Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Amgen and raised his Q4 Aimovig revenue estimate following recent neurologist survey feedback. In its second full quarter of launch, facing new market entrants Ajovy and Emgality, Aimovig “is in good shape,” Raymond tells investors in a research note. Despite new competition, physician-reported share dynamics indicate “strong trends” for Aimovig for Q4 and over the next six months, adds the analyst. He raised his Q4 Aimovig revenue estimate to $50M from $41M, ahead of consensus at $47M, and keeps an Overweight rating on Amgen with a $220 price target.
Monday, January 28, 2019
Crispr Therapeutics downgraded to Neutral from Buy at Goldman Sachs
Goldman Sachs analyst Salveen Richter downgraded Crispr Therapeutics to Neutral and cut his price target for the shares to $40 from $78.
Accuray, China Isotope And Radiation enter JV contract
Accuray, China Isotope And Radiation enter JV contract Accuray Asia, a subsidiary of Accuray, and High Energy Equipment, a subsidiary of China Isotope and Radiation Corporation, announced the formation of a joint venture, or JV, to manufacture and sell radiation oncology systems in China. Under the terms of the agreement, CIRC’s subsidiary will own 51% of the JV and Accuray’s subsidiary will own the remaining 49%. Accuray and CIRC believe that the JV, which will operate under the name CNNC Accuray Medical Technology , will be uniquely positioned to serve the world’s largest growth market for radiation oncology systems by helping to meet critical market demand as stipulated by the Ministry of Health of the People’s Republic of China, as well as addressing longer-term unmet needs. Additionally, by leveraging the strengths and capabilities of both Accuray and CIRC, CNNC Accuray Medical Technology Co., Ltd. is designed to have a competitive advantage through its locally branded and manufactured innovative radiation therapy products. The JV will be located in Tianjin, China and sales operations are expected to begin toward the end of calendar 2019. During the interim period, Accuray’s current Chinese distributor will continue its efforts to maximize orders and revenue. Accuray and CIRC believe that CIRC’s market position from both a regulatory and commercial perspective will benefit the joint venture and allow greater market access to the recent China quotas and licenses released on October 29, 2018 for 188 Type A radiotherapy systems and 1,208 Type B radiotherapy systems through the end of calendar 2020.
AbbVie announces FDA approval of IMBRUVICA plus obinutuzumab
AbbVie (ABBV) announced that the U.S. FDA approved the use of IMBRUVICA in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. The latest FDA approval expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients. IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech (JNJ).
IsoRay initiated at H.C. Wainwright
IsoRay assumed with a Buy at H.C. Wainwright. H.C. Wainwright analyst Swayampakula Ramakanth assumed coverage of IsoRay with a Buy rating and 70c price target. The company is at an inflection point of sustainable revenue growth, Ramakanth tells investors in a research note. He views the company as as a turnaround story.
Ionis Pharmaceuticals enrolls first patient in RG6042 study
Ionis Pharmaceuticals(IONS) announced that its partner Roche (RHHBY), also known as Genentech in the U.S., has enrolled the first patient in a pivotal study of RG6042, or IONIS-HTTRx, for people living with symptoms of Huntington’s disease, or HD, a hereditary neurodegenerative disorder for which there is currently no approved disease-modifying treatment. RG6042 is the first therapy in pivotal trials designed to target the underlying cause of HD by reducing production of the toxic mutant huntingtin protein, mHTT. Ionis has earned a $35M milestone payment for the initiation of the study.
Trevena provides regulatory update for oliceridine NDA
Trevena announced the receipt of the official Type A meeting minutes from the FDA regarding the complete response letter, or CRL, received for the oliceridine new drug application, or NDA. FDA has agreed that the company’s current safety database will support labeling at a maximum daily dose of 27 mg. FDA also has agreed that the company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms. The company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year. The company is not required to provide any additional efficacy data to resubmit the oliceridine NDA. To address other items in the CRL, FDA has indicated that the company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted. The company also announced that it expects cash, cash equivalents, and marketable securities as of December 31, 2018 to be approximately $61.5M, which the company anticipates will be sufficient to fund operating expenses and capital expenditure requirements into the Q2 of 2020.
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