iHub News
3月前
Xenon Pharmaceuticals shares jump 40% after strong Phase 3 seizure trial resultsMarch 9, 2026 10:16 AM
IH Market News
Shares of Xenon Pharmaceuticals Inc. (NASDAQ:XENE) surged 40% on Monday after the company reported positive topline data from its Phase 3 X-TOLE2 trial evaluating azetukalner for focal onset seizures.The study achieved its primary endpoint in both tested dose groups. Patients receiving the 25 mg dose experienced a median reduction of 53.2% in monthly focal onset seizure frequency from baseline, compared with a 10.4% reduction in the placebo group. The placebo-adjusted median reduction of 42.7% for the 25 mg dose exceeded the results seen in the company’s earlier Phase 2b X-TOLE trial, which recorded a placebo-adjusted reduction of 34.6% for the same dose.The trial also met its key secondary endpoint, Responder Rate 50. In the study, 54.8% of patients in the 25 mg group and 37.6% in the 15 mg group achieved at least a 50% decrease in monthly seizure frequency, compared with 20.8% of participants receiving placebo.A total of 380 patients with highly treatment-resistant epilepsy were enrolled in the trial. Participants had previously tried a median of five antiseizure medications and reported a baseline average of 12.75 seizures per month. Of the 332 participants who completed the double-blind portion of the study, 322 chose to continue into the open-label extension phase.Azetukalner was generally well tolerated, with a safety profile consistent with results from the earlier X-TOLE trial. The most commonly reported treatment-emergent adverse events across both dose groups included dizziness, headache, somnolence and fatigue.Xenon said it plans to submit a New Drug Application to the U.S. Food and Drug Administration in the third quarter of 2026 seeking approval of azetukalner for the treatment of focal onset seizures. If approved, the therapy would become the only KV7 potassium channel opener available for epilepsy treatment.Stifel analysts commented, “we think the results here could lead investors to reconsider their peak penetration and peak sales assumptions.”Xenon Pharmaceuticals stock price
Original: Xenon Pharmaceuticals shares jump 40% after strong Phase 3 seizure trial results
tw0122
2年前
Epilepsy
Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. We are currently developing azetukalner for the treatment of epilepsy, including focal onset seizures, or FOS, and primary generalized tonic-clonic seizures, or PGTCS, as well as major depressive disorder, or MDD, while exploring applicability in other neuropsychiatric disorders.
Epilepsy Programs
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Phase 3 FOS studies continue to advance, with the first topline data readout from X-TOLE2 anticipated in the second half of 2025. The Phase 3 FOS clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of azetukalner in patients with FOS.
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Phase 3 X-ACKT clinical study is currently enrolling patients and is intended to support potential regulatory submissions in an additional epilepsy indication of PGTCS. This multicenter, randomized, double-blind, placebo-controlled trial is evaluating the clinical efficacy, safety and tolerability of azetukalner in patients with PGTCS.
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Building upon the 600 patient-years of drug exposure to date, we continue to generate long-term scientific evidence demonstrating azetukalner’s compelling efficacy and safety profile in the ongoing X-TOLE open-label extension, or OLE, study.
crudeoil24
5年前
Xenon Pharmaceuticals Reports Positive Phase 2b Result for Epilepsy Drug
7:21 am ET October 4, 2021 (Dow Jones) Print
By Matt Grossman
Xenon Pharmaceuticals Inc.'s XEN1101 drug achieved positive results in a Phase 2b trial studying its use as an adjunctive treatment for focal epilepsy, the company said Monday.
Compared with a placebo, the drug achieved a statistically significant reduction from the baseline in monthly focal seizure frequency, meeting the study's primary efficacy endpoint.
More than half of patients who received the highest dose of the medication studied experienced a greater-than-50% reduction in seizure frequency, Xenon said. At the median, participants had been experiencing a baseline level of 13.5 seizures per month before the study.
Xenon Chief Executive Ian Mortimer said that the results support an "attractive clinical profile" for the drug. Data from the study have also encouraged Xenon's plans to additionally develop the drug for the treatment of major depressive disorder and for other types of epilepsy, he said.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
October 04, 2021 07:21 ET (11:21 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
XENE
Dr_Thorfin
10年前
Xenon (NASDAQ:XENE) has bucked the downward trend in biotech this month and is up some 10% over the past few weeks. The stock also managed to rise nicely Friday even as the overall biotech sector gave up Thursday's gains. It sells for almost the exact price of Omeros as of the close of the trading week.
Since early August, three analyst firms have reiterated or initiated Buy ratings on this small biotech concern based in Canada. Price targets proffered range from $13 to $20 a share. Guggenheim is the most optimistic on Xenon with a $20 price target. Its analyst noted three reasons to be positive on the firm.
"1. XEN801 addresses an unmet need within the, large, ~$3.7B acne market and could present a novel mechanism of action to treat acne. The three mechanisms of action most commonly used to treat acne have been available for over 30 years. That said, innovative therapies launched over the past few decades have resulted in significant sales. This gives us confidence that XEN801 sales could exceed consensus expectations if it is approved.
2. The pain market needs safer drugs, outside of opioids, which XENE's Nav1.7 blockers could address. The government and the FDA's desire to reduce the abuse of opioids supports the development of novel pain drugs such as XENE's Nav1.7 blockers. We believe XENE and its partners for these drugs are well positioned to benefit from initiatives to move the market away from opioids.
3. There is a free call option on XENE's approved drug, Glybera, and other pipeline assets such as TV-45070 and Nav1.6, among others. Some of these assets could be monetized through partnerships"
Phase II readouts for XEN801 for the treatment of acne is due out inthe first quarter of 2017 and a Phase II readout for TV-45070 against Postherpetic neuralgia should hit in the first half of 2017. The company has just a $125 million market capitalization, positive analyst support and a couple of definable upcoming catalysts. One has to like Xenon's risk/reward profile over the next few quarters.