December 15, 2025 — Immunome, Inc. (NASDAQ: IMNM) is having the kind of biotech day that traders circle in red ink: a major clinical trial win, a sharp move in the share price, and a fast-rising debate over what “best-in-class” might be worth if regulators agree.
The catalyst is Immunome’s positive topline Phase 3 RINGSIDE results for varegacestat (formerly AL102) in progressing desmoid tumors—a rare, non-metastatic but often aggressive disease that can cause severe pain and disability. Reuters reported the news pushed the stock up 34.3% in premarket trading Monday. [1]
By mid-session, IMNM remained strongly higher. As of 14:46 UTC, IMNM traded at $24.78, up $5.21 from the prior close of $19.57—a gain of about 26.6%—after touching an intraday high of $29.13.
What follows is the full picture of the day’s news, how analysts have framed the setup, and what investors are likely to watch next.
Why Immunome stock jumped today
Immunome announced that its global pivotal Phase 3 RINGSIDE trial of varegacestat met its primary endpoint: progression-free survival (PFS) improved significantly versus placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio 0.16; p<0.0001). [2]
The study also hit key secondary measures investors care about because they’re easier to “feel” than a hazard ratio:
- Objective response rate (ORR): 56% with varegacestat vs 9% with placebo (RECIST v1.1; p<0.0001) [3]
- Median best change in tumor volume:-83% with varegacestat vs +11% with placebo (exploratory analysis) [4]
- Statistically significant improvements in tumor volume reduction and worst pain intensity versus placebo [5]
In biotech-stock logic, this combination—a clean primary endpoint win plus a strong response rate and patient-centered endpoints like pain—is the closest thing to a “triple-click” catalyst you can get without FDA approval.
The RINGSIDE trial, in plain English
The Phase 3 RINGSIDE trial (NCT04871282) was randomized, double-blind, and placebo-controlled, enrolling 156 patients who received either varegacestat 1.2 mg once daily or placebo until progression or death. [6]
That design matters because desmoid tumors can behave unpredictably; a placebo-controlled format helps convince regulators and clinicians that the effect isn’t just the disease’s natural waxing and waning.
Immunome also emphasized RINGSIDE is “the largest and most comprehensive” desmoid tumor trial to date—a claim that, even if you take it as corporate phrasing, signals the company believes its dataset is regulator-grade. [7]
Safety profile: strong efficacy, but side effects still matter
Immunome said varegacestat was “generally well tolerated” with a safety profile consistent with the gamma secretase inhibitor (GSI) class. The most common adverse events in the treatment arm were:
- Diarrhea (82%)
- Fatigue (44%)
- Rash (43%)
- Nausea (35%)
- Cough (34%)
Most events were grade 1 or 2. [8]
However, Immunome’s corporate presentation (filed as an exhibit with the SEC) also flagged a key issue GSIs are known for: ovarian toxicity. The presentation states 55.6% of premenopausal women experienced ovarian toxicity, and notes there were no deaths on study. [9]
For investors, this is one of the central questions going forward: How will the label read if varegacestat is approved, and how will clinicians weigh benefits vs. reproductive/endocrine risks—especially for a disease that often affects younger adults?
Regulatory timeline: Immunome targets an NDA in Q2 2026
Immunome says it plans to submit a New Drug Application (NDA) to the U.S. FDA in Q2 2026 based on these topline results. [10]
The company also expects to share additional RINGSIDE data at an “upcoming major medical conference,” which is typically where investors look for deeper detail on:
- durability of responses (duration of response)
- subgroup performance (e.g., tumor location, baseline burden, prior therapy)
- time-to-response and symptom relief timelines
- discontinuation rates and dose modifications
- reproductive safety management approaches
Those details can meaningfully influence both regulatory confidence and commercial uptake.
As background, Immunome previously disclosed that varegacestat received Orphan Drug Designation from the FDA (November 2023) and from the European Medicines Agency (July 2025)—designations that can support development strategy and market exclusivity frameworks if approvals follow. [11]
Competition: Ogsiveo is already approved in the U.S.
A major reason this IMNM story is instantly “big” is that the market is not empty.
Reuters noted that Merck KGaA acquired SpringWorks Therapeutics in 2025, giving it access to Ogsiveo for desmoid tumors in the United States. [12]
Ogsiveo (nirogacestat) and varegacestat sit in the same broad category—GSIs—so the commercial fight will likely hinge on comparative positioning, not on first-to-market advantage.
Importantly, Immunome itself warns against simplistic cross-trial comparisons. In its SEC-filed presentation, the company explicitly notes there is no head-to-head trial between varegacestat and nirogacestat and cautions that differences in design and populations make “apples-to-apples” comparisons risky. [13]
Still, “best-in-class” debates tend to happen anyway—because markets are markets—and today’s data gives that conversation fuel.
IMNM stock price today: the numbers traders are watching
Clinical headlines move biotech, but price action tells you how aggressively the market is repricing probability.
As of 14:46 UTC, IMNM was:
- $24.78 per share, +26.6% vs. prior close
- Day range: $19.31 – $29.13
- Volume: ~3.92 million shares
- Market cap: ~$2.21 billion
The intraday swing—nearly $10 between low and high—also underlines a biotech truth: after a pivotal-data print, volatility becomes a feature, not a bug.
Analyst forecasts and price targets: what Wall Street was saying going into the readout
Analyst price targets can lag big trial news (firms often update notes after digesting full data), but there were already several visible stances heading into today:
- Truist Securities initiated coverage with a Buy rating and a $36 price target, arguing varegacestat could show superior efficacy and a more convenient regimen versus the approved option. [14]
- Goldman Sachs initiated coverage with a Buy rating and a $26 price target, emphasizing the clinical-stage pipeline and varegacestat’s Phase 3 setup. [15]
- Stephens raised its price target to $33 from $25 and maintained an Overweight rating, citing confidence ahead of the pivotal readout. [16]
On broader consensus, Investing.com reported a “strong buy” analyst consensus with targets spanning roughly $18 to $38 per share. [17]
A separate Nasdaq/Fintel roundup (as of Nov. 17, 2025) put the average one-year price target around the mid‑$20s, with a wide low-to-high range. [18]
What’s different now (post-data): after today’s surge into the mid‑$20s, IMNM has moved closer to the middle of many previously published targets—meaning upgrades and target raises (if they come) may be the next leg of the “forecast” story.
Beyond varegacestat: why investors also care about Immunome’s pipeline
One reason IMNM has remained on biotech watchlists is that the company isn’t a one-asset story on paper.
In its SEC-filed corporate presentation, Immunome lists a portfolio that includes:
- IM-1021, a ROR1-targeted antibody-drug conjugate (ADC) (Phase 1; initial lymphoma data anticipated in 2026)
- IM-3050, a FAP-targeted radiotherapy (first patient in planned for early 2026)
- A set of earlier ADC programs, with IND submissions projected across 2026 [19]
In its Q3 2025 business update, Immunome also said it has observed objective responses at multiple dose levels in B‑cell lymphoma patients treated with IM‑1021 and expects initial data in 2026, while continuing IND-enabling work for additional ADCs. [20]
And in September 2025, a Business Wire release described a research collaboration with Infinimmune to discover and optimize novel antibodies, with Immunome receiving target exclusivity (financial terms undisclosed). [21]
For stockholders, the pipeline matters because pivotal successes sometimes lift the whole platform narrative: a win can reduce “company risk,” making the market more willing to price earlier programs as options with real probability rather than science projects.
Financial snapshot: cash runway and burn rate context
Immunome is still a clinical-stage company, so investors tend to focus less on revenue and more on cash runway and financing risk.
In its Q3 2025 results, Immunome reported:
- Cash and cash equivalents of $272.6 million as of Sept. 30, 2025
- Expectation that current cash funds operations into 2027
- Net loss of $57.5 million for Q3 2025 [22]
That runway can be strategically important after a major data event: it gives management flexibility around commercialization planning, regulatory submission work, and whether to pursue partnerships versus going it alone—though future financing is always possible in biotech, especially as programs expand.
What investors should watch next
Today’s headline is powerful, but the next moves for IMNM stock will likely be driven by a handful of concrete events and a handful of unavoidable uncertainties.
Potential catalysts:
- Full dataset presentation at a major medical conference (depth matters) [23]
- FDA interactions on NDA scope and timing ahead of the targeted Q2 2026 submission [24]
- Updated analyst notes/price targets following deeper review of efficacy durability and safety
- Pipeline updates in 2026 (IM‑1021 data; IM‑3050 first patient; IND progress) [25]
Key risks:
- Topline results are preliminary by nature; final dataset nuances can shift sentiment (even when the trial “wins”) [26]
- Competition and positioning vs. an already-approved therapy (Ogsiveo), plus payer dynamics [27]
- Safety/tolerability tradeoffs, including ovarian toxicity considerations highlighted in company materials [28]
- Dilution risk over time if commercialization ramps require additional capital, even with runway into 2027 [29]
Bottom line
Immunome’s December 15, 2025 Phase 3 update is a major validation moment: RINGSIDE hit PFS with a large effect size, delivered a 56% response rate, and showed improvements in tumor volume and pain—the kinds of endpoints that can change both regulatory probability and the commercial conversation. [30]
IMNM stock’s surge reflects that repricing in real time. Whether the move proves durable will depend on the fine print that comes next: durability, discontinuations, real-world tolerability, and how convincingly varegacestat can differentiate in a market where an approved competitor already exists.
References
1. www.reuters.com, 2. www.sec.gov, 3. www.sec.gov, 4. www.sec.gov, 5. www.sec.gov, 6. www.sec.gov, 7. www.sec.gov, 8. www.sec.gov, 9. www.sec.gov, 10. www.sec.gov, 11. www.biospace.com, 12. www.reuters.com, 13. www.sec.gov, 14. www.tipranks.com, 15. www.investing.com, 16. www.investing.com, 17. www.investing.com, 18. www.nasdaq.com, 19. www.sec.gov, 20. investors.immunome.com, 21. www.businesswire.com, 22. investors.immunome.com, 23. www.sec.gov, 24. www.sec.gov, 25. www.sec.gov, 26. www.sec.gov, 27. www.reuters.com, 28. www.sec.gov, 29. investors.immunome.com, 30. www.sec.gov
