Praxis Precision Medicines Inc. (NASDAQ:PRAX) is one of the best biotech stocks to buy according to Wall Street analysts. On December 8, Praxis Precision Medicines Inc. (NASDAQ:PRAX) affirmed successful completion of a pre-New Drug Application meeting with the US Food and Drug Administration for Ulixacaltamide, its investigational oral drug for essential tremor (ET). The company hopes to submit a New Drug Application early next year. TD Cowen Lifts Praxis Precision Medicines Inc. (PRAX) Price Target amid ...

Investors with a lot of money to spend have taken a bearish stance on Praxis Precision Medicine (NASDAQ:PRAX).And retail traders should know.We noticed this today when the trades showed up on publicly available options history that we track here at Benzinga.Whether these are institutions or just wealthy individuals, we don't know. But when something this big happens with PRAX, it often means somebody knows something is about to happen.So how do we know what these investors just did? Today, Benzinga's option ...

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]

Core Insights - Praxis Precision Medicines is set to present new preclinical and clinical data on its precision epilepsy pipeline at the American Epilepsy Society Annual Meeting from December 5-9, 2025, in Atlanta, Georgia [1][2] Company Overview - Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders, particularly those related to neuronal excitation-inhibition imbalance [13] - The company utilizes genetic insights to create therapies for both rare and prevalent neurological disorders through its proprietary platforms, Cerebrum™ and Solidus™ [13] Pipeline and Research Highlights - The company will showcase its precision epilepsy programs through multiple presentations, including late-breaking presentations and a dedicated scientific exhibit at Booth 217 [3][4] - Key programs being highlighted include vormatrigine, relutrigine, and elsunersen, with specific presentations scheduled for December 6 and 8 [4][5][6] - Vormatrigine is a next-generation treatment for focal onset seizures and generalized epilepsy, showing superior selectivity and potency in preclinical studies [10] - Relutrigine is in development for developmental and epileptic encephalopathies, demonstrating robust seizure control in preclinical models and well-tolerated results in Phase 1 studies [11] - Elsunersen targets SCN2A gene expression to treat early-onset seizures, showing significant reductions in seizures and improved outcomes in preclinical models [12] Event Participation - Praxis will engage with attendees at the AES meeting, inviting them to learn more about the company's research and commitment to advancing epilepsy therapies [3][4] - The scientific exhibit will feature all conference posters, with team members available for discussions on clinical updates and progress [4]

Core Insights - Praxis Precision Medicines announced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor, with a pre-NDA meeting with the FDA scheduled for Q4 2025 [1][2] - The company plans to accelerate the development of relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies (DEE) after a comprehensive Type B meeting with the FDA [1][2] - Recruitment for the POWER1 study of vormatrigine in focal onset seizures has been completed, with topline results expected in the first half of 2026, while the POWER2 study has commenced [1][2] Clinical Development Updates - Ulixacaltamide demonstrated significant improvements in symptoms for essential tremor, with a mean improvement of 4.3 points in the modified Activities of Daily Living 11 (mADL11) at Week 8 [3][4] - The first study met all primary and secondary endpoints, while the second study showed 55% of patients on ulixacaltamide maintained their response compared to 33% on placebo [3][4] - Vormatrigine showed a 56.3% median reduction in seizure frequency in the RADIANT study, with 22% of patients achieving a 100% reduction in the last 28 days [4][15] Financial Overview - As of September 30, 2025, Praxis had $389.2 million in cash and marketable securities, down from $469.5 million at the end of 2024, primarily due to cash used in operating activities [6][7] - The company completed a public offering in October 2025, generating net proceeds of approximately $567 million, expected to fund operations into 2028 [7][8] - Research and development expenses increased to $65.8 million for Q3 2025, up from $41.9 million in Q3 2024, largely due to investments in the Cerebrum™ platform [9][10] Market Position and Future Prospects - Praxis is positioned to establish itself as a leader in innovative therapies for CNS disorders, with multiple clinical-stage product candidates across movement disorders and epilepsy [2][18] - The company is on track to nominate development candidates for early-stage antisense oligonucleotide (ASO) therapeutic initiatives in the first half of 2026 [13][18] - The EMBOLD study for relutrigine is expected to provide substantial evidence for NDA submission in early 2026, contingent on a successful interim analysis [4][16]

Core Insights - Praxis Precision Medicines experienced a significant stock surge of 251% following positive phase 3 trial results for ulixacaltamide, a treatment for essential tremor patients [2][3] - The essential tremor condition affects approximately 10 million Americans, with only one approved treatment currently available, indicating a substantial market opportunity for new therapies [5] - Ulixacaltamide has shown promising results in clinical trials, but the company is still in the pre-commercial stage, which may pose risks for investors [3][15] Company Overview - Praxis Precision Medicines is focused on developing treatments for neurological disorders, with ulixacaltamide targeting essential tremor and vormatrigine aimed at epilepsy [13][14] - The company has a market capitalization of approximately $4 billion, reflecting investor interest in its late-stage drug candidates [12][16] - Praxis recently raised $525 million in a secondary offering, bolstering its cash reserves to support ongoing development efforts [15] Clinical Trial Results - In the first phase 3 study, patients treated with ulixacaltamide showed an average improvement of 4.3 points on a modified Activities of Daily Living test, compared to a 1.7-point improvement in the placebo group [7] - The second study indicated that patients who continued treatment with ulixacaltamide had a significantly higher likelihood of maintaining a response and reported improved disease outcomes [8] - Despite the positive results, a notable discontinuation rate of 35.6% in the first study and 38.1% in the second study raises concerns about treatment tolerability [10][11] Market Potential - The potential annual sales for ulixacaltamide could reach billions, given the large population of underserved essential tremor patients [3] - Up to 77% of essential tremor patients feel inadequately treated, and nearly 50% are not receiving any treatment, highlighting a significant unmet medical need [6] Future Prospects - Praxis is also advancing other drug candidates, including vormatrigine for epilepsy, which has shown promising phase 2 results with a 60% reduction in seizure rates for treated patients [13] - The company is preparing to enter phase 3 trials for vormatrigine, indicating a robust pipeline of potential therapies [14] - Investors with a high-risk tolerance may find Praxis an attractive opportunity due to its focus on underserved populations and multiple late-stage candidates [16]

Core Insights - Bragar Eagel & Squire, P.C. is investigating potential claims against Praxis Precision Medicines, Inc. for possible violations of federal securities laws and unlawful business practices [1][2]. Financial Performance - On August 4, 2025, Praxis reported its second-quarter financial results, including mid-stage study results for its anti-seizure medication vormatrigine, where 36 out of 61 patients experienced treatment-emergent adverse events, and nearly 25% of participants discontinued the study [2]. Stock Market Reaction - Following the announcement of the adverse study results, Praxis's stock price decreased by $3.00 per share, or 5.55%, closing at $51.09 per share on August 4, 2025 [3].

Core Viewpoint - The Schall Law Firm is investigating Praxis Precision Medicines, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Praxis issued false or misleading statements and failed to disclose critical information to investors [2]. - Praxis reported its Q2 2025 financial results on August 4, 2025, revealing concerning mid-state clinical results for its anti-seizure medication, vormatrigine [2]. - More than half of the patients in the trial experienced treatment-emergent adverse events, with nearly 25% of participants discontinuing the medication [2]. Group 2: Market Reaction - Following the announcement of the adverse clinical results, shares of Praxis fell by more than 5% on the same day [2].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Praxis Precision Medicines, Inc. and its officers or directors [1]. Financial Results - On August 4, 2025, Praxis reported its second-quarter financial results, including mid-stage study results for its anti-seizure medication vormatrigine [3]. - The study revealed that 36 out of 61 patients experienced treatment-emergent adverse events, with nearly 25% of participants discontinuing the study [3]. - Following the announcement, Praxis's stock price decreased by $3.00 per share, or 5.55%, closing at $51.09 per share on the same day [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Praxis Precision Medicines, Inc. and its officers or directors [1] Financial Results - On August 4, 2025, Praxis reported its financial results for Q2 2025, including mid-stage study results for its anti-seizure medication vormatrigine [3] - The study revealed that 36 out of 61 patients experienced treatment-emergent adverse events, with nearly 25% of participants discontinuing the study [3] - Following the announcement, Praxis's stock price decreased by $3.00 per share, or 5.55%, closing at $51.09 per share on the same day [3]