Starpharma share price surges 9% higher on FDA authorisation news

The Starpharma Holdings Limited (ASX:SPL) share price has surged higher after announcing that the FDA has authorised a key clinical trial…

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The Starpharma Holdings Limited (ASX: SPL) share price has been a strong performer on the All Ords on Thursday.

In morning trade the dendrimer products developer's shares are up 9% to $1.20.

a woman

Why is the Starpharma share price charging higher today?

Investors have been buying the company's shares this morning after it announced that the U.S. Food and Drug Administration has authorised the use of AstraZeneca's DEP Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug application.

In light of this development, management advised that US clinical trials are expected to commence later this year following site set-up and approvals.

This is the first DEP candidate to reach this milestone from Starpharma's multiproduct license with AstraZeneca.

What is AZD0466?

According to the release, AZD0466 is a highly optimised nanomedicine formulation of a novel dual Bcl2/xL inhibitor which utilises Starpharma's DEP delivery technology to improve the therapeutic margin.

AstraZeneca believes AZD0466 has the potential to be a best-in-class agent in this field with a broad combination opportunity in solid and haematological tumours due to its ability to target both Bcl2 and BclxL.

Starpharma CEO, Dr Jackie Fairley, commented: "This first partnered DEP product to receive IND clearance is a really exciting and significant milestone, not only for our collaboration with AstraZeneca, but also for Starpharma's DEP platform more broadly."

"This milestone, together with the recent announcement of the granting of a US patent for DEP Bcl2/xL inhibitor conjugates, demonstrates both the therapeutic and commercial benefits of the DEP platform and provides further validation for DEP. We look forward to AstraZeneca commencing clinical trials for AZD0466 in the near future and are excited to be involved with such a ground-breaking therapy," Dr Fairley added.

This is just one of a number of products included in its multiproduct DEP license with AstraZeneca. Combined, Starpharma is eligible to receive development, launch and sales milestones of up to US$124 million, plus tiered royalties on net sales.

Another positive is that AstraZeneca is funding the development costs of DEP AstraZeneca products under the license, including for AZD0466.

James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of Starpharma Holdings Limited. The Motley Fool Australia has recommended Starpharma Holdings Limited. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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