Edgewise Therapeutics, Inc. (NASDAQ: EWTX) stock surged in intraday trading on Wednesday, December 24, 2025, after the company released a fresh update on EDG-7500, its investigational therapy for hypertrophic cardiomyopathy (HCM). By late morning, shares were trading around $26.37—up roughly 21% versus the prior close—after swinging between about $21.30 and $27.05 on the day, with volume above 2.2 million shares.
The move follows a company announcement that it has completed Parts B and C of its Phase 2 CIRRUS-HCM trial and reported favorable interim safety observations from Part D—an update that several market outlets characterized as a meaningful de-risking moment for the program’s safety profile, especially around left ventricular ejection fraction (LVEF) and arrhythmia monitoring. [1]
What Edgewise announced on Dec. 24, 2025
In its December 24 press release, Edgewise said EDG-7500 was generally well tolerated in CIRRUS-HCM, including interim safety results from Part D, with no clinically meaningful reductions in LVEF and no LVEF drops below 50% in the interim dataset highlighted by the company. [2]
Edgewise also reiterated its timeline: it remains on track to deliver a full 12-week Part D readout in Q2 2026 and aims to start a Phase 3 trial in Q4 2026. [3]
The details that got investors’ attention
A few specifics stood out in the Dec. 24 update:
- Part D enrollment and dosing progress: Edgewise reported that more than 40 participants have been enrolled in Part D, and as of a December 23, 2025 data cutoff, approximately 70% had reached 100 mg or higher. [4]
- Who’s in the interim dataset: The company described the interim safety snapshot as covering 20 participants who completed 12 weeks of dosing as of the cutoff date (8 obstructive HCM; 12 nonobstructive HCM). [5]
- Dose-optimization design: Part D uses biomarker- and physiology-guided titration—guided by LVOT gradient (obstructive HCM) and NT-proBNP (nonobstructive HCM)—with doses from 25 mg to 150 mg, and the option for further optimization up to 200 mg in an extension phase, according to the company. [6]
All of that matters because EDG-7500 is being positioned as a next-generation “cardiac sarcomere modulator” intended to improve relaxation (diastolic function) without compromising systolic function—a key theme Edgewise returned to repeatedly in the release. [7]
The safety nuance: “no AF on monitoring,” but one AF adverse event
Safety has been the center of gravity for the EDG-7500 story in 2025, and Edgewise leaned into specifics:
- The company said it deployed 300+ ambulatory cardiac monitoring devices, capturing 2,600+ patient-days of monitoring time, during which no clinically detectable atrial fibrillation (AF) or atrial flutter was observed. [8]
- At the same time, Edgewise disclosed one adverse event of new-onset AF in Part D, in an obstructive HCM participant not on active monitoring at the time and with a history of arrhythmias; the investigator deemed it not related to the study drug, per the release. [9]
That “two truths at once” framing—no AF detected during the defined monitoring windows, but one AF event occurring outside active monitoring—helps explain why coverage on Dec. 24 ranged from bullish (focus on LVEF stability and monitoring dataset) to cautious (focus on AF risk not being fully extinguished). [10]
Why this update lands differently now: the HCM market just shifted
The Dec. 24 EDG-7500 update hit less than a week after a major competitive development: the FDA approved Cytokinetics’ cardiac myosin inhibitor Myqorzo (aficamten) for adults with symptomatic obstructive HCM (oHCM) to improve functional capacity and symptoms. [11]
That approval is meaningful context for Edgewise because myosin inhibitors come with well-known monitoring and systolic function considerations. In FDA materials and labeling for Myqorzo, the agency highlights a risk of heart failure due to systolic dysfunction and the need for echocardiogram assessments prior to and during treatment. [12]
Benzinga explicitly tied these threads together on Dec. 24, noting the new approval for Cytokinetics as part of the competitive landscape while summarizing Edgewise’s emphasis on preserving LVEF and its attempt to differentiate EDG-7500’s profile. [13]
How EWTX stock reacted on Dec. 24
Different outlets captured different snapshots of the move:
- Investing.com described the stock as up in premarket trading after the EDG-7500 update. [14]
- Benzinga reported shares up roughly the high teens percent around mid-morning as it recapped the trial details. [15]
- Market data showed the rally persisting into regular trading, with EWTX around $26.37 at the latest captured trade time, after touching an intraday high above $27.
The size of the move also fits the broader pattern for clinical-stage biotech: when the “story stock” is driven by a few pipeline assets, safety and timing updates can reprice risk fast—sometimes violently.
Analyst forecasts and price targets for Edgewise Therapeutics stock
Wall Street’s published price targets for EWTX remain wide, reflecting both upside optionality (if EDG-7500 and/or sevasemten succeed) and the genuine uncertainty around clinical, regulatory, and commercialization paths.
The consensus view (Moderate Buy / Buy)
As of Dec. 24, data aggregators show a generally positive consensus:
- MarketBeat lists a “Moderate Buy” consensus rating, with an average 12‑month price target of $36, and a range from $14 (low) to $51 (high). [16]
- StockAnalysis shows a consensus “Buy” and an average target around $34.13, with the same broad $14 to $51 target range, and notes that targets were last updated in mid-November 2025. [17]
StockAnalysis also surfaces recent firm-level updates (examples shown on its page), including maintained Buy ratings and target adjustments from banks such as JPMorgan and RBC, alongside a more cautious stance from Goldman Sachs. [18]
The cautious camp: Stifel’s Hold call highlighted on Dec. 24
Notably, TipRanks’ auto-generated coverage on Dec. 24 pointed to a Hold rating from Stifel’s James Condulis and a $16 price target, arguing that (in his view) AF risk questions and an evolving competitive backdrop could keep differentiation “less clean” until longer-term, controlled Phase 3 data arrive. [19]
Whether investors agree or disagree, that spread—$16 on the bearish end versus $50+ on the bullish end—is your reminder that EWTX is still being valued like a clinical pipeline debate, not like a steady cash-flow business.
Technical and momentum-style analysis circulating today
On the technical-analysis side, Investor’s Business Daily coverage published Dec. 24 pointed to Edgewise clearing a Relative Strength (RS) threshold, discussing breakout levels and noting the stock had moved beyond an “ideal” buy range after the day’s strength. [20]
(Technical readouts don’t change trial outcomes, but they do influence who shows up in the stock on any given day—especially after a headline catalyst.)
The bigger business picture: pipeline and balance sheet context
While EDG-7500 drove today’s headlines, Edgewise is not a one-program company. In its third-quarter 2025 update (released Nov. 6, 2025), Edgewise reported:
- Cash, cash equivalents and marketable securities of ~$563.3 million as of Sept. 30, 2025. [21]
- A net loss of $40.7 million (or $0.39 per share) for Q3 2025. [22]
- Ongoing investment across programs, including EDG-7500 development activity, and initiation of a Phase 1 healthy adult trial for EDG-15400 (heart failure). [23]
On the neuromuscular side, Edgewise’s sevasemten program remains a major long-dated value driver. The company has said it expects topline data from its pivotal GRAND CANYON cohort in Becker muscular dystrophy in Q4 2026. [24]
What to watch next for Edgewise Therapeutics (EWTX) after Dec. 24
For readers tracking Edgewise Therapeutics stock into 2026, the calendar matters as much as the science:
- More complete EDG-7500 Part D efficacy and safety data (Q2 2026): Edgewise explicitly guided to a fuller readout in the second quarter of 2026. [25]
- Phase 3 design and launch timing (targeted Q4 2026 start): The company said it is advancing Phase 3 trial design with a goal to initiate by the end of 2026. [26]
- Competitive dynamics after Myqorzo’s FDA approval: With a newly approved therapy entering the market in January 2026, investor focus may sharpen around how EDG-7500 could differentiate on monitoring burden, labeling, and real-world tolerability—assuming it continues to clear safety and efficacy bars. [27]
- Sevasemten’s pivotal Becker readout (Q4 2026): Still one of the largest pipeline catalysts on Edgewise’s stated timeline. [28]
Bottom line
Edgewise Therapeutics’ Dec. 24 update gave investors new reasons to focus on EDG-7500 again—especially the LVEF stability narrative and the depth of ambulatory monitoring disclosed—driving a sharp rally in EWTX shares. [29]
At the same time, the company’s own disclosure of a single new-onset AF adverse event (even if deemed unrelated) and the arrival of a newly FDA-approved competitor in oHCM underline why forecasts and price targets remain widely dispersed. [30]
As always with clinical-stage biotech, the durable “trend” won’t be decided by one trading day—it will be decided by the next hard datasets, the Phase 3 design, and how regulators and clinicians interpret benefit-risk when the numbers get bigger.
References
1. www.prnewswire.com, 2. www.prnewswire.com, 3. www.prnewswire.com, 4. www.prnewswire.com, 5. www.prnewswire.com, 6. www.prnewswire.com, 7. www.prnewswire.com, 8. www.prnewswire.com, 9. www.prnewswire.com, 10. www.prnewswire.com, 11. www.fda.gov, 12. www.accessdata.fda.gov, 13. www.benzinga.com, 14. www.investing.com, 15. www.benzinga.com, 16. www.marketbeat.com, 17. stockanalysis.com, 18. stockanalysis.com, 19. www.tipranks.com, 20. www.investors.com, 21. www.prnewswire.com, 22. www.prnewswire.com, 23. www.prnewswire.com, 24. www.prnewswire.com, 25. www.prnewswire.com, 26. www.prnewswire.com, 27. www.reuters.com, 28. www.prnewswire.com, 29. www.prnewswire.com, 30. www.prnewswire.com
