Moderna Stock (MRNA) News, Forecasts and Analysis: CEPI Bird Flu Funding, FDA Scrutiny and the 2026 Outlook (Dec. 20, 2025)

December 20, 2025 — Moderna, Inc. (NASDAQ: MRNA) is ending the year in classic Moderna fashion: a tug-of-war between near-term uncertainty (COVID policy and demand) and long-term optionality (a pipeline that still wants to be the sequel to the pandemic-era blockbuster). The stock last traded around $33.80, up roughly 9% from the prior close, with a market cap near $13 billion and a 52-week range roughly $22–$49. ^[1]

That jump comes as investors digest a fresh burst of pandemic-preparedness funding tied to Moderna’s H5 bird flu program—while, at the same time, headlines swirl around potential FDA actions on COVID-19 vaccine warnings. Put differently: Moderna stock is being priced on two timelines at once, and the market can’t decide which calendar matters more. ^[2]

What’s moving Moderna stock heading into Dec. 20, 2025

1) CEPI backs Moderna’s bird flu vaccine with up to $54.3 million

The most straightforward bullish catalyst this week: Moderna disclosed it has secured up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support a pivotal Phase 3 trial for its investigational H5 pandemic influenza (bird flu) vaccine candidate, mRNA-1018. The trial is slated to begin in early 2026 in the UK and the U.S. ^[3]

Two details investors are paying attention to:

This is positioned as the first mRNA-based bird flu vaccine to enter a pivotal Phase 3 study. ^[4]
Under the agreement, Moderna said it would reserve 20% of its H5 pandemic vaccine manufacturing capacity for low- and middle-income countries in a pandemic scenario—an “access” clause that can matter politically as much as commercially. ^[5]

This also lands in a politically charged backdrop: earlier in 2025, Moderna’s bird flu work faced uncertainty after the U.S. government canceled a large federal contract connected to pandemic flu efforts, amplifying the significance of new external funding. ^[6]

2) COVID vaccine policy headlines are back—and they’re messy

The other stream of news is less celebratory and more… regulatory weather system.

On Dec. 9, Reuters reported that U.S. regulators are investigating deaths potentially related to COVID-19 vaccines across multiple age groups, as part of a safety review. Moderna reiterated that it has not seen new or undisclosed safety concerns tied to its shot. ^[7]
On Dec. 12, Reuters reported on a CNN story claiming the FDA intended to add a “black box” warning to COVID-19 vaccines—its most serious warning category—though U.S. health officials emphasized that claims about what the FDA “will do” are speculation until formally announced, and the report noted plans were not finalized. ^[8]
On Dec. 15, Reuters cited a Bloomberg report saying the FDA was not planning a black box warning for Moderna and Pfizer COVID-19 vaccines (directly contradicting the earlier “intends to” framing). ^[9]

For Moderna stock, this matters for two reasons:

Demand elasticity: if access tightens further or public confidence wobbles, it pressures Spikevax/mNEXSPIKE revenue.
The risk premium: investors generally charge a higher valuation penalty when regulatory outcomes feel binary or politicized.

Moderna’s 2025 story: shrinking COVID sales, cost discipline, and a pipeline reboot

Moderna’s core investment debate has become brutally simple: Can the company bridge from “COVID windfall” to “durable multi-product biotech” before cash burn and patience run out?

Q3 results: strong COVID seasonality, weak RSV start

In its third-quarter 2025 update, Moderna reported $1.0 billion in total revenue and a loss of $0.51 per share. The company said COVID vaccine sales were $971 million in the quarter, while RSV vaccine (mRESVIA) sales were $2 million, underscoring how early—and competitive—the RSV commercial ramp remains. ^[10]

Moderna also narrowed its 2025 revenue outlook to $1.6–$2.0 billion, and projected year-end cash and investments of $6.5–$7.0 billion. ^[11]

The company explicitly tied part of the COVID softness to shifting U.S. vaccine guidance that narrowed broad access and contributed to lower vaccination rates. ^[12]

A $1.5 billion loan for flexibility (and to avoid dilution)

At its November Analyst Day timeframe, Moderna announced a five-year $1.5 billion loan facility with Ares Management (with $600 million available immediately and the remainder available in tranches through 2027–2028). Management framed it as a way to fund opportunities or manage risk without issuing shares at depressed prices. ^[13]

In the same update, Moderna said it expected to trim $500 million of expenses in 2026 and 2027 and reiterated its goal of reaching break-even by 2028. ^[14]

Manufacturing “onshoring”: $140 million investment, timeline into 2027

Moderna also announced it will invest more than $140 million to add fill-finish (final drug product) capabilities to its Massachusetts site, aiming to run end-to-end mRNA manufacturing in the U.S. and reduce reliance on contract manufacturers. Completion is targeted for the first half of 2027. ^[15]

For investors, this is less about near-term revenue and more about:

Margin control (especially in lower-demand environments), and
strategic credibility as a platform company.

Pipeline reality check: wins, delays, and strategic triage

mNEXSPIKE: Moderna’s “next-generation” COVID strategy

Moderna has leaned heavily into mNEXSPIKE as a way to defend COVID revenue under tighter regulatory rules. Reuters reported in September that Moderna’s updated formulation generated a strong immune response in older adults and at-risk groups, including a reported 16-fold average increase in neutralizing antibodies against a monitored variant. ^[16]

In its Q3 update, Moderna said the FDA approved its 2025–2026 formula for mNEXSPIKE for adults 65+ and at-risk individuals 12–64, and noted filings aimed at 2026 approvals in multiple regions. ^[17]

Flu vaccine (mRNA-1010): one of the clearest 2026 catalysts

A major bright spot in 2025 was Moderna’s seasonal flu vaccine. Reuters reported that Moderna said its experimental flu shot mRNA-1010 showed greater effectiveness than a licensed comparator in a late-stage study—data Moderna has positioned as a foundation for regulatory filings. ^[18]

Moderna’s Q3 materials said it expects to complete submissions for approval by January 2026 across the U.S., Canada, Australia, and Europe. ^[19]

Flu + COVID combo (mRNA-1083): progress, but not a straight line

The combo vaccine remains strategically important (one shot, two big seasonal markets), but timelines have been choppy. Moderna previously withdrew its U.S. application while waiting for flu efficacy data; in Q3, Moderna said its filing was under review with the European Medicines Agency (EMA) and that it was awaiting further FDA guidance on refiling. ^[20]

Norovirus: bigger market dream, slower readout mechanics

Norovirus is a large opportunity on paper, but clinical reality is governed by case accrual (you can’t rush a virus into politely infecting enough trial participants on schedule). Moderna said its Phase 3 study would enroll a second Northern Hemisphere season (2025–2026) and that timing depends on case accrual. ^[21]

Oncology: the Merck partnership is still the long-game heavyweight

Moderna and Merck’s individualized cancer vaccine program remains one of the most closely watched pieces of Moderna’s “post-COVID identity.” Moderna said the Phase 3 melanoma trial is fully enrolled and that additional Phase 3 and Phase 2 studies are ongoing across multiple tumor types. ^[22]

Reuters also reported management expectation that late-stage data could arrive in 2026, with a potential 2027 launch window depending on results and regulatory outcomes. ^[23]

The CMV disappointment: a late-stage program gets cut

In October, Moderna said it would stop developing its congenital CMV vaccine program after a Phase 3 trial missed its primary goal, with reported efficacy depending on case definition. The company said it would continue evaluating the asset in transplant patients and that the failure would not change its 2025 outlook or 2028 break-even goal. ^[24]

Cost cutting includes headcount: 10% workforce reduction

Moderna also announced a plan to reduce its workforce by roughly 10% and have fewer than 5,000 employees by the end of 2025, as part of broader expense reductions. ^[25]

Moderna stock forecast: what analysts are looking at as of Dec. 20, 2025

Analyst views on Moderna stock are still split, and that’s visible in the dispersion of targets.

Investing.com’s compiled data shows an average 12‑month price target around $36.75, with a high estimate of $135 and a low estimate of $17, and an overall Neutral stance in its summarized breakdown. ^[26]
TradingView shows a consensus-style view with an average target around $35.89, and a rating mix skewing heavily toward Hold, with smaller Buy and Sell buckets. ^[27]

The common thread: analysts are typically unwilling to get aggressively bullish until Moderna proves it can replace declining COVID cashflows with repeatable seasonal revenue (flu, combo) and/or high-value pipeline readouts (oncology).

A sentiment tell: high short interest

Short interest remains elevated. MarketBeat reports that as of Nov. 28, 2025, Moderna had 68.08 million shares sold short, representing about 19.55% of the public float, with roughly 7.3 days to cover. ^[28]

High short interest doesn’t predict direction by itself, but it does raise the probability of violent moves—up or down—when real news lands.

What to watch next for Moderna (MRNA) stock

Heading into 2026, there are a few concrete “calendar items” that could reprice Moderna stock quickly:

Bird flu Phase 3 start (early 2026) — and any details on endpoints, enrollment speed, and procurement interest. ^[29]
mRNA-1010 flu filings by January 2026 — and whether regulators view the dataset as strong enough for a smooth path to approval. ^[30]
Combo vaccine regulatory clarity — particularly what the FDA asks for after Moderna’s prior withdrawal to await flu efficacy data. ^[31]
COVID policy and labeling volatility — anything that changes access, warnings, or booster norms can swing seasonal revenue assumptions fast. ^[32]
Oncology readouts and trial updates — the Merck partnership is still the “if this works, the narrative changes” lever. ^[33]

Bottom line: Moderna stock is still a two‑timeline bet

As of Dec. 20, 2025, Moderna stock is reacting to a blend of immediate catalysts (like CEPI funding for bird flu) and headline risks (FDA scrutiny and shifting COVID vaccination policy), while the underlying investment case remains anchored to one question: Can Moderna convert its platform into a stable, multi-product revenue engine before the market loses patience with the transition? ^[34]

In the near term, volatility is the feature—not the bug. In the medium term, flu (mRNA-1010) and regulatory progress on the combo shot look like the most obvious levers. In the long term, oncology is the swing factor that could fundamentally re-rate what “Moderna” means in a portfolio. ^[35]