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PharmaTher Holdings Ltd. develops specialty pharmaceutical platforms centered on microneedle drug delivery. Company updates focus on PharmaPatch™ product programs for ketamine, psychedelics, GLP-1 drugs and therapeutic peptides, along with PatchPrint™, its automated tabletop microneedle patch 3D printer designed to support end-to-end patch manufacturing.
Recurring news themes include U.S. patent applications for patch manufacturing and peptide formulations, expansion of the PharmaPatch™ platform into new drug categories, regulatory and policy developments affecting ketamine, psychedelics and peptides, and the company's retained economic participation tied to its previously approved and sold U.S. generic ketamine ANDA.
PharmaTher Holdings (OTCQB: PHRRF) has secured a crucial U.S. patent (No. 12,128,012) for using ketamine to treat Amyotrophic Lateral Sclerosis (ALS), valid until May 14, 2041. This patent complements their existing FDA Orphan Drug Designation, strengthening their market position in treating this fatal neurodegenerative disorder.
The company is targeting the global ALS treatment market, projected to reach $1.04 billion by 2030. With approximately 5,000 new ALS cases diagnosed annually in the U.S. and 30,000 current patients, PharmaTher is advancing towards Phase 2 clinical trials, with plans for FDA Fast Track designation and Phase 3 studies in 2026.
The combination of patent protection and Orphan Drug status provides PharmaTher with significant advantages, including seven years of market exclusivity, tax credits for clinical trials, and FDA application fee exemptions worth approximately $2.4 million.
PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA has extended its review period for the company's ketamine new drug application. The new approval goal date is set for August 9, 2025, pushed back from the original June 4, 2025 date. The extension is due to the FDA requiring additional time to review information requests, classified as a minor amendment.
The company confirmed it has already addressed all issues from the FDA's previous Complete Response Letter from October 2024. CEO Fabio Chianelli stated that the extension is not expected to significantly impact PharmaTher's operational, business development, and commercialization initiatives for 2025.
[ "FDA classified the amendment as MINOR, suggesting no major concerns", "Company has already addressed all previous issues from October 2024 Complete Response Letter", "Extension not expected to materially impact 2025 business initiatives" ]PharmaTher Holdings (OTCQB: PHRRF) has received an Amendment Acknowledgement Letter from the FDA for its Ketamine New Drug Application, with an approval goal date of June 4, 2025. The FDA classified this as a minor amendment qualifying for priority review.
The company previously addressed deficiencies from a Complete Response Letter dated October 22, 2024, which requested clarifications related to drug substance, product, manufacturing, and microbiology. Notably, no concerns were raised about stability, and no additional clinical studies were required.
PharmaTher aims to address the U.S. Ketamine shortage, which has persisted since February 2018. The FDA issued a compounding risk alert in October 2023 regarding potential risks of compounded Ketamine products. Upon FDA approval and removal from the shortage list, compound pharmacies may face restrictions, positioning PharmaTher to fill the market demand gap.
PharmaTher Holdings (PHRRF) has submitted its complete response amendment to the FDA for its Ketamine new drug application, addressing minor deficiencies outlined in the October 2024 complete response letter. The company expects FDA approval in Q2-2025.
The FDA's requests focused on drug substance, product, manufacturing, and microbiology information. Notably, no new preclinical or clinical studies were required, and there were no concerns about the stability of Ketamine submission batches.
The company aims to address the U.S. Ketamine shortage, which has persisted since February 2018. This shortage has led to increased availability of compounded Ketamine products, prompting FDA concerns about risks associated with compounded versions, particularly in telehealth settings.
Ketamine, listed on the WHO Essential Medicines List, is primarily used for anesthesia and pain relief in hospitals. A peer-reviewed study has shown significant patient improvement for depression, anxiety, and suicidal ideation with Ketamine intravenous therapy.
PharmaTher Holdings (OTCQB: PHRRF) announced plans to resubmit information to the FDA by end-February 2025, addressing minor deficiencies outlined in the Complete Response Letter (CRL) from October 22, 2024. The company expects FDA approval for ketamine in Q2-2025.
The FDA's requests focus on drug substance, product, manufacturing, and microbiology information. Notably, the FDA expressed no concerns about the ketamine submission batches' stability, which achieved 18 months without issues. No additional preclinical or clinical studies were requested.
Ketamine, an essential medicine used for anesthesia and pain relief in hospitals, is also administered for various mental health, neurological, and pain disorders outside FDA and Health Canada approved indications.
PharmaTher Holdings (OTCQB: PHRRF) provided a shareholder update outlining its 2025 strategic priorities. The company faced two Complete Response Letters from the FDA for its ketamine drug application in 2024 but plans to submit responses in February, anticipating FDA approval in Q2-2025.
Key focus areas include: Operations - maintaining cost control through third-party consultants and manufacturers, with sufficient cash for 2025 operations; Commercialization - plans to distribute ketamine to wholesalers, distributors, and work with Defense Health Agency and Veterans Health Administration; Clinical Development - pursuing strategic trial collaborations for ketamine research, leveraging FDA orphan designations for ALS, Rett Syndrome, and CRPS; Ketamine 2.0 - developing next-generation products including ketamine patch and wearable pump programs under 505(b)(2) pathway, with plans to select a lead compound in H2 2025.
PharmaTher Holdings announced receiving satisfactory preliminary FDA responses regarding their Ketamine product's Abbreviated New Drug Application. The company canceled the post-complete response letter meeting scheduled for December 2, 2024, as no further discussion was needed. Following the FDA's Complete Response Letter from October 22, 2024, which cited MINOR deficiencies, PharmaTher plans to submit a MINOR AMENDMENT by January 2025. The FDA's requests focus on drug substance, product, manufacturing, and microbiology updates, with no concerns about stability or need for new clinical studies.
PharmaTher Holdings announced that the FDA has granted a post-complete letter clarification meeting scheduled for December 2, 2024, following a Complete Response Letter (CRL) issued on October 22, 2024, for their ketamine Abbreviated New Drug Application. The deficiencies cited in the CRL are classified as MINOR, requiring new and updated information related to drug substance, product, manufacturing, and microbiology. The FDA expressed no concerns about ketamine submission batch stability and requested no new preclinical or clinical studies. The resubmission will be considered a MINOR AMENDMENT.