Report

Oasmia Pharmaceutical - Clarity on pathway to US approval

Oasmia’s H1 FY21 results highlight recent developments made to realign the business. In December, global partner Elevar Therapeutics announced it had concluded discussions with the FDA on the pathway to US approval for Apealea (Cremophor-free paclitaxel) in ovarian cancer. The FDA has stated it requires two additional trials to form the basis of the NDA submission. We have delayed our forecast US launch by two years to 2025, which means our forecast timeframe to maiden profitability has now shifted to 2025. In Europe (ex-Nordics), Elevar is in final-round discussions for a distribution partner and has signed an agreement with Taiba Middle East FZ for the Middle East and North Africa (MENA) region. Our revised valuation of Oasmia is SEK2.42bn or SEK5.41/share.
Underlying
Oasmia Pharmaceutical AB

Oasmia Pharmaceutical develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. Co.'s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with alternatives, show improved properties, reduced side-effects, and expanded applications. Co.'s product development is based on its proprietary in-house research and company patents.

Provider
Edison Investment Research
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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