MNTA stock surged higher in after-hours trading after JPMorgan upgrades.

JPMorgan analyst Eric Joseph last night upgraded Momenta Pharmaceuticals to Overweight from Neutral with a price target of $30, up from $14. The stock in premarket trading is up 13%, or $3.39, to $28.75. The company on Monday detailed early clinical results from its Phase 1/2 study of M254 in immune thrombocytopenic purpura and the data, albeit early, support “compelling activity / relative potency” compared with conventional intravenous immunoglobulin, Joseph tells investors in a research note. He believes the ITP data, or five of six patients achieving platelet response by standard criteria, give “real clinical credence to the disruptive potential” of M254. Current Momenta share levels under-reflect the commercial potential of M254, says Joseph.

SunTrust analyst Robyn Karnauskas raised her price target on Momenta to $50, expanding the market potential for M254 in her model to peak sales of $1B vs. $600M prior assumption while increasing her probability of success for the program to 25% from 15%. The analyst adds that her model reflects the updated share count from the company’s December disclosure which includes the 2.2M green shoe and also lowers the discount-rate to 12.0% from 12.5% given her increased confidence in its pipeline execution. Karnauskas keeps her Buy rating on Momenta.

On January 13, 2020, Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, provided a 2019 year-end corporate update and key anticipated milestones for 2020.

“We expect 2020 to be a significant year of value inflection for Momenta, as we approach key data readouts across our novel auto- and alloimmune programs. In particular, we start the year with promising interim data for our M254 program in ITP, with additional data expected in Q2, and look forward to sharing nipocalimab data in MG in Q3,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We also continue to grow our pipeline, with the goal to initiate a Phase 2 study for M254 in CIDP later this year and the nomination of a new SIFbody development candidate. With a strong balance sheet supporting our efforts, we have multiple new product and potential partnering opportunities ahead of us.

It has been a pivotal year for Momenta, due to the dedication of our team and their focus on unraveling the complexity of immune-mediated diseases. Today we are proud to reveal our new corporate identity. With a renewed purpose and a strong drive to make a meaningful difference in the lives of patients with unmet needs, this new brand is a great way to kickoff 2020.”

Overview of Programs and Anticipated 2020 Milestones

M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)

The Company’s multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) has completed Part A and is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients, followed by 1,000 mg/kg of IVIg.

Five of six ITP patients administered M254 (43 mg/kg to 250 mg/kg) responded and exhibited platelet counts >=50 x 109/L.

Based on early favorable responses to M254 and variable responses to IVIg, the Company is augmenting the number of patients in the Part B cohorts and including a lower dose cohort.

Enrollment is ongoing and the Company expects to report additional data from Part B of the study in the second quarter of 2020.

The Company also plans to initiate a clinical study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) later in 2020.
Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

Vivacity-MG, the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), continues to enroll patients, with 80% of the trial enrolled. The Company expects to report top-line data from this study in the third quarter of 2020.

Unity, the Company’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), is actively enrolling patients, with four patients currently enrolled. The Company expects to report top-line data from this study in 2021.

Energy, the Company’s adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA) commenced in the third quarter 2019. The Company is activating clinical sites in both the United States and European Union and is enrolling patients. Nipocalimab has been granted Fast Track and Orphan Drug designation by the FDA in this indication and the Company expects to report top-line data from this study around the end of 2021.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

A Phase 1 clinical trial to evaluate the safety and tolerability of M230 in healthy volunteers is ongoing and Momenta’s partner, CSL, looks forward to introducing a subcutaneous formulation into the phase 1 program.
Momenta’s SIFbody platform combines multiple Fc’s with antibody fabs to optimally activate Fc and complement effector function and effectively deplete target cells. CD38 is a target on plasmacytes, immune system cells responsible for generating autoantibodies (autoimmune disease) and M protein (multiple myeloma). Pre-clinical data suggests this CD38 SIFbody has the potential to be a best-in-class therapeutic for the management of plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and rare, auto-antibody-mediated diseases.

The Company has nominated an early development CD38 SIFbody candidate and expects to initiate IND enabling studies in 2020.

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