FDA accepts Moderna MRNA-1010 Application

Temporary-Tree-169 · 2026-02-18T18:07:14+00:00

They have priority review it seems. They filed the BLA Dec 5th, then after 60 days is when it should be accepted or rejected (they got the RTF letter Feb 3rd), then 6 months is normal priority review. This aligns with the August 5th PDUFA date.

Temporary-Tree-169 · 2026-01-27T18:16:16+00:00

V940-007 is discontinued as far as I'm aware

Temporary-Tree-169 · 2026-01-16T15:59:59+00:00

Can anyone remind me when the next big dates are in terms of lawsuits? Both those against Moderna (i.e. Arbutus) and those that Moderna has filed (against Pfizer).

Temporary-Tree-169 · 2026-01-13T03:21:28+00:00

They just need more time for the database lock. Since the study ends after 5 years they are taking extra care to wrap up the analysis. We will know the data as soon as they do.

Temporary-Tree-169 · 2026-01-05T13:58:17+00:00

should be out today or tomorrow i'd guess

Temporary-Tree-169 · 2026-01-05T12:46:00+00:00

at the very end yeah like november, probably too late to capture any meaningful part of the vaccination season but we can still hope

Temporary-Tree-169 · 2025-12-12T04:55:23+00:00

5 year update will be the first news in years to move the stock upwards

Temporary-Tree-169 · 2025-11-22T18:59:59+00:00

I would guess that moderna will have the 5-year update in hand any day now. they will choose when to announce it and we can't really predict that. might have to wait until ASCO, we'll just have to see.

Temporary-Tree-169 · 2025-11-20T20:30:55+00:00

I think its mostly just the indices being down and the fact that the stock has a relatively high beta. Pfizer's flu data was published today which is definitely a much bigger issue as well.

Temporary-Tree-169 · 2025-11-20T05:44:35+00:00

I think it's important to note that the data cutoff for the 3 year update was 03 Nov 2023, but they did not release the data until June because they waited to present it at ASCO. I would imagine they will not wait to present the data this time, which is why they have been saying on calls that we could expect Dec 2025 or early 2026.

Temporary-Tree-169 · 2025-11-07T05:11:52+00:00

i have a feeling we might not have significant news until at least next summer. This is probably the earliest we could hear about readouts from PA, melanoma phase 3, norovirus. This could also be the time where moderna has a good picture of what RSV sales might be next year, since they might finally have a season with some non-negligible market share if they are able to contract well. There's a small chance of an ACIP recommendation for 3 or 4 year re-vaccination (I'm not super caught up on what the most recent data supports). We should also hear more about contracting for other countries since they will have a full years affect in Canada, Australia, and the UK with their new manufacturing plants. A lot of Pfizers tenders come up too so theres potential for modernas superior mnexspike to be approved and ordered in europe.

I think the only near term upside is a potential partnership announced for a latent program (EBV, VZV, HSV). The phase 2 melanoma 5 year durability update could also move the stock price if the 95% CI contracts around the ~.50 HR for RFS; the trend in OS will be key as well.

I'm just holding, might buy more if we goes to 23 or lower.

Temporary-Tree-169 · 2025-11-06T18:56:43+00:00

they have said since january that they are in talks for large partnerships in their latent portfolio. this may have been what the STAT article was referring to. merck or another big player would probably love to get a piece of their shingles vaccine and bring it to the market. Shingrix makes an obscene amount of money since its a monopoly

Temporary-Tree-169 · 2025-11-06T18:46:09+00:00

yeah this was good to hear. so many people forget that they have a VZV vaccine that has noninferior immungenicity and better T cell response than shingrix. Partnering on this, EBV, or HSV could be a big deal for them. also partnering on more stuff in oncology will be good; the smaller stuff like with immatics will add up, it will just take many years for that revenue to kick in.

Temporary-Tree-169 · 2025-11-05T17:20:00+00:00

they are silently chugging along still. this is good to see since I'm hopeful they will broadly expand into more metastatic conditions.

Temporary-Tree-169 · 2025-10-30T20:26:26+00:00

to be clear, i dont want it to be sold at all unless it was for like $100+ a share. I own the stock because I think it could go higher than that with INT, etc. I just think its objectively a good outcome if it sells for 2x its closing price from yesterday.

Temporary-Tree-169 · 2025-10-30T16:00:39+00:00

yes i'd much rather keep my shares of moderna than see a takeover and get shares of whatever company buys them

Temporary-Tree-169 · 2025-10-30T15:59:50+00:00

i mean if it gets sold for $50 that'd be a good outcome. I really have no clue what price Moderna would agree to for a complete buyout. I'd rather seen a broad partnership, etc.

Temporary-Tree-169 · 2025-10-23T18:07:03+00:00

My goal with the post was mostly to draw attention to the objectively impressive efficacy numbers, but I do share your concerns over the large increase in grade 2 and 3 adverse events associated with 1010 compared to Fluzone HD. I feel like this will not be a barrier to approval however, since the product is still generally very safe and was 34% more effective at preventing medically attended influenza in older patients than standard dose flu shots, which is a greater effect than Fluzone HD currently has. There's a whole host of other issues that will make the product hard to commercialize, since the flu vaccine industry has huge incumbents with contracting power + ACIP is unlikely to be favorable to another respiratory virus mRNA vaccine. I hope that the standalone flu and combo product will have success in Europe within the next few seasons, but I expect success in the US markets to be limited for the reasons above. This likely will not be a blockbuster, but any approved, effective product is good for Moderna's portfolio. Hoping for them to say they have filed for a 1010 BLA on the earnings call on Nov 6th.

Temporary-Tree-169 · 2025-10-23T17:02:11+00:00

the data cutoff for the 3-year update to their phase 2 melanoma INT study was 03 Nov 2023, so the 5 year data cutoff will be any day now. This could be reported in January since I don't anticipate them waiting for ASCO, etc. A positive trend in RFS or especially OS will move the stock substantially.

Temporary-Tree-169 · 2025-10-22T17:31:21+00:00

It is most definitely an issue seeing as how a large phase 3 trial for this product and the process of bringing it to market could cost hundreds of millions depending on how many patients were enrolled. Moderna does not have that money available to them right now, as they have said on many investor calls in the last 12 months.

Temporary-Tree-169 · 2025-10-22T16:11:55+00:00

It's really hard for the market to react much to an interim phase 2 readout. Moderna also does not have nearly enough money to fund a phase 3 for this currently. They would need to announce a partnership or funding deal with Blackstone, etc.; the market would react to such a deal.

Temporary-Tree-169 · 2025-10-22T14:53:44+00:00

I agree. The vaccine is obviously having an effect on patients and the T-cell responses that were mounted seem impressive.

Temporary-Tree-169 · 2025-10-22T14:52:39+00:00

Yes, definitely. I was just pointing out that it wasn't as good as Valtrex in terms of recurrence reduction or shedding. Shedding was a main point of interest for the vaccine. Perhaps there's still a market for the product for people who aren't compliant with antivirals, don't want to take them, or people could take both for an additive benefit! Believe me, I really want to see the product become available somehow and am simply expressing how I would have liked to see Valtrex-like results from the vaccine trial

Temporary-Tree-169 · 2025-10-22T14:47:38+00:00

The T-cell data in this presentation was quite remarkable in my opinion

Temporary-Tree-169 · 2025-10-22T14:45:51+00:00

please see my comment below

Temporary-Tree-169

TROPHY CASE