Praxis Precision Medicines, Inc. - PRAX STOCK NEWS

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.

The FDA has granted rare pediatric disease (RPD) and orphan drug designation (ODD) for Praxis Precision Medicines' PRAX-222, targeting SCN2A developmental and epileptic encephalopathy (SCN2A-DEE). Additionally, RPD has been awarded to PRAX-562 for both SCN2A-DEE and SCN8A-DEE. These designations recognize the urgent need for treatment options for severe pediatric epilepsies. PRAX-562 is currently in Phase 1 trials for adults, while PRAX-222 is in IND-enabling studies. Both drugs aim to address critical gaps in current treatment paradigms for rare CNS disorders.

Praxis Precision Medicines (NASDAQ: PRAX) announced the transition of Stuart Chaffee, Ph.D., from CFO to a part-time strategic advisor, while the company searches for a new full-time CFO. Lauren Mastrocola will serve as the interim principal financial officer. Dr. Chaffee expressed pride in the company's progress and aims to focus on early-stage company development. Praxis is dedicated to creating therapies for central nervous system disorders, with five disclosed programs targeting conditions like pediatric epilepsy and psychiatric diseases.

Praxis Precision Medicines (NASDAQ: PRAX) announced its participation in two upcoming virtual investor conferences. The Piper Sandler 32nd Annual Healthcare Conference will feature a prerecorded fireside chat on November 23, 2020, at 10:00 a.m. ET, with institutional meetings on December 1, 2020. Additionally, the 3rd Annual Evercore ISI HealthCONx Conference will host a fireside chat on December 3, 2020, from 3:55 – 4:15 p.m. ET. Webcasts will be available on the company’s website for 90 days post-event.

Praxis Precision Medicines announced on November 17, 2020, that the FDA placed its Investigational New Drug (IND) submission for PRAX-114 on clinical hold due to concerns regarding non-clinical pharmacology and toxicology. The FDA requested further toxicological studies related to fertility and embryofetal development. Praxis anticipates beginning a Phase 2/3 clinical trial for PRAX-114 in major depressive disorder (MDD) in the first half of 2021, pending resolution of the hold. The company continues dialogue with the FDA to expedite the trial initiation.

Praxis Precision Medicines (NASDAQ: PRAX) announced that the U.S. FDA has placed a full clinical hold on its Investigational New Drug (IND) submission for PRAX-114, intended for treating major depressive disorder (MDD). This follows the company's IND submission in October 2020 to initiate a Phase 2/3 clinical trial. As of now, the FDA has not disclosed reasons for the clinical hold, but Praxis is in active communication with the agency and expects to receive detailed feedback within 30 days.