Omeros announced that the European Commission has adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union for treatment in hematopoietic stem cell transplantation, or HSCT. The adoption by the EC follows a positive opinion for orphan designation of OMS721 in this indication by the European Medicines Agency’s Committee for Orphan Medicinal Products. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system. There are three Phase 3 development programs ongoing with OMS721 in each of HSCT-associated thrombotic microangiopathy, atypical hemolytic uremic syndrome, and immunoglobulin A nephropathy.
Tuesday, August 28, 2018
Ionis CRL for Waylivra raises questions on Tegsedi approval, says JPMorgan
Ionis Pharmaceuticals (IONS) announced last night that its subsidiary Akcea Therapeutics (AKCA) received a complete response letter for Waylivra from the FDA. JPMorgan analyst Jessica Fye says she had a chance to catch up with management but that they did not provide much in the way of details regarding the CRL. Given that Waylivra and Tegsedi are both generation 2.5 products and both have had platelet safety issues, the market will naturally question if the risk of a CRL also extends to Tegsedi, Fye tells investors in a research note. The analyst expects Ionis shares to reflect greater risk to approval for Tegsedi as well as Waylivra. She notes that Waylivra is worth $2 per share in her model for Ionis while Tegsedi contributes greater than $10 per share. The stock in premarket trading is down 12%, or $6.68, to $47.02. Fye keeps a Neutral rating on Ionis Pharmaceuticals.
FDA proposal positive for Endo if finalized, says B. Riley FBR
B. Riley FBR analyst David Buck believes the FDA proposal to remove vasopressin, which is active in Endo’s Vasostrict, from 503 Bulks List, which allows compounding, is a net positive for Vasostrict if it becomes finalized. He notes that Vasostrict accounts for 15% of Endo’s sales. The analyst reiterates a Buy rating on the shares with an $18.50 price target.
Tetraphase price target raised to $7 from $6 at B. Riley FBR
B. Riley FBR analyst Madhu Kumar raised his price target for Tetraphase Pharmaceuticals to $7 following the FDA approval of Xerava. The drug’s broad label and reasonable pricing should support a rapid U.S. launch, Kumar tells investors in a research note. He reiterates a Buy rating on Tetraphase.
Magellan Health should trade higher on ‘favorable’ settlement, says Jefferies
Jefferies analyst David Styblo expects Magellan Health o trade higher today following a “favorable” settlement with Florida officials regarding its Serious Mental Illness contract. In April, Magellan was not selected to continue its $600M contract, but last night’s update allows the company to retain about 40% of its business, Styblo tells investors in a research note titled “A Bird In The Hand: MGLN Settles and Retains Part of Florida SMI Contract.” The analyst believes the contract should be a contributor to earnings in 2020 after management “right-sizes fixed costs.” He keeps a Buy rating on Magellan Health with a $90 price target.
https://bit.ly/2NrZk40
Ascom, Stryker partner to deliver Stryker iBed wireless notifications
Ascom announced a new North American strategic alliance with Stryker to integrate Ascom Unite software with Stryker’s iBed Wireless Smartbed system. This clinical integration can help prevent patient falls by enabling automatic remote monitoring of bed status, checking for compliance with hospital protocol, and alerting staff to potential patient safety risk conditions. Ascom Unite can monitor and evaluate bed status vs. prescribed protocols for each patient. It supports an advanced rules engine that can have tailored responses to siderails down, bed exit system disabled, bed not in low height, and more. These responses can include mobile alerts, display on a dashboard, and reporting. Ascom Unite can also suppress alerts for unoccupied beds or turn them off for patients not deemed a fall risk. To avoid unnecessary work interruptions, rules can be easily customized to help ensure only important and actionable alerts are sent to clinicians.
https://bit.ly/2LsKBnH
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