Ra Pharmaceuticals, Inc. RARX announced that it has successfully completed the End-of-Phase II interactions with the FDA for its phase III study on zilucoplan for the treatment of generalized myasthenia gravis (gMG).
Based on FDA’s feedback, Ra Pharma plans to initiate a pivotal, phase III study to evaluate the efficacy of a once-daily, subcutaneously (SC) self-administered dose of 0.3 mg/kg of zilucoplan versus placebo. The study is expected to enroll about 130 patients with gMG, who are acetylcholine receptor (AChR)-antibody-positive, regardless of their prior therapies. The primary endpoint will be the change in the MG Activities of Daily Living (MG-ADL) score from baseline to week 12.
Once the phase III study is complete, patients will have the option to enroll themselves in an open-label, long-term extension study. Ra Pharma expects to initiate the phase III study in the second half of 2019.
The End-of-Phase II interactions were conducted after the company completed the phase II study on zilucoplan for the treatment of gMG. Statistically significant improvements in the pre-specified primary and key secondary endpoints were observed for both zilucoplan dose groups versus placebo at 12 weeks.
Shares of the company have increased 30.9% in the past year compared with the industry’s growth of 10%.
After having reached an alignment with the FDA based on the phase III study, Ra Pharma has decided to prioritize gMG as the lead indication for zilucoplan, with aim to build a complement-focused neurology franchise. The company thus plans to initiate a phase II study in an undisclosed neuromuscular indication in the second half of 2019.
As a result, the company has decided to postpone further clinical development of zilucoplan in paroxysmal nocturnal hemoglobinuria (PNH). Dosing will continue in the company’s long-term extension of the phase II PNH program.
Notably, Alexion Pharmaceuticals, Inc.’s ALXN blockbuster drug, Soliris is also approved for the treatment gMG and PNH.
Zacks Rank & Stocks to Consider
Ra Pharmaceuticals currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks worth considering are Johnson & Johnson JNJ and Bayer AG BAYRY, each carrying a Zacks Rank #2 (Buy).
Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters at an average of 1.61%.
Bayer’s earnings per share estimates have increased from $1.92 to $1.95 for 2019 over the past 60 days.
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