It’s a very rewarding trading day for investors in Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) with shares up nearly 80%, making the stock Wall Street’s bull of the day. The reason? The drug maker announced that following positive End-of-Phase II meeting with the FDA for its blood disorder drug Coversin, it plans to initiate a Phase III clinical study in the first quarter of 2018.
Akari CEO David Horn Solomon stated, “Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018 […] We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.”
“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin’s actions on both the complement and leukotriene (LTB4) pathways play a role. Its two leading targets in this area are atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP), a rare skin disorder,” Solomon continued.
Akari plans to carry out two Phase III clinical studies: CAPSTONE, in naïve PNH patients where eculizumab (Soliris®; Alexion) is not the standard of care, with co-primary clinical endpoints based on hemoglobin and transfusion data, and ASSET, a Phase III clinical study switching PNH patients from eculizumab, the current standard of care treatment in PNH in the U.S., to treatment with Coversin.
The FDA indicated that providing safety and efficacy data from the Company’s clinical trials for the proposed number of unique PNH patients on Coversin for more than one year seems reasonable, subject to review of the actual data upon submission. The number proposed includes patients having C5 polymorphisms conferring eculizumab resistance.
On the ratings front, AKTX has been the subject of a number of recent research reports. In a report issued on June 26, Canaccord analyst Arlinda Lee reiterated a Buy rating on the stock, with a price target of $15.00, which represents a potential upside of 133% from where the stock is currently trading. On May 31, Chardan’s Madhu Kumar upgraded the stock to Hold and has a price target of $6.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Arlinda Lee and Madhu Kumar have a yearly average return of 1.3% and 27% respectively. Lee has a success rate of 44% and is ranked #2194 out of 4658 analysts, while Kumar has a success rate of 65% and is ranked #297.
Akari is a clinical-stage biopharmaceutical company, which focuses in the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases caused by dysregulation of complement C5, including paroxysmal nocturnal hemoglobinuria, Guillain Barré syndrome, and atypical Hemolytic Uremic Syndrome.