Bloomberg reports
Wednesday, October 31, 2018
H.C. Wainwright ‘cautiously optimistic’ about Can-Fite after trial results delay
After Can-Fite BioPharma announced earlier today that top line efficacy results are now expected during the first quarter of 2019 in its Phase 2 clinical trial of drug candidate Namodenoson for the treatment of advanced hepatocellular carcinoma due to patient survival, H.C. Wainwright analyst Jason Kolbert said he is “cautiously optimistic” given that he finds it surprising that the trial has gone on this long. His understanding is that a six week or bigger difference between the active and control arms is considered clinically meaningful in this indication, adding that if the data is strong enough the trial is could be used as a registrational study given the unmet medical need. He keeps a Buy rating on Can-Fite shares, which were down 5% in morning trading.
Novartis’ Sandoz: FDA OK for rheumatoid arthritis biosimilar Hyrimoz
Sandoz, a Novartis (NVS) division, announced that the U.S. Food and Drug Administration approved its biosimilar, Hyrimoz. The FDA granted approval for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. On October 11, 2018, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie (ABBV) concerning all indications of the proposed Sandoz biosimilar adalimumab for the reference medicine. The license enables patient access in the U.S. to Hyrimoz, or Sandoz adalimumab or Sandoz biosimilar, as of September 30, 2023.
Intuitive Surgical, Varian rise amid expanded surgical robot quota in China
Shares of Intutive Surgical (ISRG) and Varian Medical Systems (VAR) are rising after the Chinese government announced its medical equipment plans through 2020, including a new 154-system quota for Intuitive Surgical. PIPER RAISES PRICE TARGET ON INTUITIVE SURGICAL: On Wednesday, Piper Jaffray analyst JP McKim noted that the National Health and Family Planning Commission in China announced an “unexpected” new 154-system quota for Intuitive Surgical Wednesday, calling this a “clear accelerant” for its international procedure volume. The company has between 70 and 80 systems in China which are amongst the highest utilized systems in the world, so this should accelerate procedure growth as well, McKim added. He also said the system upgrade cycle remains underway as trade-in activity remain elevated despite being down from the second quarter. Given the new China quota, he raised his 2019 and 2020 sales and earnings estimates and increased his price target on Intuitive Surgical shares to $625 from $613. McKim kept an Overweight rating on the stock. CITI UPS VARIAN MEDICAL TARGET: Also on Wednesday, Citi analyst Amit Hazan raised his price target for Varian Medical Systems to $145 and kept a Buy rating on the shares. China posted medical equipment plans through 2020 which include new linear accelerators of nearly 1,400 total units, Hazan said, adding he views this as a “major positive” for radiation oncology players that “far exceeds expectations.” Inclusive in the quota are 188 Class A and 1,208 Class B systems, and Varian “is better positioned than ever before to capture both ends of the quality spectrum,” Hazan writes. PRICE ACTION: Intuitive Surgical was up 6.6% to $523.26 in afternoon trading, while Varian rose 6.7% to $119.67.
Judge orders J&J CEO be questioned over defense of baby powder
A Missouri judge has ordered Johnson & Johnson CEO Alex Gorsky to submit to questioning by lawyer Mark Lanier about the basis for his public statements that the company’s talc-based powder does not contain asbestos and does not pose a health risk, Bloomberg reports. Gorksy questioned on a call with analysts in July the medical premise that talc in the baby powder caused the development of ovarian cancer, the report notes.
https://thefly.com/landingPageNews.php?id=2814719
Piper says Integra long-term prospects intact despite ‘concerning’ guidance
Piper Jaffray analyst Matt O’Brien noted that Integra LifeSciences lowered FY18 sales guidance by $13M at the midpoint following a Q3 revenue shortfall that was blamed on further year-over-year declines in Ortho Extremities and a weaker than expected Codman performance outside of the U.S. While the headwinds are “frustrating,” O’Brien still sees “a lot to like” about the margin and cash flow improvements and top-line outlook for the business. He reiterates an Overweight rating on Integra shares.
https://thefly.com/landingPageNews.php?id=2814723
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