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 reports developments for a central nervous system precision neuroscience biopharmaceutical company focused on therapies for disorders involving neuronal excitation-inhibition imbalance. Its recurring updates cover the Cerebrum small molecule platform, the Solidus antisense oligonucleotide platform, and product candidates across movement disorders and epilepsy, including ulixacaltamide, relutrigine, vormatrigine and elsunersen.
Company news commonly addresses FDA review activity, clinical trial data, scientific presentations, operating and financial results, commercial-readiness updates, equity inducement grants under Nasdaq rules and governance matters. Disease areas highlighted in its disclosures include essential tremor and developmental and epileptic encephalopathies associated with SCN2A and SCN8A.
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.
• Six major study readouts expected across four programs in next 12 months • Preparing to launch pivotal studies for two DEE programs: EMERALD and EMBRAVE3 • Vormatrigine showing promising safety profile with no food effect • RADIANT study topline results expected by mid-2025 • Essential3 program for ulixacaltamide continuing despite interim analysis recommendation
Financial highlights for Q1 2025: • Net loss of $69.3M vs $39.6M in Q1 2024 • R&D expenses increased to $60.8M from $27.0M YoY • G&A expenses decreased to $13.9M from $15.3M YoY • 20.3M shares outstanding as of March 31, 2025
Praxis Precision Medicines (NASDAQ: PRAX) has announced a virtual investor event scheduled for May 2, 2025, from 10:00 a.m. to 11:30 a.m. EDT. The webinar will focus on the company's clinical programs in developmental and epileptic encephalopathies (DEEs).
The presentation will cover three key clinical studies:
- The EMBOLD study evaluating relutrigine for SCN2A and SCN8A DEEs
- The EMERALD study evaluating relutrigine for broader DEEs
- The EMBRAVE3 study evaluating elsunersen for SCN2A gain-of-function DEE
The event will be hosted by the Praxis management team, with a replay available on the company's website for 90 days under the 'Events & Presentations' page.