Rhelion Life Sciences' Wholly Owned Subsidiary Filament Health to Deliver Oral Comments at FDA Public Hearing on the Potential Future Therapeutic Use of Psychedelic Drugs
Rhelion’s subsidiary Filament will speak at an FDA hearing on psychedelic therapeutics and reiterates details of its investigational psilocybin candidate PEX010.
Rhea-AI Summary
Rhelion Life Sciences (TRUFF) announced that Sarit Hashkes, President of wholly owned subsidiary Filament Health, will deliver oral comments at the FDA public hearing on “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” on September 14, 2026.
The hearing, convened by the FDA’s Center for Drug Evaluation and Research, is gathering input on development, evaluation and potential future therapeutic use of psychedelic drugs. Filament is one of the organizations speaking during the public comment period, with remarks expected around 3:40 p.m. ET. The event will be streamed live on FDA’s YouTube channel.
The release also highlights Filament’s lead drug candidate PEX010, a patented, standardized, GMP-manufactured botanical psilocybin product, and notes Rhelion’s April 30, 2026 acquisition of Filament and its portfolio of 77 issued patents across 13 patent families. PEX010 is investigational and not approved by FDA or any other regulator.
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- Sarit Hashkes, President of Filament Health Corp., will provide oral remarks at the United States Food and Drug Administration public hearing "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs", being held later today, September 14, 2026
Toronto, Ontario--(Newsfile Corp. - September 14, 2026) - Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX0) (OTCQB: TRUFF) ("Rhelion" or the "Company"), an Ontario-based organization advancing innovation and research within the legal psychedelic sector, is pleased to announce that Sarit Hashkes, President of its wholly owned subsidiary Filament Health Corp. ("Filament"), will deliver oral comments at the United States Food and Drug Administration ("FDA") public hearing on Considerations for Potential Future Therapeutic Use of Psychedelic Drugs, being held virtually and in person today, September 14, 2026.
The hearing has been convened by FDA's Center for Drug Evaluation and Research to gather input on the development, evaluation and potential future therapeutic use of psychedelic drugs. Filament is among the organizations providing oral remarks during the public comment period.
The full hearing will be streamed live on the FDA's youtube channel. https://www.youtube.com/live/5Kg1gj3KbAI - again, Sarit will be speaking around 3:40pm ET.
More info on the hearing's agenda: https://www.fda.gov/media/194795/download?attachment
"We plan to seize this important moment while remaining grateful and honoured for the opportunity to speak directly with the FDA," said Todd Shapiro, Chief Executive Officer of Rhelion Life Sciences Corp. "Filament has spent years building deep expertise in pharmaceutical-grade psychedelics across multiple jurisdictions, and we look forward to contributing meaningfully to this important dialogue. Our intention is to ensure Rhelion is ready on day one should the United States establish a regulated access pathway. We applaud the FDA for convening this groundbreaking hearing and for its thoughtful, forward-looking approach to how psychedelic medicines can responsibly help Americans in need."
PEX010 is Filament's patented, standardized, GMP manufactured botanical psilocybin drug candidate, produced using proprietary extraction, purification and stabilization methods that give investigators consistent composition across every dose, every study and every research site. On April 30, 2026, the Company completed its previously announced acquisition of Filament Health Corp., including its portfolio of 77 issued patents across 13 patent families and its lead drug candidate, PEX010.
Filament supplies PEX010 as an investigational drug product. Participation in the FDA public hearing does not constitute an endorsement of the Company, of Filament or of PEX010 by FDA or by any other regulatory authority. PEX010 has not been approved by FDA or by any other regulatory authority for any indication.
About Rhelion Life Sciences:
Rhelion Life Sciences is a science and research led company advancing the natural psychedelic drug discovery and development sector. Through its wholly owned subsidiary Filament Health Corp., the Company is developing naturally derived psilocybin drug candidates, including its patented PEX010, and supporting clinical research and compassionate use programs with leading institutions around the world.
For additional information:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@rhelion.com
Website: www.Rhelion.com
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Examples of such information include statements with respect to: the outcome, timing and effect of the FDA public hearing and of any regulatory process that may follow it; the potential development of expanded access, Right to Try or other patient access pathways for psilocybin in the United States; the implementation of Executive Order 14401; the potential adoption of dose-dependent supervision requirements in any jurisdiction; the therapeutic potential of psilocybin and PEX010 in mental and behavioral health and other indications; the number of academic and philanthropic research studies supplied with PEX010; the continued ability of Filament to manufacture and supply PEX010; the Company's intention to submit written comments to the public docket; and the future development, commercialization and regulatory approval of PEX010.
Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the continued ability of Filament and Psilo Scientific Ltd. to manufacture and supply PEX010; the maintenance of the Company's licences, permits and GMP certifications; the continued progression and funding of the studies Filament supplies; the ability to obtain and maintain any required regulatory permits and approvals, including clinical trial, ethics, institutional review board, import and export authorizations; and general business, market and economic conditions. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, namely: the risk that FDA does not adopt, or materially alters, any of the positions described in the Company's comments; the risk that no expanded access, Right to Try or other access pathway is established for psilocybin, or that any such pathway does not permit supply by the Company; regulatory or enforcement developments affecting the legal framework for psilocybin supply and research; delays in regulatory permitting, including clinical trial, ethics, import and export authorizations; the risk that studies supplied by Filament do not proceed, enrol, progress or produce positive or clinically meaningful results; and adverse changes in the regulatory or political landscape affecting psychedelic research and access, together with the other risk factors described in the Company's continuous disclosure documents available under the Company's profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned that the foregoing list is not exhaustive.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
Source: Rhelion Life Sciences Corp.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/314170
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When and how can investors watch Filament Health’s comments at the FDA hearing?
The FDA public hearing is being held virtually and in person on September 14, 2026. The full hearing will be streamed live on the FDA’s YouTube channel at https://www.youtube.com/live/5Kg1gj3KbAI, and Sarit Hashkes is expected to speak at around 3:40 p.m. ET.
What is PEX010 and what status does it currently have?
PEX010 is Filament Health’s patented, standardized, GMP-manufactured botanical psilocybin drug candidate, produced using proprietary extraction, purification and stabilization methods designed to provide consistent composition across doses, studies and research sites. Filament supplies PEX010 as an investigational drug product. Participation in the FDA hearing does not constitute endorsement by FDA or any other regulator, and PEX010 has not been approved by FDA or any other regulatory authority for any indication.
What assets did Rhelion acquire when it bought Filament Health Corp.?
On April 30, 2026, Rhelion completed its previously announced acquisition of Filament Health Corp., including Filament’s portfolio of 77 issued patents across 13 patent families and its lead drug candidate, PEX010.