Shares of Momenta Pharmaceuticals Inc. (MNTA) are up nearly 63 percent over the last one month as the Company approaches key data readouts across its clinical programs.
Momenta Pharma is a biotechnology company developing novel biologic therapeutics to treat rare immune-mediated diseases. The Company has 3 novel drug candidates in clinical development – Nipocalimab, M254, and M230.
— An adaptive phase II/III clinical study of Nipocalimab (M281) in warm Autoimmune Hemolytic Anemia (wAIHA), launched last August, is ongoing. This study is designed to enroll 105 patients.
wAIHA is a rare autoimmune hemolytic anemia characterized by the destruction of red blood cells due to the presence of pathogenic IgG autoantibodies. Destruction of red blood cells results in severe anemia, leading to weakness and fatigue. Up to 8% of wAIHA patients may die prematurely, with those experiencing active and uncontrolled hemolysis most at risk.
Data from the wAIHA study is expected by year-end 2021.
— A phase II study of Nipocalimab (M281) in pregnant women for the prevention of hemolytic disease of the fetus and newborn (HDFN), dubbed UNITY, is underway. The study is designed to enroll 15 patients.
HDFN is a serious blood disorder in a fetus or newborn that occurs when red cell incompatibility exists between the blood types of a mother and baby.
The Company expects to report top-line data from the UNITY study in 2021.
— A phase II study of Nipocalimab in generalized myasthenia gravis, known by the name Vivacity-MG, continues to enroll patients. The study, designed to enroll 60 patients, has enrolled 80%of its target.
Myasthenia gravis is a chronic autoimmune neuromuscular disease that affects skeletal muscles that are responsible for eye movements, breathing, and moving parts of the body, resulting in muscle weakness and fatigue.
The Company expects to report top-line data from the Vivacity-MG study in the third quarter of 2020.
— A multi-part phase I/II clinical trial of M254 in idiopathic thrombocytopenic purpura (ITP) has completed Part A and is progressing through Part B. Enrollment is ongoing and the Company expects to report additional data from Part B of the study in the second quarter of 2020.
— A phase II clinical study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to be initiated in the fourth quarter of this year.
— A phase I clinical trial of M230 in healthy volunteers is ongoing and Momenta’s partner, CSL, looks forward to introducing a subcutaneous formulation into the phase 1 program this year.
The Company has two legacy products.
— Glatopa, developed and commercialized in collaboration with Sandoz. Available in 20 mg/mL and 40 mg/mL strengths, Glatopa is a generic version of COPAXONE for patients with relapsing forms of multiple sclerosis.
— M710, a proposed biosimilar to EYLEA, under late-stage testing in patients with diabetic macular edema. This compound is being developed in collaboration with Mylan. The BLA submission for M710 is expected in 2021.
The Company reported a net loss of $44.5 million or $0.45 per share for the third quarter ended September 30, 2019, compared to a net loss of $50.3 million or $0.65 per share for the same period in 2018.
Total revenue for the third quarter of 2019 was $6.4 million, including $5.6 million in product revenue from Sandoz’s sales of Glatopa and $840 thousand from R&D revenue. This compared with total revenue of $14.9 million for the same period in 2018. The decrease in product revenue from the prior-year period was primarily due to continued competition.
Momenta ended September 30, 2019, with cash, cash equivalents and marketable securities of $325.9 million.
MNTA has traded in a range of $9.51 to $31.90 in the last 1 year. The stock closed Wednesday’s trading at $28.90, up 13.96%.
Source: Read Full Article