The European Commission has granted marketing authorization for Dengvaxia, Sanofi’s dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use to approve use of the dengue vaccine in European endemic areas.
Wednesday, December 19, 2018
Myriad says EndoPredict test receives NICE recommendation
Myriad Genetics announced that the United Kingdom’s National Institute for Health and Care Excellence has included EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative early breast cancer and who are lymph node-negative. After an extensive technical review, NICE concluded that the clinical evidence justifies EndoPredict for patients with intermediate risk of distant recurrence as determined by a validated tool such as PREDICT or the Nottingham Prognostic Index. The information provided by the EndoPredict test will help patients choose, with their clinician, whether or not to pursue adjuvant chemotherapy.
Bausch Health to reduce debt by additional $76M
Bausch Health Companies announced it put in notice to pay down an additional $76M of its senior secured term loans next week, using cash generated from operations. After this payment, the Company will have eliminated all mandatory amortization for the first quarter of 2019. In addition, as previously disclosed, Bausch Health redeemed or called for redemption $325M of debt earlier in the fourth quarter of 2018. Together, these transactions bring the Company’s total debt repayment in this quarter to approximately $400M.
Medtronic rating change at JPMorgan
JPMorgan upgrades Medtronic to Overweight, boosts target to $109. JPMorgan analyst Robert Marcus upgraded Medtronic to Overweight from Neutral and raised his price target for the shares to $109 from $100. The analyst says that over the past year he’s seen a “significant turnaround in performance” at Medtronic. Management has delivered four consecutive beat and raise quarters and “materially improved” free cash flow generation, Marcus tells investors in a research note. Over the next 12-18 months, the company can grow at least in line with its end-markets at 5% growth, contends the analyst. Plus, he believes a “number of underappreciated data presentations and transformative new product launches” do not appear to be fully appreciated by the Street. Marcus sees “meaningful upside” to Street estimates and the potential for multiple expansion on sustained execution.
Dicerna and Eli Lilly close global licensing and research collaboration
Dicerna (DRNA) announced the closing of the global licensing and research collaboration between Dicerna and Eli Lilly (LLY) following clearance under the HSR Act. The companies entered into a global licensing and research collaboration focused on the discovery, development and commercialization of potential new medicines in the areas of cardio-metabolic disease, neurodegeneration and pain. The companies will utilize Dicerna’s proprietary GalXC RNAi technology platform to progress new drug targets toward clinical development and commercialization. In addition, the partners will collaborate to move beyond the current technical paradigm in order to generate next-generation oligonucleotide therapeutic agents. Dicerna will receive an upfront payment of $100M, as well as an equity investment of $100M at a premium. Dicerna is also eligible to receive up to approximately $350M per target in development and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales. The two companies anticipate collaborating on more than 10 targets.
Strongbridge Biopharma closes Macrilen rights transaction with Novo Nordisk
Strongbridge Biopharma closes Macrilen rights transaction with Novo Nordisk Biopharma (SBBP) announced the closing of the transaction with Novo Nordisk (NVO) to transfer the rights to Macrilen in the United States and Canada. Strongbridge received a one-time upfront cash payment of $145M, of which a portion was used to fully repay outstanding debt. In addition, Novo Nordisk purchased 5.2M ordinary shares of Strongbridge at a purchase price of $7.00 per share, resulting in gross proceeds of $36.7M. Strongbridge will also be entitled to receive tiered royalties related to the sales of Macrilen through 2027. Novo Nordisk will fund Strongbridge’s rare endocrine commercial field organization to promote Macrilen in the U.S. for up to three years.
FibroGen rating change at Citi
Citi upgrades FibroGen to Buy after 40% pullback since August. Citi analyst Joel Beatty last night upgraded FibroGen to Buy from Neutral with an unchanged price target of $71. Down 40% since August, the shares offer a favorable risk/reward heading into the Phase 3 Roxadustat results expected in the first half of 2019, Beatty told investors in a research note. The analyst continues to anticipate an 80% probability of U.S. approval of Roxadustat in some form. He believes the non-dialysis market makes up the majority of the Roxadustat market opportunity.
Subscribe to:
Posts (Atom)