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 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.
Praxis Precision Medicines (NASDAQ: PRAX) announced an underwritten public offering of 4,000,000 shares of common stock, with underwriters having an option to purchase an additional 15%. The offering aims to raise funds to advance the clinical development of PRAX-114 for major depressive disorder (MDD), PTSD, essential tremor, and other CNS disorders, alongside supporting ongoing trials for PRAX-944 and PRAX-562. Proceeds will also support working capital and general corporate purposes. The offering is subject to market conditions and regulatory approval.
Praxis Precision Medicines (PRAX) announced significant progress in its CNS disorder pipeline, with new Phase 2 trials for PRAX-114 in post-traumatic stress disorder and essential tremor starting in 2H21, and PRAX-944 for Parkinson's in 1H22. The company reported a cash balance of $270.8 million as of March 31, 2021, sustaining operations into 4Q22. First-quarter net loss was $27.4 million, up from $8.3 million a year earlier, driven by increased R&D and administrative costs. Key trial results are anticipated in 2022.
Praxis Precision Medicines announced that the FDA has granted orphan drug designation to PRAX-562 for treating SCN2A developmental and epileptic encephalopathy (SCN2A-DEE). This designation recognizes the drug as a potential treatment for a rare condition that affects fewer than 200,000 individuals in the U.S. The company plans to initiate a Phase 2 clinical trial in the first half of 2022. PRAX-562 has shown promise in preventing seizures in animal models and could provide new treatment options for patients suffering from this debilitating condition.
Praxis Precision Medicines (NASDAQ: PRAX) announces the appointment of Dr. Merit Cudkowicz to its board of directors. Dr. Cudkowicz, a prominent neurologist at Mass General Hospital and Harvard Medical School, brings extensive expertise in CNS research and clinical development. Her experience includes leading innovative treatments for neurological disorders and participation in clinical trials. Praxis aims to leverage her insights to enhance its pipeline of therapies targeting CNS disorders, fostering innovation and improved patient outcomes.
Praxis Precision Medicines (NASDAQ: PRAX) has appointed Dr. Jeffrey Chodakewitz to its board of directors, bringing over 30 years of biopharmaceutical experience, including leadership roles at Vertex Pharmaceuticals and Merck & Co. This move follows the resignation of board members Dr. Nicholas Galakatos and Dr. Kiran Reddy. The company emphasizes Dr. Chodakewitz's valuable insights in global development as it advances its clinical-stage pipeline, which targets CNS disorders. Praxis aims to expand its portfolio with precision therapies focusing on rare disorders.
Praxis Precision Medicines (NASDAQ: PRAX) has received orphan drug designation from the FDA for PRAX-562, targeting SCN8A development and epileptic encephalopathy. This designation, aimed at developing treatments for rare diseases, provides benefits like tax credits and market exclusivity for seven years post-approval. PRAX-562 is a first-in-class selective persistent sodium current blocker, currently in a Phase 1 trial. Preliminary data shows promising results in animal models, including a favorable safety profile and effective seizure protection at high doses.
Praxis Precision Medicines (NASDAQ: PRAX) announced management's participation in a fireside chat at Stifel’s 3rd Annual CNS Day, scheduled for March 31, 2021, at 8:30 a.m. ET. The event aims to showcase the company's innovations in therapies for central nervous system disorders, leveraging genetic insights. A live webcast will be accessible on their website, with a replay available for 90 days post-event. Praxis is advancing multiple clinical-stage product candidates targeting conditions such as depression and epilepsy.
Praxis Precision Medicines reported a corporate update and Q4 2020 financial results, highlighting IND clearance for PRAX-114 to treat major depressive disorder (MDD). The Phase 2/3 trial is set to begin in March 2021, with topline data anticipated in H1 2022. The company has a robust cash balance of $296.6M, expected to last into Q4 2022. R&D expenses surged to $16.3M in Q4 2020 while the net loss was $25.7M. The collaboration with The Florey Institute adds three ASOs targeting rare epilepsies.
Praxis Precision Medicines (NASDAQ: PRAX) will report its financial results for Q4 and full year 2020 on March 17, 2021, before market open. A conference call and webcast will follow at 8:00 a.m. ET, discussing business progress and pipeline developments. Praxis is focused on therapies for CNS disorders, leveraging genetic insights to address conditions such as severe pediatric epilepsies and psychiatric diseases. They have three clinical-stage candidates in their portfolio.