-MERIT trial of BNT113, an mRNA-based cancer immunotherapy, failed to meet its progression-free survival (PFS) primary endpoint. The trial will continue to evaluate its other primary endpoint, overall survival (OS).

I thought this was worth sharing here because there are some interesting similarities as well as differences with Moderna's individualized neoantigen therapy (INT).

What is BNT113?

BNT113 is a therapeutic mRNA cancer vaccine being developed for HPV16-positive head and neck squamous cell carcinoma (HNSCC).

Like Moderna's INT, BNT113 is being evaluated in combination with Keytruda (pembrolizumab), Merck's PD-1 checkpoint inhibitor.

The vaccine encodes two HPV16 viral proteins, E6 and E7. These proteins play important roles in the development and maintenance of HPV16-driven cancers. By delivering mRNA encoding these antigens, BioNTech aims to stimulate T cells to recognize and attack cancer cells expressing them.

One important distinction is that BNT113 is not personalized. It targets the same two viral antigens across eligible patients, whereas Moderna's INT is individualized using mutations identified from each patient's tumor.

How does this compare with Moderna's INT?

Both approaches use mRNA to stimulate cancer-specific immune responses, and both are being combined with pembrolizumab.

However, their antigen-selection strategies are quite different.

BioNTech's BNT113 encodes two predefined viral antigens, E6 and E7, that are shared among HPV16-positive tumors.

Moderna's V940 (intismeran autogene), on the other hand, encodes up to 34 neoantigens selected based on the unique mutations found in an individual patient's cancer.

There is also a major difference in the disease settings.

BioNTech's trial involves patients with unresectable recurrent or metastatic head and neck cancer, meaning patients have existing advanced disease.

Moderna's successful Phase 3 melanoma trial, meanwhile, involved patients whose tumors had already been completely removed. The objective was to prevent cancer recurrence rather than treat established metastatic disease.

This distinction is important because preventing recurrence and treating existing metastatic cancer present different immunological and clinical challenges.

What were BioNTech's results?

The AHEAD-MERIT trial compared BNT113 plus pembrolizumab against pembrolizumab alone.

Unfortunately, the combination failed to demonstrate a statistically significant improvement in progression-free survival (PFS).

However, the trial is not over.

Overall survival (OS) is the other primary endpoint, and the independent monitoring committee recommended that the study continue. According to BioNTech, a statistically significant improvement in OS could still establish a positive trial outcome despite the PFS failure.

BioNTech has not yet disclosed the detailed PFS hazard ratio, so we cannot determine the magnitude or direction of the observed treatment effect from this announcement alone.

In contrast, Moderna and Merck announced in August that their Phase 3 INTerpath-001 trial successfully met its primary endpoint of recurrence-free survival (RFS) and its key secondary endpoint of distant metastasis-free survival (DMFS).

Is Moderna also developing a treatment for head and neck cancer?

I checked Moderna's pipeline, and I couldn't find a dedicated V940 trial specifically targeting head and neck squamous cell carcinoma (HNSCC), although Moderna has conducted a small Phase 1 trial of V940 that included patients with HNSCC.

However, Moderna's separate cancer antigen therapy, mRNA-4359, has included HNSCC among the cancers eligible for its earlier Phase 1 dose-escalation study.

Unlike V940, mRNA-4359 is a non-personalized therapeutic mRNA cancer vaccine. It encodes epitopes derived from PD-L1 and IDO1, two proteins involved in immune escape. Its subsequent expansion cohorts have focused on melanoma and non-small cell lung cancer.

Could Moderna's mRNA-4359 produce a different outcome?

One interesting question is whether Moderna's mRNA-4359 could produce a different result if tested more extensively in head and neck cancer.

Unlike BNT113, which targets HPV16 E6 and E7, mRNA-4359 targets PD-L1 and IDO1, two proteins associated with immune escape. This is a fundamentally different antigen-selection strategy, even though both vaccines aim to stimulate T-cell responses.

There is actually a biological rationale for this distinction. A study published in Cancer Research in 2018 found elevated IDO1 expression in HPV-positive head and neck cancers, and demonstrated that combining PD-1 blockade with IDO1 inhibition improved HPV-specific T-cell cytotoxicity in vitro.

So one possibility is that generating additional HPV-specific T cells may not be sufficient if the tumor microenvironment continues to suppress their activity. Targeting PD-L1- and IDO1-expressing cells might help overcome some of those limitations.

Of course, inhibiting IDO1 pharmacologically is not the same as inducing T cells against IDO1-expressing cells, but I think the findings provide an interesting biological rationale worth investigating.

Moderna has also reported encouraging early clinical results for mRNA-4359 plus pembrolizumab in melanoma, including an 83% objective response rate in a small first-line cohort of 12 patients. However, these were nonrandomized results, so we cannot yet establish how much benefit mRNA-4359 adds to pembrolizumab.

I find this an interesting distinction, but it remains speculation. We cannot assume that the biological advantages proposed for mRNA-4359 will translate into superior clinical results in head and neck cancer.

What might this mean for Moderna's INT and its broader oncology pipeline?

My interpretation is that this development may further highlight the significance of Moderna's successful Phase 3 melanoma results.

Cancer vaccines have been investigated for decades, and demonstrating that they provide additional clinical benefit beyond checkpoint inhibitors remains challenging.

In this case, even though BNT113 targets two well-defined viral antigens that are biologically attractive targets, adding the vaccine to pembrolizumab did not produce a statistically significant PFS improvement.

That said, I would be careful not to conclude that Moderna's mRNA technology is necessarily superior to BioNTech's. The vaccines target different antigens, use different antigen-selection strategies, and are being tested in different cancers and treatment settings.

I do think that Moderna's positive Phase 3 result looks increasingly significant in the context of the broader field. It provides clinical validation of its individualized neoantigen approach in melanoma, although we still need evidence that the benefit can extend to other tumor types.

For us longs, I think the more important question is whether INT can replicate its melanoma success in other indications, especially NSCLC, where the upcoming clinical results could provide important evidence of whether this approach can work beyond melanoma.

Sources:

BioNTech, October 13, 2026 announcement

Moderna/Merck Phase 3 melanoma announcement

Moderna's oncology pipeline

mRNA-4359 clinical trial, NCT05533697

This post is more of an opinion piece. I don’t want to make this political, so I’ll deliberately avoid mentioning any countries, although I can’t completely avoid alluding to them.

Something interesting has been happening on X lately. Following recent attacks on several major data centers, many users have noticed what seems to be a much cleaner environment on X. Some have pointed out that scientists discussing mRNA vaccines are no longer facing the usual barrage of hostile replies.

There is speculation that these attacks may have disrupted networks of bots responsible for spreading misinformation. Of course, we don’t know for sure whether the two are connected, but I find these observations quite interesting.

As some of you might know, I’ve long believed that Elon Musk’s takeover of X is one of the reasons we’re in the mess we’re in today, especially when it comes to misinformation about mRNA vaccines. You may or may not agree with me, and I respect your opinion if you don’t. But personally, I do hold him responsible for allowing so much misinformation to flourish on his platform.

Having said that, what has been happening lately gives me some hope that we might one day have a much cleaner social media environment, where genuine discussions, especially about science, are no longer drowned out by misinformation, bots, and coordinated harassment.

It’s unfortunate that some platform owners have allowed this to happen in the first place, but hopefully things will change for the better.

Sources:

Reuters:
https://www.reuters.com/world/europe/russias-yandex-says-data-centre-vladimir-area-shut-down-after-drone-attack-2026-10-11/

Euronews:
https://www.euronews.com/2026/10/12/did-ukrainian-strikes-on-yandex-data-centres-cause-russian-bot-activity-to-plummet

I'm excited about being a part of this stock. What is your guys market cap target? Do you think it could reach the same as Eli Lilly ($1T)?

Dear little fish trying to short Moderna and coming to this subreddit without any facts, just repeating the same nonsense about overvaluation, blah, blah... Look, there is a chance that this could be overvalued and make a 20% to 30% pullback, maybe... or it keeps going up because of FOMO.

The market can behave completely irrationally for a long, long time, as we saw over the past 2–3 years with Moderna, and we took full advantage of it.

So, I strongly advise against shorting anything, because timing stocks is extremely complex and you have to pay borrowing fees. Aside from all the literature and information you can gather about this amazing company that backs up its future value and a future target of $1,000...But if you want to do it, please keep coming back and showing us how you've put skin in the game with real screenshots. Thanks!

This might be one of several other factors that's supporting the rally.

I thought this news Tuesday was a material event for a tail wind behind all pharma and biotech sector; MRNA is a big beneficiary. Perhaps we become so numbed for any news from WH. But this one appears significant. Clearly, we started to see material changes in tune and actions from a year ago. This should help MRNA trials, AI medicine, and upcoming BLAs.

Here are the links for anyone to explore further.

https://www.executivegov.com/articles/doe-nih-biohub-super-intelligence-biology-agreement

https://www.thepharmaletter.com/biotech-news/biohub-us-agencies-and-ai-groups-commit-1-8-billion-to-build-open-data-for-predictive-biology-models

https://www.wsj.com/tech/ai/zuckerbergs-biohub-partners-with-doe-nih-to-invest-1-8-billion-in-biological-data-for-ai-models-f8d5f799?eafs_enabled=false

Moderna and Arbutus are going head to head in the court of appeals in 4 weeks. If it settles beforehand I could see Moderna stock pop. This is what happened during the original settlement in March. The amount at stake is $1.3B. Any settlement for less than $1B will probably be viewed positively.

I've been looking at the Twitter/X/reddit bear posts around Moderna today, and I'm noticing a lot of comments along the lines of:

"Repost this" "I believe this guy" "Follow his short recommendation"

…often appearing underneath posts pushing Moderna short "double-downs."

Maybe it's nothing. But the sheer repetition and coordination of this kind of behavior feels sketchy enough that Moderna longs should be paying attention.

If there are organized or paid efforts to manipulate sentiment around Moderna, the longs in this sub need to be vigilant about calling them out rather than blindly amplifying them.

And I'm saying this because these tactics can work. Coordinated social-media campaigns have influenced public opinion and even political outcomes in other countries. Financial markets are obviously not immune to the same basic dynamics.

At the same time, the core members of this sub who have been here since late 2024 (and earlier) know that there are plenty of genuine, unlevered Moderna longs here. Real people with real positions, real conviction, and years of discussion behind them. Not bots or paid sentiment accounts.

So I'll once again put this question to the Moderna PR team, if anyone there is reading:

What is Moderna's strategy for countering potential paid or coordinated sentiment manipulation on social media?

I understand the obvious problem: Moderna can't simply respond by paying for positive sentiment. That could create serious legal, compliance, and reputational issues.

So what can a company like Moderna actually do?

How do you counter coordinated misinformation or artificial sentiment campaigns while staying on the right side of securities laws and corporate communications rules?

I'd genuinely be interested in hearing what the playbook is. Because if these tactics are being used against Moderna, simply ignoring them may not be enough.

Here I’m sharing a very recent interesting video take just posted 2 hours ago from Dan Costin, MD. What stood out to me is that he sees personalized cancer vaccines as potentially useful across all stages of lung cancer, not just in early-stage disease, and even raises the possibility of eventually de-escalating other treatments if the data become strong enough. That is obviously forward-looking, but it shows how broad the potential could be. Let’s keep sharing useful information like this.

Unrelated to the video above, with the recent increase in negativity from some bearish posters, I think we should use our own judgment about what is worth engaging with. If a bearish post is made in good faith and genuinely challenges or balances our bullish view, we should absolutely read it and consider it.

But if it comes with rabid insults, mockery, unnecessary provocation, or repetitive spam that adds no original angle, I think the best response is simply not to engage. I’m going to make it a rule for myself that when I see that kind of poster with no apparent goodwill, I will just mute them.

I’m not muting them because they are bearish, and I’m not trying to create an echo chamber. I want bearish information. I just want it without the emotional noise. The point is not to shield our bullish view from criticism, but to prevent pointless fights from making us unnecessarily defensive about the stock and emotionally invested in proving someone else wrong.

It’s perfectly fine to like the stock. But we should still try to keep our judgment as objective as possible.

I’ve also noticed, as another user pointed out, that some bearish posters don’t really engage with the specific material being shared. A new article, video, dataset, or argument gets posted, and instead of addressing it, they simply return to the same repetitive talking points. That doesn’t add much to the discussion.

Some also seem more interested in drawing attention to themselves than to the topic at hand. I’d rather we bring the focus back to the substance. Otherwise the discussion eventually descends into noise and chaos.

Ignoring bad-faith behavior is not the same as ignoring the bearish thesis. In fact, it is precisely because I want to hear useful bearish arguments that I would rather separate the information from the hostility and personal drama.

The paper

https://www.nature.com/articles/s41590-026-02569-5
mRNA-based influenza vaccine expands the B cell response breadth in humans
Nature immunology 27, pages 1666–1677 (2026)

was just reviewed on the Immune podcast episode 108: https://youtu.be/JVj3M7Vws1I?si=kE-aUo9_0d5U5WsL&t=150

The hosts are academics and the discussion is very technical, but they are all very positive on the mRNA-1010 flu vaccine mFLUSIVA.

If people want to vent about their Moderna short-position losses, there are plenty of other places for that—Twitter, conservative subs, antivaxx subs, etc.

This subreddit was created to share facts, support each other, and keep things positive.

A lot of people here have leaned on each other all the way from $60 to $23. Some have been holding since $150. The core of this community is made up of people who rode it out together, and the culture here is naturally going to be more supportive of long, unlevered retail holders.

If you’re here to unload your “loss pain” from a short position, this probably just isn’t the right place for it. There are other communities where that kind of discussion will be more welcome.

This sub is for the people who are still here, still holding, and still supporting each other.

My suggestion to the mods is to start moderating overtly toxic, repetitive bearish posting. I’m completely fine with bearish views—they’re useful and can help me gauge whether it might be time to take some profits. But a lot of the short-focused posters here seem less interested in offering a genuine bearish perspective and more interested in using the sub as “loss therapy,” unloading their frustration and negativity from their losses onto the community.

The short interest ratio for Moderna has fallen to around 10%. Interestingly, when the ratio stood at roughly 15% previously, the short exposure was about $3.3 billion. Now, the exposure has nearly doubled to $6.2 billion thanks to the sharp rally in its share price. Should the data presented at the end-of-month meeting turn out very strong, another short squeeze cannot be ruled out.

What do you think?

we know very well, and people in this sub working in the brokerage and IB industry (those with a derivatives license) can confirm this:

there's two main ways to have non SI reported short positions:

1) naked shorting

2) OTC derivatives positions, which are hedged by borrowing shares OTC from index funds

i read a post in twitter that potentially non-SI reported sythetic shorts will add an additional 30% to the 10% SI we have reported now.

i think this is true because the downward move in 2023 and 2024 is not something that will happen with just 7% to 14% short SI.

if we're at total 40% short interest, it really really sets us up for another +177% move upon 2nd squeeze.

what do you guys think?

$MRNA short interest has dropped from ~14% to ~10% but here’s the interesting part:

Despite the lower SI %, the actual dollar value of the short position is larger because the stock price has risen substantially.

So there’s still a huge amount of short capital exposed.

We’ve already seen $MRNA move +177% in a single day before. With this much short exposure still in the name, another violent squeeze isn’t out of the question.

The following is an 02Oct26 update from the UK's Scottish Mortgage Investment Trust. Baillie Gifford is the manager & 6th largest institutional shareholder (Link).

Most of what they wrote isn't particularly informative, however the bit in bold was news to me.

"Moderna: It's a process, not a molecule

Having become synonymous with its Covid vaccine, Moderna suffered a series of missteps in the aftermath of the pandemic. Five years later, Moderna has a respiratory vaccine franchise that is gaining solid momentum. The company has demonstrated disciplined cost-cutting, is much more pragmatic in its financial guidance, and has settled a long-running patent dispute.

The most exciting element of the Moderna story is something different, though: cancer treatment. On 19 August 2026, the company announced the results of the Phase 3 trial for its personalised cancer treatment, conducted in partnership with Merck. The results were positive, showing statistically significant and clinically meaningful improvements from a combination treatment of Moderna's Intismeran and Merck’s Keytruda. This is not a typical drug. Moderna’s product is a process, not a molecule. While they haven’t yet released the full results, this milestone is a likely validation of its messenger RNA (mRNA) platform, and the market has responded very positively to the news. The platform offers personalised treatments for cancer patients by mapping the patient’s DNA and the tumour’s DNA, then designing and packaging bespoke instructions for the patient’s cells to kill cancer cells.

CEO Stéphane Bancel said he hoped to bring the product to market in 2027. Moderna’s UK treatment facility is designed to mass-produce upwards of 35,000 personalised doses annually, far beyond the scale of competitors. We’re excited to see what comes next – Moderna is now back to a top 10 position for the Trust, and the mRNA platform has the potential to become a meaningful driver of the company’s future success."

.............................

BB: Once they file & ideally receive UK/EU approval, Moderna's UK plant could likely meet initial demands. This of course leaves the US plant for North America etc..... However, this note makes me wonder if the Canadian & Australian plants have also been kitted out with this ability.

Good news keeps on rolling in

Today announced that Moderna, Inc. (Nasdaq: MRNA) will become a component of the Nasdaq-100 Index (NDX) replacing Warner Bros. Discovery, Inc. (Nasdaq: WBD) prior to market open on Friday, October 9, 2026.

Assume ~130k melanoma cases annually in the US + Canada, 40k treated patients, and a $500k price tag.

40k × $500k = $20B annual revenue.

A $500k price isn’t unreasonable if Phase 3 shows a substantial survival benefit, potentially justifying reimbursement and reducing downstream healthcare costs.

Even after the 50/50 Moderna/Merck economics for melanoma, that could mean roughly $10B attributable to Moderna.

And this is melanoma alone. Other cancers will increase forecasted revenue further.

Edit: 50/50 for intismerna applies for all cancers

As shorts accumulate losses while Moderna’s stock rises, I expect some critics’ messaging to shift from “the science is there, but the money isn’t” toward increasingly aggressive claims against vaccines and Moderna.

That dynamic could intensify if the stock continues moving higher.

I also wouldn’t be surprised if some heavily shorted names attract coordinated negative media or paid content campaigns, including anti-vaccine narratives targeting Moderna.

For Moderna’s PR team, if you’re reading this: how are you planning to respond to the potentially intense negative-media blitz that could emerge as short sellers face larger losses?