Morgan Stanley analyst Matthew Harrison downgraded Biohaven Pharmaceutical to Equal Weight from Overweight, citing his view that the stock’s current valuation reflects a balanced risk/reward. However, he noted that he continues to see a high probability of success for lead product candidate rimegepant in the acute treatment of migraine and expects approval of the drug in early 2020. Harrison has a $55 price target on Biohaven shares.
Tuesday, April 9, 2019
Myriad Genetics submits 1st PMA application module to FDA for test
Myriad Genetics announced that it has submitted the first module of its premarket approval, or PMA, application to the FDA for its myChoice HRD CDx test. Myriad is submitting myChoice HRD as a companion diagnostic for the identification of patients with ovarian, fallopian or primary peritoneal cancer who have received three or more lines of therapy and whose tumors harbor a BRCA mutation or are BRCA wild type yet are deficient in homologous recombination DNA repair and sensitive to their last round of platinum and could derive clinical benefit from treatment with the poly ADP ribose inhibitor Zejula.
Galmed agrees with FDA for Phase 3/4 development plan for Aramchol
Galmed Pharmaceuticals announced that the company has completed its End-of-Phase 2 meeting with the FDA and reached general agreement on key aspects of the Phase 3/4 development and registration plan for Aramchol and on the pivotal registration study ARMOR. ARMOR is a Phase 3/4 multinational, multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy, safety and tolerability of Aramchol in subjects with NASH and fibrosis. Galmed previously announced results from its Phase 2b study which were subsequently presented at AASLD 2018.
United Therapeutics price target lowered to $155 from $160 at Oppenheimer
Oppenheimer analyst Hartaj Singh lowered his price target for United Therapeutics to $155 from $160 after the company reported negative results from its Phase 3 BEAT study of oral esuberaprost in combination with Tyvaso. The analyst notes that the study did not meet its primary endpoint of delayed time to first clinical worsening event, leading to United Therapeutics’ discontinuation of esuberaprost development. Despite the disappointing results, Singh continue to see United Therapeutics in a trough year for sales/earnings with an emerging pipeline highlighted from his 2019 OPCO Healthcare Conference Update. He reiterates an Outperform rating on the shares.
Cerner in cooperation agreement, board refreshment plan with Starboard
Cerner announced that the company has entered into a cooperation agreement with Starboard. The cooperation agreement includes a board refreshment plan, operational improvement initiatives, commitments for operating margin targets, a new finance and strategy committee of the board and an expanded capital return program to drive the next phase of profitable growth and value creation. The company’s board has appointed four new directors, effective immediately: John Greisch, former president and CEO of Hill-Rom Holdings, R. Halsey Wise, former chairman and CEO of MedAssets, Melinda Mount, former president of AliphCom and George Riedel, former chairman and CEO of Cloudmark. The four new directors have been appointed to Classes II, III, II and III, respectively. As members of Class III, Wise and Riedel will be standing for election at the annual meeting of shareholders. Current Cerner board member William Zollars has been appointed to the newly created position of lead independent director. The company also announced that Denis Cortese is retiring from the board at the end of his term and will not stand for re-election. Following the annual meeting, the board will comprise 10 members, nine of whom are independent. With Cortese’s retirement, the previously announced retirement of co-founder Cliff Illig and the additions of the four new directors, Cerner will have refreshed more than one half of its board since 2017. Starboard, which owns approximately 1.2% of Cerner’s outstanding shares, has agreed to vote all of its shares in favor of Cerner’s nominees at the annual meeting and has entered into other customary standstill and voting commitments. The full cooperation agreement between Cerner and Starboard will be filed on a Form 8-K with the SEC.
PhaseBio licenses global rights for PB1023 to ImmunoForge
PhaseBio announced it has licensed to ImmunoForge, the global rights for PB1023, a long-acting, recombinant GLP-1 analogue for the treatment of certain diseases, including conditions related to sarcopenia. PB1023 was created as a genetic fusion protein utilizing PhaseBio’s proprietary elastin-like polypeptide, or ELP, technology platform. Under the terms of the agreement, PhaseBio has granted ImmunoForge an exclusive, worldwide license, with rights to sublicense, to PB1023 for the development and commercialization of treatments for all diseases except diabetes, obesity and non-alcoholic steatohepatitis. PhaseBio will receive an upfront payment upon execution of the agreement and is eligible to receive development milestone payments and royalty payments on net sales of products, including sales from sublicense agreements.
Chembio Diagnostics gets Brazil approval of DPP Zika/Dengue/Chikungunya System
Chembio Diagnostics announced the approval of its DPP Zika/Dengue/Chikungunya System by Agencia Nacional de Vigilancia Sanitaria, or ANVISA, Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos/Fiocruz. Chembio’s DPP Zika/Dengue/Chikungunya multiplex test allows simultaneous detection of antibodies for both active, or IgM, and prior exposure, or IgG, to the Zika, dengue and chikungunya viruses, which is important for both treatment and surveillance. The test is performed using a small drop of fingertip blood and provides quantitative results in approximately 15 minutes when used with the company’s DPP Micro Reader. An evaluation of the multiplex test by Brazil’s Instituto Nacional de Controle de Qualidade em Saude demonstrated analytical performance using patient samples in this endemic region, with all six results yielding sensitivity between 95.2%-100% and specificity between 96.6%-100%.
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