Updated: December 12, 2025
Company: Milestone Pharmaceuticals Inc. ( NASDAQ: MIST )
Milestone Pharmaceuticals Inc. stock is drawing heightened attention on December 12, 2025 , as investors position ahead of a make-or-break FDA decision for the company’s lead program, CARDAMYST™ (etripamil) nasal spray , aimed at treating paroxysmal supraventricular tachycardia (PSVT) . The regulatory catalyst arrives after a volatile year that included an FDA Complete Response Letter (CRL) earlier in 2025, followed by the FDA’s acceptance of Milestone’s resubmission and a new target action date set for mid-December. [1]
In the market, MIST shares closed at $2.95 on Dec. 11 , a +10.49% single-session jump with heavy trading volume, and were indicated modestly higher in early pre-market trading on Dec. 12 . [2]
What’s happening with Milestone Pharmaceuticals stock today
Momentum in Milestone Pharmaceuticals stock has been building into the second week of December:
- Dec. 11 close:$2.95 , up 10.49% on the day, with ~7.54 million shares traded and an intraday high near $2.965 . [3]
- Early Dec. 12 pre-market: Yahoo Finance showed MIST trading around $2.98 in early pre-market prints (timing varies by venue). [4]
- 52-week range (as tracked by Investing.com): approximately $0.625 to $2.965 , underscoring how strongly the stock has rebounded from its 2025 lows as the FDA date approaches. [5]
This is a classic biotech setup: a relatively small-cap development-stage company with a binary FDA catalyst can see sharp price swings as traders and long-term investors reprice both approval odds and commercialization potential.
The main catalyst: FDA target action date for CARDAMYST on Dec. 13, 2025
Milestone’s near-term story centers on CARDAMYST (etripamil) nasal spray , which the company describes as a rapid-onset calcium channel blocker designed to be self-administered by patients outside the hospital during symptomatic PSVT episodes. [6]
The company’s most recent corporate update reiterates that the New Drug Application (NDA) is under FDA review with a PDUFA target action date of December 13, 2025 , and that Milestone has positioned itself for a “quick-start” promotional launch if approval arrives. [7]
Why this matters to investors: approval would potentially shift Milestone from a clinical-stage biotech into a commercial company—often a major valuation inflection point—while a negative decision could reset timelines and funding needs.
Why PSVT and CARDAMYST are getting attention
PSVT is a heart rhythm condition involving episodes of rapid heart rate that can be frightening and disruptive. In a March 2025 report covering the earlier FDA setback, Reuters cited Milestone’s spray as a treatment for this type of heart condition and noted that around two million people in the US suffer from PSVT (context: prevalence estimates vary across sources). [8]
Market watchers are focused on CARDAMYST because it is being developed as an on-demand, self-administered option—contrasting with many current acute interventions that occur in monitored clinical settings. Nasdaq/RTTNews highlighted the potential for a first-in-class, self-administered approach and framed the December FDA decision as one of Milestone’s most significant corporate milestones. [9]
The regulatory backstory investors should know: CRL, resubmission, and the new timeline
Milestone’s FDA path in 2025 has been eventful:
1) March 28, 2025: FDA declines approval and issues a Complete Response Letter
Reuters reported that the FDA declined to approve Milestone’s nasal spray and issued a CRL requesting, among other items, an inspection of a facility involved in drug testing and additional nitrosamine impurity data under updated guidance. Reuters also noted the FDA did not raise concerns about the therapy’s safety or efficacy in that decision, but cited chemistry/manufacturing/control issues that needed to be addressed. [10]
2) July 11, 2025: FDA accepts Milestone’s CRL response for review
Milestone later announced that the FDA accepted for review its response to the CRL and assigned a new PDUFA target action date of December 13, 2025 . [11]
3) Why funding became part of the FDA narrative
At the same time as the July resubmission acceptance, Milestone disclosed an extension of a $75 million Royalty Purchase Agreement arrangement with RTW Investments , structured as a contingent funding source tied to FDA approval timing and customary closing conditions. [12]
This sequence—CRL followed by accepted resubmission—helps explain both (a) why the stock traded near its lows earlier in the year and (b) why it has been re-rated upward into December as the FDA clock runs down.
Latest company update: launch readiness, cash position, and financing
In its Nov. 12, 2025 update (reported with third-quarter results), Milestone emphasized both operational readiness and capital planning:
- Cash: Milestone reported $82.6 million in cash, cash equivalents, and short-term investments as of Sept. 30, 2025. [13]
- Financing: The company said it completed an underwritten public offering with net proceeds of approximately $48.7 million , and referenced the amended royalty purchase agreement as part of its launch funding toolkit. [14]
- Launch posture: Management stated it has increased pre-launch activities and aims to be able to quickly launch following potential FDA approval. [15]
- Clinical narrative: The company pointed to new analyzes presented at AHA Scientific Sessions 2025 and described a dataset spanning more than 600 unique enrolled patients , highlighting consistent efficacy and safety across trial phases and regions. [16]
Milestone also reiterated that etripamil is being advanced beyond PSVT, noting that the company finalized the ReVeRA-301 Phase 3 protocol for atrial fibrillation with rapid ventricular rate (AFib-RVR) and discussed plans to pursue a supplemental NDA pathway for a potential second indication. [17]
Other current news items investors are watching around Dec. 12, 2025
Even when no single press release hits on a specific day, small signals can matter in a catalyst trade. Here are several “current” items circulating in the days leading into Dec. 12:
Induction grants (Dec. 2, 2025)
Milestone reported that it granted 30,000 stock options (under its induction plan) to two new employees, with:
- Grant date: Dec. 1, 2025
- Exercise price:$2.69
- Vesting: four years (25% after one year, then monthly) [18]
Hiring-related equity awards are common—but in the context of a potential commercial launch, investors often read headcount activity as a directional signal of commercialization buildout.
Insider transaction filing (Form 4 disclosed Dec. 11, 2025)
A Reuters/Refinitiv item carried by TradingView reported that Lorenz Muller (officer) filed a Form 4 disclosing a gift of 25,000 shares (transaction date Dec. 9, 2025 ) and showed ending direct holdings of 150,052 shares . [19]
Insider gifts can occur for many non-market reasons (estate planning, family transfers), so traders typically treat this as contextual—not decisive—information.
Options and positioning chatter (early December)
MarketBeat published an item about traders purchasing a large volume of call options in Milestone Pharmaceuticals, while also summarizing recent price levels, market cap estimates, and the biotech’s upcoming catalyst setup. [20]
Options activity around FDA dates is common; it can reflect speculation, hedging, or volatility trading rather than pure directional conviction.
Analyst forecasts for MIST stock: price targets, ratings, and what they imply
Wall Street analyst targets (compiled)
Investing.com’s analyst compilation (as displayed in December 2025) shows:
- 4 analysts tracked in its consensus set
- Average 12-month price target:$3.75
- High:$5
- Low:$2 [21]
It also lists specific firm actions and targets in 2025, including:
- Jefferies: Hold with $2.00 target (Nov. 13, 2025)
- Wells Fargo: Buy with $4.00 target (coverage initiated Sep. 11, 2025)
- HC Wainwright: Buy targets shown at $5.00 (June 2025 updates; Investing.com also displays an earlier higher target in April 2025) [22]
How to interpret this on Dec. 12: the consensus target above the recent ~$3 area suggests analysts in that compilation generally see upside— but price targets are highly sensitive to FDA outcomes. In practice, many buy-side models treat MIST as a probability-weighted trade scenario (approval vs. non-approval), not a smooth linear forecast.
Model-based “intrinsic value” analysis
A Yahoo Finance-hosted analysis (attributed to a valuation approach using a two-stage FCFE DCF) cited a projected fair value of about $4.13 for Milestone Pharmaceuticals. [23]
This kind of estimate can be useful as a reference point, but it depends heavily on assumptions (approval probability, peak sales, margins, discount rate, dilution). For pre-revenue biotech, those assumptions can swing dramatically on one FDA headline.
Technical/quant-style forecasts (short-term signal services)
StockInvest, a technical-signal site, noted the stock’s sharp move and described volume expansion as a positive technical sign, reflecting what many momentum traders track into catalysts. [24]
These services can help summarize trend and volatility, but they do not replace fundamental FDA/label/commercial analysis—which is the true driver here.
What investors are really betting on: scenarios for the FDA decision
With the Dec. 13, 2025 PDUFA target date in view, the market is implicitly weighing a handful of scenarios:
Scenario A: FDA approval (with a commercially workable label)
If CARDAMYST is approved, key investor questions will likely shift immediately to:
- Launch speed and execution: Milestone says it has “quick-start” promotional launch plans and has increased pre-launch activity. [25]
- Balance sheet impact: Milestone has referenced a $75 million royalty payment upon FDA approval (tied to RTW agreements and conditions), which could meaningfully strengthen launch resources. [26]
- Commercial adoption curve: whether cardiologists/ER physicians/patients view self-administered intranasal therapy as practice-changing for appropriate PSVT patients.
In this scenario, bullish investors often argue that the company’s value shifts from “option on approval” to “option on uptake,” which can still be volatile—but typically changes the investor base.
Scenario B: CRL / non-approval (timing slips again)
A negative outcome could force the market to refocus on:
- What the FDA is asking for (manufacturing, inspections, nitrosamines, or other items)
- Time and cost to remediate
- Whether additional clinical work is needed
- Potential financing/dilution risk
That dynamic played out earlier in 2025 when the FDA declined approval and highlighted facility inspection and nitrosamine-related requests, leading to a sharp share drop at the time. [27]
Scenario C: Delay or narrow approval dynamics
Even without a clean “yes/no,” biotech catalysts sometimes generate complexity:
- An approval could arrive with post-marketing commitments, manufacturing constraints, or other conditions.
- A decision can also land “on or around” the target action date (PDUFA dates are targets, not guarantees).
Because of this, traders often plan for elevated volatility through the decision window and the first conference call or guidance update that follows.
Key risks to include in any Milestone Pharmaceuticals stock analysis
For a Google News/Discover audience, it’s essential to highlight the risks alongside the upside narrative:
- Regulatory and CMC risk remains central. The March 2025 CRL was tied to manufacturing/controls topics and facility inspection requirements, even as the FDA did not raise safety/efficacy concerns in that decision. [28]
- Commercial execution risk. Milestone has increased commercial expense and pre-launch activities to prepare for a potential launch, but uptake, reimbursement, and awareness building are real-world execution challenges. [29]
- Financing/dilution risk. The company completed a public offering for approximately $48.7 million net proceeds and has structured contingent funding tied to FDA approval timing; future capital needs will depend on outcomes and launch burn. [30]
- Concentration pipeline. Etripamil/CARDAMYST is the dominant value driver. While Milestone is also advancing AFib-RVR plans, the near-term stock story remains heavily dependent on PSVT approval. [31]
Bottom line on Dec. 12, 2025: why MIST stock is moving, and what to watch next
Milestone Pharmaceuticals Inc. stock is trading like a company approaching a defining event: a US FDA decision on CARDAMYST (etripamil) for PSVT with a Dec. 13, 2025 target action date. Recent company updates emphasize launch readiness , a cash position of $82.6 million at Sept. 30, and added resources from a public offering (~$48.7 million net) plus a potential $75 million royalty-linked payment contingent on approval and closing conditions. [32]
Meanwhile, the market has already started repricing the event: the stock’s Dec. 11 surge to $2.95 (+10.49%) and elevated volume suggest investors and traders are actively positioning into the decision window. [33]
For readers tracking Milestone Pharmaceuticals stock today, the next “must-watch” items are straightforward:
- Any FDA decision headline and the specific label/conditions (if approved)
- Management commentary on launch timing, payment strategy, and early demand signals
- Updates on the RTW-linked funding mechanics and cash runway after the decision [34]
References
1. www.globenewswire.com, 2. ng.investing.com, 3. ng.investing.com, 4. finance.yahoo.com, 5. www.investing.com, 6. www.nasdaq.com, 7. www.globenewswire.com, 8. www.reuters.com, 9. www.nasdaq.com, 10. www.reuters.com, 11. www.globenewswire.com, 12. www.globenewswire.com, 13. www.globenewswire.com, 14. www.globenewswire.com, 15. www.globenewswire.com, 16. www.globenewswire.com, 17. www.globenewswire.com, 18. www.globenewswire.com, 19. www.tradingview.com, 20. www.marketbeat.com, 21. www.investing.com, 22. www.investing.com, 23. finance.yahoo.com, 24. stockinvest.us, 25. www.globenewswire.com, 26. www.globenewswire.com, 27. www.reuters.com, 28. www.reuters.com, 29. www.globenewswire.com, 30. www.globenewswire.com, 31. www.globenewswire.com, 32. www.globenewswire.com, 33. ng.investing.com, 34. www.globenewswire.com
