Latest news with #XENE
Yahoo
6 days ago
- Business
- Yahoo
Xenon Pharmaceuticals Inc (XENE) Q2 2025 Earnings Call Highlights: Strategic Advances and ...
Cash and Cash Equivalents: $624.8 million as of June 30, 2025. Marketable Securities: Included in the cash and cash equivalents total. Cash Burn: Decrease from $754.4 million as of December 31, 2024, indicating cash used in operations. Funding Outlook: Sufficient cash to fund operations into 2027. Warning! GuruFocus has detected 3 Warning Signs with XENE. Release Date: August 11, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Xenon Pharmaceuticals Inc (NASDAQ:XENE) completed patient recruitment for the X-TOLE2 Phase 3 clinical trial, a significant milestone for the development of azetukalner. The company anticipates having sufficient cash to fund operations into 2027, demonstrating strong fiscal management. Azetukalner has shown promising results in Phase 2b trials with compelling placebo-adjusted efficacy in focal onset seizure patients. Xenon Pharmaceuticals Inc (NASDAQ:XENE) has initiated multiple Phase 3 studies for azetukalner in major depressive disorder and bipolar depression, expanding its clinical development program. The company has a strong presence in the epilepsy community, with plans to present data at upcoming international conferences, enhancing its scientific outreach and educational efforts. Negative Points The timeline for filing the NDA after the X-TOLE2 data readout is approximately six months, which may delay commercialization. There is uncertainty regarding the final number of patients to be randomized in the X-TOLE2 study, which could impact study outcomes. The company has not yet established a compassionate use program for azetukalner, despite interest from the medical community. Xenon Pharmaceuticals Inc (NASDAQ:XENE) faces potential challenges in the epilepsy market, including overcoming the inertia of established treatment practices. There are concerns about potential safety issues with the Nav1.7 program, although no cardiovascular signals have been observed in preclinical data. Q & A Highlights Q: Can you remind us how quickly you think you'll be able to file on the back of the top line FOS data? Also, could you talk about your confidence in the Nav1.7 program in pain regarding safety issues? A: We estimate approximately six months from topline data to filing the NDA for the X-TOLE2 data. Regarding the Nav1.7 program, we believe we have a good handle on potential safety issues, such as cardiovascular signals seen in earlier molecules. We haven't observed any cardiovascular signals in preclinical safety data and will monitor this in human clinical development. Q: For X-TOLE2, when do you expect all patients to be randomized, and what was the patient recruitment split US versus ex-US? A: We have completed patient recruitment for X-TOLE2, and the last patients will go through an eight-week baseline period before randomization. We haven't finalized the specific breakdown of US versus ex-US recruitment or the number of sites yet, but we aim to maintain consistency with the X-TOLE study. Q: Have you seen any compassionate use interest for azetukalner? A: Yes, there is constant interest in compassionate use for azetukalner, not just within neurology and psychiatry but beyond. We are having active discussions about when a compassionate use program could be implemented. Q: How are you thinking about the potential difference in dose response for the 15 and 25 mg doses in the Phase 3 study versus the Phase 2? A: We expect to see a dose response between 15 mg and 25 mg in the Phase 3 program, similar to the clear dose response observed in Phase 2. Our discussions with the FDA suggest having multiple doses on label to provide flexibility to the epilepsy community. Q: On the Nav1.7 program, once you establish proof of concept, would you consider exploring combinations with a Nav1.8? A: We are excited about the leadership position in Nav1.7 and are focused on establishing proof of concept. Long-term, we may consider different combinations of non-opioid mechanisms, including Nav1.8, but it's early to start planning those combinations. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
03-07-2025
- Business
- Yahoo
RBC Raises Xenon Price Target, Cites Phase III Optimism for Epilepsy Drug
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) ranks among the 30 stocks expected to beat the market by 20 percentage points this year. RBC Capital maintained its Outperform rating on Xenon Pharmaceuticals Inc. (NASDAQ:XENE) and increased its price target from $55 to $57 on June 13. The change comes after the company examined the translatability of previous Phase II to Phase III medications for epilepsy. The bank's study showed a strong association between the efficacy results of Phase II and Phase III drugs for focal onset seizures, particularly in terms of responder rates and seizure reductions. According to the findings, Xenon's top medication candidate, azetukalner, will likely exhibit similarly encouraging outcomes in its Phase III data, which is expected to be released early next year. Azetukalner's novel Kv7 mechanism of action, quick onset, and possible mood improvements are cited by RBC Capital as competitive advantages in a market dominated by polypharmacy, with the firm suggesting that future sales might reach $1.2 billion. Xenon Pharmaceuticals Inc. (NASDAQ:XENE) is a biopharmaceutical company that specializes in creating therapies for mental and neurological conditions, such as major depressive disorder (MDD) and epilepsy. While we acknowledge the potential of XENE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
28-06-2025
- Business
- Business Insider
Xenon Pharmaceuticals joins Russell 3000, Russell 2000 Indexes
Xenon Pharmaceuticals (XENE) announced that the company has been added to the broad-market Russell 3000 and small-cap Russell 2000 Indexes as part of the annual reconstitution, effective at the close of U.S. equity markets on Friday, June 27, 2025. The Russell 3000 Index is an equity index that tracks the performance of the largest 3,000 U.S. stocks by market capitalization. The Russell 2000 Index measures the performance of the 2,000 smallest companies within the Russell 3000 Index. Inclusion in the Russell 2000 results in automatic inclusion in the appropriate growth and value style indexes. Russell U.S. Indexes are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for investment strategies. Approximately $10.6T in assets are benchmarked against Russell U.S. indexes.
Yahoo
14-05-2025
- Business
- Yahoo
Why Xenon Pharmaceuticals Inc. (XENE) Declined on Tuesday
We recently published an article titled . In this article, we are going to take a look at where Xenon Pharmaceuticals Inc. (NASDAQ:XENE) stands against the other stocks. Wall Street's main indices finished mixed on Tuesday, as investors digested the country's latest inflation figures, which came out lower than expected. On Tuesday, the Labor Department reported that the Consumer Price Index for April rose by only 0.2 percent last month, bringing the annual inflation rate to 2.3 percent, versus the 2.4 percent in March. It was the lowest annual rate since February 2021. Only the S&P 500 and the tech-heavy Nasdaq registered gains among all major indices, up by 0.72 percent and 1.61 percent, respectively. The Dow Jones, on the other hand, was down by 0.64 percent. Beyond the main indices, 10 firms lagged in performance amid negative news, sparking sell-offs. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5-million trading volume. A team of scientists in lab coats studying a biopharmaceutical molecule in a lab. Xenon Pharmaceuticals Inc. (NASDAQ:XENE) decreased by 17.43 percent on Tuesday to finish at $29.60 apiece following the delayed results of its Phase 3 epilepsy study and a dismal earnings performance in the first quarter of the year. In a statement, Xenon Pharmaceuticals Inc. (NASDAQ:XENE) said that the results of the study are now expected to be released in early 2026. 'While this timing represents a modest shift from our prior guidance, we are encouraged that we are nearing the end of this important study, which represents a significant milestone for Xenon, getting us one step closer to a potential first commercial product launch,' said President and CEO Ian Mortimer. In the first three months of the year, Xenon Pharmaceuticals Inc. (NASDAQ:XENE) said net loss widened by 35.7 percent to $65 million from $47.9 million in the same period last year, despite incurring $7.5 million in revenues during the period. Research and development expenses grew by 38 percent to $61.2 million from $44.3 million year-on-year. Overall XENE ranks 3rd on our list of Tuesday's worst performers. While we acknowledge the potential of XENE as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than XENE but that trades at less than 5 times its earnings, check out our report about this . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
Why Xenon Pharmaceuticals Inc. (XENE) Declined on Tuesday
We recently published an article titled . In this article, we are going to take a look at where Xenon Pharmaceuticals Inc. (NASDAQ:XENE) stands against the other stocks. Wall Street's main indices finished mixed on Tuesday, as investors digested the country's latest inflation figures, which came out lower than expected. On Tuesday, the Labor Department reported that the Consumer Price Index for April rose by only 0.2 percent last month, bringing the annual inflation rate to 2.3 percent, versus the 2.4 percent in March. It was the lowest annual rate since February 2021. Only the S&P 500 and the tech-heavy Nasdaq registered gains among all major indices, up by 0.72 percent and 1.61 percent, respectively. The Dow Jones, on the other hand, was down by 0.64 percent. Beyond the main indices, 10 firms lagged in performance amid negative news, sparking sell-offs. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5-million trading volume. A team of scientists in lab coats studying a biopharmaceutical molecule in a lab. Xenon Pharmaceuticals Inc. (NASDAQ:XENE) decreased by 17.43 percent on Tuesday to finish at $29.60 apiece following the delayed results of its Phase 3 epilepsy study and a dismal earnings performance in the first quarter of the year. In a statement, Xenon Pharmaceuticals Inc. (NASDAQ:XENE) said that the results of the study are now expected to be released in early 2026. 'While this timing represents a modest shift from our prior guidance, we are encouraged that we are nearing the end of this important study, which represents a significant milestone for Xenon, getting us one step closer to a potential first commercial product launch,' said President and CEO Ian Mortimer. In the first three months of the year, Xenon Pharmaceuticals Inc. (NASDAQ:XENE) said net loss widened by 35.7 percent to $65 million from $47.9 million in the same period last year, despite incurring $7.5 million in revenues during the period. Research and development expenses grew by 38 percent to $61.2 million from $44.3 million year-on-year. Overall XENE ranks 3rd on our list of Tuesday's worst performers. While we acknowledge the potential of XENE as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than XENE but that trades at less than 5 times its earnings, check out our report about this . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
