Welcome to our dedicated page for Praxis Precision Medicines news (Ticker: PRAX), a resource for investors and traders seeking the latest updates and insights on Praxis Precision Medicines stock.
Praxis Precision Medicines, Inc. (NASDAQ: PRAX) is a clinical-stage biopharmaceutical company focused on central nervous system (CNS) disorders characterized by neuronal excitation–inhibition imbalance. The PRAX news page on Stock Titan aggregates company announcements, clinical updates, regulatory milestones and capital markets activity related to its precision neuroscience pipeline.
Investors and followers of Praxis can use this page to track developments across the company’s diversified CNS portfolio. News items include progress updates on late-stage product candidates such as ulixacaltamide for essential tremor, vormatrigine for focal onset seizures and generalized epilepsy, relutrigine for developmental and epileptic encephalopathies (DEEs), and elsunersen for early-onset SCN2A-DEE. Praxis frequently reports on Phase 2 and Phase 3 study readouts, FDA interactions such as pre-NDA meetings and Breakthrough Therapy Designations, and changes to registrational trial designs.
The feed also covers corporate and financial disclosures, including underwritten public offerings, at-the-market equity programs, and governance or leadership changes. Form 8-K filings referenced in press releases provide additional detail on clinical data, regulatory feedback and financing terms. Because Praxis emphasizes precision neuroscience and genetic epilepsies, its news often highlights mechanistic data, biomarker findings and functional outcomes in epilepsy and movement disorder studies.
By reviewing this PRAX news stream, readers can follow key catalysts such as NDA preparation, pivotal trial milestones, regulatory designations and capital raises that may influence the company’s trajectory as it advances its CNS portfolio. Bookmark this page to access an organized view of Praxis Precision Medicines’ latest public communications and disclosures.
Praxis Precision Medicines (NASDAQ: PRAX), a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders, has announced its upcoming participation in a virtual event. CEO Marcio Souza will engage in a fireside chat hosted by Truist Securities analyst Joon Lee on August 5, 2025 at 10:00 AM EST.
Praxis Precision Medicines (NASDAQ: PRAX) reported significant progress across its epilepsy treatment portfolio in Q2 2025. The company's RADIANT study for vormatrigine showed a 56.3% median reduction in seizure frequency in focal onset seizure patients, with 22% achieving complete seizure elimination. Two registrational studies were initiated: EMERALD for DEEs with relutrigine and EMBRAVE3 for SCN2A GoF with elsunersen.
The FDA granted Breakthrough Therapy Designation for relutrigine in treating SCN2A and SCN8A DEEs. Financially, Praxis maintains a strong position with $446.6 million in cash and investments as of June 30, 2025, extending runway into 2028. Q2 2025 saw a net loss of $71.1 million, with R&D expenses increasing to $63.0 million from $27.3 million year-over-year.
Praxis Precision Medicines (NASDAQ: PRAX) announced positive topline results from its Phase 2 RADIANT study of vormatrigine for focal onset seizures. The study demonstrated a 56.3% median reduction in seizure frequency over 8 weeks, with 22% of patients achieving complete seizure freedom in the final 28 days of treatment.
Key highlights include 54% of patients achieving 50% response in the first week of treatment. Vormatrigine showed a favorable safety profile and demonstrated advantages as a fast-acting, no-titration, once-daily oral drug with no food requirements. The company plans to complete its pivotal POWER1 study in Q4 and initiate POWER2 study based on these results.
Additional data will be presented at the 36th International Epilepsy Congress on August 31, 2025, with plans to present full study results at the American Epilepsy Society Annual Meeting in December 2025.
Praxis Precision Medicines (NASDAQ: PRAX), a clinical-stage biopharmaceutical company focused on CNS disorders, has scheduled a significant announcement combining two key updates. The company will release topline results from the RADIANT trial of vormatrigine along with its Q2 2025 financial results before market open on August 4, 2025.
The company will host a live webcast at 8:30 AM ET on the same day to discuss these results. Investors can access the webcast through a registration link or the company's website, with a replay available for 90 days following the event.
Praxis Precision Medicines (NASDAQ: PRAX) has received FDA Breakthrough Therapy Designation (BTD) for relutrigine in treating seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The designation was based on compelling Phase 2 EMBOLD trial results showing:
The trial demonstrated 46% placebo-adjusted monthly motor seizure reduction during the 16-week double-blind period, with over 30% of patients achieving seizure freedom. In the 11-month open-label extension, patients showed ~90% seizure reduction and increased seizure-free periods from 3 to 67 days.
The company expects topline results from the registrational EMBOLD cohort 2 study in H1 2026, followed by an NDA filing. Additionally, Praxis has initiated the EMERALD study investigating relutrigine across all DEEs.
Praxis Precision Medicines (NASDAQ: PRAX), a clinical-stage biopharmaceutical company focused on CNS disorders, has granted restricted stock unit (RSU) awards to three new non-executive employees. The awards, totaling 2,100 shares of common stock, were issued under the company's 2024 Inducement Plan on July 1, 2025.
The RSUs will vest over four years in equal annual installments, contingent on continued employment. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as inducement awards for new hires who were not previously Praxis employees.
Praxis Precision Medicines (NASDAQ: PRAX), a clinical-stage biopharmaceutical company focused on developing CNS disorder therapies, has announced its participation in three upcoming investor conferences:
- H.C. Wainwright BioConnect Conference - Fireside chat on May 20th at 9:30am ET at NASDAQ
- Mizuho Neuro & Ophthalmology Summit - Participation on May 21st in New York City
- Jefferies Global Healthcare Conference - Corporate overview presentation on June 4th at 8:10am ET at Marriott Marquis, NYC
The company will be available for one-on-one meetings during all events, with webcasts available for select presentations through the company's website for 90 days.
Their lead drug relutrigine showed promising results in the EMBOLD study, with patients achieving ~90% seizure reduction and extending seizure-free periods from 3 to 67 days after 11 months. The company plans to initiate the EMERALD registrational study in mid-2025, targeting a US market potential of $3+ billion.
For elsunersen, the EMBRAVE3 registrational trial will begin mid-2025, initially enrolling patients ages 2-18 with plans to extend to newborns. The global market potential is estimated at $1 billion with 5,000 addressable patients.
In their pipeline, Praxis expects to nominate development candidates for PRAX-100 (targeting monogenetic autism) by mid-2025, and PRAX-080 and PRAX-090 by end of 2025.
Praxis Precision Medicines (NASDAQ: PRAX) has granted restricted stock unit (RSU) awards to five new non-executive employees under its 2024 Inducement Plan. The awards cover a total of 3,688 shares of common stock and were approved by the Compensation Committee on May 1, 2025. The RSUs will vest over four years in equal annual installments, contingent on continued employment.
The grants were made as employment inducements in accordance with Nasdaq Listing Rule 5635(c)(4). Praxis, a clinical-stage biopharmaceutical company, focuses on developing therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance.
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