Nightstar Therapeutics shares can rally 60% on positive data, says Mizuho. Mizuho analyst Yang says Nightstar Therapeutics is one of her firm’s top picks for 2019. The analyst sees an attractive valuation into the mid-2019 data from the Phase 2/3 expansion study in XLRP, which she calls the stock’s most important catalyst. If the data are positive, Yang sees “significant upside” of 60% to her $22 price target. Further, downside “appears limited” as the pathway to registration for the Nightstar’s most advanced pipeline program in choroideremia is “de-risked” given positive data and alignment with FDA draft guidance on clinical trial design, Yang tells investors in a research note. She reiterates a Buy rating on Nightstar Therapeutics.
Monday, February 4, 2019
Piper Jaffray likes the set-up for Cigna shares in 2019
Piper Jaffray analyst Sarah James likes the set-up for Cigna (CI) in 2019. The company has built 25c-50c of conservatism into its earnings guidance and has potential for a “strong” 2020 driven by better cost trend control, its specialty business, and working down the $200M stranded overhead cost from Anthem’s departure, James tells investors in a research note. Further, the analyst does not have the pharmacy benefits manager volume coming back in-house from UnitedHealth (UNH) in her numbers yet, which she sees as “likely upside to 2021.” The analyst also believes Cigna “screens as cheap” at 10.6 times expected 2020 earnings. James reiterates an Overweight rating on the shares with a $227 price target.
SI-Bone announces additional exclusive coverage policies for iFuse
SI-BONE announced the addition of several exclusive coverage policies for the iFuse Implant System. CareFirst BlueCross BlueShield, Premera Blue Cross Blue Shield and Excellus BlueCross BlueShield have published positive coverage policies for MIS SI joint fusion when performed exclusively with the triangular iFuse Implant System providing coverage for over 6.5 million lives. In total, there are 32 Blue Cross Blue Shield plans that now cover MIS SI joint fusion, 27 of which are exclusive to the triangular iFuse Implant System based on published clinical evidence. CareFirst is the largest health care insurer in the Mid-Atlantic region, covering 3.2 million members in Maryland, the District of Columbia and parts of Northern Virginia. CareFirst’s iFuse only policy took effect January 1, 2019. Premera Blue Cross is the largest health plan in the Pacific Northwest, covering over 2 million lives throughout Washington and Alaska. The Premera exclusive iFuse policy became effective February 1, 2019. Excellus BlueCross BlueShield policy took effect December 20, 2018 and provides access to the iFuse Procedure for almost 1.5 million customers in central and upstate New York.
https://thefly.com/landingPageNews.php?id=2858369
https://thefly.com/landingPageNews.php?id=2858369
Calithera Biosciences completes patient enrollment in Phase 2 Entrata trial
Calithera Biosciences announced that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma. CB-839 now has the International Nonproprietary Name telaglenastat, as recommended by the World Health Organization. The ENTRATA trial is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival. Calithera plans to report efficacy and safety data from the trial in the second half of 2019. Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.
Optinose enters EDS license agreement with Inexia
Optinose announced that it has entered into a license agreement with Inexia whereby Inexia has obtained certain rights that will enable the use of Optinose’s exhalation delivery systems, or EDS, and other intellectual property in their effort to discover and develop novel therapies based on positive modulators of Orexin OX1 and OX2 for neurological diseases. Inexia was recently formed as part of a structured financing agreement between Japan-based Sosei Group and Medicxi. In exchange for this license, Optinose will receive an upfront payment and for each product developed under the license agreement is eligible to receive up to $8M of development milestone payments and up to $37M of sales milestone payments. In addition, Optinose is eligible for tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the license agreement. Inexia will be responsible for all costs and activities related to the identification, development and commercialization of potential products under this license.
EyePoint announces commercial launch of Yutiq in U.S.
EyePoint announced it has commercially launched Yutiq in the United States. Yutiq is the company’s FDA approved, three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The product is available for ordering and delivery to physicians. The company has also launched EyePoint Assist, a program to ensure access to Yutiq for eligible patients in need of financial assistance.
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