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Tuesday, January 8, 2019

Loxo Oncology downgraded to Neutral from Buy at Citi


Citi analyst Yigal Nochomovitz downgraded Loxo Oncology (LOXO) to Neutral saying the company is unlikely to receive a competing takeover bid. The analyst raised his price target for the shares to $235 from $201 to reflect the takeover agreement by Eli Lilly (LLY). He believes Mirati Therapeutics (MRTX) is another potential takeover candidate in the oncology space.

CareTrust REIT upgraded to Strong Buy from Outperform at Raymond James

https://thefly.com/landingPageNews.php?id=2845301

Medtronic price target lowered to $104 from $113 at Barclays


Barclays analyst Kristen Stewart lowered her price target for Medtronic to $104 saying management yesterday made some cautious commentary on the near-term sales outlook and recent tax regulation proposals. It seems that Medtronic “is a bit two steps forward and now one step back,” Stewart tells investors in a research note. The analyst, who is not surprised by the 6.5% selloff yesterday, keeps an Overweight rating on the shares, citing valuation and Medtronic’s longer term growth prospects with its pipeline.

UroGen announces ‘positive’ results of UGN-101 in Phase 3 OLYMPUS trial


UroGen Pharma announced topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer. This analysis showed that on an intent-to-treat basis, 57% of patients achieved a complete response rate at their primary disease evaluation, which was conducted four to six weeks after completion of UGN-101 treatment. Importantly, all evaluated patients in CR remain disease free at six months. This international, multi-center trial completed enrollment with 71 patients in December 2018. Of the 71 patients enrolled in the trial, 61 patients have been evaluated for the primary endpoint which was a CR as defined as a negative ureteroscopic evaluation and a negative wash cytology. The remaining 10 patients are awaiting PDE evaluation. Approximately 45% of tumors treated were categorized as unresectable by surgery at baseline. Of the patients who achieved CR, UroGen now has six-month durability on half of these patients. Durability is a key secondary endpoint for the trial. The safety profile of UGN-101 continues to be acceptable with most treatment-emergent adverse events characterized as mild or moderate and transient and in line with ureteral procedures. These included ureteral narrowing and hydronephrosis, urinary tract infection, flank pain and creatinine elevation. UroGen intends to seek regulatory approval of UGN-101 in LG UTUC based on data from all 71 patients and initiated its rolling submission of the New Drug Application to the U.S. Food and Drug Administration in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

ePlus, Intel and Surgical Theater partner for VR surgical imaging


ePlus (PLUS) announced a new partnership with Intel (INTC) and Surgical Theater. Together with its partners, ePlus will assist customers to bridge the knowledge gap between doctors and patients with Surgical Theater’s precision VR technology. Accurate information and imagery is important for surgeons. Patients and families also depend on data to make informed decisions about critical procedures. Virtual reality, or VR, is emerging as an important tool for healthcare stakeholders-and Intel, Surgical Theater and ePlus are bringing these capabilities to healthcare professionals and the people who depend on them for life-saving treatment. Powered by Intel Core i7 processors, Precision VR combines F-16 flight simulation technology with 360 degrees VR to bring conventional medical imaging to life. Its Precision VR Engage visualization platform helps doctors educate patients and their families.
https://thefly.com/landingPageNews.php?id=2845439

Moderna expects cash, cash equivalents to be approx. $1.7B as of Dec. 31


The company said, “We expect our cash, cash equivalents, and investments in marketable securities as of December 31, 2018 to be approximately $1.7B as compared to $902M as of December 31, 2017. The year over year increase includes approximately $564M in net proceeds from our initial public offering completed in December 2018, approximately $661M in net proceeds from our preferred stock issuances in 2018, and a $13M premium associated with the 2018 amended and restated personalized cancer vaccines agreement with Merck & Co. (MRK).”
https://thefly.com/landingPageNews.php?id=2845445

Corvus Pharmaceuticals initiates second arm of CPI-006 study


Corvus Pharmaceutical announced that it has initiated patient enrollment in the second arm of its ongoing Phase 1/1b dose-escalation study. This arm is evaluating CPI-006, a humanized monoclonal antibody directed against CD73, in combination with CPI-444, a selective and potent inhibitor of the adenosine A2A receptor. The Phase 1/1b study is currently enrolling patients with non-small cell lung cancer, renal cell carcinoma and other cancers who have failed standard therapies. The first arm of the study is evaluating CPI-006 as a single agent and has dosed patients in several cohorts of escalating doses. A third arm is planned to evaluate CPI-006 in combination with pembrolizumab, an anti-PD-1 antibody.
https://thefly.com/landingPageNews.php?id=2845491