In the absence of “transformational change,” Allergan is not well positioned for value recovery “anytime soon,” Piper Jaffray analyst David Amsellem tells investors in a research note. And senior management, at a recent investor conference, made it clear that it is not looking at transformational change, says Amsellem. He believes Allergan’s commercial portfolio is facing “myriad headwinds” and continues to have concerns surrounding the extent to which the pipeline will contribute to its sales over time. The analyst does not believe Allergan shares represent an attractive risk/reward profile at current levels. He reiterates a Neutral rating on the name with a $164 price target.
Tuesday, January 8, 2019
Integra LifeSciences sees preliminary Q4 revenue at higher end of $378M-$383M
Q4 revenue is expected to be at the higher end of the company’s previous guidance range of $378M-$383M.
Amarin price target lowered to $20 from $28 at Citi
Citi analyst Joel Beatty lowered his price target for Amarin to $20 after the company’s 2019 revenue guidance came in lower than he expected. The analyst, however, continues to view Vascepa as an “attractive and differentiated cardiovascular risk reduction therapy.” His peak sales estimate is now $2.5B, down from $3.0B previously.
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.
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.
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