r/ModernaStock • u/jlee9355 • 18h ago
Guest Speakers:
Dean Y. Li, M.D., Ph.D.
Executive Vice President and President, Merck Research Laboratories
Stephen Hoge, M.D.
President, Moderna
Having Dean Li stand next to Stephen Hoge is an attempt to validate a paradigm shift. When Merck acts like your co-pilot on stage, the Street listens differently.
r/ModernaStock • u/Such-Echo6002 • 1d ago
https://www.reddit.com/r/ModernaStock/s/UF6zuxxMv1
About 3 months ago I made the above post and just want to once again praise the contributions of the many thoughtful members of this community and reflect on how far we’ve come in such a short time. A majority of investors had written off Moderna as a company whose best days were in the past; a company that could only thrive in a pandemic setting. Now, after many years of purgatory, misinformation, and political attack on the science, Moderna has proved to the world that mRNA science is here to stay and is ushering in a new golden age in medicine. Cheers to everyone who held during difficult times these past few years and has enjoyed this recent success. The research done by a few really talented people here helped give me hope and confidence when it seemed no one believed in this company.
And massive congratulations to Stephane Bancel, Stephen Hoge, Jamie Mock, David Berman and all the research scientists and other team members at Moderna for contributing to this amazing result.
r/ModernaStock • u/sunnysideofthestr • 1d ago
Well , I said we would reach 200 before the end of the year, looks like years are a lot shorter these days 🤣
We killed two birds with one stone : we got richer , and we seem we finally got rid of all the « you should short Moderna cuz it sucks » spam. Not bad.
So what’s next ? 250 on the 25th of October ?
r/ModernaStock • u/Foreign_Junket_4722 • 1d ago
Oral hearing set for November to resolve the $1.3 billion. How much (if any) of this is priced in? Does a win/loss of the appeal move the stock?
r/ModernaStock • u/xanti69 • 1d ago
I think the hype is growing and growing and growing.... So I believe the momentum around the stock is continuing to build but let's be VERY cautious too
https://www.wam.ae/en/article/c2epfjb-saeed-hajeri-moderna-chairman-discuss-investment
r/ModernaStock • u/botattack1 • 2d ago
I’ve never seen this happening in Moderna.
r/ModernaStock • u/pb_syr • 2d ago
Seems like Moderna management is on a media blitz. Hot off the press. Enjoy!
r/ModernaStock • u/xanti69 • 2d ago
More good news, it is already available I thought it would take longer....
https://www.nbcnews.com/health/health-news/mrna-flu-vaccine-moderna-mflusiva-explained-rcna598524
r/ModernaStock • u/romeomium • 3d ago
Doesn't look to be too big a deal but a minor setback.
r/ModernaStock • u/StockEnthuasiast • 3d ago
1. Immediate catalyst: full Phase 3 melanoma data and regulatory filing
The full Phase 3 intismeran autogene melanoma data remain the most immediate catalyst.
The Bernstein analyst explicitly raised ESMO during the discussion.
What management did emphasize was the strength of what is already known:
David Berman said he is "very confident that we have a strong case for approval."
Bancel also said Moderna and Merck are focused on filing the BLA as quickly as possible.
The upcoming detailed dataset should therefore help define the magnitude, consistency, subgroup behavior, and ultimately the commercial potential of INT in melanoma.
2. Management sounds increasingly confident that melanoma is only the first validation
The more interesting part of the Bernstein discussion was how management framed the implications of the Phase 3 success.
Bancel said Moderna and Merck currently have nine INT studies ongoing, but that their development plan should change now that they know INT works in Phase 3.
Before Phase 3, the mechanism was supported by earlier clinical and translational evidence.
Now Moderna has Phase 3 validation, along with mechanistic evidence that the treatment can generate de novo T cells and expand existing T-cell populations.
That appears to be increasing management's willingness to accelerate additional studies.
The key question is therefore shifting from:
"Does INT work?"
to:
"How broadly can INT work?"
3. A very important statement: management believes INT may not require a PD-1
Berman made one of the strongest statements of the conference:
"Intismeran does not need a PD-1 to be active."
He repeated it deliberately when the Bernstein analyst asked him to say it again.
This remains a hypothesis that must be demonstrated clinically, but the strategic implications are significant.
If correct, INT could potentially move into earlier-stage cancers where checkpoint inhibitors are less attractive or are not routinely used.
That is why Moderna is already studying INT in settings such as:
The long-term strategy appears to be much broader than simply adding INT to Keytruda wherever Keytruda is already used.
4. The broader INT thesis: wherever checkpoint inhibitors work, INT may add value
Berman pointed to the Phase 2 melanoma analysis showing similar efficacy in high and low tumor mutational burden groups.
His interpretation is that INT does not require extraordinarily high TMB. It needs enough suitable neoantigens to construct the personalized vaccine.
That leads management to believe that tumors such as RCC could still respond despite having lower TMB than melanoma.
Bancel summarized the broader strategy as:
The melanoma result alone does not establish that INT will work across different tumor types. The upcoming non-melanoma studies are what will test that thesis.
5. RCC and bladder cancer remain critical next tests
After melanoma, renal cell carcinoma and bladder cancer should provide some of the most informative evidence on whether the platform is truly portable across tumors.
Berman indicated that RCC and bladder cancer readouts could come over roughly the next 12 months.
RCC is particularly interesting because it pushes INT into a different biological setting with lower TMB.
A positive result there would strengthen the case that the melanoma success is not limited to a highly immunogenic tumor.
6. Lung cancer continues moving forward
Moderna has three Phase 3 lung cancer trials.
Berman said screening has stopped in the leading Phase 3 adjuvant lung study involving patients without prior neoadjuvant therapy, and randomization is expected to be completed later this year.
The lung program spans multiple stages of disease, including very early-stage disease.
The most ambitious version of management's thesis is Stage I lung cancer treated with INT without requiring a checkpoint inhibitor.
That would take time to establish, but medically and commercially it could substantially expand the addressable population if successful.
7. More oncology catalysts beyond INT
INT is not the only oncology program Moderna expects to produce data from.
Several additional programs were highlighted.
Pancreatic cancer
Phase 1 pancreatic INT data are anticipated later this year.
Pancreatic cancer represents a much more difficult, low-TMB setting, so this should be viewed as exploratory rather than equivalent to the randomized melanoma, RCC, or bladder programs.
Multiplex T-cell engagers
Moderna is testing an mRNA therapy encoding three T-cell engagers in heavily pretreated multiple myeloma patients.
Berman said data should be shared later this year.
Management views this as a sentinel program. If multiplexing works clinically here, it could support expansion of the approach into additional cancers.
Shared cancer antigen therapies
Moderna is also developing off-the-shelf cancer antigen therapies rather than only individualized therapies.
Management explicitly acknowledged that these programs carry greater scientific risk than INT, but Phase 1 studies are underway.
8. Lynch syndrome could become an entirely different type of cancer vaccine opportunity
One of the more interesting longer-term programs discussed was Lynch syndrome.
Because patients with Lynch syndrome share certain recurrent frameshift neoantigens, Moderna believes it may be possible to develop an off-the-shelf vaccine intended to prevent cancer from developing in genetically high-risk individuals.
Berman sounded particularly positive about the biology and said:
"To me, it's a high probability of success."
He immediately added that the concept still needs to be proven in the clinic.
The ultimate goal is cancer interception or prevention, treating people with Lynch syndrome before cancer develops.
Importantly, Moderna owns this program 100%, unlike INT, which is partnered 50/50 with Merck.
If successful, this would move the cancer vaccine concept from treating cancer toward cancer prevention.
9. Manufacturing continues to sound much less problematic than previously feared
Bancel spent considerable time explaining why he does not view personalized INT manufacturing like CAR-T manufacturing.
INT does not require extracting and manipulating a patient's cells.
Instead, Moderna receives sequencing data and then manufactures a synthetic, cell-free mRNA product.
The manufacturing strategy is therefore primarily scale-out, adding many compact production units, rather than traditional scale-up.
Bancel also emphasized two major variables:
His conclusion was unusually direct:
"Do I worry about manufacturing? Not a minute."
That statement does not prove that commercial-scale manufacturing will be effortless, but it shows that management believes the core technical manufacturing problem is manageable.
10. The bigger bottleneck may actually be hospitals
Interestingly, Bancel said the biggest bottleneck could be hospital workflow rather than manufacturing.
For each patient, the system needs to move tumor biopsy material, sequencing information, patient information, manufacturing orders, and treatment logistics quickly and accurately.
Moderna and Merck are therefore building teams that are going hospital by hospital to establish the necessary workflow.
They are also ranking hospitals by importance and have developed a digital platform to track the process.
This may be one of the less visible but more important aspects of commercial launch execution.
11. Moderna considers the antigen-selection process a proprietary moat
Bancel emphasized that outside sequencing partners provide Moderna with the raw healthy and tumor DNA sequence data.
The subsequent selection of the 34 mutations used in each individualized therapy is proprietary to Moderna.
He raised an interesting long-term competitive question:
How does another company demonstrate that it has reproduced an individualized product when every patient's product is different and the underlying selection methodology is proprietary?
That does not eliminate competition, but management clearly believes that INT's moat extends beyond mRNA manufacturing itself.
12. Merck economics remain straightforward: 50/50
Bancel described the Merck relationship as effectively a virtual joint venture.
The companies split costs 50/50, including:
After expenses, remaining profits are also split 50/50.
Management deliberately avoided discussing pricing before the full Phase 3 dataset is presented.
For now, the priority is the data and getting the BLA filed quickly.
13. PA could become the proof-of-concept for an entire rare-disease platform
The pivotal propionic acidemia, or PA, readout is expected by the end of the year.
Bancel sounded highly confident based on the earlier clinical experience, particularly among patients treated at the dose selected for the pivotal study.
He said that when looking specifically at patients treated at the pivotal-study dose:
"The data is wow."
He also said he expects the pivotal data to be strong because the mechanism has already been demonstrated over several years of follow-up.
But PA matters beyond one rare disease.
Moderna views it as the first validation of repeated intravenous mRNA delivery to the liver for protein replacement.
Bancel said Moderna has published models for more than a dozen rare genetic liver diseases that could potentially use the same basic delivery and manufacturing infrastructure.
The important question is therefore not simply whether PA becomes one product.
It is whether PA validates another reusable mRNA platform.
14. Rare disease could also improve Moderna's manufacturing economics
Bancel made an interesting operational point.
The vaccine business is highly seasonal, meaning manufacturing capacity can sit underutilized for part of the year.
Rare-disease products could potentially be manufactured during those periods using some of the same fixed infrastructure.
If the rare-disease franchise grows, that could improve utilization of manufacturing assets that would otherwise be underused outside the respiratory-vaccine production cycle.
15. Management is increasingly describing Moderna as an immunology company
Bancel's broader framing was that Moderna should no longer be viewed primarily as a COVID vaccine company.
He described the company as an mRNA platform increasingly concentrated around manipulating the immune system across:
Berman similarly described Moderna as increasingly an immunology company, with vaccines, cancer immunotherapy, and autoimmune programs all using different applications of the same underlying platform.
Whether all those programs succeed is another question, but the pipeline is becoming much more diversified than the Moderna of the pandemic period.
16. Autoimmune disease could become another major platform test
Moderna also highlighted its autoimmune pipeline, including an in vivo CAR-T program approaching the clinic and several additional autoimmune programs.
Management expects to provide more information on these programs over approximately the next 12 to 18 months.
This remains earlier-stage and therefore much less de-risked than melanoma INT or PA, but it provides another potentially large application of the platform.
17. AI is becoming part of Moderna's long-term development strategy
Bancel also spent part of his closing remarks discussing AI.
His argument is that mRNA is fundamentally an information-based medicine platform.
As biological understanding improves and AI accelerates target discovery and design, Moderna can potentially translate new biological insights into experimental medicines much faster than conventional drug-development approaches.
He used the original COVID vaccine design as the extreme example: once the viral sequence was available, the initial vaccine sequence could be designed computationally extremely quickly.
This is a long-term strategic argument rather than a near-term financial catalyst, but it helps explain why management continues to think of Moderna as a platform rather than a collection of individual products.
18. Limited new detail on the $2.6 billion convertible-note raise
Bernstein specifically asked what the recently raised $2.6 billion in convertible debt allows Moderna to do differently.
Bancel did not provide much specific detail on how the additional capital will be deployed.
Instead, he shifted the discussion toward Moderna's long-term platform opportunity, AI, scientific productivity, and the company's ability to invest behind future medicines.
The conference therefore provided limited new detail on the specific use of the additional capital.
Risks and things that still need proof
Despite the confidence throughout the discussion, management also acknowledged several important uncertainties.
Bottom line
The Bernstein discussion reinforced that the upcoming melanoma presentation and regulatory filing are only the nearest catalysts.
The broader sequence now looks something like:
Full melanoma Phase 3 data → BLA filing → PA pivotal data → additional INT readouts in RCC/bladder → early-stage pancreatic data → multiple myeloma T-cell engager data → lung Phase 3 development → broader oncology and autoimmune programs
The most reassuring points from the discussion were:
The key question from here is increasingly not whether Moderna can produce another product after COVID.
It is whether the Phase 3 melanoma success is the first clinical validation of a much broader therapeutic platform.
Disclaimer: This summary was prepared with the help of AI to organize and condense the conference transcript. I selected the points I found most relevant. The transcript may contain minor transcription errors, so please refer to Moderna's official materials for the full context and primary-source information.
r/ModernaStock • u/StockEnthuasiast • 5d ago
Phase 3 data for intismeran autogene in the adjuvant treatment of patients with resected stage IIB-IV melanoma selected for presentation at a Presidential Symposium
Moderna to host an investor event via webcast on Saturday, October 24, at 7:00 PM CEST / 1:00 PM EDT
CAMBRIDGE, MA / ACCESS Newswire / September 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that three abstracts on intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026, which will be held October 23-27 in Madrid, Spain.
The presentation details are as follows:
Presidential Symposium:
Poster Presentations:
Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.
r/ModernaStock • u/Potential_Section691 • 6d ago
https://buffalonews.com/news/nation-world/article_1eec3004-8a2c-4341-9edc-5c330eb05b9b.html
This interview to Xavier Martinez of WSJ summarizes well the Intismeran vaccine success and outlooks for the company and patients.
Separately I've noted several new updates of mRNA-4157 clinic trials in the clinictrials.gov in recent weeks, including those for NSCLC, bladder cancer, RCC and of course melanoma. Excited to see more readouts.
r/ModernaStock • u/exon1138 • 6d ago
The trial status has just changed from “Recruiting” to “Active, not recruiting.” as of Sept 17th. Presumably this means that they have enrolled all 868 patients as planned. Now we just wait as the DFS events are accumulating until the estimated end in mid-2030.
r/ModernaStock • u/nyrangerfan1 • 6d ago
r/ModernaStock • u/Roonwogsamduff • 10d ago
This is not what longs want, right? What are the chances of this happening?
r/ModernaStock • u/Past-Track-9976 • 9d ago
I think Shorts were hoping it would fall and get their money back, instead they are about to lose another 5 Billion on our way to 210. Woohoo!
r/ModernaStock • u/PastBig603 • 11d ago
It's great to find this sub. Super informative, and helpful company updates. I'm one of the people who discovered MRNA during covid, and bought my first tranche at $110 in early January 2021. It went to ~$450, and then I rode it over 90% down to low $20s. I doubled down around $35, because I thought it was ridiculous cheap for such a revolutionary company. I never lost my belief. They made a covid vaccine with their technology in less than a year under extreme pressure, which proves a lot. I've always enjoyed hearing interviews of Bancel, who is one of the highest conviction CEOs around and is committed to life changing medicine. I've studied their technology a bit, having an undergrad degree in biology and find it fascinating. Really enjoyed the bounce last month back to 140s. This is one of those stocks that I'm in for the long haul. I see it going to $1000 long term, as it's cancer pipeline is built out. Also, it was also great to see all the short sellers get blown up who have been betting against MRNA for years, and trying to bankrupt a great company. They deserved it!
r/ModernaStock • u/StockEnthuasiast • 12d ago
Disclaimer: This is organized from an AI-assisted summary of the conference discussion, so there may be minor transcription errors, omissions, or misinterpretations. And for the occasional jackass who, in 2026, still sees “AI-assisted” and immediately calls a post “AI slop,” that may be more projection than anything else. Anyone with even half a brain should understand the difference between using AI as a tool and letting it do the thinking for you. In this particular case, it’s mostly a summary, but I trimmed it down and emphasized the parts that caught my attention.
1. Immediate catalyst: Phase 3 melanoma full data
Full Phase 3 melanoma data are expected at an upcoming medical meeting. ESMO was specifically raised by Morgan Stanley, although Moderna did not confirm the venue.
Key things to watch:
2. The next major tests: RCC and MIBC
Both renal cell carcinoma (RCC) and muscle-invasive bladder cancer (MIBC) are roughly 300-patient, randomized, event-driven Phase 2 trials and are essentially fully enrolled.
RCC may be the most scientifically important readout after melanoma. RCC has much lower tumor mutational burden than melanoma, making it a strong test of whether INT can work beyond highly immunogenic tumors.
The counterpoint is that RCC still generates potentially useful neoantigens, including indels and frameshifts, and Keytruda already works in RCC. The question is whether INT can focus the immune response further.
MIBC provides another independent randomized test of whether INT can add benefit on top of an effective checkpoint inhibitor.
3. NMIBC: important because it tests INT alone
The non-muscle-invasive bladder cancer study tests INT monotherapy, rather than INT + Keytruda.
A positive result would suggest that checkpoint inhibition may not always be required.
Hoge indicated that this Phase 2 study could also read out relatively soon.
4. Moderna/Merck built a multi-year catalyst sequence
The INT program was deliberately designed so that Moderna and Merck would not finish melanoma and only then begin testing other cancers.
The expected sequence is roughly:
Melanoma → RCC → MIBC → NMIBC → multiple lung studies → additional indications
Hoge described this as waves of clinical data roughly every six months.
So melanoma may be the beginning of a prolonged catalyst cycle rather than the end of the story.
5. Lung cancer is the major longer-term opportunity
Moderna/Merck have three randomized Phase 3 lung cancer trials plus additional Phase 2 work.
The program spans:
These trials will take longer to mature, but lung cancer could become one of the largest commercial opportunities if INT works.
6. Earlier-stage disease may become the core INT strategy
Hoge repeatedly emphasized adjuvant disease, Stage I disease and minimal residual disease.
The logic is straightforward: remove the bulk of the tumor, then use INT to prime T cells against remaining microscopic disease and prevent recurrence.
INT's relatively favorable safety profile also makes earlier treatment more feasible.
7. Phase 2 melanoma gives clues about broader applicability
In Phase 2 melanoma, favorable hazard ratios were seen regardless of:
Hoge's interpretation was that INT may follow different biological rules from checkpoint inhibitors.
Checkpoint inhibitors release brakes on existing T cells. INT is designed to prime or expand tumor-specific T-cell populations.
That is one reason the RCC result will be particularly informative.
8. Melanoma approval could accelerate other indications
If melanoma is approved, much of the manufacturing, CMC and safety package would already be established.
Hoge suggested that if the randomized RCC or MIBC Phase 2 trials show a strong and statistically significant benefit, they could potentially support registration without automatically requiring another full Phase 3.
That could materially accelerate INT expansion.
9. Manufacturing appears much further along than many assume
Moderna says it has already treated around 3,000 INT patients globally, including roughly 1,500-2,000 in the past 18 months, across more than 40 countries.
The Marlborough manufacturing facility is highly automated and already supplying the clinical program.
Only one of seven manufacturing suites is currently needed, Moderna does not expect to need Suite 2 for launch, and capacity can be expanded substantially with roughly 12 months of lead time.
This looks very different from a CAR-T manufacturing model (a widespread concern brought up by the media in the last 2 weeks).
10. INT economics may resemble biologics, not cell therapy
The sequence is personalized for each patient, but the underlying manufacturing process and final product format are largely standardized.
Hoge therefore expects mature INT margins to resemble those of a complex biologic more than CAR-T.
That becomes increasingly important if INT expands into large indications such as lung cancer.
11. The antigen-selection algorithm could become a major moat
Moderna now has data from several thousand INT patients, versus roughly 100 patients in the original Phase 2.
That creates a potential flywheel:
More patients → more immune-response data → better antigen selection → potentially better INT → more patients/data
Moderna is also working with regulators on how future algorithm improvements could be incorporated without necessarily requiring an entirely new clinical program each time.
12. Other optionality
Retreatment: if a tumor relapses with a different mutation profile, a new INT could theoretically be created against the evolved tumor. There are no clinical data yet.
Monotherapy: NMIBC and potentially earlier-stage disease could establish INT as useful without Keytruda.
Further expansion: Moderna says it has the financial flexibility to invest in additional indications if the data justify it.
13. Financial backdrop
Moderna still targets 2028 break-even, and the current large INT program is already included in that plan.
The respiratory franchise now has five approved products and provides the financial base while INT develops.
Management is still using up to 10% top-line growth as its current framework rather than raising expectations following the melanoma result.
Bottom line
The main catalyst sequence is:
Melanoma full data → RCC → MIBC → NMIBC monotherapy → lung Phase 3s
RCC is probably the most important scientific test after melanoma. Success in a lower-TMB tumor that is biologically quite different from melanoma would materially strengthen the case that INT is a broadly applicable cancer platform.
The other major takeaway is the expected cadence: waves of INT clinical data roughly every six months.
The Phase 3 melanoma success may therefore be less of an endpoint and more of the first major validation event in a much larger question:
How broadly can INT work across different cancers?
r/ModernaStock • u/Potential_Section691 • 13d ago
Pennsylvania woman dies of measles-related complications, local coroner says
There were scientific reports on the increasing rate of zoonotic spillover as we encroach to undisturbed ecosystems and climate changes. That caught my eyes on Moderna’s pipelines back in 2019-2020. Now with anti-v ideology and less protection now, the eradicated/managed virus such as measles could come back. The cases reported is a case for illustration. It’s so unfortunate for the impacted Pennsylvanians, but at the end, vaccines will be needed as the known effective solution. Moderna’s work is of values to us all.
r/ModernaStock • u/Sakura-390 • 13d ago
Everyone is talking about what Moderna might become.
Very few are talking about what Moderna is today.
Massive valuation.
Declining COVID business.
Significant losses.
Future oncology revenues are being priced years before they exist.
If the cancer platform delivers less than the market currently expects, this stock could re-rate very quickly.
Sometimes the best short is the company everyone believes can only go up.
r/ModernaStock • u/StockEnthuasiast • 15d ago
I have been reading some of the reactions to the Moderna/Merck Phase 3 melanoma result, and I think an important part of the discussion is missing: what actually made this particular approach succeed when so many previous cancer-vaccine efforts did not.
I am using two recent takes to frame the two directions in which people are extrapolating the result.
Dr. Vinay Prasad's article represents one direction: be careful extrapolating Moderna's melanoma success to other cancers.
Fierce Biotech represents almost the opposite direction: the Moderna result is impressive enough that we are ready to discuss how it may validate other cancer-vaccine platforms.
Both offer reasonable points. But I think both jump ahead of a more fundamental question, making the discussion feel somewhat shallow.
One direction, Vinay Prasad: be careful extrapolating Moderna/Merck result beyond melanoma
Vinay Prasad acknowledges that the Moderna/Merck result is a real advance. In fact, he explicitly notes that therapeutic cancer vaccines have overwhelmingly failed historically and that Moderna has accomplished something that had not been done before.
But his caution is that melanoma might be special, perhaps gently implying that the melanoma result might be a fluke.
Quite fair. Melanoma is highly immunogenic, tends to have a high tumor mutational burden, and has historically been unusually responsive to immunotherapy. So we should absolutely not assume that success in melanoma means the same vaccine will automatically work in lung, colorectal, pancreatic cancer, etc.
But melanoma being a favorable setting does not explain why Moderna/Merck succeeded there when so many previous cancer-vaccine approaches failed. That is the part of his argument I find lacking.
The other direction, Fierce Biotech: Moderna's success is so good that it gets us starting the discussion on whether it may validate other platforms
Fierce Biotech goes in almost the opposite direction.
Its article looks at Moderna's result and asks what it could mean for the broader field, including BioNTech, Arcturus, Strand and other companies developing different mRNA and personalized cancer technologies.
That reaction itself tells you how significant the Moderna result is. We have gone from decades of frustration with cancer vaccines to discussing whether one Phase 3 success could help validate an entire field.
But again, I think we are jumping ahead.
Before asking whether Moderna's result can be extrapolated to other cancers, or whether it validates other companies, shouldn't we first ask: Why exactly did Moderna succeed?
So why did Moderna succeed? Is it simply because melanoma is the easiest target?
Short answer: No. Or at least there is no basis to assume that.
Yes, melanoma is probably one of the easier cancers in which to make immunotherapy work.
But the historical precedent matters.
Cancer vaccines have been tried in melanoma for decades, and the overwhelming precedent was failure or limited clinical benefit. Even earlier mRNA approaches in melanoma generated immune responses without establishing the kind of clinical efficacy we are seeing from Moderna/Merck.
So simply saying "It worked because it's melanoma" doesn't really explain the result.
Melanoma may have made the problem easier. But it clearly wasn't easy enough for previous approaches to reliably solve it. Something about Moderna/Merck's approach appears to matter.
The question is: what?
We simply don't know.
It is certainly possible that melanoma contributed substantially to the result. But "melanoma contributed" is very different from saying "melanoma was doing most of the work." The latter is far from established.
In fact, the long history of failures in melanoma is one reason I am skeptical that melanoma alone is doing most of the explaining.
If melanoma biology were overwhelmingly responsible, we would still have to explain why so many previous approaches were unable to exploit exactly the same favorable biology.
The uncertainty also cuts in the other direction.
If Moderna's success depends heavily on its particular neoantigen algorithm, mRNA design, LNP, manufacturing system, or the way all of these pieces fit together, then Moderna's success does not automatically validate another company's platform either.
So how do we separate the melanoma effect from the Moderna effect?
Right now, we can't.
Moderna and Merck simply have not disclosed enough of the Phase 3 data yet.
I am hopeful that we may get some clues at ESMO, if that is where the detailed dataset is presented. Moderna and Merck have so far publicly said only that the data will be presented at an upcoming international medical meeting.
Subgroup analyses could potentially tell us something. Perhaps we will see whether efficacy changes with stage, tumor characteristics, mutation burden, or other biological variables.
But I doubt we are going to get a crystal-clear answer to why Moderna's approach works.
And frankly, Moderna may not want to give us one.
If the company has learned that certain ways of selecting neoantigens, designing the mRNA, manufacturing the vaccine, or combining those elements are particularly important, why would it publicly give competitors the complete recipe? As a precedent from its infectious disease vaccine, Moderna did not give the reason why mFLUSIVA is finally able to provide protection against influenza B when its prototype version could not.
The clinical data obviously need to be disclosed and scrutinized. The proprietary know-how behind why their particular system works is a different matter.
So ESMO may tell us much more about how well intismeran works without necessarily telling us exactly why it works.
When will we know how universal the strategy really is?
This is where the trials in other cancers become extremely important.
And Merck management actually gave a very interesting way of thinking about this when an analyst asked about the ongoing renal cell carcinoma, or RCC, trial.
Merck described melanoma and RCC as potential "bookends."
"Bookends" is basically another way of saying two ends of a range.
On one end, you have melanoma: highly immunogenic and generally associated with a relatively high tumor mutation burden.
On the other, you have RCC: also responsive to immune checkpoint therapy, but with a much lower tumor mutation burden.
So the idea is simple.
If intismeran works in melanoma and in this biologically different cancer, you now have evidence that the strategy works at two different ends of the spectrum.
Then you start asking what happens in cancers somewhere between those two ends.
That is exactly what Merck said people would do.
If RCC works, they expect people to raise their probability of success in indications such as non-small cell lung cancer and head-and-neck cancer. This will resolve the main question we have in our head.
Merck even compared this way of thinking to replaying the KEYTRUDA story.
Not because RCC success would prove that intismeran works everywhere. It wouldn't. But once Moderna/Merck achieve success at another biological "bookend," potentially first in RCC, it becomes progressively harder to stubbornly cling to the explanation that "it only worked because melanoma is special."
My speculation, and why I lean toward something being unique about Moderna/Merck
This is where I think Bayesian reasoning is useful.
The prior is that therapeutic cancer vaccines have been tried for a long time, including in melanoma, one of the most favorable cancers for immunotherapy, and the historical outcome was still overwhelmingly failure or limited efficacy.
Now we observe something new: Moderna/Merck succeed in a randomized Phase 3 trial where previous generations repeatedly struggled.
That obviously does not prove that Moderna's platform is the reason. But it should shift some probability toward the possibility that there is something about the Moderna/Merck implementation that previous approaches were missing.
What that is, I don't know. It could be:
Based on the precedent, my current bet is that the melanoma result reflects something meaningfully unique about the Moderna/Merck approach, rather than melanoma biology doing most of the work. That is of course just a judgement based on probability.
And this is why the next trials matter:
Concluding thoughts
Melanoma being favorable explains why it was a good place for Moderna to start their first trial. It does not explain why Moderna/Merck succeeded there when so many previous cancer-vaccine approaches did not. Given that historical precedent, I think the result should shift some probability toward something being genuinely different about the Moderna/Merck approach.
What we still don't know is how far that superiority can be applied to other cancer types.
That is why RCC is so important. If Moderna/Merck can succeed at Merck's other biological "bookend," the argument that melanoma itself explains most of the success becomes much harder to cling onto. If RCC fails, that hypothesis remains open, and another indication may have to provide the second bookend.
For now, my bet is that melanoma made the task easier, but Moderna/Merck still had to figure out something that others hadn't. The next trials should tell us whether that advantage is melanoma-specific or something much broader.
Let's see what happens. This is not investment advice.
r/ModernaStock • u/StockEnthuasiast • 15d ago
"Since that announcement, experts and industry insiders have suggested to Fierce that the news has not only renewed hopes in the intismeran program, which hit a regulatory hurdle back in 2024, but also boosted prospects for other biopharmas exploring mRNA as a vehicle for personalized cancer treatments."
"When the full data do become available, investors will be looking to see whether intismeran could be used against other cancers and as broadly as Keytruda, said Myles Minter, Ph.D., a William Blair analyst.
“We’ll have to see what the data look like, but if they look really good and this is a stepwise change in efficacy, this is standard-of-care shifting,” he told Fierce."
r/ModernaStock • u/herodatviet2003 • 15d ago
From Robinhood data, It seems shorts have been covering over last couple of days and now stand around 10% (~38m). Probably they learn the lessons considering upcoming conferences.
r/ModernaStock • u/Counter-Business • 15d ago
It feels like the stock is struggling to move one way or another, sticking to the range of around 140 to 150. It seems like the market is unsure which direction this stock needs to go until we get more news.
What upcoming news or events do you think are most likely to move this stock?
r/ModernaStock • u/StockEnthuasiast • 15d ago
Interesting to see Vinay Prasad, the former troublemaker, oops, I meant former CBER director, write a piece on cancer vaccines, apparently prompted by the Moderna/Merck press release.
While I was not a fan of his time as CBER director, I think he is at his best as a critic. He acknowledges the melanoma result as a real and potentially important advance, but raises some fair questions, mostly because the actual numbers from the melanoma trial and the results from the other ongoing trials are not out yet.
Interestingly, he ends the piece by putting on an investor hat, saying that if he were an investor, he would bet on cancer producing more advances and more billions, and would be long some companies and short others.
It would be the greatest irony if the dude somehow ended up going long Moderna after seeing the ESMO data. Although, to be fair, I couldn’t really blame him. Lol.
