Shares in Immune Pharmaceuticals Inc (NASDAQ:IMNP) shot up 38% Thursday after the company announced it had received inputs from the FDA for its Ceplene drug for Acute Myeloid Leukemia.
The stock ended at $0.26 with 19.69 million shares changing hands. That’s a huge volume considering average volume has been just 3.41 million.
Considering Immune touched a high of $149.94 in June 2009, these piffling daily gains may matter little to long-term investors in the stock holding the bag from those heady days, if there are any left.
But such are the vicissitudes of drug research, so let’s move on from the past to the more immediate future, where Immune is seeing some light in the FDA tunnel for Ceplene.
Immune Pharmaceuticals Inc (NASDAQ:IMNP) receives guidance from the FDA
The company said yesterday that the FDA, which was reviewing the proposed phase III study design for Ceplene in combination with low dose IL-2 for the maintenance of remission in patients with Acute Myeloid Leukemia (AML), provided guidance as well as feedback relating to specific design elements of the study.
“Our path forward to proceed with a pivotal study following regulatory guidance of Ceplene/IL-2 meets our goal to address the urgent unmet medical need for remission maintenance therapy in AML,” stated Monica Luchi, MD, Immune’s Chief Medical Officer.
Immune plans to submit the final protocol for the phase III study in early 2017 and, upon approval, proceed with conducting a global Phase III Pivotal Overall Survival Study in AML maintenance of response with Ceplene/IL2, the company said in a statement.
Investors may note that Ceplene/IL-2 has previously been approved in Europe and Israel following a successful phase III study with Leukemia Free Survival as the primary endpoint.
Immune Pharmaceuticals Inc (NASDAQ:IMNP) cash situation
As on June 30, Immune had cash and cash equivalents of just $0.40 million. For the second quarter, the company incurred a net loss of $5.7 million on zero revenues.
Last month, Immune raised $2 million from an existing shareholder by issuing 4 million shares at $0.50 per share.
Also last month, Immune designated its Maxim Pharmaceuticals subsidiary to develop its phase 3-stage Amiket topical analgesic cream for peripheral neuropathies.
Immune has transferred AmiKet to Maxim in exchange for an equity position valued initially $15 Million and milestones of up to $145 Million as well as royalties on future sales.
Immune also signed a funding agreement last month whereby a syndicate of healthcare investors will initially finance an amount of $5 million, and ultimately purchase up to $20 million of Maxim’s capital stock.