Praxis Precision Medicines, Inc. Stock Price, News & Analysis

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.

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.