Psychedelics

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received a positive opinion on European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

(PRNewsfoto/Seelos Therapeutics, Inc.)

The positive opinion issued by COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days. Under orphan designation in the European Union (EU), Seelos stands to benefit from several incentives such as protocol assistance, reduced regulatory fees and market exclusivity. European guidelines for Orphan Drug Designation are for diseases affecting not more than five in 10,000 people in the EU.

In November, SLS-005 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for ALS. SLS-005 was previously granted Orphan Drug Designation from the FDA and EMA for Spinocerebellar Ataxia Type 3 (SCA3), Sanfilippo syndrome and Oculopharyngeal Muscular Dystrophy (OPMD). SLS-005 has also been granted Fast Track designation from the FDA for OPMD.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the receipt of Orphan Drug Designation for the EU for SLS-005 in amyotrophic lateral sclerosis from the European Commission, the expected timing for receiving Orphan Drug Designation from the European Commission and the expected incentives associated with receiving Orphan Drug Designation for SLS-005. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk that the European Commission does not grant Orphan Drug Designation for the EU for SLS-005 in amyotrophic lateral sclerosis, the risk of Seelos not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund Seelos' development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Cision View original content to download multimedia: http://www.prnewswire.com/news-releases/seelos-therapeutics-receives-positive-ema-opinion-on-orphan-drug-designation-for-sls-005-trehalose-in-amyotrophic-lateral-sclerosis-als-301272013.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Seelos Therapeutics Receives a Notice of Allowance in the U.S. for an Additional Patent for SLS-007

- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received a Notice of Allowance for U.S. patent application number 16833,515 from the United States Patent and Trademark Office (USPTO) covering SLS-007 titled: "Structure-Based Peptide Inhibitors of Alpha-Synuclein Aggregation".

(PRNewsfoto/Seelos Therapeutics, Inc.)

This Notice of Allowance covers the method of treating several neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease (PD), Lewy body dementia and multiple system atrophy, through contacting alpha-synuclein (α-synuclein) protofilaments with an effective amount of SLS-007.

Seelos is currently delivering SLS-007 via an adeno-associated virus (AAV) in a preclinical study designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement. SLS-007 is comprised of endogenously available amino acids and thus is expected to be a novel approach to target prevention of α-synuclein aggregation and slow disease progression in synucleinopathy diseases. Preliminary data from the study is expected in the second half of 2022.

About SLS-007

SLS-007 is a family of rationally designed peptide inhibitors that target the non-amyloid component core (NACore) of α-synuclein to inhibit protein aggregation in patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and Lewy neurites which are the hallmarks of the pathology in brains of patients with PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson's disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the potential for SLS-007 to be a disease-modifying gene focused on intracellular α-synuclein aggregates in PD, the initiation and completion of the preclinical study of SLS-007, the ability of SLS-007 and related peptides to slow the progression of PD by stopping the seeding and potential propagation of α-synuclein aggregates, the ability of SLS-007 delivered via an AAV to target the NACore, expectations regarding the results of the study, including the establishment of the in vivo pharmacokinetic and pharmacodynamics profiles and target engagement parameters of SLS-007 and the expected timing for releasing preliminary data regarding the study. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-receives-a-notice-of-allowance-in-the-us-for-an-additional-patent-for-sls-007-301549493.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Optimi Health

Optimi Health Acquires Extensive Catalog of Psychedelic and Functional Mushroom Genetics

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, is pleased to announce that it has completed the acquisition of a diverse catalog of psilocybin and functional mushroom strains intended for cultivation in its 20,000 square foot, EU-GMP compliant facility in Princeton, British Columbia.

The Company's acquisition includes 24 psychedelic and nine functional strains, giving it one of the largest genetic banks in the sector. Formulated psychedelic strains will be made available to licensed researchers, Canada's Special Access Program (SAP), as well as being utilized for on-site research in Optimi's recently expanded analytical laboratory, while the functional strains will be optimized for the Company's growing whole body, natural supplement brand, Optimi Life .

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Nirvana Signs Letter of Intent with Innovate Phytotechnologies Inc.

Nirvana Signs Letter of Intent with Innovate Phytotechnologies Inc.

Collaboration with British Columbia Lab to open doors for psychedelics product development and distribution.

Nirvana Life Sciences Inc. (CSE: NIRV) (Nirvana or the "Company"), a Canadian based life sciences company aimed at developing non-addictive chronic pain and relapse preventing products, is pleased to announce that it has signed a letter of intent with Innovate Phytotechnologies Inc. (INVP) for the development and distribution of the Company's psilocybin and psilocin based products. The strategic relationship will begin with the production of 20g each of psilocybin and psilocin and will increase with market demands.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Awakn Life Sciences Appoints UK Leader in Addictions Psychiatry, Dr. Arun Dhandayudham, as Chief Medical Officer

Awakn Life Sciences Appoints UK Leader in Addictions Psychiatry, Dr. Arun Dhandayudham, as Chief Medical Officer

Dr. Dhandayudham Brings Significant Frontline Addiction and Mental Health Medical Leadership Experience to Awakn

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that Dr. Arun Dhandayudham is joining Awakn as its Chief Medical Officer. Dr. Ben Sessa is stepping back from his role as CMO to become Awakn's Head of Psychedelic Medicine, allowing him to continue his work in research, academic and training activities, as well as a greater focus on the day-to-day treatment of his clients as the Lead Physiatrist for Awakn Clinics Bristol.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Seelos Therapeutics to Participate in the 2022 Jefferies Global Healthcare Conference

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that it will participate in the 2022 Jefferies Global Healthcare Conference, June 8-10, 2022 .

(PRNewsfoto/Seelos Therapeutics, Inc.)

Raj Mehra, Ph.D., Chairman and CEO and Michael Golembiewski , CFO, will present on Friday, June 10th at 12:00 PM ET and host 1x1 meetings.

The 2022 Jefferies Global Healthcare Conference is an annual gathering where over 500 public & private healthcare companies and 3,000 leading executives, institutional investors, private equity investors & VCs will address near-term and long-term investment opportunities and discuss the current trends driving healthcare in the U.S. and internationally.

Presentation webcast registration may be accessed here .

For questions about the conference, please email healthcareconference@jefferies.com .

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson's disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-to-participate-in-the-2022-jefferies-global-healthcare-conference-301545553.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

COMPASS Pathways to participate in upcoming Citi's Biopharma Virtual Co-Panel Day and H.C. Wainwright Global Investment Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in two upcoming events as follows:

  • Citi's Biopharma Virtual Co-Panel Day: panel "Mood Disorders/Mental Health Panel" at 11:00 am ET on 18 May 2022
  • HC Wainwright Global Investments Conference: presentation at 9:00 am ET on 24 May 2022

A live audio webcast of both events will be available on the "Events" page of the Investors section of the COMPASS website. A replay of the webcast will be available for 30 days following each event. For more information, please visit ir.compasspathways.com.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×