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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) 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.
Praxis Precision Medicines announced participation in a fireside chat at the 2021 Wedbush PacGrow Healthcare Virtual Conference, scheduled for August 10, 2021, at 9:10 a.m. ET. The event will feature management discussing the company's advancements in therapies for central nervous system disorders driven by genetic insights. Investors can access the live webcast through the company's website, with a replay available for 90 days post-event. Praxis focuses on a range of CNS disorders, including depression and epilepsy, with three clinical-stage product candidates.
Praxis Precision Medicines (NASDAQ: PRAX), a clinical-stage biopharmaceutical company, has announced its participation in two upcoming virtual investor conferences. The first event is the Cowen Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13, 2021, featuring a fireside chat at 3:00 p.m. ET. The second is the William Blair Biotech Focus Conference on July 15, 2021, with an 'Updates in Neuropsych' panel at 12:00 p.m. ET. Both events will be webcasted and available for replay for 90 days post-event. For more details, visit www.praxismedicines.com.
Praxis Precision Medicines (NASDAQ: PRAX) announces the appointment of Tim Kelly as chief financial officer, effective immediately. Kelly joins from Foundation Medicine, bringing over 20 years of experience in finance within the life sciences sector. CEO Marcio Souza highlighted Kelly’s diverse background, emphasizing his role in guiding the company’s strategic objectives amid a well-capitalized position following recent equity financing. Kelly expressed enthusiasm for joining Praxis, noting the potential of the deep pipeline of CNS drug candidates and upcoming milestones.
Praxis Precision Medicines (NASDAQ: PRAX) has announced its participation in two upcoming virtual investor conferences. The RBC Capital Markets Global Healthcare Conference presentation is scheduled for May 19, 2021, at 2:30 p.m. ET. Additionally, a prerecorded presentation at the Oppenheimer Rare & Orphan Disease Summit will be available on May 21, 2021, at 8:00 a.m. ET. Both events can be accessed via the company's website, and replays will be available for 90 days.
Praxis Precision Medicines has priced an underwritten public offering of 5,000,000 shares at $18.25 each, totaling approximately $91.25 million. The offering, expected to close by May 18, 2021, is aimed at advancing clinical trials for PRAX-114 and PRAX-944 targeting major depressive disorder and other CNS disorders. The offering includes a 30-day option for underwriters to acquire an additional 750,000 shares. Proceeds will also support ongoing trials for PRAX-562 and other development initiatives.
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