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Tuesday, February 5, 2019

Inspire Medical reports positive coverage policies from 5 BCBSA plans

Inspire Medical Systems announced an additional five Blue Cross Blue Shield Association healthcare plans have issued positive coverage policies of Inspire therapy. These plans include Blue Cross Blue Shield of Mississippi, BCBS Regence, Premera Blue Cross, BCBS of Kansas, and BCBS of Massachusetts, which provide coverage for an aggregate of 8.4 million members. BCBS of Mississippi covers approximately 590,000 members and took effect January 1, 2019. Regence covers approximately 2.6 million members across Washington, Oregon, Idaho and Utah and took effect February 1,2019. Premera is the largest health plan in the Pacific Northwest covering over 2.1 million members in Washington and Alaska and took effect February 1, 2019. BCBS of Kansas covers approximately 560,000 members and took effect February 1, 2019. BCBS of Massachusetts covers approximately 2.6 million members and will take effect May 1, 2019. There have now been eight positive coverage policies issued by BCBSA healthcare plans following BCBSA Evidence Street’s January 7, 2019 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. These eight Inspire therapy coverage policies comprise approximately 16.6 million members, or 17%, of the total 97 million members currently covered under the BCBSA healthcare plans.

AstraZeneca initiated at Exane BNP Paribas

AstraZeneca initiated with an Outperform at Exane BNP Paribas

Moderna doses first subject in Phase 1 clinial trial of mRNA-1944

Moderna announced the dosing of the first subject in a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of mRNA-1944 via intravenous infusion in healthy adults. This is the first monoclonal antibody encoded by mRNA to be dosed in a human and the first development candidate from the Company’s systemic therapeutics modalities to start clinical testing. mRNA-1944 encodes a fully human IgG antibody originally isolated from B cells of a patient with a prior history of potent immunity against Chikungunya infection. It is composed of two mRNAs that encode the heavy and light chains of this anti-Chikungunya antibody within Moderna’s proprietary lipid nanoparticle technology. Preclinical studies of mRNA-1944 showed linear dose-dependence, meaning increases in the dose of mRNA led to nearly proportionate increases in antibody production. The research and development of mRNA-1944 was financially supported by the Defense Advanced Research Projects Agency, an agency of the U.S. Department of Defense.

Benchmark downgrades Amedisys to Hold after rally, awaits better entry point

Benchmark analyst Bill Sutherland downgraded Amedisys to Hold from Buy, noting that the stock has risen 36% since the company announced its now-closed deal to acquire Compassionate Care Hospice and a strong Q3 earnings report. Amedisys now sells at “a wide premium” to other home health/hospice names and Sutherland recommends investors await a better entry point, as he also thinks there is modest integration risk for Compassionate.

Piper Jaffray reiterates Overweight rating on Xencor after Genentech deal

Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $52 price target on Xencor, after the company partnered with Genentech to develop IL-15 targeted cytokine therapies, including XmAb24306. The analyst noted that Xencor will receive $120M upfront, and that the company is also eligible for $160M in XmAb24306-related milestones and $180M in milestones for each new IL-15 candidate. Tenthoff also noted that Xencor will have the right to co-promote in the U.S. and is eligible to receive 45% share of net profits sales.

Piper says argenx cusatuzumab study may enable registration if responses hold

Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $161 price target on argenx (ARGX) after the company announced a collaboration agreement with Halozyme (HALO). In a research note to investors, Tenthoff says that an ongoing Phase II study of cusatuzumab, which was licensed to Janssen (JNJ) after demonstrating a 92% response rate in AML at ASH, could enable registration if responses hold. The company will host an R&D Day in NYC on May 16 to introduce ARGX-117 and also expects the company will introduce ARGX-118.

Shire unit ordered to pay Bayer $155.2M in royalties

Shire’s (SHPG) Baxalta unit must pay Bayer (BAYRY) $155.2M in royalties for infringing a patent for hemophilia treatment Adynovate, Bloomberg reports, citing a verdict from a federal court in Wilmington, Delaware. Jurors rejected Shire’s contention that the patent is invalid, Bloomberg adds.