10:44 AM EDT, 08/26/2025 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) was edging up Tuesday after announcing plans to bring its ketamine drug, Ketarx, to market and to broaden its approved indications to include rare disorders.

Chief Executive Fabio Chianell said the company's immediate priority is market entry. "Our strategy involves establishing a high-integrity ketamine franchise through a two-pronged approach: initially focusing on surgical and diagnostic anesthesia, then expanding into rare disorders leveraging ketamine's proven efficacy and safety."

PharmaTher ( PHRRF ) plans to submit al New Drug Application (NDA) for ketamine for Complex Regional Pain Syndrome (CRPS) by the end of the fourth quarter of this year. It is aiming for a Prescription Drug User Fee Act (PDUFA) date by end of next year.

With orphan drug designation for CRPS, Ketarx would qualify for substantial benefits and incentives, including seven years of marketing exclusivity, potential tax credits, exemption of post-approval fees, and the waiver of the FDA New Drug Application filing fee of US$2.4 million.

PharmaTher ( PHRRF ) plans to submit another NDA for Ketarx to treat a different rare disorder by the first quarter of next year, but didn't provide additional details.

Shares are up $0.01, to $0.41, on the Canadian Securities Exchange.

Price: 0.41, Change: +0.01, Percent Change: +2.53