Newron Prepares FDA Rebuttal as Evenamide's Late-Stage Clock Keeps Ticking
Published on 10/09/2026 at 17:51 | Editorial boerse-global.de
Newron Pharmaceuticals is assembling a formal response to the US Food and Drug Administration in a bid to lift a recruitment freeze at American trial sites, even as its lead candidate Evenamide pushes ahead toward a pivotal data readout in early 2027.
At the heart of the agency's scrutiny is the theoretical risk of cardiac arrhythmia posed by sodium-channel blockers. To counter that concern, the Italian biotech is leaning on a deep pool of safety data: more than 10,000 electrocardiograms drawn from roughly 700 treated patients, which the company says show no discernible pattern of cardiac abnormalities.
A Statistical Counterargument on Mortality
Newron disclosed the substance of the FDA's written notice on the previous day. The regulator flagged four deaths among patients on Evenamide against a single death on placebo across the entire development program to date. Investigators attributed three of the four Evenamide cases to causes unrelated to treatment, while one was judged possibly linked to the therapy. Because the FDA could not fully rule out a fatal arrhythmia, it treated the cluster as a potential safety signal.
The company's answer rests on a duration-adjusted reading of the data. On an unadjusted basis, incidence stands at 0.56% on Evenamide versus 0.27% on placebo — a gap that flips once time on treatment is factored in. Adjusted for exposure, Newron recorded 1.31 deaths per 100 patient-years in the active arm, compared with 1.81 deaths per 100 patient-years on placebo.
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CEO Stefan Weber pointed to the company's track record with sodium-channel compounds, citing the Parkinson's drug Xadago, which has been on the market in Europe for eleven years and in the US for nine.
Protocol Change Targets US Sites
To address the American hold, Newron has proposed extra safety checks for the second Phase 3 trial, ENIGMA-TRS 2. Every participant would first be screened for Brugada syndrome and other sodium-channel disorders. The protocol amendment is due to be filed with the FDA within 10 to 12 days, with the agency required to respond within 30 days of receipt.
The FDA had informed Newron of the continued US recruitment halt roughly two weeks earlier. No patient had received the drug at US sites before the stop was imposed. Elsewhere, enrollment in ENIGMA-TRS 2 continues without interruption, and the company is bringing additional international sites on board to protect its timeline. The study's target of at least 400 patients remains unchanged, and management expects only minor delays to the overall program, with the clinical development cost base largely stable.
ENIGMA-TRS 1 Takes Center Stage
With the US arm stalled, investor attention has shifted squarely to the first Phase 3 study, ENIGMA-TRS 1, which spans more than 600 patients across 20 countries. Patient enrollment is expected to wrap up by mid-October 2026, setting the stage for topline results from the 12-week primary assessment in the first quarter of 2027.
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The uncertainty over the US path weighed on the stock in the prior session, with the shares shedding 3.0% to close at EUR 7.72. Even so, the price remains 40% above its 52-week low of EUR 5.50. In today's trading, the stock climbed 7.5% to EUR 8.30.
Funding Covers the Runway Into Late 2027
Newron's balance sheet gives management room to maneuver through the coming trial phases. At the end of June, the company reported cash and short-term investments of EUR 32.9 million. Fresh capital arrived about a month ago through a financing tranche and a milestone payment, and management says current liquidity is sufficient to fund development operations through most of 2027.
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