Praxis Precision Medicines, Inc. - PRAX STOCK NEWS

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.

Praxis Precision Medicines has announced a collaboration with Ciitizen to improve drug development for SCN2A developmental and epileptic encephalopathy (SCN2A-DEE). The partnership aims to leverage real-world data through the Ciitizen platform for enhanced clinical trial designs and biomarker identification. Both PRAX-222 and PRAX-562 have received rare pediatric disease and orphan drug designations from the FDA. PRAX-562 is currently in a Phase 1 clinical trial, while PRAX-222 is in IND-enabling studies. This collaboration underscores Praxis' commitment to patient-centered approaches.