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Praxis Precision Medicines, Inc. (NASDAQ: PRAX) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for central nervous system (CNS) disorders characterized by neuronal imbalance. By leveraging genetic insights, Praxis aims to address conditions ranging from major depressive disorder to epilepsy.
The company's lead product candidates include:
- Prax-114: An extrasynaptic-preferring GABAA receptor positive allosteric modulator, currently in Phase IIa trials for treating major depressive disorder and perimenopausal depression.
- Prax-944: A selective small molecule inhibitor of T-type calcium channels, in Phase IIa trials for essential tremor treatment.
- Prax-562: A persistent sodium current blocker in Phase I trials aimed at severe pediatric epilepsy and adult cephalgia.
- Prax-222 (Elsunersen): An antisense oligonucleotide targeting gain-of-function SCN2A epilepsy, under collaboration with Ionis Pharmaceuticals and RogCon, Inc.
- PRAX-628: A next-gen small molecule targeting sodium-channels in the brain, being developed as a treatment for focal epilepsy.
- Ulixacaltamide: A small molecule inhibitor for essential tremor, currently in late-stage development.
Recent news highlights include a partnership with Tenacia to extend ulixacaltamide's reach to Greater China, and advances in the PRAX-628 program demonstrating its potential as a best-in-class epilepsy drug.
Financially, Praxis has shown significant progress. As of the latest reports, the company has sufficient funding to continue operations into 2027, driven by strategic public offerings and a lean operational model.
For more details, visit www.praxismedicines.com and follow them on social media channels.
Praxis Precision Medicines (NASDAQ: PRAX) announced positive results from a preclinical study of PRAX-562, a new sodium channel blocker targeting rare Developmental and Epileptic Encephalopathies (DEEs). The study showed robust antiseizure activity and improved tolerability compared to existing therapies. Praxis plans to initiate a Phase 2 trial in Q1 2022 for treating DEEs, supported by favorable data presented at the American Epilepsy Society Annual Meeting. PRAX-562 has received Orphan Drug Designation from the FDA, indicating its potential as a viable treatment for epilepsy.
Praxis Precision Medicines (NASDAQ: PRAX) will host a Movement Disorder Day on December 17, 2021, from 9:00 a.m. to 12:00 p.m. ET, both virtually and in New York City. The event will provide insights into the company’s Movement Disorder franchise, highlighting the Essential Tremor market and development plans for PRAX-944 and PRAX-114. Additionally, updates on the upcoming clinical study for PRAX-944 in Parkinson’s disease will be discussed. Webcast access will be available through the company's website, with a replay for 90 days.
Praxis Precision Medicines has appointed Megan Sniecinski as its new chief business officer, enhancing its executive leadership team. Promoting Alyssa Wyant to chief regulatory and quality officer and Karl Hansen, Ph.D. to chief technical operations officer reflects the company’s commitment to advancing its clinical-stage programs targeting central nervous system disorders. Sniecinski, with extensive experience in corporate development from her previous roles at BioCryst Pharmaceuticals and Merck, is expected to drive operational excellence and innovation within the company.
Praxis Precision Medicines (NASDAQ: PRAX) announced upcoming presentations at the American Epilepsy Society 2021 Annual Meeting from December 3-7, 2021. They will showcase data from rare disease programs, including PRAX-562, a sodium channel blocker, and a KCNT1 inhibitor. Presenters include senior scientists discussing the efficacy and potency of these treatments. Praxis also emphasizes their broad pipeline for rare epilepsies and ongoing collaborations to explore genetic influences on CNS disorders.
Praxis Precision Medicines (NASDAQ: PRAX) announced its participation in a fireside chat at Piper Sandler’s 33rd Annual Virtual Healthcare Conference on December 2, 2021, at 10:30 a.m. ET. The event will be available via live webcast on the company’s website, with a replay accessible for 90 days thereafter. Praxis focuses on developing therapies for central nervous system (CNS) disorders, leveraging genetic insights to address neurological and psychiatric conditions, and has three clinical-stage candidates in its portfolio.
Praxis Precision Medicines (NASDAQ: PRAX) reported a net loss of $44.7 million for Q3 2021, up from $16.2 million in Q3 2020. The company maintains a cash reserve of $314.4 million as of September 30, 2021, supporting operations until Q2 2023. Clinical advancements include ongoing Phase 2/3 trials for PRAX-114 in Major Depressive Disorder (MDD) anticipated for early 2022, and Phase 2 trials for essential tremor (ET). R&D expenses rose to $33.1 million, driven by clinical and personnel costs. Upcoming data readouts are crucial for the company’s therapeutic pipeline.
Praxis Precision Medicines (NASDAQ: PRAX) will provide a corporate update and report its Q3 2021 financial results on November 3, 2021, before U.S. market opens. The management team will discuss recent business progression and pipeline developments during a conference call at 8:30 a.m. ET. Praxis specializes in creating therapies for CNS disorders, utilizing genetic insights to enhance treatment strategies. The company has a diverse portfolio targeting epilepsy, depression, movement disorders, and pain syndromes, with three clinical-stage candidates.
Praxis Precision Medicines (NASDAQ: PRAX) will participate in the ‘Emerging Therapies for Psychiatric Disorders’ panel at Citi’s 16th Annual BioPharma Virtual Conference on September 8, 2021, at 10:40 a.m. ET. The event will focus on translating genetic insights into therapies for CNS disorders. Interested individuals can access the live webcast on the company’s website, with a replay available for 90 days post-event. Praxis is advancing multiple clinical-stage product candidates targeting epilepsy, depression, and more.
Praxis Precision Medicines has initiated the Phase 2 Acapella Study for adjunctive treatment of Major Depressive Disorder (MDD), with topline results expected in 1H22. The company reported a cash balance of $339.2 million as of June 30, 2021, supporting operations into 2Q23. Key highlights include growth in R&D investments to $25.7 million, driven by clinical programs and personnel increases. However, the net loss for Q2 2021 widened to $36.4 million, reflecting a significant rise in operating expenses compared to the previous year.
Praxis Precision Medicines announced positive results from its PRAX-114 Phase 2a proof-of-concept trial for perimenopausal depression (PMD). Participants receiving a daily 60 mg dose showed a 60% reduction in moderate-to-severe hot flashes and a 68% decrease in the Meno-D total score after 14 days. Mood symptoms also improved, with a 47% reduction in HAM-D scores. PRAX-114 was well tolerated with no significant safety concerns. Given these results, the company plans to advance PRAX-114 to a Phase 2b study by the end of 2021, responding to the substantial unmet need of approximately 3 million U.S. women suffering from PMD.
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