Moderna (MRNA) Stock: French Study Sparks Rally After FDA Shock – Latest News, Analyst Forecasts and 2026 Outlook

Updated: December 6, 2025

Moderna, Inc. (NASDAQ: MRNA) has just had one of its most dramatic weeks of 2025. Shares plunged early in the week after news that the U.S. Food and Drug Administration (FDA) may tighten vaccine approval standards, then rebounded sharply on Friday after a massive French real‑world study reaffirmed the safety and effectiveness of its COVID‑19 vaccine. ^[1]

As of the close on Friday, December 5, Moderna stock finished at $27.70, up 8.7% on the day and trading near the middle of its 52‑week range of $22.28 to $48.92, giving the company a market capitalization of about $10.8 billion. ^[2] That’s a tiny fraction of its pandemic-era valuation and underscores how dependent investor sentiment remains on two things: vaccine policy and the company’s ability to turn its mRNA pipeline into sustainable, diversified revenue.

Where Moderna Stock Stands Now

Market data from StockAnalysis shows Moderna with: ^[3]

Share price: $27.70 at the December 5 close, $27.60 in after‑hours trading
Market cap: $10.82 billion
Revenue (trailing 12 months): $2.23 billion
Net income (trailing 12 months): –$3.12 billion
52‑week range: $22.28 – $48.92
Analyst consensus rating: Hold
Average 12‑month price target: $33.91 (about 22% upside from the latest price)

In other words, Moderna today trades like a mid‑cap, loss‑making biotech with a still‑unproven but very extensive pipeline, not like the pandemic hyper‑growth story it once was.

Regulatory Shock: FDA Memo Slams Vaccine Makers

The latest bout of volatility started on December 1, 2025. An Investopedia report detailed how an internal FDA memo from Vinay Prasad, the new head of the Center for Biologics Evaluation and Research (CBER), linked COVID‑19 vaccines to at least 10 pediatric deaths between 2021 and 2024 and outlined plans to tighten oversight of vaccine trials and approvals. ^[4]

The memo, as summarized in that report, proposed tougher requirements for evidence of safety and efficacy before vaccines get the green light, without naming specific companies. Analysts at William Blair warned that such changes would add to headwinds for Moderna and peers like Pfizer and BioNTech. ^[5]

On the same day, a companion “S&P 500 Gains and Losses” article noted that Moderna shares tumbled about 7%, leading declines in the index, as investors reacted to the possibility of stricter vaccine approval rules. ^[6] Additional coverage in Barron’s echoed the concern, emphasizing that Prasad’s memo and his prior criticisms of the U.S. COVID response could mean a materially tougher regulatory environment for vaccine developers. ^[7]

This is more than a headline risk: Moderna still derives the “bulk” of its current revenue from its COVID‑19 vaccine, as multiple articles pointed out, so any regulatory shift that slows trials or approvals hits both its present business and its longer‑term pipeline. ^[8]

Scientific Reassurance: French Study Triggers a Relief Rally

By Friday, December 5, the narrative flipped. Another Investopedia markets piece reported that Moderna stock “jumped close to 9%” after results from a huge nationwide French study were released. ^[9]

Key details from that study:

Included data on about 28 million people
Found that recipients of Moderna or Pfizer mRNA vaccines had roughly a 75% lower risk of dying from COVID‑19 than unvaccinated people
Confirmed the vaccines’ safety and effectiveness in long‑term, real‑world use ^[10]

For a company suddenly under renewed regulatory scrutiny, a massive independent dataset reinforcing the benefit–risk profile of its flagship product is strategically important. It doesn’t negate the FDA’s safety concerns or the new political mood around vaccines, but it strengthens the scientific case that these products continue to provide substantial protection, especially for high‑risk groups.

The rally also built on earlier upside from news of a $1.5 billion credit facility and a major U.S. manufacturing expansion (more on that below), with some trading‑focused research noting that Moderna had broken above its 20‑day moving average and bounced off its 52‑week low near $22. ^[11]

Earnings Check: 2025 Results, Guidance and Cost Cuts

Moderna reported third‑quarter 2025 results on November 6. The company’s own earnings release shows: ^[12]

Q3 2025 total revenue: $1.016 billion (down from $1.86 billion in Q3 2024)
Net product sales: $973 million, almost all from its COVID booster
Other revenue: $43 million
GAAP net loss:$200 million
GAAP EPS:–$0.51, compared with +$0.03 a year earlier

For the nine months ended September 30, 2025, Moderna recorded:

Total revenue: $1.266 billion (vs. $2.27 billion in the same period of 2024)
Net loss: $1.996 billion (slightly improved from a $2.441 billion loss in the prior-year period) ^[13]

StockAnalysis data also notes that full‑year 2024 revenue was $3.24 billion, down more than 50% from 2023, with losses of $3.56 billion. ^[14] The financial trajectory is still negative, but the quarterly loss trend is inching in the right direction.

A BioSpace analysis summarized the pattern: Moderna posted losses of about $1.0 billion in Q1, $800 million in Q2, and $200 million in Q3, highlighting how the fall booster season is now crucial to the business. ^[15] Management reiterated that seasonality is here to stay: most COVID vaccine revenue will likely be concentrated in a few months each year.

On guidance, the company narrowed its 2025 revenue outlook to $1.6–$2.0 billion, trimming the top end versus earlier commentary as U.S. booster uptake lagged expectations under more restrictive vaccination guidelines. ^[16]

Cost Cutting and the Path to 2028 Breakeven

Given shrinking COVID demand, Moderna has launched an aggressive cost‑cutting campaign:

CEO Stéphane Bancel told investors that operating expenses fell 34% in Q3 2025 across R&D, sales and other functions versus the prior year. ^[17]
The company’s original goal was to reduce GAAP operating expenses from $7.2 billion in 2024 to $6.4 billion in 2025, but management now says it is on track to beat that 2025 cost plan by about $1 billion on a capital basis and $900 million on a cash basis. ^[18]

At its Analyst Day on November 20–21, Moderna laid out a three‑year business strategy: ^[19]

Target up to 10% revenue growth in 2026
Continue to lower R&D intensity and operating expenses through 2027
Achieve cash breakeven in 2028
Fund oncology and rare‑disease programs with cash flow from a growing “seasonal vaccine franchise”

From a balance‑sheet perspective, the Q3 release shows cash and investments of about $6.6 billion as of September 30, 2025. ^[20] Analyst Day materials referenced a projected year‑end 2025 cash and investment balance in the mid‑$7 billion range, helped by new financing and working‑capital inflows. ^[21]

The $1.5 Billion Ares Loan and U.S. Manufacturing Expansion

To extend its runway without issuing new equity, Moderna recently arranged a five‑year, $1.5 billion credit facility with Ares Management. A summary on StockAnalysis, citing a Reuters report and the company’s own release, notes that the financing is non‑dilutive and meant to provide extra flexibility as Moderna reshapes its portfolio and invests in late‑stage programs. ^[22]

On the industrial side, a November 19 Reuters piece reported that Moderna will spend more than $140 million to add “fill‑finish” capability to its campus in Norwood, Massachusetts, allowing it to run end‑to‑end mRNA manufacturing in the U.S. rather than relying on contract partners for the final drug‑product steps. ^[23]

The Analyst Day press release describes this as part of a broader global production network: Moderna says it has exited eight contract manufacturers and added three company‑run sites in the UK, Canada and Australia, while streamlining its network to support multi‑year strategic partnerships with governments. ^[24]

For investors, the takeaway is that Moderna is deliberately trading some short‑term margin for long‑term control over supply and quality — and potentially better bargaining power in government and commercial negotiations.

Pipeline Reset: CMV Setback, Seasonal Vaccines and Oncology

CMV Vaccine Failure and Program Shutdown

The biggest negative pipeline surprise of 2025 came from mRNA‑1647, Moderna’s long‑touted vaccine for cytomegalovirus (CMV), a common infection that can cause serious birth defects when transmitted in utero.

In October, Moderna announced that a Phase 3 pivotal trial of mRNA‑1647 in about 7,500 women aged 16–40 failed its primary endpoint of preventing CMV infection in previously uninfected women. ^[25] Efficacy ranged from roughly 6% to 23%, far below expectations and the pre‑specified target of around 49%. ^[26]

The company is:

Discontinuing its congenital CMV program aimed at preventing birth defects
Continuing to study mRNA‑1647 in bone marrow transplant patients, where CMV reactivation is dangerous but the efficacy bar is different ^[27]

Several news outlets, including Barron’s and Investor’s Business Daily, noted that expectations had already been tempered by earlier signals, but the failure still removed what many on Wall Street had seen as Moderna’s next big infectious‑disease revenue driver. ^[28]

Importantly, Moderna said the CMV setback does not change its 2025 financial guidance or its 2028 breakeven goal, and some analysts argued that halting the program could even be modestly positive for near‑term cash flow, given the heavy launch‑and‑education costs that would have been required. ^[29]

Building a Seasonal Vaccine Franchise

With CMV off the table (at least for congenital infection), the company is refocusing on respiratory and seasonal vaccines:

Spikevax® / mNEXSPIKE® (COVID‑19 boosters) – Still the core revenue driver, though Moderna’s Q3 commentary and BioSpace’s coverage stressed that U.S. “shots in arms” are down roughly 30% this season, in part due to more restrictive and confusing eligibility guidelines. ^[30]
mRESVIA® (RSV vaccine) – Approved in the U.S. in 2024, and later gained a label expansion to adults 18–59 at higher risk, plus approvals in dozens of countries. Despite that, Q3 sales were just $2 million, underscoring a slow ramp against established competitors. ^[31]
mRNA‑1010 (seasonal flu vaccine) – Moderna expects to complete regulatory submissions in the U.S., EU, Canada and Australia by January 2026, positioning the product for potential launches in the 2026–27 flu season. ^[32]
mRNA‑1083 (flu + COVID combination) – Under review at the European Medicines Agency, with a submission filed in Canada. The company is currently “awaiting further guidance” from the U.S. FDA on refiling, reflecting the new regulatory climate. ^[33]
Norovirus vaccine candidate – Still in development; Moderna highlighted this as part of a plan to have up to six approved seasonal products by 2028, vs. three today (COVID, RSV, and pandemic‑focused COVID). ^[34]

Strategically, the goal is clear: create a recurring, multi‑product seasonal business in adults at risk for respiratory and enteric viruses, then use that cash flow to bankroll riskier oncology and rare‑disease bets.

Oncology and Rare‑Disease Programs

Oncology is the second pillar of Moderna’s post‑COVID strategy. At Analyst Day, the company emphasized: ^[35]

Nine ongoing Phase 2 and Phase 3 oncology studies, including three Phase 3 trials for intismeran autogene (the new name for mRNA‑4157, its personalized cancer vaccine developed with Merck’s Keytruda)
A focus on combining mRNA‑encoded neoantigens with checkpoint inhibitors in melanoma and other solid tumors
Additional early‑stage oncology assets, such as T‑cell–engaging therapies and other immune‑modulating constructs

Separately, rare‑disease programs in areas like inborn errors of metabolism remain a longer‑dated option. While they don’t generate near‑term catalysts, Moderna sees them as a key way to leverage its platform beyond vaccines. ^[36]

Not all oncology news has been positive. A GuruFocus report in October highlighted that Moderna shares fell about 4.2% after the company disclosed new data on mRNA‑4359, an immuno‑oncology candidate, underscoring that not every pipeline readout will move in the right direction. ^[37]

What Wall Street Expects: Analyst Targets and Quant Models

Despite all the drama, Wall Street’s overall stance on Moderna is surprisingly measured.

StockAnalysis aggregates 13 analysts with an average rating of “Hold” and an average 12‑month price target of $33.91, implying roughly 22% upside from the latest price. ^[38]

Other data providers show similar — but not identical — numbers:

MarketBeat and MarketWatch both categorize the stock as Neutral/Hold, with average targets generally in the low‑to‑mid $30s and a wide spread between bullish and bearish estimates. ^[39]
An Investing.com consensus based on a larger analyst set lists an average target in the mid‑$30s, with the highest forecast around $135 and the lowest around $17, illustrating just how divisive Moderna has become. ^[40]

Quant and technical models are just as split:

CoinCodex’s algorithmic forecast recently projected Moderna trading mostly in the mid‑$20s in 2025, implying modest downside from current levels. ^[41]
Short‑term trading analysis from AInvest flagged Moderna’s 5.7% intraday surge on December 5 as a breakout above its 20‑day moving average and noted resistance near the 200‑day moving average around $27.68, but characterized the longer‑term technical picture as still “bearish.” ^[42]

Putting it together: the consensus view is cautious. The average price targets suggest some upside, but the rating cluster around “Hold” reflects deep uncertainty about booster demand, regulatory risk and execution in oncology.

How Cheap (or Expensive) Is Moderna Now?

At roughly $10.8 billion in market value and $2.23 billion in trailing 12‑month revenue, Moderna trades at a bit under 5 times sales, according to StockAnalysis metrics. ^[43] That’s not outrageous for a platform biotech with multiple late‑stage shots on goal — but it’s also not “deep value” considering:

The core COVID business is shrinking and highly seasonal
RSV uptake has been slow so far
CMV, once seen as a potential blockbuster, has fallen away as a revenue driver ^[44]

Bulls will argue this multiple undervalues:

A potential six‑product seasonal vaccine franchise by 2028
A robust oncology pipeline with nine Phase 2/3 trials underway
A large cash balance and non‑dilutive financing that together provide years of runway ^[45]

Bears counter that:

Regulatory risk has structurally risen, especially in the U.S.
The core vaccine market is politically sensitive and vulnerable to shifts in public sentiment
The oncology programs, while exciting, are high‑risk and will face intense competition from both large pharma and other biotech innovators ^[46]

Bull vs. Bear Case for MRNA Stock

The Bull Case

Supporters of Moderna stock today tend to emphasize:

Platform and pipeline depth – A diversified mRNA platform spanning respiratory, oncology and rare diseases, with multiple late‑stage programs and nine anticipated Phase 2/3 oncology readouts. ^[47]
Seasonal vaccine franchise – A realistic path to six approved seasonal vaccines by 2028 (COVID, RSV, flu, flu/COVID combo, pandemic influenza variants and Norovirus), which could yield more stable, recurring revenue. ^[48]
Financial runway – Billions in cash and investments, a new $1.5 billion credit facility, and a disciplined cost‑cutting plan that is already exceeding internal targets. ^[49]
Manufacturing moat – Full end‑to‑end U.S. mRNA manufacturing and a global network that could make Moderna a preferred partner for governments seeking domestic supply security. ^[50]
Positive real‑world data – The French nationwide study reinforcing strong mortality benefits from mRNA vaccination, which supports ongoing clinical and regulatory arguments for boosters in high‑risk populations. ^[51]

If you believe management can hit its 10% revenue growth target for 2026 and cash breakeven by 2028, today’s valuation could look attractive in hindsight. ^[52]

The Bear Case

Skeptics focus on a different set of facts:

Structural demand risk – U.S. COVID booster uptake is down roughly 30% year‑on‑year, and new guidelines limit eligibility, shrinking the addressable market. ^[53]
Regulatory overhang – The Vinay Prasad memo, the linking of vaccines to pediatric deaths, and proposed tougher trial standards could slow development and approval of new vaccines, raise costs and extend timelines. ^[54]
Pipeline casualties – The CMV failure shows that late‑stage programs can still break, and that years of investment can be written off. ^[55]
Execution risk in oncology – Cancer drug development is crowded, expensive and high‑risk, with a long history of apparently promising platforms falling short in pivotal trials. Early share reaction to mRNA‑4359 data illustrates that investors are not giving Moderna a free pass. ^[56]
Still‑large losses – Despite improving trends, Moderna is on track to lose billions of dollars again in 2025 and is counting on successful launches in multiple new markets to change that trajectory. ^[57]

In this view, the current valuation is not cheap if COVID demand continues to erode, RSV and flu vaccines underperform, or oncology readouts disappoint.

Is Moderna Stock a Buy, Sell or Hold Right Now?

From a neutral, information‑driven perspective:

Wall Street’s average stance is “Hold.” Price targets cluster in the low‑to‑mid $30s, with meaningful upside from current levels but huge disagreement between bulls and bears. ^[58]
Near‑term trading is being driven by headlines. The week’s wild swings around the FDA memo and the French study are reminders that regulatory and real‑world data can move MRNA double digits in a single session. ^[59]
The long‑term thesis hinges on execution. Investors are effectively betting that Moderna can evolve from a single‑product COVID company into a diversified vaccine and oncology franchise, while navigating an increasingly politicized vaccine environment.

For conservative or income‑oriented investors, Moderna will likely look too volatile and too dependent on uncertain scientific and regulatory outcomes.

For risk‑tolerant biotech or growth investors, MRNA is a classic high‑beta, high‑uncertainty opportunity: the downside is that the COVID cash flows fade faster than the pipeline matures; the upside is that a few successful oncology and seasonal launches could transform today’s modest market cap into something much larger.

Either way, Moderna is no longer a simple “COVID vaccine” trade. It’s a full‑blown pipeline and policy story, where valuation, science and politics are now tightly intertwined.