Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

December 18, 2025 — Merck & Company, Inc. (NYSE: MRK) is back in the spotlight for investors today as three threads converge: a fresh Wall Street upgrade tied to Merck’s post‑Keytruda strategy, a potentially meaningful FDA fast‑track development for two pipeline assets, and new Phase 3 momentum for the company’s blockbuster oncology franchise in earlier‑stage bladder cancer.

Merck shares traded around $101 intraday on Thursday, reflecting a modest gain versus the prior close, as markets absorbed a busy stream of pharma catalysts and analyst commentary. [1]

Below is a comprehensive, publication‑ready roundup of the key news, forecasts, and analyses dated Dec. 18, 2025 (18.12.2025)—and what they may mean for MRK stock heading into 2026.


Today’s MRK headlines (Dec. 18, 2025)

Here are the main stock‑moving items investors are parsing today:

  • Analyst upgrade: BMO Capital Markets upgraded Merck to Outperform and raised its price target to $130 (from $82), arguing the company is building a credible portfolio to grow through Keytruda’s 2028 loss of exclusivity (LOE). [2]
  • FDA fast‑track watch: A Reuters report says the FDA is preparing to accelerate reviews for two experimental Merck drugs—enlicitide decanoate (cholesterol) and sacituzumab tirumotecan (oncology)—under the Commissioner’s National Priority Voucher program. [3]
  • Oncology pipeline momentum: Merck announced positive topline Phase 3 results for KEYTRUDA (pembrolizumab) + Padcev (enfortumab vedotin) in cisplatin‑eligible muscle‑invasive bladder cancer (MIBC), showing statistically significant improvements in survival outcomes when used before and after surgery. [4]

Merck’s new Phase 3 readout: why Keytruda + Padcev matters for MRK stock

Merck reported positive topline results from the Phase 3 KEYNOTE‑B15 (EV‑304) trial in cisplatin‑eligible MIBC. The company said the perioperative regimen (before and after surgery) produced statistically significant and clinically meaningful improvements across:

  • Event‑free survival (EFS)
  • Overall survival (OS)
  • Pathologic complete response (pCR)

…versus standard neoadjuvant chemotherapy and surgery. [5]

Merck also emphasized that the safety profile was consistent with known profiles of each agent, with no new safety signals, and said it plans to present the data at an upcoming medical meeting and discuss potential filings with regulators. [6]

Why this lands with investors now

For MRK stock, the strategic significance is straightforward: Merck is trying to extend the Keytruda franchise beyond today’s indications by pushing into earlier‑stage settings and combination regimens that can defend market share as competitive pressure rises and patent timelines approach.

Partners Pfizer and Astellas framed the result as another step toward a platinum‑free standard of care in an earlier stage of bladder cancer, highlighting how the EV‑304 data complements the broader development arc for this combo. [7]

Industry coverage echoed that view, noting the combination’s continued “winning streak” as it advances across bladder cancer treatment settings. [8]

Investor takeaway: A positive Phase 3 signal in an earlier‑stage setting doesn’t automatically translate to near‑term revenue, but it can strengthen the longer‑range thesis that Merck can expand and defend oncology cash flows while it builds a more diversified portfolio.


FDA fast‑track development: what the National Priority Voucher program could mean for Merck

A second catalyst in focus today comes from FDA review mechanics—specifically the Commissioner’s National Priority Voucher (CNPV) pilot program.

What the FDA program is designed to do

The FDA’s CNPV pilot program is intended to reduce review times from roughly 10–12 months to 1–2 months for selected drug/biologic applications or efficacy supplements, supported by enhanced communication and a multidisciplinary review approach. [9]

Why MRK investors care today

Reuters reported that two experimental Merck assets were selected for (or are being prepared for) this accelerated pathway:

  • Enlicitide decanoate (a cholesterol‑lowering pill), expected to be filed in April
  • Sacituzumab tirumotecan (sac‑TMT) (a cancer therapy), expected later (Reuters described timing extending into 2026) [10]

BioSpace, summarizing the Reuters reporting and broader context, described the vouchers as potentially “drastically” shortening review timelines—while also noting that government officials characterized the status as speculative absent formal FDA announcement. [11]

The strategic angle: pipeline timing and “patent‑cliff math”

This matters because Merck’s 2028 Keytruda LOE is not just a headline—it’s a looming revenue‑replacement equation. Faster reviews (where appropriate) can shift when pipeline assets start contributing.

Still, investors should keep expectations disciplined: the FDA’s own description notes the agency retains discretion to extend the review window if submissions are insufficient, ambiguous, or complex. [12]

Investor takeaway: Even the possibility of accelerated review can be a sentiment tailwind, but it is not the same thing as approval—nor a guarantee that timelines won’t slip.


BMO’s upgrade: the market is rewarding a clearer post‑Keytruda narrative

Merck’s biggest stock‑overhang remains the same: Keytruda’s expected LOE in 2028. Today’s analyst commentary is notable because it argues the market may be turning from “fear of the cliff” to “pricing the bridge.”

What BMO said (and why it raised the target so sharply)

A Reuters‑distributed item published via TradingView noted BMO upgraded Merck to outperform and hiked its price target to $130 from $82, citing a growing pipeline and portfolio of clinical assets to “grow through” the upcoming LOE. [13]

One of the most attention‑grabbing lines for MRK bulls: BMO said it is now confident that “90% of peak sales can be replaced by the mid‑2030s.” [14]

TipRanks’ TheFly summary added that BMO expects near‑term commercial outperformance from assets such as Enflonsia, Reblozyl, and Welireg, and argued sentiment improved following Merck’s Gardasil beat in Q3. [15]

How this maps to Merck’s latest reported fundamentals

Merck’s third‑quarter 2025 results highlighted the company’s current revenue engine and its newer growth platforms:

  • Q3 worldwide sales $17.3B (+4% YoY)
  • Keytruda Q3 sales $8.1B (+10% YoY)
  • Winrevair sales $360M
  • Capvaxive sales $244M
  • Gardasil/Gardasil 9 sales $1.7B (decline reported in the release) [16]

BMO’s thesis essentially assumes that as newer products scale—and as pipeline shots on goal mature—Merck can narrow the gap between “Keytruda peak” and “post‑LOE reality.”

Investor takeaway: The upgrade doesn’t remove the cliff, but it signals a major bank believes the market has underpriced Merck’s ability to replace Keytruda cash flows over time.


Merck stock forecast for 2026: Wall Street price targets and consensus view (as of Dec. 18, 2025)

Analyst forecasts don’t predict the future, but they do show how professional investors are framing the risk/reward today.

Consensus targets

  • StockAnalysis.com shows an average analyst price target around $111.93, with a low around $85 and a high around $130, and a consensus rating described as “Buy.” [17]
  • TipRanks lists a “Moderate Buy” consensus (14 ratings in the past three months) and an average price target around $112.69, with a high target of $139 and a low of $82 (per its page snapshot). [18]

What the forecasts are really saying

Across the major aggregators, the message is consistent:

  • Upside exists, but it’s not a “straight line” story.
  • Targets cluster around the low‑to‑mid‑$110s—implying analysts expect Merck to hold up through 2026 while investors wait for clearer visibility into post‑2028 revenue.

In other words, today’s forecasts read less like a momentum bet and more like a valuation + durability call—especially in a market that tends to rotate into cash‑generative, dividend‑paying pharma names when macro uncertainty rises.


The Keytruda patent cliff remains the central MRK debate

Even on a newsy day like today, Merck’s long‑term narrative is still anchored by Keytruda.

A Nasdaq‑published Zacks analysis (Dec. 12, 2025) noted:

  • Keytruda faces patent expiration in 2028
  • It accounts for more than 50% of Merck’s pharmaceutical sales
  • It generated $23.3B in sales in the first nine months of 2025 [19]

This is why MRK stock can move sharply on any credible sign of “replacement capacity,” whether that’s:

  • earlier‑stage oncology wins (like KEYNOTE‑B15/EV‑304), [20]
  • faster pipeline timelines (via mechanisms like CNPV), [21]
  • or analyst confidence that the company’s new launches can scale through 2026 and beyond. [22]

Investor takeaway: Merck doesn’t need every pipeline asset to be a blockbuster. But it likely needs a portfolio of meaningful contributors to make the post‑2028 transition look manageable.


Near-term MRK catalysts to watch next

If you’re tracking Merck stock into year‑end and early 2026, today’s news points to several upcoming milestones.

1) Q4 2025 earnings call: February 3, 2026

Merck lists its Q4 2025 Earnings Call for February 3, 2026 at 9:00 a.m. ET. [23]

2) Possible pipeline timeline milestones (2026)

Reuters’ reporting on the CNPV program suggested a potential April filing expectation for enlicitide decanoate (cholesterol), and later submissions for sacituzumab tirumotecan. [24]

Separately, Nasdaq’s Zacks piece pointed to an FDA decision expected in April for a fixed‑dose HIV combination (doravirine + islatravir), showing how multiple pipeline clocks are running simultaneously. [25]

3) Dividend watch: Jan. 8, 2026 payment

Merck declared a quarterly dividend of $0.85 per share for Q1 2026, payable Jan. 8, 2026, to shareholders of record Dec. 15, 2025. [26]
StockAnalysis’ dividend page reflects the same payment schedule and indicates the most recent ex‑dividend date as Dec. 15, 2025. [27]


Risks and watch-outs (what could go wrong)

A balanced MRK stock outlook also needs to account for what can derail the bull case:

  • Keytruda LOE concentration risk: The more Keytruda dominates the mix, the more valuation hinges on replacement credibility. [28]
  • Regulatory uncertainty—even with fast‑track programs: The FDA states it can extend review windows if submissions are incomplete or complex, meaning “accelerated” does not equal “guaranteed.” [29]
  • Execution risk on new launches: BMO’s optimism relies on scaling multiple assets—not just one—into durable revenue contributors. [30]
  • International demand swings: Merck’s vaccine franchise (including Gardasil) has been a sensitivity point for sentiment; today’s analyst commentary explicitly referenced past investor concerns and a perceived reset of expectations. [31]

Bottom line: Merck stock is being repriced as “more than Keytruda,” but the clock still matters

As of Dec. 18, 2025, the MRK stock conversation is shifting from “What happens when Keytruda falls off?” to “How much of Keytruda can Merck replace—and how fast?”

Today’s flow of headlines supports both sides of that debate:

  • The KEYNOTE‑B15/EV‑304 win reinforces Merck’s ability to keep expanding Keytruda in earlier‑stage oncology. [32]
  • The FDA fast‑track voucher reporting highlights a path (even if not guaranteed) to accelerate certain high‑value pipeline assets. [33]
  • The BMO upgrade is a clear signal that at least one major brokerage believes the market has become overly pessimistic—and that multiple 2026 catalysts could help rerate the stock. [34]
Why Merck Stock Could Gain 45% by 2025 (Hidden Gem at $77!)

References

1. stockanalysis.com, 2. www.tradingview.com, 3. www.reuters.com, 4. www.merck.com, 5. www.merck.com, 6. www.merck.com, 7. www.pfizer.com, 8. www.fiercepharma.com, 9. www.fda.gov, 10. www.reuters.com, 11. www.biospace.com, 12. www.fda.gov, 13. www.tradingview.com, 14. www.tradingview.com, 15. www.tipranks.com, 16. www.merck.com, 17. stockanalysis.com, 18. www.tipranks.com, 19. www.nasdaq.com, 20. www.merck.com, 21. www.reuters.com, 22. www.tradingview.com, 23. www.merck.com, 24. www.reuters.com, 25. www.nasdaq.com, 26. www.merck.com, 27. stockanalysis.com, 28. www.nasdaq.com, 29. www.fda.gov, 30. www.tradingview.com, 31. www.tradingview.com, 32. www.merck.com, 33. www.reuters.com, 34. www.tradingview.com

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