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RARX

RA Pharmaceuticals

$22.47

0.54 (2.46%)

07:38
05/07/19
05/07
07:38
05/07/19
07:38

RA Pharmaceuticals announces gMG phase 2, long-term data at AAN meeting

Ra Pharmaceuticals announced the presentation of data from the Company's Phase 2 clinical trial evaluating zilucoplan for the treatment of generalized myasthenia gravis , including data from the open-label, long-term extension study, at the 2019 American Academy of Neurology Annual Meeting, in Philadelphia, PA, from May 4-10, 2019. The 0.3 mg/kg dose of zilucoplan consistently achieved rapid, sustained, and near-complete complement inhibition. The 0.1 mg/kg dose of zilucoplan achieved rapid, sustained, but sub-maximal complement inhibition. Based on the pharmacokinetic, pharmacodynamic, and efficacy results, the 0.3 mg/kg dose of zilucoplan was selected for evaluation in the upcoming pivotal Phase 3 trial. As previously reported, the pre-specified primary efficacy endpoint of change from baseline to week 12 in Quantitative Myasthenia Gravis score was met with zilucoplan dosed at 0.3 mg/kg SC daily, resulting in a clinically meaningful and statistically significant improvement over placebo. The key secondary efficacy endpoint of change from baseline to week 12 in the MG Activities of Daily Living score was met with zilucoplan dosed at 0.3 mg/kg SC daily, resulting in a clinically meaningful and statistically significant improvement over placebo.The 0.3 mg/kg dose of zilucoplan led to rapid, statistically significant, and clinically meaningful reductions in additional pre-specified secondary endpoints, the MG Composite and the 15-item MG Quality of Life revised scale, versus placebo at week 12. Rescue therapy with intravenous immunoglobulin or plasma exchange was required by 3/15 patients in the placebo arm, 1/15 patients in the 0.1 mg/kg zilucoplan arm, and in zero patients in the 0.3 mg/kg zilucoplan arm. Treatment with zilucoplan had a favorable safety and tolerability profile in the study, consistent with previously-completed Phase 1 and Phase 2 studies. The majority of adverse events reported were mild and were not considered by the investigators to be related to study drug. There were no serious AEs observed related to treatment with zilucoplan. Sustained responses were observed for all four efficacy endpoints after 24 weeks at the 0.3 mg/kg dose of zilucoplan. Placebo subjects crossing over to the 0.3 mg/kg dose of zilucoplan after 12 weeks experienced rapid, clinically meaningful, and statistically significant improvements for all four efficacy endpoints from weeks 12 to 24, with changes from week 12 to week 24. Based on feedback provided by the U.S. Food and Drug Administration, Ra Pharma plans to initiate a single, 12-week, pivotal, Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy of a once-daily, SC self-administered dose of 0.3 mg/kg of zilucoplan versus placebo. The trial is expected to enroll approximately 130 patients with gMG who are acetylcholine receptor-antibody-positive, regardless of their prior therapies. The primary endpoint will be the change in the MG-ADL score from baseline to week 12. Following completion of the Phase 3 clinical trial, patients will have the option to enroll into an open-label, long-term extension study.

RARX RA Pharmaceuticals
$22.47

0.54 (2.46%)

12/10/18
RBCM
12/10/18
NO CHANGE
RBCM
Outperform
RA Pharmaceuticals could be strategic target for Alexion, says RBC Capital
RBC Capital analyst Kennen MacKay believes RA Pharmaceuticals' (RARX) zilucoplan gMG data "should impress even the skeptics," but he has received questions about why the stock hasn't inflected higher on data that left him "overall highly impressed." He believes the recent run-up of the stock into the data suggests anticipation of a positive result and also thinks the upside has likely been limited by some anticipation for a dilutive financing. Commenting on why the news "isn't more negative" for Alexion (ALXN), MacKay added that he anticipates that Alexion could have strategic interest in an acquisition of RA, with sufficient financial flexibility to pursue a deal, as the latter gets closer to commercialization. MacKay maintains an Outperform rating on RA Pharmaceuticals shares.
12/11/18
RHCO
12/11/18
NO CHANGE
Target $35
RHCO
Buy
RA Pharmaceuticals price target raised to $35 from $28 at SunTrust
SunTrust analyst Edward Nash raised his price target on RA Pharmaceuticals to $35 and kept his Buy rating after its positive top-line results from a Phase II zilucoplan trial that are "comparable, if not better, to Soliris' Phase III REGAIN data." The analyst notes that the patients in the trial "did not require rescue therapy" and that the drug's safety profile was "mild". Nash believes that "zilucoplan is well positioned to treat broader generalized myasthenia gravis, or gMG, patients than Soliris, given its subQ delivery and a more accessible pricing."
02/08/19
STFL
02/08/19
INITIATION
Target $55
STFL
Buy
RA Pharmaceuticals initiated with a Buy at Stifel
Stifel analyst Stephen Willey started RA Pharmaceuticals with a Buy rating and $55 price target. The positive Phase 2 proof-of-concept zilucoplan data generated in generalized myasthenia gravis and paroxysmal nocturnal hemoglobinuria "cement the validity of the zilucoplan value proposition and significantly de-risk" future Phase 3 development plans, Willey tells investors in a research note. He believes RA shares at current levels remain "significantly underappreciated by investors."
02/08/19
02/08/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. American Airlines (AAL) initiated with a Hold at Argus. 2. Walmart (WMT) and Sprouts Farmers Market (SFM) were initiated with a Neutral at Buckingham, while Kroger (KR) was initiated with an Underperform. 3. Wrap Technologies (WRTC) initiated with a Buy at Chardan. 4. nLight (LASR) initiated with a Hold at Craig-Hallum. 5. RA Pharmaceuticals (RARX) initiated with a Buy at Stifel. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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Preliminary option volume of 15.7M today »

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