As of 8:54 a.m. ET in New York on Friday, December 26, 2025, U.S. stock exchanges have not yet opened for the regular session (standard hours are 9:30 a.m. to 4:00 p.m. ET). [1]
Edgewise Therapeutics, Inc. (NASDAQ: EWTX) is in focus heading into the post-holiday session after the company delivered an encouraging clinical update for EDG-7500—its investigational therapy for hypertrophic cardiomyopathy (HCM)—that helped drive a sharp rally in the last session before Christmas. [2]
Where EWTX stock stands pre-market
Market data tracked by MarketBeat shows EWTX closing at $27.38 on December 24 (the last regular session before Christmas Day), up about 26% on the day, with extended-hours trading around $27.46 as of 8:52 a.m. ET. [3]
The broader tape is also worth watching today: Reuters reported subdued index futures and light post-Christmas trading conditions—a backdrop that can magnify moves in high-beta names like clinical-stage biotech stocks. [4]
What just happened: the EDG-7500 CIRRUS-HCM update that sparked the rally
On December 24 (8:00 a.m. ET), Edgewise announced it had completed Parts B and C of its Phase 2 CIRRUS-HCM trial and shared a favorable interim safety update from the ongoing Part D study. [5]
Here’s what investors keyed in on:
- No clinically meaningful reductions in LVEF (left ventricular ejection fraction) and no drops below 50% were observed in the interim Part D cohort (20 participants who completed 12 weeks as of the data cutoff). [6]
- The company highlighted extensive rhythm surveillance: more than 300 ambulatory monitoring devices capturing over 2,600 patient-days of active monitoring, with no clinically detectable atrial fibrillation (AF) or atrial flutter observed during monitoring. [7]
- One new-onset AF adverse event was reported, but it occurred in an obstructive HCM participant not on active monitoring at the time, with a history of arrhythmias; the investigator deemed it not related to EDG-7500. [8]
- Management reiterated a clear timeline: the company is on track for a full 12-week Part D readout in Q2 2026 and is targeting a Phase 3 start in Q4 2026. [9]
In a statement that captured the market’s attention, CEO Kevin Koch, Ph.D. said he was “especially pleased” with EDG-7500’s safety profile and the lack of ejection fraction drops below 50%. [10]
Why the safety details matter: LVEF and atrial fibrillation have been the swing factors
If you’ve been watching Edgewise for a while, the market’s hair-trigger reaction makes sense.
Earlier in 2025, Edgewise’s EDG-7500 data package drew scrutiny after reports of atrial fibrillation events, including serious cases requiring cardioversion, even as measures like LVOT gradient improved. Investopedia quoted RBC Capital Markets analyst Leonid Timashev warning that “two were serious” could prompt closer FDA review—exactly the kind of regulatory-risk narrative that can crush or lift a development-stage biotech stock in a single session. [11]
Edgewise’s own corporate materials also show why the latest monitoring-heavy update hit differently: earlier CIRRUS trial safety summaries listed atrial fibrillation among treatment-emergent adverse events (for example, 4 of 29 participants in combined cohorts in one slide deck view). [12]
So the December 24 message wasn’t just “good news.” It was “good news in the exact place investors had circled in red ink.”
The investment narrative: differentiated mechanism, reduced monitoring burden, bigger prescribing opportunity
Edgewise positions EDG-7500 as a cardiac sarcomere modulator designed to improve impaired relaxation in HCM without impacting systolic function—a key point because some drug mechanisms in this category can carry systolic dysfunction / heart failure monitoring concerns.
In its release, the company argued that—unlike cardiac myosin inhibitors (CMIs) associated with risks of systolic dysfunction—EDG-7500 has shown no meaningful effect on LVEF to date, which could translate into a lighter monitoring burden and broader adoption beyond specialty “centers of excellence,” if approved. [13]
That “if approved” is doing real work here: nothing is guaranteed in Phase 2. But the market clearly liked the direction of travel.
What analysts are forecasting now: targets, ratings, and what’s embedded in expectations
Wall Street’s consensus view (as aggregated by MarketBeat) currently reflects a “Moderate Buy” stance on EWTX, based on 11 analyst ratings, with an average 12-month price target of $36 (high $51, low $14). [14]
MarketBeat’s analyst table also indicates notable coverage from major firms, including JPMorgan Chase & Co. and Royal Bank of Canada, and shows recent target adjustments—useful context when assessing whether the December move is “new information” or simply the market catching up to an existing bull thesis. [15]
On fundamentals, Edgewise remains a pre-revenue clinical-stage company. In its Q3 2025 update, it reported $563.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, alongside a Q3 net loss of $40.7 million (-$0.39/share). [16]
The company has also emphasized capitalization: an investor deck describes Edgewise as “well-capitalized,” highlighting ~105M common shares outstanding and a stated cash runway through 2028 (noting the deck’s cash figure is presented on a different date basis than the Q3 press release). [17]
Beyond EDG-7500: why Edgewise is more than a one-program stock
While EDG-7500 is driving today’s tape action, Edgewise’s longer-term valuation is also tied to sevasemten (EDG-5506)—its fast skeletal myosin inhibitor program in muscular dystrophies.
Edgewise describes sevasemten as an oral, first-in-class therapy designed to protect muscle from contraction-induced damage in conditions including Becker and Duchenne muscular dystrophy. [18]
Company materials outline clinical work in Becker, including trial designs and endpoints such as the North Star Ambulatory Assessment (NSAA) in longer-duration studies. [19]
And on the cardiac pipeline depth, Edgewise has also disclosed EDG-15400 (a separate cardiac sarcomere modulator program) in Phase 1 development, per the company’s Q3 business highlights. [20]
What investors should know before the next session begins
Because it’s still pre-market in New York, the next regular session can behave a little like a physics lab: you’ve got thin holiday liquidity, a catalyst-driven biotech, and a stock that just made a large percentage move.
A few practical, non-glamorous things that tend to matter more than hot takes:
- Expect wider spreads early. Premarket and the first minutes after the open can be jumpy—especially after a holiday and after a large catalyst move. (Reuters specifically flagged thin post-Christmas conditions.) [21]
- Know what the catalyst actually was. This week’s rally is tied to EDG-7500 safety monitoring and LVEF/AF narratives—not a final efficacy readout. The more comprehensive Part D dataset is slated for Q2 2026, with Phase 3 targeted for Q4 2026. [22]
- Watch for “second-day” behavior. Big biotech moves often face profit-taking, particularly into year-end. December 26 is historically part of the “Santa Claus rally” window, but seasonal tendencies are not destiny. [23]
- Track analyst notes and target changes. MarketBeat’s coverage list shows major-bank analysts following the name; upgrades/downgrades and target moves can add fuel—or a speed bump—to momentum. [24]
- Keep the balance sheet in view. Edgewise’s cash position is substantial for a clinical-stage company, but the business still reports ongoing losses typical of R&D-heavy biopharma. [25]
Bottom line
Edgewise Therapeutics stock is entering the December 26 session with real momentum after its EDG-7500 update delivered what the market most wanted to see: continued preservation of LVEF and an intensive monitoring dataset that found no clinically detectable AF/flutter during active monitoring, alongside a clear path to a fuller readout in Q2 2026. [26]
References
1. www.nasdaq.com, 2. www.prnewswire.com, 3. www.marketbeat.com, 4. www.reuters.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.investopedia.com, 12. s204.q4cdn.com, 13. www.prnewswire.com, 14. www.marketbeat.com, 15. www.marketbeat.com, 16. www.prnewswire.com, 17. s204.q4cdn.com, 18. edgewisetx.com, 19. s204.q4cdn.com, 20. www.prnewswire.com, 21. www.reuters.com, 22. www.prnewswire.com, 23. www.marketwatch.com, 24. www.marketbeat.com, 25. www.prnewswire.com, 26. www.prnewswire.com
