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Xenon Pharmaceuticals' Azetukalner Retains Core Epilepsy Value, RBC Capital Markets Says

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Xenon Pharmaceuticals' (XENE) enrollment pause in an ongoing phase 3 trial of azetukalner adds risk to the experimental treatment's expansion into major depressive disorder and bipolar depression, but should not impact the main value-driving epilepsy indication, RBC Capital Markets said in a note Thursday.

The investment firm said the risk/benefit in psychiatric indications had been deemed less certain given prior safety observations, while the adverse events profile in epilepsy is "cleaner" compared with other anti-seizure medications.

The company has submitted a new drug application for azetukalner in focal seizures to the US Food and Drug Administration and RBC said it does not see any major risk to the filing timelines or commercial launch. Azetukalner is expected to have a strong uptake after its likely approval, according to the note.

The firm said the company may still see a path forward for azetukalner in psychiatry, but the commercial opportunity is likely "a bit more diminished" and the probability of expansion into major depressive disorder and bipolar depression is now lower.

RBC Capital Markets lowered its price target on the stock to $70 from $81, with a rating of outperform, speculative risk.

Shares of Xenon Pharmaceuticals were down more than 29% in Friday trading.

Price: $40.55, Change: $-16.80, Percent Change: -29.29%

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Loop Industries to Evaluate Alternatives, India Joint Venture Financing

Loop Industries (LOOP) formed a committee to evaluate alternatives aimed at advancing commercialization and strengthening its capital position, including a broader project-financing structure for its planned India joint venture.The review will consider "strategic investments, project-level financing, licensing and commercial partnerships, regional joint ventures, business combinations, corporate-structure alternatives, a potential sale, merger or going-private transaction," the company said Thursday in a statement.Loop said there is no assurance the process will result in a sale, merger, going-private transaction or any other transaction or outcome.The review follows Jeff Geygan's appointment as chairman and the separation of the chairman and CEO roles, establishing a board-led process to evaluate capital needs and strategy.Loop shares rose 2% in after-hours trading.

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Top Cryptocurrencies Rise; Bitcoin Tops $76,000 Level

Major digital assets rose Thursday, with Bitcoin (BTC-USD) topping the $76,000 level.The CoinDesk Market Index, which tracks dozens of digital assets including Bitcoin, rose 2% in the past 24 hours. The Nasdaq 100 rose 1.8%, the S&P 500 added 1.2%, and the Dow Jones Industrial Average increased 0.6%.Bitcoin gained 0.8% to $76,473, according to CoinMarketCap data. The most popular cryptocurrency's 24-hour trading volume dropped 24.4% to $23.4 billion.Ethereum (ETH-USD), the second-largest digital asset by market value, rose 1.8% to $2,445.XRP (XRP-USD) declined 0.3%, BNB (BNB-USD) rose 1.6%, and Solana (SOL-USD) gained 2.6%. Dogecoin (DOGE-USD) increased 1.5%, while Cardano (ADA-USD) advanced 3.7%.The total market value of the cryptocurrency industry rose 1.2% in the past 24 hours to $2.62 trillion, with trading volume dropping 12.6% to $77 billion.Price: $76600.00, Change: $+456.19, Percent Change: +0.60%

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Wire

Ultragenyx Shares Rise After FDA Approval for Sanfilippo Syndrome Treatment

Ultragenyx Pharmaceutical (RARE) shares rose 11% after the company won FDA approval for Fayuvi, the first treatment for children with Sanfilippo syndrome type A, a rare genetic condition that progressively damages the brain and nervous system.Delivered as a one-time IV infusion, Fayuvi uses a modified virus to deliver a healthy gene, replacing the enzyme the patients lack. the FDA said Thursday in a statement. In clinical trials, treated children aged 2 to 5 maintained or improved their cognitive abilities compared to historical patient outcomes, the agency said.The FDA noted common side effects like fever, nausea, and elevated liver enzymes. The label also warns of potential long-term risks, including blood clotting issues and tumor formation, requiring patients to take immune-suppressing steroids around the time of treatment.Price: $14.34, Change: $+1.46, Percent Change: +11.34%

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