vormatrigine

Search documents
PRAXIS ALERT: Bragar Eagel & Squire, P.C. is Investigating Praxis Precision Medicines, Inc. on Behalf of Praxis Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-08-23 13:32
Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Praxis (PRAX) To Contact Him Directly To Discuss Their Options If you purchased or acquired stock in Praxis and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. NEW YORK, Aug. 23, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential cla ...
PRAX Investors Have Opportunity to Join Praxis Precision Medicines, Inc. Fraud Investigation with the Schall Law Firm
Prnewswire· 2025-08-14 13:28
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].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Praxis Precision Medicines, Inc. - PRAX
GlobeNewswire News Room· 2025-08-13 14:59
[Click here for information about joining the class action] On August 4, 2025, Praxis issued a press release reporting its financial results for the second quarter of 2025. Among other items, Praxis disclosed mid-stage study results for its anti-seizure medication vormatrigine. The Company reported that 36 of 61 patients experienced treatment-emergent adverse events, and that almost one in four participants discontinued the study. On this news, Praxis's stock price fell $3.00 per share, or 5.55%, to close a ...
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Praxis Precision Medicines, Inc. - PRAX
GlobeNewswire News Room· 2025-08-09 15:33
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]
Praxis Precision Medicines, Inc. Investors: Company Investigated by the Portnoy Law Firm
GlobeNewswire News Room· 2025-08-05 21:50
Core Viewpoint - Praxis Precision Medicines, Inc. is under investigation for possible securities fraud following disappointing clinical trial results and a significant drop in stock price [1][3][4] Financial Results - On August 4, 2025, Praxis reported its financial results for Q2 2025, including mid-stage clinical trial results for its anti-seizure medication, vormatrigine [3] - The trial revealed that 36 out of 61 patients experienced treatment-emergent adverse events, with nearly 25% of participants discontinuing the study [3] Stock Performance - Following the announcement of the financial results and clinical trial outcomes, Praxis's stock price fell by $3.00 per share, approximately 5.55%, closing at $51.09 per share on August 4, 2025 [4] Legal Actions - The Portnoy Law Firm has initiated an investigation into Praxis and may file a class action on behalf of investors who suffered losses [1][2] - Investors are encouraged to contact the law firm for a complimentary case evaluation regarding their legal rights [2]
Praxis (PRAX) Q2 Loss Widens 90%
The Motley Fool· 2025-08-04 13:23
Praxis Precision Medicines (PRAX -6.06%) is a clinical-stage biopharmaceutical company specializing in therapies for central nervous system (CNS) disorders. On August 4, 2025, it reported financial results for Q2 FY2025. The most notable news from the release was widening operational losses (GAAP), with no recognized revenue and sharply higher research spending. The company posted a GAAP loss per share of ($3.31), missing the consensus estimate of ($3.25) GAAP, with actual GAAP EPS reported as ($3.39), and ...
Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-04 12:30
Core Insights - Praxis Precision Medicines reported positive results from the RADIANT study, showing a 56.3% median reduction in seizure frequency over eight weeks in focal onset seizure patients, with 22% achieving 100% seizure reduction in the last 28 days [1][2][3] - The company has initiated two registrational studies for Developmental and Epileptic Encephalopathies (DEEs): EMERALD for broad DEEs with relutrigine and EMBRAVE3 for SCN2A Gain-of-Function with elsunersen [1][2] - Relutrigine received U.S. FDA Breakthrough Therapy Designation for treating seizures associated with SCN2A and SCN8A DEEs, facilitating expedited development [1][2] - As of June 30, 2025, Praxis had approximately $447 million in cash and investments, providing a financial runway into 2028 [1][5] Clinical Development - The RADIANT study demonstrated a rapid and sustained response, with around 60% of patients achieving a 50% response rate [3] - Enrollment for the POWER1 pivotal study for vormatrigine is progressing well, with plans to initiate POWER2 and POWER3 studies soon [2][3] - The EMERALD study for relutrigine is expected to enroll up to 160 patients, with completion anticipated in 2026 [6] - The EMBRAVE3 study for elsunersen has been initiated, targeting SCN2A patients aged 2 to 18 years [6] Financial Performance - For Q2 2025, Praxis reported a net loss of $71.1 million, compared to a net loss of $32.7 million in Q2 2024 [10][21] - Research and development expenses increased to $63.0 million in Q2 2025 from $27.3 million in Q2 2024, primarily due to investments in the Cerebrum™ platform [8][21] - General and administrative expenses rose to $13.1 million in Q2 2025 from $10.6 million in Q2 2024 [9][21] Future Outlook - Praxis plans to present additional data at the 36th International Epilepsy Congress on August 31, 2025, and at the American Epilepsy Society Annual Meeting in December 2025 [3] - The company is on track to nominate development candidates for its early-stage ASO therapeutic initiatives by the end of 2025 [6]
Praxis Precision Medicines Announces Positive, Best-in-Disease Topline Results in Patients with Focal Onset Seizures from the RADIANT Study of Vormatrigine
Globenewswire· 2025-08-04 12:00
Dosing with vormatrigine over 8 weeks led to 56.3% median reduction in seizure frequency Approximately 22% of patients reached 100% reduction in seizure frequency in the last 28 days on treatment Rapid and sustained response, with over 54% of patients achieving 50% response in the first week Vormatrigine was generally well tolerated and continues to demonstrate favorable safety profile BOSTON, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutic ...
Praxis Precision Medicines to Host Conference Call to Announce Topline Results from the RADIANT Trial and Provide Second Quarter 2025 Financial Results
Globenewswire· 2025-07-29 12:00
BOSTON, July 29, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced it will report topline results from the RADIANT trial of vormatrigine and its financial results from the second quarter ended June 30, 2025, before the financial markets open on Monday, August 4, 2 ...
Praxis Precision Medicines (PRAX) Earnings Call Presentation
2025-05-02 14:19
Pipeline and Catalysts - The company has 4 assets in late stage development[6] - Clinical readouts are expected in the next 4 quarters[6] - Topline results for the RADIANT open label study of Vormatrigine in focal onset or generalized epileptic seizures are expected by mid-2025[17, 37] - Topline results from the ESSENTIAL3 studies of Ulixacaltamide in Essential Tremor are expected in Q3 2025[17] - EMBOLD Cohort 2 topline results for Relutrigine in SCN2A GoF and SCN8A are expected in 1H 2026, with NDA filing in 2026[17] Epilepsy Portfolio - The US market opportunity for Vormatrigine in common epilepsy (3.5 million US prevalence) is estimated to be greater than $2.5 billion[20] - The US market opportunity for Relutrigine in developmental epilepsies (over 200,000 patients) is estimated to be greater than $3 billion[20] - The US market opportunity for Elsunersen in SCN2A genetically typified developmental epilepsies (~2,000 patients) is estimated to be greater than $500 million[20] - EMBRAVE Part 1 data showed a 39% mean and 43% median reduction in seizures from baseline in SCN2A GoF patients treated with Elsunersen[82] Essential Tremor - Up to 50% of Essential Tremor patients are not receiving treatment for their condition[105] - 85% of neurologist visits are for patients seeking Essential Tremor treatment[108]