Edison Investment Research - Pharnext SA (ALPHA) Pharnext - First patient enrolled in PREMIER extension study

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Edison Investment Research

Sean Conroy

Pharnext - First patient enrolled in PREMIER extension study

Pharnext has announced enrolment of the first patient in the PREMIER open-label extension study (PREMIER-OLE) in the United States. All patients who complete the 15-month pivotal Phase III PREMIER trial, evaluating PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A), will be eligible to join the PREMIER-OLE study and will receive the high dose of PXT3003 until the treatment is commercially available. The first patient enrolled in the PREMIER-OLE study completed the PREMIER trial in July/August 2022. Since CMT1A is a slowly progressive disease, we expect continued long-term treatment to deliver incremental benefits, as evidenced by readouts from the other ongoing long-term study, PLEO-CMT-FU. Early data from the PREMIER-OLE study should support the case of a regulatory approval following the conclusion of the Phase III PREMIER study in Q423, in our opinion.

12/09/2022 1 EN

Underlying

Pharnext SA

Pharnext SA is a France-based biopharmaceutical company. The Company is focused on discovering, developing and licensing new therapeutic solutions (Pleodrugs) and companion tests for unmet medical needs (large and niche markets) by using the Pleotherapy approach. Pharnext SA runs all its own activities, from research through to clinical development (no further than the end of Phase II trials), and then licenses the Pleodrugs to industrial partners. The Company's prime focus is on neurodegenerative diseases and metabolic diseases.

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FR0011191287 Euronext Paris France

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

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Pharnext - First patient enrolled in PREMIER extension study

Pharnext - Termination of coverage

Pharnext - Potential licensing deals could add confidence

Pharnext - Improving FY23 financial footing

Basilea Pharmaceutica - Cresemba milestone payments continue to roll in

AAC Clyde Space - Solid start to the year with further order growth

Tinexta - Typical seasonality in Q124

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