Shares of Humanigen (HGEN) nose-dived at the start of September after lenzilumab – the company’s prospective treatment for hospitalized Covid-19 patients – was rejected by the FDA. In fact, the negative news drove share losses of 64% during the month, a downturn H.C. Wainwright’s Joseph Pantginis calls “a gross overreaction.”
“The agency remains quite engaged and was essentially asking for more data,” says the analyst, who believes that all that has essentially changed is that the potential timing of lenzilumab making its way to patients has been “pushed out.”
“Even if the company ends up going down the route of normal BLA submission, the impact on NPV (net present value) is nowhere near the impact the shares have seen,” the analyst went on to say. Pantginis also thinks the drug has potential for other indications beyond Covid-19, which could give it “significant value.” In the near term, the company intends on submitting more trial data to the regulatory body.
Progress might have slowed down in the U.S., but the company is making inroads elsewhere.
Last week, Humanigen announced a partnership with Clinigen Group, to launch a Managed Access Program (MAP) – called LenzMAP – in 16 European countries. The MAP’s objective – where local regulatory authorities allow and where the treating physician has judged that there are no suitable treatment alternatives for the patient – is to be able to provide lenzilumab on a patient-by-patient basis.
Clinigen’s reach is not to be sniffed at; the company oversees 161 MAP programs of a similar ilk for other companies and its remit will include taking charge of the key elements of regulatory oversight, logistics, and access management for lenzilumab.
The news follows on from another recent development. As part of its U.K. application for Conditional Marketing Authorization (CMA), Humanigen has now completed the submissions of all modules. Humanigen’s CMA had previously been accepted for expedited rolling review by the MHRA (The Medicines and Healthcare Products Regulatory Agency).
To this end, Pantginis rates HGEN a Buy along with a $28 price target. The implication for investors? Upside of a huge 347%. (To watch Pantginis’ track record, click here)
While the Street’s average target is not quite as exuberant, it’s still overwhelmingly positive; the figure clocks in at $17.25, suggesting room for ~176% of share gains over the one-year timeframe. All in all, the stock boasts a Moderate Buy consensus rating, based om 4 Buys, and 1 Hold and Sell, each. (See HGEN stock forecast on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
