Earnings summaries and quarterly performance for Praxis Precision Medicines.
Executive leadership at Praxis Precision Medicines.
Board of directors at Praxis Precision Medicines.
Research analysts who have asked questions during Praxis Precision Medicines earnings calls.
Ami Fadia
Needham & Company, LLC
4 questions for PRAX
Douglas Tsao
H.C. Wainwright & Co.
4 questions for PRAX
Joon Lee
Truist Securities
4 questions for PRAX
Ritu Baral
TD Cowen
4 questions for PRAX
Yasmeen Rahimi
Piper Sandler & Co.
4 questions for PRAX
Yatin Suneja
Guggenheim Partners
4 questions for PRAX
François Brisebois
Oppenheimer & Co. Inc.
3 questions for PRAX
Joel Beatty
Baird
3 questions for PRAX
Kambiz Yazdi
Jefferies
3 questions for PRAX
Brian Skorney
Robert W. Baird & Co.
1 question for PRAX
David Hoang
Citigroup
1 question for PRAX
Doug Tsao
H.C. Wainwright & Co.
1 question for PRAX
Jay Olson
Oppenheimer & Co. Inc.
1 question for PRAX
Laura Chico
Wedbush Securities
1 question for PRAX
Rudy Li
Chardan Capital Markets
1 question for PRAX
Recent press releases and 8-K filings for PRAX.
- Praxis Precision Medicines, Inc. (NASDAQ: PRAX) announced the appointment of Dr. Orrin Devinsky, M.D., as its new Head of Clinical Strategy on January 13, 2026.
- Dr. Devinsky is a world-renowned neurologist and epilepsy authority with over four decades of experience, having shaped the development of multiple transformative therapies and served as Principal Investigator for pivotal clinical trials leading to the first FDA approval of cannabidiol therapy for rare epilepsies.
- In this new leadership role, Dr. Devinsky will guide clinical strategy and global medical affairs, focusing on program architecture, evidence generation, and external scientific engagement as Praxis advances its growing late-stage portfolio toward commercialization.
- Praxis Precision Medicines, Inc. entered into an underwriting agreement on January 6, 2026, for an underwritten offering of 2,212,000 shares of its common stock at $260.00 per share.
- The underwriters fully exercised their option to purchase an additional 331,800 shares on January 7, 2026.
- The offering is expected to generate approximately $621.2 million in net proceeds, which the company plans to use for commercialization preparation, research and development, and general corporate purposes.
- These proceeds, combined with existing capital, are anticipated to fund the company's operating expenses and capital expenditure requirements into 2028.
- Praxis Precision Medicines (NASDAQ: PRAX) priced an underwritten public offering of 2,212,000 shares of its common stock at $260.00 per share.
- The offering is expected to generate approximately $575 million in gross proceeds for the company, before deducting underwriting discounts and commissions and estimated offering expenses.
- Praxis has granted the underwriters a 30-day option to purchase up to 331,800 additional shares of common stock.
- The offering is anticipated to close on or about January 8, 2026.
- Praxis Precision Medicines received Breakthrough Therapy Designation from the FDA for ulixacaltamide for the treatment of essential tremor, based on positive topline results from its Essential3 Phase 3 program.
- The company plans to submit a New Drug Application (NDA) in early 2026 after completing a pre-NDA meeting with the FDA.
- Following the announcement, Praxis shares were up nearly 11% to $297.83 in premarket trading, from a closing price of $268.95 on Friday.
- Despite this regulatory milestone, Praxis faces financial challenges, including negative margins and a high price-to-sales ratio, with a market capitalization of approximately $6.73 billion.
- On December 29, 2025, Praxis Precision Medicines, Inc. (PRAX) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for its drug ulixacaltamide.
- The BTD was granted for the treatment of patients with essential tremor (ET), based on positive topline data from the Essential3 program's two pivotal Phase 3 studies.
- This designation is expected to expedite the development and regulatory review process for ulixacaltamide.
- Praxis Precision Medicines announced the FDA granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for the treatment of essential tremor (ET).
- The BTD was awarded based on positive topline results from the Essential3 Phase 3 program and enables expedited development and regulatory review.
- The company is on track to submit the ulixacaltamide NDA in early 2026, having recently completed a pre-NDA meeting with the FDA.
- Essential Tremor is a significant market, affecting approximately seven million people in the United States and representing a multi-billion dollar commercial opportunity.
- Praxis Precision Medicines, Inc. announced FDA agreement to convert the EMBRAVE3 registrational study of elsunersen into a single-arm study, reducing patient enrollment from 40 to 30 patients.
- The company expects to disclose topline results for Part A of the EMBRAVE Study in the first half of 2026.
- The FDA has confirmed that Praxis Precision Medicines, Inc. can file a New Drug Application for relutrigine in early 2026 for SCN2A and SCN8A DEEs.
- Praxis Precision Medicines has successfully completed discussions with the FDA, confirming its plan to file a New Drug Application (NDA) for relutrigine in early 2026.
- The NDA for relutrigine, a treatment for developmental and epileptic encephalopathies (DEEs) including SCN2A and SCN8A, is supported by statistically significant and clinically meaningful improvements observed in the EMBOLD study.
- Relutrigine has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA, and Breakthrough Therapy Designation from the European Medicines Agency for SCN2A-DEE and SCN8A-DEE.
- Praxis Precision Medicines announced FDA alignment to convert the EMBRAVE3 registrational study for elsunersen into a single-arm, baseline-controlled study, reducing patient enrollment from 40 to 30.
- This change ensures all patients in the EMBRAVE3 trial will receive active treatment from day one, with the primary analysis focusing on the change from baseline in countable motor seizures.
- Praxis anticipates topline results for EMBRAVE3 in 2026 and for the EMBRAVE study (Part A) in the first half of 2026.
- Praxis Precision Medicines, Inc. successfully completed its pre-New Drug Application (NDA) meeting with the FDA for ulixacaltamide, with the NDA submission anticipated in early 2026.
- The company announced positive results from the registrational EMBOLD study for relutrigine, which was stopped early for efficacy, demonstrating a 53% placebo-adjusted reduction in seizures over 16 weeks.
- Full results from the RADIANT study for vormatrigine showed a 54% median reduction in seizures for focal onset seizure patients, with over 11% achieving seizure freedom for 8 weeks. Recruitment for the POWER1 pivotal study is complete, and the POWER3 monotherapy study is on track to begin in the first half of 2026.
Quarterly earnings call transcripts for Praxis Precision Medicines.
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