MEI Pharma, Inc. (MEIP)

[EM]

Market Cap was >200mm (>$6 pps) before they announced phase ii failed for pracinostat and the following downgrades of analysts PT.
That happened on March 23, 2015.
Now, after two years of new studies, they announced that "site recruitment is ongoing for a global Phase 3 study of Pracinostat + Azacitidine in newly diagnosed AML patients unfit for intensive induction chemotherapy" following the great data results presented at ASH meeting on December 2016.

From ASH meeting presentation:
http://www.meipharma.com/sites/default/files/ash_2016-pracinostat-aza_aml_-_final.pdf
i. Pracinostat + azacitidine is well tolerated in elderly AML
ii. Prolong survival in the overall population and in patient subsets defined by cytogenetics risk group, de novo or secondary AML, age and ECOG performance status
iii. Results compare favorably to the Phase 3 study of azacitidine in a similar AML patient population
iv. Marrow remission typically achieved within the first 2 cycles, but prolonged exposure required in some patients to maximize response
v. Site recruitment is ongoing for a global Phase 3 study of Pracinostat + Azacitidine in newly diagnosed AML patients unfit for intensive induction chemotherapy

In particular, Initiation of Phase III study in newly diagnosed AML, ≥75 years or unfit for intensive chemotherapy is expected in Q1/2017.

In the meanwhile, MEIP has started preclinical and phase i drugs candidate (ME-401 and ME-344).

Regarding ME-401, it is a "Potential Best-in-Class PI3Kd Inhibitor".
http://finance.yahoo.com/news/mei-pharma-announces-clinical-data-120000346.html
ME-401 (formerly PWT143) is an orally bioavailable, potent and selective inhibitor of phosphatidylinositol 3 kinase (PI3K) delta, a molecular target that has been shown to play a critical role in the proliferation and survival of certain hematologic cancer cells. ME-401 has a distinct chemical structure from other PI3K delta inhibitors, including idelalisib. Data presented at the American Society of Hematology Annual Meeting in December 2012 demonstrated that ME-401 has superior pre-clinical activity compared to idelalisib. In March 2015, the U.S. Food and Drug Administration approved an Investigational New Drug application for ME-401 in B-cell malignancies. MEI Pharma expects to initiate a Phase Ib dose-escalation study of ME-401 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or follicular non-Hodgkin's lymphoma (fNHL) in June 2016. The study is expected to enroll 42-84 patients at approximately 10 sites, with a starting dose of 60 mg.

November, 2016. Helsinn decided to partner with MEIP (they also bought a stake in MEIP for $5 million at a price of $1,91 pps).
https://www.helsinn.com/news-and-events/helsinn-group-and-mei-pharma-enter-strategic-agreement-for-the-development-of-pracinostat-for-the-treatment-myeloid-leukemia-and-other-diseases/

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, said: “Helsinn is delighted to be entering into this agreement with MEI Pharma, for the exclusive rights on Pracinostat, a promising late-stage novel asset. In the first instance we will target acute myeloid leukemia (AML), an area of huge unmet medical need. As part of the development, we will also target additional indications. Helsinn is committed to helping people to survive cancer and offer a better quality of living with cancer.
“This agreement broadens our focus beyond cancer supportive care products and into the development of oncology therapeutics. Helsinn Therapeutics (HTU), our US sales organization, will allow us to accelerate the development and commercialization of this product, once approved, as we will be able to leverage our clinical and regulatory expertise coupled with our existing oncology specialist sales organization.”