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Xenon Pharmaceuticals Inc

Xenon Pharmaceuticals Inc. is a neuroscience-focused biopharmaceutical company that discovers, develops, and delivers therapeutics for neurological and psychiatric disorders. Its lead candidate, Azetukalner, is a novel, potent Kv7 potassium channel opener in Phase 3 clinical development for epilepsy, including focal onset seizures and primary generalized tonic-clonic seizures, as well as neuropsychiatric disorders such as major depressive disorder and bipolar depression. The company's Phase 1 Single Ascending Dose/Multiple Ascending Dose products include XEN1701 targeting the sodium channel and XEN1120 targeting the Kv7 potassium channel for pain. Xenon has a license and collaboration agreement with Neurocrine Biosciences, Inc. for the development of NBI-921355, a Nav1.2/1.6 sodium channel inhibitor in Phase 1 clinical trials for certain types of epilepsy. Incorporated in 1996, the company is headquartered in Burnaby, Canada.

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Xenon plunges 24% on trial pause; Netflix downgraded by Wells Fargo

Xenon Pharmaceuticals plunged 24% in premarket trading after submitting a New Drug Application to the U.S. Food and Drug Administration for azetukalner as a treatment for focal seizures in epilepsy while voluntarily pausing new patient enrollment in ongoing Phase 3 trials for major depressive disorder and bipolar depression. Netflix slipped 2.1% after Wells Fargo downgraded the streaming giant to Underweight from Equal Weight and cut its price target to $57 from $80, citing weakening engagement trends. Array Technologies fell 3.1% to $4.11 after UBS downgraded the solar tracking company to Neutral from Buy and cut its price target to $5 from $10, pointing to a shift from payment-in-kind to cash payments on preferred dividend obligations that UBS estimates will total roughly $162 million in cumulative cash payments through 2030. Steel Dynamics dropped 3.4% after guiding third-quarter 2026 earnings to $5.34 to $5.38 per diluted share, below the analyst consensus of $5.60. Frontline fell 6% as the tanker company went ex-dividend for a combined payout of $3.41 per share, made up of a regular second-quarter dividend of $2.61 and a special dividend of $0.80 funded by the sale of two very large crude carriers.
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Xenon plunges 27% on enrollment pause; Nucor and Steel Dynamics guide below consensus

Xenon Pharmaceuticals shares plunged 27% after the company paused enrollment in azetukalner studies for major depressive disorder and bipolar depression following reports of neuropsychiatric adverse events. Xenon said the events are consistent with the drug's known safety and tolerability profile and mechanism but had not previously been observed in its Phase 2 X-NOVA study in MDD, and it expects the pause to be temporary while it evaluates dosing adjustments; currently enrolled patients and those in open-label extension studies will continue treatment. The pause does not affect azetukalner studies in focal seizures or primary generalized tonic-clonic seizures, and Xenon has submitted an NDA to the FDA for focal seizures. Nucor fell 2% and Steel Dynamics fell 2% after both steelmakers issued Q3 earnings guidance below Wall Street expectations, with Nucor expecting Q3 earnings of $5.55-$5.65 per share versus the $5.99 consensus and Steel Dynamics expecting $5.34-$5.38 per share versus the $5.60 consensus. Intapp rose 3% after announcing a partnership with OpenAI to make Celeste, its expert AI coworker, available as a plug-in for ChatGPT Enterprise, with the plug-in available to eligible Intapp Celeste clients starting Thursday.
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Xenon Submits Azetukalner NDA to FDA for Focal Seizures, Pauses Psychiatry Enrollment

Xenon Pharmaceuticals has submitted a New Drug Application to the U.S. Food and Drug Administration for azetukalner in focal seizures, based on positive data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials in which all four doses produced statistically significant reductions in monthly seizure frequency versus placebo. The company also said it has voluntarily paused enrollment of new patients in its ongoing psychiatry studies in major depressive disorder and bipolar depression after an analysis of neuropsychiatric adverse events, though patients already enrolled remain on study and the pause is expected to be temporary. Enrollment in the X-NOVA2 study in MDD has reached approximately 80% of its initial target of 450 patients, and topline data are now expected in the first quarter of 2027. The Phase 3 X-TOLE3 and X-ACKT epilepsy studies continue to enroll focal seizure and primary generalized tonic-clonic seizure patients, respectively, and the epilepsy program has generated more than 1,500 patient-years of safety and exposure data. Xenon will host a conference call today at 4:30 pm Eastern Time to discuss the NDA submission and the psychiatry program update.
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BofA downgrades Biohaven to Underperform, cuts price target to $11

BofA downgraded Biohaven to Underperform from Neutral and lowered its price target to $11 from $12, citing a cautious view of the near-term risk-reward profile ahead of pivotal Phase 3 data for the company's Kv7 epilepsy program expected in the second half of the year. The firm noted Biohaven trails a competing program from Xenon Pharmaceuticals by at least two years and believes consensus expectations for approximately $1 billion in peak sales could face downside risk unless the company demonstrates meaningful clinical differentiation. Earlier, on June 26, Deutsche Bank raised its price target on Biohaven to $20 from $15 while maintaining a Buy rating, highlighting the troriluzole program for spinocerebellar ataxia as a potentially significant value driver that could benefit from the FDA's recent willingness to reconsider previous regulatory decisions in certain neurological diseases.
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Xenon Pharmaceuticals Stock Gains 22% in Six Months on Azetukalner Progress

Xenon Pharmaceuticals shares have risen approximately 22% over the past six months, outperforming the industry's 5.2% decline, driven by investor confidence in its neuroscience pipeline. The lead asset azetukalner met its primary endpoint in the phase III X-TOLE2 study for focal onset seizures, with the 25 mg dose showing a placebo-adjusted median percent change in monthly seizure frequency of -42.7%. Xenon plans to submit a new drug application to the FDA in the third quarter of 2026, and if approved, azetukalner would become the only KV7 potassium channel opener for epilepsy. The company is also advancing azetukalner in phase III studies for major depressive disorder and bipolar depression, with top-line data from the X-NOVA2 MDD study expected in the first half of 2027. Early-stage assets XEN1120 and XEN1701 are in phase I trials for pain, with data anticipated in the second half of 2026.
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