u/StockEnthuasiast

Please excuse the short post. But the information could be of interest to some of us here.

Respect to Stéphane Bancel for not trying to time the positive announcement ahead of his stock sales.

His sales were made under a prearranged 10b5-1 plan, so the timing of the sales themselves was largely predetermined. But that does not automatically determine when the company announces clinical results. If the positive Phase 3 result had been ready for disclosure earlier, announcing it before the sales could obviously have benefited him financially.

I am not claiming that Bancel personally controlled the announcement date, especially since this is a joint Moderna-Merck program. I am simply pointing out that the sequence, stock sales first, major positive announcement afterward, is hardly something that benefited him personally.

The media, of course, won’t give him any credit for this.

For context on what her appointment might mean for mRNA technology and vaccine, we have this article that she wrote in 2021 to provide us with a clue:

https://www.americafirstpolicy.com/issues/operation-warp-speed-innovating-vaccine-development-while-addressing-a-national-crisis

What I find really weird is that HHS keeps talking about Americans getting “too many shots” without even defining what “too many” is supposed to mean.

Too many what, exactly?

I can think of at least five possibilities. Some of them are fair concerns if that is actually what HHS means, although I am still not convinced these distinctions were even thought through when the policy was made.

1. Too many diseases being vaccinated against? Fair, if this is what HHS means. I can see an argument that some vaccines may not need to be routinely recommended for every child when the actual risk is very different across populations.
2. Too many injections? Also fair. Nobody enjoys getting injected, especially children. But then why break the combined MMR vaccine into three separate measles, mumps, and rubella shots? If the whole complaint is that people are getting too many shots, turning one shot into three is a pretty strange way to solve it.
3. Too many repeated doses or boosters? Fair concern, but this is where policy can only do so much. How often you need another dose depends on the virus, how quickly it changes, how long immunity lasts, and what the available vaccine technology can actually achieve. You cannot just write a policy saying, “fewer boosters,” and expect viral biology to cooperate. If NIH wants fewer repeated doses, then show me the R&D strategy for broader and longer-lasting immunity. I do not see how simply saying “traditional vaccines” answers that.
4. Too many antigens? Fair, if that is the concern. But then why move back toward whole-virus vaccines? If you are worried that the immune system is being exposed to too many unnecessary antigens, subunit vaccines are literally designed to avoid that problem. You pick the antigen you actually want. mRNA can do the same by encoding selected targets. Why go in the opposite direction and give the immune system the whole virus, including a bunch of components that may contribute little or nothing to the protection you actually want? The HHS now hates subunit vaccines and this is weird. I just do not see the logic here.
5. Too much vaccine material at once, with some unknown component supposedly causing autism or some other hidden problem? This one is different. I suspect this particular point is the definition of the "too many" that is driving the recent policy. It is completely fair to investigate whether particular ingredients, combinations, or dosing patterns have safety problems. But if the claim is that some unknown element in vaccines may be causing autism, identify the element, state the hypothesis, and produce evidence for it. Thimerosal was one of the major suspects historically, but it was removed from routine U.S. childhood vaccines years ago and the proposed autism link did not disappear. If HHS now suspects some other ingredient, interaction, or dosing pattern, then say what it is and test it. “Maybe there is something in there” is not a scientific hypothesis.

That is what is confusing about the whole thing. “Too many shots” keeps getting used as though it explains everything, but depending on what HHS actually means by it, some of the policies seem to point in completely opposite directions.

I can understand individual arguments here and there. What I still cannot see is the coherent vaccine strategy tying them together.

Disclaimer: I do not work for HHS. This is just my own take as an observer, not completely an unbiased one.

My speculative take on when we should expect the INTerpath-001 Phase 3 melanoma result.

Clues:

1. The trial itself:

https://clinicaltrials.gov/study/NCT05933577

2. Enrollment was already completed in 2024.

https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231.htm

3. Moderna said the first interim RFS analysis is expected in H2 2026.

On the July 31 call, Stephen Hoge sounded fairly confident that they would either get the data in H2 or at least have the interim analysis conducted in H2.

https://www.aol.com/articles/moderna-mrna-q2-2026-earnings-023256000.html

4. Moderna also said all patients have now passed the minimum 18-month follow-up requirement.

Again, this came from the July 31 call:

https://www.aol.com/articles/moderna-mrna-q2-2026-earnings-023256000.html

So at this point, the main thing controlling the timing should be the number of RFS events, not waiting for patients to mature.

5. UBS estimated October-November for the interim analysis.

https://www.investing.com/news/analyst-ratings/ubs-reiterates-moderna-stock-rating-on-melanoma-trial-catalyst-93CH-4710209

6. ESMO is October 23-27.

https://www.esmo.org/meeting-calendar/esmo-congress-2026

7. Interestingly, Barron's also recently mentioned that the Phase 3 interim could potentially be shared at ESMO in late October.

https://www.barrons.com/articles/biotech-stocks-to-buy-new-drugs-1b626dfc

8. Moderna Analyst Day is November 12.

https://www.sec.gov/Archives/edgar/data/1682852/000168285226000057/exhibit9912026q1pressrelea.htm

9. According to a post by u/SustainableStocks, quoting a Goldman Sachs note, Goldman estimates that around 310-320 RFS events may already have occurred, representing roughly 85% of the eventual event count.

https://www.reddit.com/r/ModernaStock/comments/1v5tjft/goldman_note_on_moderna_framing_the_upcoming/

I have not seen the original Goldman note myself.

10. If that estimate is even roughly correct, this would be an "interim" analysis in the statistical sense, but not necessarily an immature analysis. It could already contain most of the information needed for the final RFS analysis.

A few things that make me think August is less likely (less likely, not not likely):

• If the event threshold had already clearly been crossed and analysis was imminent, I would probably expect management to sound more definite than they did on July 31.
• Their wording still sounded like H2 guidance rather than "data very soon."

A few things that make October-November look more likely:

• It is consistent with the UBS estimate.
• It is consistent with management's H2 expectation.
• It gives more time for the remaining RFS events to accumulate if needed.
• ESMO gives them an obvious place to present detailed data if timing works.
• Analyst Day on November 12 is another obvious date sitting right after ESMO.

My conclusion:

• August: possible, but I think unlikely
• September: plausible
• October: Single best guess
• November: plausible
• December: possible, but I would start wondering whether RFS events accumulated slower than expected
• Q1 2027: still possible because this is event-driven, but IMO not the base case anymore

If I had to circle one period, I would pick:

late October to early November 2026

My rough probability:

• by end of September: ~25-30%
• by end of October: ~50-60%
• by November 12: ~70-75%
• by year-end: ~85%
• slips into 2027: ~15%

Obviously, those percentages are just my own estimates.

One other thing worth keeping in mind:

The 2026 result should be the first interim, not the final analysis.

But Moderna confirmed on the July 31 call that there are subsequent planned analyses if the first interim does not cross the early efficacy boundary.

https://www.aol.com/articles/moderna-mrna-q2-2026-earnings-023256000.html

So:

not stopping at the first interim ≠ Phase 3 failure

It could simply mean the effect was not strong enough to cross the stricter early-stopping boundary, and the trial continues to a later prespecified analysis.

Obviously, I would much rather see them win at the interim.

JMHO.

Moderna also said they intend to have this ready for the 2026/2027 season. That would still require an ACIP recommendation, but it is worth noting that the newly appointed CDC director is a genuinely qualified expert in this field, not a loon.

And just to be clear, that last part is my own take, not something from Moderna's blog, although the use of the word "loon" probably gives that away.

Good job and congrats guys.

Courtney Breen, Bernstein:

Thank you so much for taking the questions. Good morning. Just a couple of others.

First, I wanted to push a little further on the norovirus update. The question that I think many of us are asking is whether this is an enrollment issue, an efficacy issue, or an events issue. Perhaps you can help us understand the overall event rate relative to expectations and what might be driving it.

The second question is a little different. You have just announced a new chief commercial officer, and you obviously have a broadening business, particularly as we look at the pipeline and the number of readouts over the next couple of years.

Can you help us understand the top priorities for the chief commercial officer over the next six months? Longer term, what changes or evolution might be required in the commercial structure to support this evolving business?

Moderna:

Great. Thank you. I’ll take the first question and then turn it over to Stéphane to handle the second.

On the first question regarding norovirus, I’m limited in what I can say because the trial remains blinded. But suffice it to say, we are going forward with another season this year.

We have been able to enroll the trial cohorts, which I think was your question, but the epidemiology of the primary-endpoint cases has been a little slower. As we previously discussed, some of that during the first season of the trial was the result of a unique outbreak involving a different set of norovirus strains that were not contributing to the primary endpoint. Cases therefore accumulated a little more slowly that season, and for that reason, we were slower to reach the interim analysis than we intended.

We ultimately did power the study for a final analysis with the full number of cases. Now that we have gone through the second season and conducted the interim analysis, we are preparing for the third winter this year.

This has happened with other vaccines in the past. If you think about flu vaccines, they often require multiseason studies to recruit sufficient cases. That ultimately appears to have happened to us here.

For that reason, we are preparing to begin accruing new cases. It is unique in that we have to enroll new patients to obtain new cases because this is a seasonal vaccine for a seasonal infection. Ultimately, we expect mRNA-1403 to continue for one more season this winter.

Nothing we didn’t already know, but this might be an interesting youtube clip to watch while waiting for the earnings call on Friday.

3 Reasons the mRNA-4157 Readout Could Revalue Moderna (The Motley Fool youtube channel)

Huge news:

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-wins-eu-contract-rsv-vaccine-supply-2026-07-09/

You may or may not see a paywall depending on whether you have exhausted your free articles from Reuters.

I tried to post this a while ago, but Reddit’s filter rejected it, probably because I included the article link. I remember someone saying that Reddit’s filter can be harsh on Seeking Alpha links, so I am reposting it without the link to see if it gets through.

Overall, this is quite a good article by Robert J. Lake. I disagree with the writer’s comment that he had hoped for an entry at $50, but that does not change my overall impression that the article is good.

PS: Welcome back all to the $80s!!!

People can be broadly divided into two groups: those who strive to become individual persons, capable of independent judgment, and those who feel more comfortable as tribal followers, submitting themselves to authority. That tribal behavior may have evolutionary roots, but in modern society it becomes toxic when the need to belong turns into leader worship. So when we say we are fighting dictators, we are not really fighting one individual. We are fighting the entire ecosystem of followers, enablers, opportunists, and worshippers who sustain that dictator’s power.

• Richard Pazdur, an oncologist, is under consideration to return to the US Food and Drug Administration, people familiar with the matter said.
• He is being considered for a senior leadership role, according to the people, who spoke on condition of anonymity because the discussions are confidential.
• The FDA has been without a permanent leader since Marty Makary resigned as commissioner after a tumultuous tenure marked by conflicts with staff and drug companies.

Surprise, surprise. More grown-ups will be back in the room. The agency is healing.

A study on Covid vaccines that the Centers for Disease Control and Prevention’s acting director blocked from publication came out Tuesday in a different journal.

The findings show that Covid vaccines reduced the likelihood of severe illness by about half among adults last fall and winter. The study was originally scheduled to be released in March in the CDC’s flagship scientific publication, the Morbidity and Mortality Weekly Report (MMWR). Instead, it was published in JAMA Network Open, a highly regarded, peer-reviewed journal from the American Medical Association.

The paper: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2850668