Praxis Precision Medicines

Praxis Precision Medicines, Inc. is a clinical-stage genetic neuroscience company that develops therapies for patients and families affected by complex and debilitating brain disorders. The company was founded by Kiran Reddy, David Goldstein, and Steven Petrou on September 22, 2015 and is headquartered in Cambridge, MA.

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Praxis Precision Medicines reports progress in Q2 2024 earnings call

Praxis Precision Medicines delivered a solid performance in Q2 2024, with progress on key clinical programs and a healthy financial position. While facing challenges in managing expenses and meeting regulatory requirements, the company remains optimistic about future milestones. Opportunities lie in leveraging potential drug approvals and advancing innovative therapies.

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Praxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company, which engages in the genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. It focuses on two proprietary platforms: Cerebrum and Solidus. The Cerebrum platform utilizes a deep understanding of neuronal excitability and neuronal networks and applies a series of computational and experimental tools to develop orally available precision therapies. The Solidus platform consists of antisense oligonucleotide, or ASO. It is a targeted precision medicine discovery and development engine anchored on a proprietary, computational methodology. The company was founded by Kiran Reddy, David Goldstein, and Steven Petrou on September 22, 2015 and is headquartered in Boston, MA.

On track to initiate Phase 3 studies for ulixacaltamide in Q4 2023 after favorable End-of-Phase 2 meeting with FDA PRAX-628 Phase 1 study showed consistent safety profile and target engagement in measures of qEEG activity at all doses with first administration Praxis will hold an R&D Portfolio Day on October 2 Cash of $124.3 million  as of June 30, 2023 expected to support runway into Q1 2025 BOSTON, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update and reported financial results for the second quarter 2023. “Our four clinical-stage programs continue to make great progress, and we are excited to be advancing ulixacaltamide into Phase 3,” said Marcio Souza, president and chief executive officer of Praxis.

Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Patients dosed with ulixacaltamide up to 14 weeks showed maintained or improved efficacy results, as measured by mean changes in the modified Activities of Daily Living 11 (mADL11 1 )

Praxis Precision Medicines Announces Positive Data from Randomized Withdrawal Sub-Study and Long-Term Extension of Essential1 Study for Ulixacaltamide

Composite qEEG measure showed change from placebo after first dose of 5 mg Effect in the composite qEEG measured through 10-day treatment period Ongoing PRAX-628 Phase 2 Photo-Paroxysmal Response (PPR) expected to read out in 2H 2023 BOSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the results from an analysis of EEG activity for subjects in the recent Phase 1 study that demonstrated pharmacodynamic activity across all dose levels for study subjects who received PRAX-628 at first administration as compared with subjects who received placebo. PRAX-628 is a next generation functionally selective small molecule targeting the hyperexcitable state of sodium channels in the brain, which is currently being developed as a rapid acting, once daily, oral treatment for adult focal onset epilepsy.

Praxis Precision Medicines Announces Positive Results of EEG Analysis of PRAX-628 Phase 1 Study

BOSTON, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will participate at the 2023 Wedbush PacGrow Healthcare Conference on Wednesday, August 9, 2023 at 9:30a.m. ET on the panel David vs. Goliath - How Can Orphan Epilepsy Development Accelerate and Broaden its Reach? Please contact your Wedbush representative for details about how to participate.

Praxis Precision Medicines to Participate at the 2023 Wedbush PacGrow Healthcare Conference

In the last one year, Praxis stock has been decimated because of many trial failures. The company is still planning phase 3 trials of their lead asset. They have very little cash.

Praxis Precision Medicines: Long List Of Failures And Mixed Data

Strong demand for financing including full exercise of overallotment option with net proceeds of $63.3 million Cash runway extended into Q1 2025 Phase 2 Photoparoxsymal Response (PPR) study to evaluate PRAX-628 expected to read-out by YE 2023 Plan to begin ulixacaltamide Phase 3 enrollment in Q4 2023 to support a 2025 NDA filing BOSTON, June 22, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the closing of the underwritten public offering of shares of common stock and pre-funded warrants, including the full exercise of the underwriters' overallotment option. The net proceeds from the offering are $63.3 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Praxis Precision Medicines Announces Closing of Financing and Reiterates Corporate Priorities

BOSTON, June 15, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the pricing of its underwritten public offering of 55,150,000 shares of its common stock at a public offering price per share of $0.95 and, in lieu of shares of common stock, a pre-funded warrant to purchase up to an aggregate of 7,050,000 shares of common stock at a purchase price of $0.9499, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant. The gross proceeds from the offering are expected to be approximately $59.1 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Praxis. All shares and the pre-funded warrant in the offering are being offered by Praxis. In addition, Praxis has granted the underwriters a 30-day option to purchase up to 9,299,690 additional shares of common stock at the public offering price, less the underwriting discount and commission. The offering is expected to close on or about June 21, 2023, subject to market conditions and the satisfaction of customary closing conditions.

Praxis Precision Medicines, Inc. Announces Pricing of $59.1 Million Public Offering

Phase 3 program to include one parallel group study and one randomized withdrawal study mADL11 as primary endpoint Single 60 mg/day dose to be tested BOSTON, June 09, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the outcomes from a recent end-of-Phase 2 meeting with the U. S. Food and Drug Administration (FDA) regarding plans to advance ulixacaltamide into Phase 3 for essential tremor (ET).

Praxis Precision Medicines Announces Plans to Begin Ulixacaltamide Phase 3 in Essential Tremor by Year End After Completing End of Phase 2 Meeting with FDA

BOSTON, June 02, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will present at the 2023 Jefferies Healthcare Conference on Friday, June 9, 2023 at 8:00 a.m. ET.

Praxis Precision Medicines to Present at the 2023 Jefferies Healthcare Conference

Ulixacaltamide essential tremor End-of-Phase 2 meeting with FDA scheduled for June 2023 PRAX-628 Phase 1 study results support preclinical profile indicating potential for best-in-class-efficacy for focal epilepsy Cash and investments of $85.8 million  as of March 31, 2023 supports runway into 2Q24 BOSTON, May 11, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update and reported financial results for the first quarter 2023. “Each of our four clinical-stage programs has made meaningful progress this year and we anticipate additional value inflecting milestones throughout the pipeline in the coming months,” said Marcio Souza, president and chief executive officer of Praxis.

Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2023 Financial Results

PRAX-628 demonstrated a favorable safety and tolerability profile in healthy volunteers at concentrations more than 15-fold the MES EC50; PRAX-628 predicted therapeutic range at least 3-fold wider than current market leader based on MES model

Praxis Precision Medicines Announces Positive Topline Results from PRAX-628 Phase 1 Study Enabling Best-in-Class Profile

BOSTON, April 19, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will deliver presentations on its clinical stage programs at the upcoming American Academy of Neurology (AAN) 2023 Annual Meeting, held April 22-27, 2023 in Boston, Massachusetts.

Praxis Precision Medicines to Present at the American Academy of Neurology 2023 Annual Meeting

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Ulixacaltamide essential tremor end-of-phase 2 meeting with FDA scheduled for June 2023 Ulixacaltamide essential tremor end-of-phase 2 meeting with FDA scheduled for June 2023

Praxis Precision Medicines Announces Upcoming Ulixacaltamide Presentations & Events

BOSTON, April 06, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will present at the 22nd Annual Needham Virtual Healthcare Conference on Monday, April 17, 2023 at 12:45 p.m. ET.

Praxis Precision Medicines to Present at 22nd Annual Needham Virtual Healthcare Conference

BOSTON, March 03, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will participate in the following upcoming investor conferences:

Praxis Precision Medicines to Present at Upcoming Investor Conferences

Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23

Praxis Precision Medicines Announces Topline Results from the Essential1 Study of Ulixacaltamide for the Treatment of Essential Tremor and Continued Advancement of Program to Phase 3

Praxis Precision Medicines' ulixacaltamide (PRAX-944) is a potent and selective small molecule T-type Ca2+ channel blocker being developed for the potential treatment of essential tremor. ET is a common movement disorder affecting 4% of adults > 40. Current treatments like beta-blockers, anticonvulsants, and benzodiazepines are often ineffective or cause side effects, leaving patients with limited options.

Praxis: Shaking The Dust Off Calcium Channel Blockers For Essential Tremor

Ulixacaltamide (PRAX-944) Phase 2b Essential1 study topline results for essential tremor expected in 1Q23; Praxis to enter quiet period following market close on Thursday, February 9

Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

BOSTON, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company, and UCB (EURONEXT BRUSSELS: UCB), a global biopharmaceutical company, today announced a strategic collaboration, based upon Praxis' PRAX-020 program, for the discovery of small molecule therapeutics as potential treatments of KCNT1 related epilepsies.

Praxis Precision Medicines and UCB Announce Epilepsy Research Collaboration

BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will deliver presentations on its epilepsy programs at the American Epilepsy Society (AES) 2022 Annual Meeting, held December 2-6, 2022 in Nashville, Tennessee.

Praxis Precision Medicines to Present at the American Epilepsy Society 2022 Annual Meeting

PRAX-944 Phase 2b Essential1 study topline results for essential tremor expected in 1Q23

Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2022 Financial Results

BOSTON, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will participate in a fireside chat at the Guggenheim Nantucket Therapeutics Conference on Wednesday, September 28, 2022 at 11:45 a.m. ET.

Praxis Precision Medicines to Present at Guggenheim Nantucket Therapeutics Conference

First use of Ciitizen platform as source of real-world data in regulatory filing First use of Ciitizen platform as source of real-world data in regulatory filing

Invitae's Real-World Ciitizen Data Utilized in Praxis Precision Medicines' PRAX-222 IND Filing

BOSTON, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on Wednesday, September 14, 2022 at 10:30 a.m. ET.

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