NEW YORK — Friday, December 26, 2025 (1:07 p.m. ET). U.S. stocks are trading in a post-holiday session with major benchmarks close to flat, while biotech is notably weaker.
Against that backdrop, Edgewise Therapeutics, Inc. (NASDAQ: EWTX) is pulling back after a sharp midweek move tied to a clinical update in hypertrophic cardiomyopathy (HCM). As of the latest trade captured around 12:55 p.m. ET, EWTX traded near $26.00, down about 4.7% on the day, with an intraday range of $25.40 to $27.92 and volume above 1.0 million shares.
EWTX price action in today’s market: biotech pressure meets profit-taking
Today’s tape is delivering a familiar cocktail for biotech investors: light holiday-week liquidity + risk-off sector flows + headline-driven single-stock volatility.
- Broad-market proxies are essentially flat: SPY -0.11% and QQQ -0.02% (at the latest timestamps available).
- Biotech is softer: XBI -1.16% and IBB -0.86%, suggesting sector-level selling pressure even as the broader market holds steady.
That sector weakness matters because Edgewise is a clinical-stage company—meaning the stock often trades more like a “future expectations contract” than a conventional earnings-driven equity.
The headline catalyst: EDG-7500’s CIRRUS-HCM update (and why investors care)
The move that put Edgewise back in traders’ crosshairs this week came from its EDG-7500 program in HCM.
On December 24, 2025, the company announced it had completed Parts B and C of its Phase 2 CIRRUS-HCM trial and shared an interim safety update from the ongoing Part D study. The company emphasized that EDG-7500 was generally well tolerated and reported no clinically meaningful reductions in LVEF (left ventricular ejection fraction) and no LVEF values below 50% in the interim look. [1]
Key disclosed details investors are parsing now:
- Part D enrollment: “more than 40” participants enrolled, with a December 23, 2025 data cutoff. [2]
- Dose levels: about 70% had reached 100 mg or higher by the cutoff date. [3]
- Rhythm monitoring: the company said it deployed 300+ ambulatory monitoring devices capturing 2,600+ patient-days of monitoring, during which no clinically detectable atrial fibrillation (AF) or atrial flutter was observed. [4]
- Important nuance: it also disclosed a single new-onset AF adverse event that occurred when the participant was not on active monitoring, and investigators deemed it not related to the study drug. [5]
- Next EDG-7500 milestones: a full 12-week Part D readout in 2Q 2026 and a planned Phase 3 start in 4Q 2026. [6]
CEO Kevin Koch, Ph.D. highlighted both recruitment momentum and the safety narrative, saying the company had “exceeded our year-end enrollment goal,” while pointing to the lack of ejection-fraction declines below key thresholds. [7]
Why “no LVEF drop” is the obsession in HCM right now
Edgewise’s messaging around LVEF is not random—it’s laser-targeted at the competitive and regulatory reality in HCM.
Just last week, the U.S. FDA approved Cytokinetics’ Myqorzo (aficamten) for adults with symptomatic obstructive HCM to improve functional capacity and symptoms. [8] That approval arrived with a clear safety framework: Myqorzo is a cardiac myosin inhibitor, and FDA communications around the product highlight the risk of heart failure due to systolic dysfunction that requires formal risk-management controls in the marketed setting. [9]
Edgewise is essentially telling the market: if EDG-7500 can deliver meaningful symptom/hemodynamic benefits without LVEF suppression, it could (in theory) reduce monitoring burden and broaden prescriber comfort—if later trials confirm the signal and regulators agree. That is the bet, and it’s why the stock moves so violently on incremental safety data.
Volatility context: Edgewise has been here before (April 2025’s AF scare)
Investors also remember that EDG-7500’s story has not been a straight line.
In April 2025, Edgewise shares fell sharply after Phase 2 trial results that—despite showing the drug hit an efficacy goal—raised concerns about side effects including atrial fibrillation, with two serious cases requiring cardioversion. Investopedia reported RBC Capital Markets analyst Leonid Timashev warning that “The fact that two were serious is a complexity” that could draw closer FDA scrutiny. [10]
That history helps explain why the market is now treating the December 2025 interim safety discussion as both:
- potentially differentiating, and
- not yet definitive—because longer exposure, larger patient counts, and controlled designs still lie ahead.
Analyst forecasts and price targets: what Wall Street (and aggregators) say now
Forecasting a clinical-stage biotech is basically a ritual of structured uncertainty, but investors still watch consensus targets for sentiment and positioning.
Here’s what major tracking services are currently showing:
- StockAnalysis (as of targets last updated Nov. 14, 2025): consensus “Buy” from 8 analysts, average target $34.13, with a wide range from $14 to $51. [11]
- Benzinga’s consensus snapshot: consensus price target $37.30 (10 analysts), high $51 (Piper Sandler, Apr. 2, 2025) and low $14 (Scotiabank, Apr. 3, 2025). Benzinga also lists JP Morgan’s most recent target at $34 (Nov. 14, 2025). [12]
What “experts” are debating right now is less about whether HCM is a market—and more about whether EDG-7500’s safety profile becomes clean enough, convincingly enough, for broad adoption.
A Stocktwits news report summarized that split reaction, saying Stifel still saw open safety questions, while Truist reiterated optimism and cited a $46 target; it also referenced H.C. Wainwright with a $42 target and a Buy view. [13]
Beyond EDG-7500: Edgewise’s pipeline, catalysts, and the long calendar
Edgewise is not a one-asset company, and longer-term holders tend to anchor around a handful of big future readouts:
Sevasemten (muscular dystrophy)
Edgewise’s lead program, sevasemten, is being studied in Becker and Duchenne muscular dystrophies. The company has described GRAND CANYON as a global, placebo-controlled study in Becker, and its clinical-trial materials point to an 18-month evaluation with NSAA as the primary endpoint. [14]
In its Q3 2025 update, Edgewise said it expects the pivotal GRAND CANYON cohort readout in Q4 2026, while noting progress on commercialization infrastructure to support a potential launch if data are positive. [15]
EDG-15400 (heart failure)
Edgewise also initiated a Phase 1 healthy adult trial for EDG-15400, aimed at future studies in heart failure. It expects topline results in the first half of 2026. [16]
Next earnings
MarketBeat estimates Edgewise’s next earnings report (Q4) for March 2, 2026 (before market opens), based on historical reporting patterns (not a company-confirmed date). [17]
Balance sheet and dilution: what the SEC filings say investors should track
For clinical-stage biotechs, cash runway isn’t just “nice to have”—it’s the oxygen supply.
In its Form 10‑Q for the quarter ended Sept. 30, 2025, Edgewise reported $563.3 million in cash, cash equivalents and marketable securities and stated it expected those resources to be sufficient to fund the operating plan for at least the next 12 months. [18]
The same filing describes prior financing activity, including an April 3, 2025 registered direct offering with net proceeds of $187.1 million, and notes the company has an at-the-market (ATM) program that could be used for additional funding if needed. [19]
Translation: Edgewise is not in the “tomorrow morning financing panic” bucket, but investors still need to watch burn rate, trial expansion costs, and commercialization buildout, because those can change the runway math fast.
Corporate developments investors may have missed: CFO change and governance
Edgewise has also been tuning its leadership bench as it moves toward later-stage development and (potentially) commercialization.
An SEC 8‑K filed Nov. 10, 2025 details the appointment of Michael Nofi as Chief Financial Officer and outlines transition timing for the prior CFO, including continued support into early 2026. [20]
Separately, the company has framed board and leadership additions as part of preparing for a possible first commercial launch in Becker muscular dystrophy, consistent with its Q3 business update emphasis on commercial infrastructure buildout. [21]
What investors should watch into the close—and before the next session
Because it’s 1:07 p.m. ET and the market is open, EWTX can still move sharply on:
- end-of-day positioning (especially after a news-driven spike earlier this week), and
- any incremental commentary, notes, or follow-up coverage around EDG-7500 safety and dosing.
Practical checklist for the next session (the next regular session after today is Monday, Dec. 29, 2025):
- Confirm the closing print and volume (holiday-week trading can exaggerate moves).
- Track any fresh trial-related filings or updates—the next true catalyst is the full 12-week Part D readout in 2Q 2026. [22]
- Keep an eye on the competitive narrative: FDA’s recent Myqorzo approval keeps investor attention on HCM safety/monitoring requirements, which is exactly where Edgewise is trying to differentiate. [23]
Bottom line for EWTX stock right now
Edgewise Therapeutics stock is behaving like a classic clinical-stage biotech in a competitive therapeutic area: big upside optionality tied to differentiated trial outcomes, paired with high volatility and long timelines.
This week’s EDG-7500 update strengthened the company’s argument that it may deliver HCM benefits without the LVEF suppression that complicates adoption for some existing approaches—but investors also know the real verdict comes later, with bigger datasets and longer follow-up. [24]
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.fda.gov, 9. www.fda.gov, 10. www.investopedia.com, 11. stockanalysis.com, 12. www.benzinga.com, 13. stocktwits.com, 14. edgewisetx.com, 15. www.biospace.com, 16. www.biospace.com, 17. www.marketbeat.com, 18. www.sec.gov, 19. www.sec.gov, 20. www.sec.gov, 21. www.biospace.com, 22. www.prnewswire.com, 23. www.fda.gov, 24. www.prnewswire.com


