ImmuPharma PLC (LON:IMM) has provided an update regarding its submission to the US Food & Drug Administration (FDA) of a Special Protocol Assessment (SPA) for Lupuzor's Phase III trial in Lupus patients.
In a brief statement, the specialist drug discovery and development company said that, in discussions, Avion Pharmaceuticals, its licensing partner for Lupuzor, has confirmed that, whilst the review period by the FDA for an SPA request is normally up to 45 days - which has now passed - Avion has as yet not received a response from the regulator and as such the file is still in the review queue, due to the current workload at the FDA.
ImmuPharma said it will provide an update to the market as soon as Avion has received a response from the FDA and the company has been notified.
Earlier this month, Immupharma raised £6.5mln via an oversubscribed share placing with the cash earmarked to develop the group's drug pipeline.
New and returning investors were given the chance to acquire shares at 11p each. Backers of the fundraiser, Stanford Capital Partners and SI Capital, meanwhile, were granted warrants exercisable at 11p under the terms of the deal.
Capital Global Opportunities Master Fund and Lind Global Macro Fund, providers of a convertible security deed, have so far given no indication whether they will trigger a repurchase option that would net them a quarter of the placing proceeds. However, the conversion price of their 'convertible' will be adjusted down to the placing price, investors were told.
The cash injection will be used to bring through new promising targets, including BioAMP-B, for the treatment of fungal infections such as the lung condition aspergillosis.
Avion Pharmaceuticals in the US, which is funding the final-stage clinical assessment of Lupuzor.