Two NDA submissions expected by mid-February 2026 for ulixacaltamide in essential tremor and relutrigine in SCN2A/8A-DEEs, both with Breakthrough Therapy Designation from the FDA Multiple registrational readouts expected across vormatrigine, relutrigine and elsunersen in 2026 Strong balance sheet, with $1.5 billion in pro forma cash and investments Combined peak revenue estimates for the four late-stage assets expected to exceed $20 billion BOSTON, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medici ...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news from Praxis Precision Medicines, Rezolute and Geron, as well as updates from Rhythm Pharmaceuticals and Centessa Pharmaceuticals that you may have missed. Praxis Precision Medicines on Thursday announced plans to, sometime early next year, submit an experimental seizure drug for U.S. approval. Researchers have been evaluating the ...

Core Insights - Praxis Precision Medicines Inc. is recognized as a promising biotech stock by Wall Street analysts, particularly due to its advancements in drug development for essential tremor and epilepsy [1][4] Group 1: Drug Development Progress - The company successfully completed a pre-New Drug Application meeting with the US FDA for Ulixacaltamide, an oral drug aimed at treating essential tremor, with plans to submit a New Drug Application early next year [1] - Positive results were confirmed from the EMBOLD study, which evaluated riluzole for patients with SCN2A- and SCN8A-related developmental and epileptic encephalopathies, showing a 53% placebo-adjusted reduction in seizures without serious adverse events [2] - Updated Phase 2 RADIANT trial data indicated that the candidate vormatrigine achieved nearly 100% median seizure reduction in focal onset seizures and about 80% in generalized epilepsy [3] Group 2: Analyst Ratings and Price Target - Analysts at TD Cowen reiterated a Buy rating on Praxis and raised the price target from $251 to $353, reflecting confidence in the company's epilepsy pipeline [3] - The interim EMBOLD results revealed that relutrigine provided a 53% placebo-adjusted reduction in seizures, contributing to the positive outlook from analysts [3]

Core Viewpoint - Praxis Precision Medicines has experienced significant stock performance improvements due to positive clinical trial results and analyst upgrades, indicating strong investor confidence in the company's future prospects [1][5]. Stock Performance - PRAX's stock has increased by 520% over the past three months, primarily driven by successful late-stage studies of ulixacaltamide for essential tremor treatment [2][5]. - The current stock price is $264.06, reflecting a slight decrease of 2.55% or $6.92 from previous levels [3][5]. - The stock has shown considerable volatility over the past year, with a high of $278.44 and a low of $26.70 [3]. Analyst Ratings - Jefferies upgraded PRAX's stock to a "Buy" rating, raising the price target from $300 to $450 [1][5]. Market Capitalization and Trading Volume - Praxis Precision Medicines has a market capitalization of approximately $5.58 billion, with a trading volume of 238,597 shares [4][5]. Clinical Development - The company's progress on pre-New Drug Application steps and positive data for relutrigine have contributed to the recent stock rally, with a regulatory filing anticipated in early 2026 [4].

Core Insights - Shares of Praxis Precision Medicines (PRAX) have increased by 519.5% over the past three months, driven by positive data from late-stage studies of ulixacaltamide for essential tremor [1][6] - The stock has surged 272.6% in the past year, significantly outperforming the industry growth of 9.2% [5] Study Results - The Phase III Essential3 program demonstrated strong efficacy for ulixacaltamide, meeting all primary endpoints and most key secondary measures [2] - In Study 1, ulixacaltamide showed a statistically significant 4.3-point improvement in the Modified Activities of Daily Living 11 (mADL11) score at Week 8, with effects observed as early as Week 2 [2][3] - Study 2 confirmed the treatment's effectiveness, with 55% of responders maintaining their response after an additional four weeks of ulixacaltamide compared to 33% for placebo [4] Safety and Tolerability - Ulixacaltamide was generally well tolerated, with treatment-related adverse events mostly mild in severity, consistent with previous studies [7] Regulatory Progress - Praxis completed a pre-NDA meeting with the FDA, aligning on the content for the upcoming NDA submission for ulixacaltamide, expected in early 2026 [8] - This regulatory progress is seen as a key factor contributing to the recent stock price rally [8] Additional Catalysts - Positive results from the EMBOLD study for relutrigine, another late-stage asset, have also contributed to the stock's upward momentum, with interim analysis showing significant efficacy [9] - The FDA has confirmed a meeting to discuss the regulatory path for relutrigine, providing clarity on next steps [10] Future Opportunities - The ongoing registrational EMERALD study for relutrigine could support a supplemental NDA by 2027 if successful, expanding its market potential [12]

Core Insights - The article identifies 7 hidden multibagger stocks that have shown significant returns and potential upside, emphasizing the importance of selecting stocks with strong fundamentals and growth prospects [1][5]. Group 1: Stock Selection Criteria - Stocks were selected based on a minimum return of 75% over the past year and a market capitalization of at least $1 billion [1]. - The shortlisted stocks were required to have at least 30% potential upside, leading to a ranking of the top 7 stocks [1]. Group 2: Market Outlook - The S&P 500 index is expected to show positive performance for the third consecutive year, with AI adoption potentially driving a productivity boom similar to the late 90s [3]. - Goldman Sachs anticipates that reducing tariff uncertainties could enhance economic security, leading to increased capital deployment in defense, energy, and infrastructure sectors [4]. Group 3: Individual Stock Highlights - **Praxis Precision Medicines, Inc. (NASDAQ:PRAX)**: Achieved a 264% price return over the past year with a potential upside of 33%. The company reported positive results from a key study on a treatment for severe epilepsy [6][8]. - **Solaris Resources Inc. (NYSEAMERICAN:SLSR)**: Recorded a 139% price return with a potential upside of 43.36%. The company is focused on copper and other minerals, with a significant project expected to produce 4.5 million tonnes of Copper Equivalent [10][11]. - **Ouster Inc. (NASDAQ:OUST)**: Experienced a 138.5% price return and has a potential upside of 55.37%. The company is noted for its strong client base and growth prospects in lidar sensor technology [14][15]. - **Xeris Biopharma Holdings, Inc. (NASDAQ:XERS)**: Achieved a 75% price return with a potential upside of 61.3%. The company is advancing a new formulation for hypothyroidism treatment [18][19]. - **Applied Digital Corporation (NASDAQ:APLD)**: Saw a 192.6% price return and has a potential upside of 62.36%. The company is investing in advanced cooling systems for data centers, positioning itself for growth in the AI sector [21][22]. - **IREN Limited (NASDAQ:IREN)**: Recorded a 190.5% price return with a potential upside of 91.23%. Despite recent funding challenges, the company has strong fundamentals supported by a significant AI contract with Microsoft [24][26]. - **UniQURE (NASDAQ:QURE)**: Achieved a 186% price return with a potential upside of 117.16%. The company is developing a gene therapy for Huntington's disease, although it faces regulatory challenges [28][29].

Core Viewpoint - Investors with significant capital have adopted a bearish stance on Praxis Precision Medicine, indicating potential upcoming developments that may impact the stock [1][2]. Options Trading Activity - Benzinga's options scanner identified 21 unusual options trades for Praxis Precision Medicine, with a split sentiment of 38% bullish and 47% bearish among large investors [2][3]. - The total amount for put options reached $481,965, while call options totaled $1,290,815, suggesting a stronger interest in bullish positions despite the overall bearish sentiment [3]. Predicted Price Range - Over the last three months, large investors have targeted a price range for Praxis Precision Medicine between $65.0 and $300.0 based on volume and open interest in options contracts [4]. Volume and Open Interest Analysis - An analysis of volume and open interest reveals crucial insights into liquidity and interest levels for Praxis Precision Medicine's options, particularly within the strike price range of $65.0 to $300.0 over the past month [5]. Current Market Status - In the last month, five experts provided ratings on Praxis Precision Medicine, with an average target price of $203.2, indicating a generally positive outlook despite mixed sentiments [14]. - Analysts from HC Wainwright & Co. maintain a Buy rating with a target price of $340, while another analyst from the same firm downgraded to a Buy with a target of $258 [15]. - Wedbush analysts have a more cautious view, maintaining an Underperform rating with target prices of $83 and $77 [15]. Company Overview - Praxis Precision Medicine is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders, with three clinical-stage product candidates and one in-licensed candidate [12].

Core Insights - Praxis Precision Medicines Inc. stock increased following positive results from the EMBOLD study evaluating relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies [1] - The FDA has scheduled a meeting to review the data and discuss the next steps, with Praxis planning to determine the timing for filing a New Drug Application (NDA) post-meeting [2][4] - Analyst commentary suggests relutrigine is expected to be a blockbuster drug, with increased probability of success and projected peak sales significantly raised [5][7] Study Results - The Data Monitoring Committee recommended stopping the EMBOLD study early due to efficacy [1] - Topline results from the EMBOLD study will be presented at the American Epilepsy Society Annual Meeting [3] Regulatory Developments - Praxis completed its pre-NDA meeting with the FDA, receiving written feedback and conducting an in-person meeting [3] - The company expects to submit its NDA in early 2026 after aligning with the FDA on the content [4] Analyst Insights - HC Wainwright views relutrigine as overlooked but anticipates a shift in perception following EMBOLD data [5] - The analyst increased the probability of success for relutrigine to 80% from 60% and raised projected peak sales to $2.8 billion from $760 million [6][7] - The firm maintains a Buy rating for Praxis Precision and increased the price forecast from $258 to $340 [7] Pipeline Developments - Praxis previously shared positive topline results from its Phase 2 RADIANT study, showing a median seizure reduction of approximately 56.3% in patients with focal onset seizures and generalized epilepsy [8] - The stock price rose by 30.84% to $248.56, reaching a new 52-week high [8]

This live blog is refreshed periodically throughout the day with the latest updates from the market.To find the latest Stock Market Today threads, click here. Happy Friday. This is TheStreet’s Stock Market Today for Dec. 5, 2025. You can follow the latest updates on the market here in our daily live blog. Update: 12:00 p.m. Midday Moers: Praxis Precision Medicines, DigitalBridge, Parsons, Argan, Warner Bros. Heading into midday, stocks have paled back from the morning's excitements, including the first ...

U.S. Stock Market Performance - U.S. stocks traded higher, with the Nasdaq Composite gaining around 0.2% on Friday [1] - The Dow increased by 0.17% to 47,933.71, while the NASDAQ rose 0.16% to 23,543.03, and the S&P 500 gained 0.15% to 6,867.40 [1] - Communication services shares jumped by 0.9%, while utilities stocks fell by 0.6% [1] Economic Indicators - The U.S. PCE price index increased by 0.3% month-over-month in September, consistent with the previous month and market estimates [2][11] - U.S. personal income rose by 0.4% month-over-month to $26.397 trillion in September [8] Commodity Market - Oil traded up 0.7% to $60.08, gold increased by 0.1% to $4,245.70, silver rose by 2.7% to $59.035, and copper gained 1.2% to $5.4385 [5] Company-Specific Movements - Praxis Precision Medicines Inc shares surged 31% to $248.00 after announcing completion of its pre-NDA meeting with the FDA [9] - DigitalBridge Group Inc shares increased by 32% to $12.86 following reports of SoftBank's interest in acquiring the company [9] - Rubrik Inc shares rose 23% to $86.80 after reporting better-than-expected third-quarter results and raising FY26 guidance [9] - Parsons Corp shares dropped 25% to $62.97 after losing a joint bid with IBM for a new air traffic control system [9] - Sportsman's Warehouse Holdings Inc shares fell 30% to $1.70 after reporting third-quarter results [9] - Domo Inc shares decreased by 23% to $8.87 after reporting third-quarter results and issuing lower-than-expected fourth-quarter sales guidance [9]