VANCOUVER, British Columbia, Dec. 13, 2022 (GLOBE NEWSWIRE) -- PharmAla Biotech (CSE:MDMA) is pleased to announce that it has completed its pre-IND meeting with the US Food and Drug Administration (USFDA). PharmAla thanks agency staff for guidance relating to its submission of an IND Data package, and looks forward to updating investors on its progress at the KCSA Mental Health Virtual Investor Conference at 1:30 PM ET on December 15th.
DATE: December 15, 2022
TIME: 1:30 PM ET
LINK: https://bit.ly/3Ub0iE3
Available for 1x1 meetings: December 14th and 16th
“In less than 2 years, PharmAla has achieved significant milestones. We’re the first publicly-traded company to synthesize GMP MDMA, and our novel drug development program continues to bear significant fruit,” said Nick Kadysh, CEO of PharmAla Biotech. “I look forward to updating both our current, and new, investors on our progress.”
Recent Company Milestones:
- Presented pre-IND data to FDA regarding ALA-002, PharmAla’s first novel chemical entity
- Became the only authorized global reseller for GMP Psilocybin manufactured by Mindset Pharma, now the only entity globally selling two GMP Psychedelic APIs
- Completed manufacturing of our first batch of GMP MDMA in August, 2022
For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.
About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. For more information, visit www.PharmAla.ca.
For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
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OTC Markets Group
(212) 220-2221
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Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale 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