r/ModernaStock

I’ve been holding since 2021 at $185 a share, considering breaking even or riding it higher. I don’t think it’s unlikely we see $300 in the next few years.

Neutral rating remains, but PT raised to $120.

MRNA disclosed highly anticipated data from the Phase 3 INTerpath-001 study evaluating MRK-partnered individualized neoantigen therapy intismeran in combination with Keytruda in Stage II-IV adjuvant melanoma (n= 1,137) and we spoke with management. At a pre-specified interim analysis, the combination demonstrated statistically significant and clinically meaningful improvements in recurrence free survival (primary endpoint) and distant metastasis-free survival (key secondary) versus Keytruda and per protocol, the study will continue to evaluate other secondary endpoints, including overall survival. Importantly, intismeran's safety profile is benign with no new signals observed. While specific data was not provided, our prior analysis suggests a hazard ratio in the low-to-mid 0.70 range would support statistical significance, noting management has described the bar at the interim as high, and we expect more fulsome data at an upcoming international medical meeting (potentially the European Society for Medical Oncology, October 23-27, which we are attending). In our view, success in melanoma was priced in, with MRNA shares trading +100% now reflecting readthrough to other solid tumor indications (per nine ongoing intismeran studies, with Phase 2 data in renal cell carcinoma (RCC) in 2026/early-27 followed by muscle invasive bladder cancer and Phase 3 non-small cell lung cancer (NSCLC) data in 2027, where success in RCC would suggest likely efficacy in indications where Keytruda is effective). MRNA and MRK intend to discuss the data with regulators to potentially file for approval - we model for global peak sales of $4.3bn in melanoma, and $6.6bn in NSCLC, pre-adjustment for 50/50 economics with MRK. Overall, this data is the initial unlock for MRNA's cancer vertical, and the first positive pivotal data for MRNA outside of the respiratory vaccine franchise.

Phase 3 Intismeran study in adjuvant melanoma met the primary and a key secondary endpoint at interim
Fully enrolled as of September 2024, INTerpath-001 is a randomized, double-blind, placebo- and active comparator-controlled study assessing the safety and efficacy of intismeran plus Keytruda (versus placebo plus Keytruda) in preventing disease recurrence in patients (n=1,089) with resected melanoma who are at a high risk of recurrence. Today, MRNA announced positive topline results, noting the study met the primary endpoint of recurrence-free survival (RFS) and key secondary endpoint of distant metastatis-free survival (DMFS) at an interim analysis. On safety, the profile was consistent with that observed in prior studies of the combination, with no new safety signals observed. MRNA and partner MRK (covered by Asad Haider) plan to present the data at an upcoming international medical meeting (potentially at the European Society for Medical Oncology conference, October 23-27), and will engage with regulators on filing submissions for intismeran in combination with Keytruda.
Recall, the Phase 3 study design is consistent with the prior Ph2b trial, where patients in INTerpath-001 are randomized 2:1 to receive treatment with either intismeran + Keytruda (the combination treatment arm) or placebo + Keytruda (the control treatment arm), where intismeran is administered for up to 9 doses (Q3W) and Keytruda is administered until the earlier of 1) roughly one year of treatment, and 2) patients experience either disease recurrence or unacceptable toxicity. As in the Ph2b trial, the Ph3's primary endpoint is RFS, with distant metastasis-free survival (DMFS) and overall survival (OS) evaluated as secondary endpoints (though we note the latter, OS, was an exploratory endpoint rather than secondary in the Ph2b). Similarly, patient baseline characteristics in the Ph3 trial will include a diagnosis of resectable, cutaneous melanoma, complete surgical resection within 13 weeks prior to receipt of the first Keytruda dose, and patients' being disease free at study entry, all as in the Ph2b trial. Beyond melanoma, MRNA is evaluating intismeran across multiple tumor types and stages of disease, including non-small cell lung cancer (NSCLC), bladder cancer (data likely in 2027) and renal cell carcinoma (RCC; data potentially in 2026 or 2027). Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC.
We spoke with management, who noted that the study met the primary RFS and secondary DMFS endpoints, and that per the protocol, the study will continue in order to evaluate other key secondary endpoints, including overall survival (OS). MRNA additionally noted the higher statistical bar for an interim analysis. On readthrough to additional indications, MRNA expressed confidence per the translational data in melanoma presented earlier this year, noting the intismeran mechanism appears synergistic with Keytruda. In colder tumors, MRNA is taking a taking signal seeking (Phase 1) approach, including in pancreatic and gastric tumors - per management, data in these indications could be available in 2026/27.
In our view, the positive topline Phase 3 INTerpath-001 result is encouraging, and is the initial unlock for MRNA's cancer vertical. We next look to intismeran data in RCC, which is considered a colder tumor vs. melanoma - if intismeran can show benefit in RCC, then efficacy in additional indications where Keytruda has shown benefit is likely.

Model Changes: We 1) Increase our PoS for intismeran in melanoma to 100% (from 90% prior), given we now think approval is likely based on this morning's update. We also increase our peak sales in melanoma to $4.3bn from $2.8bn prior, given the success at the interim analysis supports a stronger clinical profile than our base assumption; 2) Increase our PoS for intismeran in non-small cell lung cancer (NSCLC) to 85% (from 70% prior), given we see readthrough from the supportive data from the Phase 3 study in melanoma. We also increase our peak sales in NSCLC to $6.6bn from $4bn prior given the readthrough and increased confidence on the commercial opportunity given the profile that was achieved in the large Phase 3 in melanoma; and 3) Increase our TGR to 5% (from 4%), given we see increased platform value per readthrough to other solid tumor indications. Our 12-month PT moves to $120 (from $67 prior).
MRNA (Neutral): We are Neutral rated on MRNA. Our 12-month PT of $120 is based on a 100% DCF value (11% WACC and 5% TGR, from 4% prior given the unlocking of the platform in oncology). Upside risks: Commercial risk - higher than anticipated sales and penetration into patient populations, earlier-than-expected approval timelines from the oncology programs, other pipeline success and competitive failures. Downside risks: Failure to demonstrate clinical proof of concept across additional modalities or across additional oncology indications, IP risk, manufacturing difficulties and financing/dilution, failure to achieve the projected commercial profile, physician/payor pushback on use and coverage, approval of competitor drugs.

After being down 50% for nearly 3 years, I exited all my positions today with a modest 40% gain.

Not sure if the stock will continue to go up but a 150% gain in one day will surely see a correction in coming days.

Would like to know what everyone’s plan is for their investment.

To those of you that were following modernas trials for the cancer vaccine and had calls open for today's spike, where were you getting the news from?

Hello, I sold today at the opening after the good news. I have been holding this stock for about 6 months, and before this, there was a downtrend. Do you expect to see a short-term price correction so I can re-enter, or do you think there's no stopping this train?

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

Finally got updates of the trial… which is great! Anyone has any hypothesis of what comes next?

I say Merck announces the acquisition of Moderna. $100B-$150B purchase price. Anyone else think this?

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.

Merck & Co. and Moderna's personalized mRNA cancer vaccine has successfully lengthened recurrence-free survival (RFS) when paired with Keytruda for patients with high-risk skin cancer. The phase 3 win sets the partners up to potentially seek accelerated approval.

i asked my crystal ball for the compounded rate of return from 62 to 85 over 2 years. the reply was 17.9 percent.

i know alot of investors are impatient and want to cut open the golden goose because they believe theres only one more egg but i disagree. even if it takes 2 years a 17.9 percent return to 85 on your money isnt that bad.

within the next 2 years revenue and other catalysts will increase. i expect the 85 dollar stock price to be surpassed this year.

again, moderna is a wild stock not for weak hands. do your homework.

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

I think it makes some interesting points like regulators will have to change the current strain selection or the potential forecast for 27 and 28

https://www.pharmavoice.com/news/moderna-mrna-flu-vax-fda-nod-blockbuster-hurdles/827961/

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.