Results:
From Jul 2019 to Sep 2021,157 pts were randomized to intismeran + pembro (n=107) or pembro (n=50). With an additional 2 y of follow-up (data cutoff, Dec 15, 2025; median planned follow-up, 60.3 [range, 50.5–76.4] mo) after the 3-y analysis, minimal new events occurred. RFS risk reduction for intismeran + pembro vs pembro alone was 49% (HR, 0.51; 95% CI, 0.29–0.89), with landmark 5-y RFS rates of 68.8% (95% CI, 56.3%–78.3%) for intismeran + pembro vs 49.1% (95% CI, 33.3%–63.0%) for pembro alone. DMFS risk reduction was 59% (HR, 0.41; 95% CI, 0.20–0.84). In the intismeran + pembro arm, 7 pts (6.5%) died (disease progression, n=4) vs 7 pts (14.0%) in the pembro arm (disease progression, n=6). There was a trend for improved OS (HR, 0.47; 95% CI, 0.17–1.35); 5-y rate was 92.2% (95% CI, 84.2%–96.3%) for intismeran + pembro vs 71.3% (95% CI, 35.4%–89.6%) for pembro alone. The safety profile of intismeran was consistent with prior analyses.

Conclusions:
After a median 5 y of follow-up, intismeran + pembro continued to prolong RFS and DMFS, along with a trend for improved OS vs pembro alone in pts with high-risk resected melanoma. These long-term findings show that intismeran + pembro treatment benefits were sustained and durable over time, despite all pts having completed study treatment before primary analysis (2021). As reported previously, intismeran was well tolerated, with a manageable safety profile for intismeran + pembro. Intismeran + pembro is being evaluated in a phase 3 study of high-risk resected stage II–IV melanoma (INTerpath-001; NCT05933577) and in studies of pts with other malignancies.

May 21 (Reuters) - Moderna and Merck's combination therapy for skin cancer helped reduce risk of cancer spreading to another part of the body by 59% after five years of follow-up, data from ‌a mid-stage trial showed Thursday.

The study tested Moderna's experimental personalized cancer vaccine intismeran autogene, in combination with Merck's blockbuster immunotherapy Keytruda, in melanoma patients after surgery to assess whether the combination prevented their cancer from returning. The trial enrolled 157 patients from 2019 ⁠to 2021.

Link: https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-merck-cancer-combo-cuts-melanoma-spread-risk-five-years-2026-05-21/

There are now 600 suspected Ebola cases after the outbreak in Congo and Uganda, the World Health Organisation has said.

WHO Director-General Tedros Adhanom Ghebreyesus said the risk of the disease spreading nationally and regionally was now high - but low at a global level.

He said 51 cases had so far been confirmed in the northern provinces of Ituri and North Kivu in Congo, "although we know the scale of the epidemic is much larger".

Uganda had also told the UN health agency of two confirmed cases in Uganda's capital, Kampala, he added.

"There are several factors that warrant serious concern about the potential for further spread and further deaths," he said.

"First, beyond the confirmed Ebola cases, there are almost 600 suspected cases and 139 suspected deaths. We expect those numbers to keep increasing, given the amount of time the virus was circulating before the outbreak was detected.

"Second, the epidemic has expanded, with cases reported in several urban areas. Third, deaths have been reported among health workers, indicating healthcare-associated transmission. Fourth, there is significant population movement in the area."

Dr Tedros said the outbreak of the rare Ebola strain, known as Bundibugyo, is likely to have started a couple of months ago.

He said there was a suspected death on 20 April but that investigations were continuing.

"WHO has a team on the ground supporting national authorities to respond. We have deployed people, supplies, equipment and funds," he said, adding that $3.9m in emergency funding from the agency had now been approved to support the response.

Congo was expecting shipments from the US and UK of an experimental vaccine for different types of Ebola, developed by researchers at Oxford, Jean-Jacques Muyembe, a virus expert at the National Institute of Biomedical Research, said on Tuesday.

"We will administer the vaccine and see who develops the disease," he said.

Health experts said the delayed detection of the virus, large movements of population in the affected areas, along with the preexisting humanitarian crisis, complicated the response. Parts of eastern Congo are in the hands of armed rebels, hampering the delivery of aid.

Congo had said the first person died from the virus on 24 April in Bunia, but the confirmation did not come for weeks. The body was repatriated to the Mongbwalu health zone, a mining area with a large population.

"That caused the Ebola outbreak to escalate," said Congo's health minister Samuel Roger Kamba.

Dr Anne Ancia, the head of the WHO team in Congo, said authorities still had not identified "patient zero".

There was a long road ahead, she said, adding that cuts in funding had "a marked detrimental effect on humanitarian actors".

>Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.

but then

>The FDA’s report, dated Dec. 5, flagged 96 “unique” pediatric deaths in the U.S. as of Aug. 14, 2025, as reported to the agency’s Vaccine Adverse Event Reporting System (VAERS). Of these, “no cases were classified as certain in relation to COVID-19 vaccination,” the report read—a stark contradiction to Prasad’s initial claim of causality.

https://www.biospace.com/fda/fdas-own-report-shows-no-child-deaths-definitively-caused-by-covid-vaccination

Does anyone know if the said experimental vaccine from Oxford, delivered from the US is also the same Moderna and Oxford were working on?

6 months follow up to:

https://www.reddit.com/r/wallstreetbets/comments/1pd8vex/moderna_is_in_a_generational_yolo_territory/

My prediction has officially come true.

FDA concerns are gone. Vinay Prasad got pushed out. Marty Makary resigned. The flu vaccine is now being reviewed. The lawsuits are resolved, and the Phase 3 Intismeran autogene (mRNA-4157/V940) data is coming this summer, with an anticipated FDA application in the fall.

This resolves all known risks and the path ahead is clear.

Intismeran is initially going to be used for melanoma and non-small cell lung cancer. Between those two and the profit-sharing agreement with Merck, revenue should still top $10 billion combined with existing revenue that already beat estimates.

The price has also been stable around ~50 for the last few months, so very likely this goes from 50 to 100 on positive Intismeran data, and there is no reason for the data to be bad based on the 5-year results.

Doubling the price while there is still a massive short position, around ~20% on most days, means that even a small squeeze could momentarily push this into the 200-300 range.

All in.

Position: 30k shares @ 27.5

As the title says, there appears to be a heavy buyer and seller sitting at tops and bottoms of current range. This range has now existed for 4 months about.

The good news is, the seller at the top range seemed to have sold heavily around 57 during that spike from the hantavirus scare.

My personal hopes are that the seller expended their holdings and now sits empty-ish for any big announcements.

Did you all see the same spikes in volume? Is your interpretation the same as mine?

I’m hoping that 48 buyer isn’t the same as the 57 seller :)

Not financial advice, just noticed very intriguing volume that I hadn’t seen since the last big movement upward.

Putting aside the Hantavirus for a moment, A few genuine candidates:

1. Personalised cancer vaccines (V940/intismeran autogene) This is the most Ozempic-like candidate. If the melanoma data holds and it gets approved, you're talking about a fundamentally new category of medicine,,where a vaccine personalised to your tumour's mutations, manufactured in weeks. There's no ceiling on that market. Every solid tumour becomes a potential indication. This is the one that could redefine Moderna into a mag-7 adjacent stock the way GLP-1 redefined Lilly.

2. CMV vaccine Cytomegalovirus is massively underappreciated publicly but enormous medically, it's the leading infectious cause of birth defects, causes serious disease in immunocompromised patients, and has no approved vaccine despite decades of attempts. Moderna's candidate is the most advanced ever. Not as flashy as cancer vaccines but potentially a $10-15B annual market with no competition.

3. Moderna's mRNA synthesis and delivery platform. If they become the infrastructure for personalised medicine broadly, cancer, rare disease, autoimmune , then the platform itself becomes the moat, not any single product.

It's worth remembering, analysts were way too conservative on NVDA for years, and LLY underperformed despite the fact it had GLP-1 research 15 years before Ozempic became a thing. Thank you for reading

OTHER DEPARTURES ​EXPECTED

Hoeg's departure would come amid a broader shake-up of the health department. The White House has exerted more control over the ​department in recent months as polls show Kennedy's efforts to rewrite U.S. vaccine policy could prove costly with voters in November's midterm elections that will decide whether Republicans retain control of Congress.

Source: https://www.reuters.com/world/fda-drug-center-head-expected-leave-after-commissioners-exit-sources-say-2026-05-15/

Deeper dive: FDA shake-up: Makary loyalists in limbo - Politico .

X post from Adam Cancryn, White House reporter at CNN:

>New: Trump officials want to recommend a new pick for FDA commissioner to the president by early June—a quick timeline that comes as they race to stabilize the agency.

>But first: More senior-level exits likely at FDA soon as today amid a broad review of Makary's leadership team

Currently 23 shares@ 54.37 average. Anyone bought it for the recent surge of virus news?

US-based pharmaceutical company Moderna confirmed that it has been working on the development of hantavirus vaccines in collaboration with the Vaccine Innovation Center of Korea University College of Medicine (VIC-K). This comes after an outbreak of hantavirus occurred on a Dutch cruise ship that sailed from Argentina and disembarked its passengers and crew in the Canary Islands on May 10. At least three people aboard the MV Hondius died, and several cases were reported as serious.

Moderna is the Cambridge, Massachusetts-based biotechnology company that perfected messenger RNA (mRNA) vaccines during the Covid-19 pandemic. Following the announcement that Moderna was developing a hantavirus vaccine using this same technology, the drugmaker's stock rose from $49 on May 7 to $55 the next day. But it is important to note that Moderna did not begin work on immunization in the wake of the outbreak at MV Hondius. In fact, the drugmaker undertook this collaborative project with VIC-K in 2023.

The Fight for a Vaccine

The hantavirus outbreak on the high seas has been one of the big international events of recent weeks, which means that many people around the world have only just learned of the existence of this virus—but it is not a newcomer. In fact, hantavirus has been a known pathogen for decades. Transmitted mainly through exposure to the droppings, urine, or saliva of infected rodents, it can cause hemorrhagic fever with renal syndrome (prevalent in Asia or Europe) or hantavirus pulmonary syndrome (more common in the Americas). The wife of actor Gene Hackman may be one of the best known recent people to have died from the latter disease, but it is far from being an exceptional phenomenon. Overall, hantaviruses cause around 50,000 serious and often fatal infections worldwide each year. The so-called New World hantaviruses, such as Andean hantavirus (ANDV), are mostly found in South America and can reach a case fatality rate of up to 40 percent; ANDV is the only hantavirus with documented human-to-human transmission, and just the variant that the World Health Organization identified in MV Hondius.

May 12, 2026 11:20 AM PT

The timing of this conference is interesting. With the current hantavirus news cycle, Moderna may get a natural chance to comment on the broader infectious disease angle without making it look forced.

Otherwise, it would probably be awkward for Moderna to address it directly.