PRAX Praxis Precision Medicines Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
PRAX-562
Healthy volunteers
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
PRAX-944
Essential Tremor
|
Phase 2a
Phase 2a
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
PRAX-114
Major depressive disorder
|
Phase 2a
Phase 2a
|
IND for Phase 2/3 trial has been placed on clinical hold - November 9, 2020. Expects to initiate trial 1H 2021.
|
Latest News
-
View Full Article Hide Full Article
CAMBRIDGE, Mass., Nov. 20, 2020 (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 disorders characterized by neuronal imbalance, today announced that management will participate in the following upcoming virtual investor conferences:
- Piper Sandler 32nd Annual Healthcare Conference
Prerecorded fireside chat available on Monday, November 23, 2020 at 10:00 a.m. ET; Institutional investor meetings to be conducted on Tuesday, December 1, 2020
- 3rd Annual Evercore ISI HealthCONx Conference
Fireside chat on Thursday, December 3, 2020 from 3:55 – 4:15 p.m. ET
The events will be available via webcast through the "Events & Presentations" page of the "Investors & Media" section of the company's website at www.praxismedicines.com. Replays of the webcasts will be available for 90 days following the events.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for severe pediatric epilepsies and more broadly for prevalent psychiatric diseases and neurologic disorders. Praxis has established a broad portfolio, including five disclosed programs across multiple central nervous system disorders including, depression, epilepsy, movement disorders and pain syndromes, with three clinical-stage product candidates.Investor Contact:
Alex Kane
Praxis Precision Medicines
[email protected]
617-300-8481Media Contact:
Ian Stone
Canale Communications
[email protected]
619-849-5388
- Piper Sandler 32nd Annual Healthcare Conference
-
View Full Article Hide Full Article
- Praxis expects to initiate Phase 2/3 clinical trial for PRAX-114 in MDD in 1H21 -
CAMBRIDGE, Mass., Nov. 17, 2020 (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 disorders characterized by neuronal imbalance, today announced that it has received comments from the U.S. Food and Drug Administration (FDA) on the full clinical hold of its Investigational New Drug (IND) submission for PRAX-114 for the treatment of major depressive disorder (MDD).
The IND for PRAX-114 was placed on clinical hold by the FDA pending the resolution of certain non-clinical pharmacology and toxicology matters. In its comment letter, the FDA proposed that the Company conduct further toxicological investigation of the effect of PRAX-114 and its metabolites on fertility, reproduction, and embryofetal development to support the planned trial. The Company believes that the results of its ongoing standard fertility and reproductive studies, expected to be completed in the first quarter of 2021, together with the available toxicology package will satisfy the FDA request. The FDA also requested updates to the Investigator's Brochure and to the requirements for contraception in the protocol.
The Company now expects to initiate the randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in MDD in the first half of 2021. The Company is in dialogue with the FDA and intends to explore potential options to accelerate the initiation of the Phase 2/3 clinical trial.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for severe pediatric epilepsies and more broadly for prevalent psychiatric diseases and neurologic disorders. Praxis has established a broad portfolio, including five disclosed programs across multiple central nervous system disorders including, depression, epilepsy, movement disorders and pain syndromes, with three clinical-stage product candidates.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company's expectations regarding the timing in which it will receive additional communications regarding the clinical hold on its IND submission for PRAX-114 from the FDA. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the timing and outcome of the Company's planned interactions with regulatory authorities, including resolution of the current PRAX-114 clinical hold; the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the impact of COVID-19 on countries or regions in which we have operations or do business; the delay of any current preclinical studies or future clinical trials or the development of Praxis' drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Praxis' ability to successfully demonstrate the safety and efficacy of its drug candidates; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Praxis' final prospectus related to its initial public offering, dated October 20, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Praxis' subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Praxis' views only as of today and should not be relied upon as representing its views as of any subsequent date. Praxis explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact: Alex Kane [email protected] 617-300-8481 Media Contact: Ian Stone ian.sto[email protected] 619-849-5388
-
View Full Article Hide Full Article
CAMBRIDGE, Mass., Nov. 09, 2020 (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 disorders characterized by neuronal imbalance, today announced that it has received a response from the U.S. Food and Drug Administration (FDA) on the Investigational New Drug (IND) submission for PRAX-114 for the treatment of major depressive disorder (MDD).
In October 2020, Praxis submitted the IND for PRAX-114 in connection with the initiation of its randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in MDD, as previously discussed with the FDA at a pre-IND meeting earlier this year. At the end of the 30-day IND review period, the FDA notified the Company that the IND has been placed on full clinical hold. The FDA has not provided any reason for the clinical hold. The Company has subsequently been in communication with the FDA, which advised that comments have not been finalized. The Company expects to receive final comments from the FDA within 30 days and intends to work closely with the agency to understand and resolve key issues.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company's expectations regarding the timing in which it will receive additional communications regarding the clinical hold on its IND submission for PRAX-114 from the FDA. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: ; the timing and outcome of the Company's planned interactions with regulatory authorities; the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the impact of COVID-19 on countries or regions in which we have operations or do business; the delay of any current preclinical studies or future clinical trials or the development of Praxis' drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Praxis' ability to successfully demonstrate the safety and efficacy of its drug candidates; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Praxis' final prospectus related to its initial public offering, dated October 20, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Praxis' subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Praxis' views only as of today and should not be relied upon as representing its views as of any subsequent date. Praxis explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact: Alex Kane [email protected] 617-300-8481
-
View Full Article Hide Full Article
CAMBRIDGE, Mass., Oct. 20, 2020 (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 disorders characterized by neuronal imbalance, today announced the closing of its upsized initial public offering of 11,500,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,500,000 additional shares of common stock, at a public offering price of $19.00 per share. The aggregate gross proceeds to Praxis from the offering, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by Praxis, were $218.5 million. All of the shares in the offering were sold by Praxis. The shares began trading on the Nasdaq Global Select Market on October 16, 2020, under the ticker symbol "PRAX."
Cowen, Evercore ISI and Piper Sandler acted as joint book-running managers for the offering, Wedbush PacGrow acted as Lead Manager for the offering, and Blackstone Capital Markets* acted as Co-Manager for the offering.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on October 15, 2020. The offering was made by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by e-mail at: [email protected]; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
*Securities are offered through Blackstone Securities Partners L.P.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.Contact: Alex Kane [email protected] 617-300-8481
-
View Full Article Hide Full Article
CAMBRIDGE, Mass., Oct. 15, 2020 (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 disorders characterized by neuronal imbalance, today announced the pricing of its upsized initial public offering of 10,000,000 shares of common stock at a public offering price of $19.00 per share. All of the shares are being offered by Praxis. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Praxis, are expected to be approximately $190.0 million. Praxis has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.
The shares are expected to begin trading on the Nasdaq Global Select Market on October 16, 2020 under the ticker symbol "PRAX." The offering is expected to close on October 20, 2020, subject to the satisfaction of customary closing conditions.
Cowen, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering, Wedbush PacGrow is acting as Lead Manager for the offering, and Blackstone Capital Markets* is acting as Co-Manager for the offering.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on October 15, 2020. The offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by e-mail at: [email protected]; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
*Securities are offered through Blackstone Securities Partners L.P.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding Praxis's expectations regarding the commencement of trading of its shares on the Nasdaq Global Select Market, the completion and timing of the closing of the offering and the anticipated gross proceeds from the offering. Forward-looking statements are based on Praxis's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the offering to be filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Praxis undertakes no duty to update such information except as required under applicable law.Contact: Alex Kane [email protected] 617-300-8481
