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Faron Pharma shares surge as US FDA grants fast track designation

27th Aug 2024 11:08

(Alliance News) - Faron Pharmaceuticals Ltd on Tuesday said its loss widened in the first half of 2024, as the company successfully advanced the development of its flagship bexmarilimab treatment.

The Turku, Finland-based clinical-stage biopharmaceutical company said its pretax loss widened to EUR14.3 million in the six months that ended June 30 from EUR13.7 million last year.

Faron Pharmaceuticals shares were up 16% at 200.00 pence each in London on Tuesday morning.

Faron is not yet revenue generating. Research & development expenses fell 22% to EUR6.7 million from EUR8.5 million, but general & administrative expenses rose 7.8% to EUR4.6 million from EUR4.3 million. Faron also incurred EUR3.1 million in net financial expenses, compared to EUR918,000 a year before.

Cash held improved to EUR30.0 million from EUR6.3 million after Faron raised EUR3.2 million from a convertible loan issuance and EUR35.5 million from two share placements.

Chief Executive Officer Juho Jalkanen said: "After a tough start we have ended the first half of 2024 in a very strong position...Despite some financial challenges earlier in the year, we have significantly strengthened our balance sheet and are now in a strong position. Everything is progressing as planned and our focus is to ensure that we are armed with adequate resources to be able to meet our objectives of completing Phase II of the Bexmab trial and optimizing the outcome of partnering with phase II data."

Also on Tuesday, Faron said bexmarilimab received fast track designation from the US Food & Drug Administration for the treatment of relapsed or refractory myelodysplastic syndrome.

"Fast track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval," Faron noted.

Looking ahead, Faron said it is focused on advancing bexmarilimab through clinical development with conversations ongoing with potential partners to take it into phase three and approval.

By Elijah Dale, Alliance News reporter

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Copyright 2024 Alliance News Ltd. All Rights Reserved.

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