Monday, November 5, 2018
Intersect ENT story remains interesting even without J-Code, says Piper Jaffray
Piper Jaffray analyst Matt O’Brien noted that Intersect ENT management said along with the company’s Q3 report that SINUVA is most likely not going to receive a product-specific J-code for 2019, which he said is in contrast to previous messaging. However, he believes the code is not necessary, but would have provided upside, to the SINUVA ramp. O’Brien still believes the Intersect ENT story remains interesting and keeps an Overweight rating on the shares, which are down 3% to $27.98 in afternoon trading.
https://thefly.com/landingPageNews.php?id=2817659
Gritstone Oncology Inc’s Quiet Period Set To End on November 7
Gritstone Oncology’s (NASDAQ:GRTS) quiet period is set to end on Wednesday, November 7th. Gritstone Oncology had issued 6,666,667 shares in its IPO on September 28th. The total size of the offering was $100,000,005 based on an initial share price of $15.00. During the company’s quiet period, insiders and underwriters involved in the IPO are restricted from issuing any research reports or earnings estimates for the company because of SEC regulations. Following the end of the company’s quiet period, it’s expected that the brokerages that served as underwriters on the stock will initiate research coverage on the company.
Mazor Robotics granted 510(k) approval for Mazor X Stealth Edition
The Mazor X Stealth Edition was granted 510(k) premarket approval as “substantially equivalent” by the FDA on November 2, according to a post to the agency’s website. Medtronic (MDT) announced an agreement to acquire Mazor Robotics (MZOR) on September 20. The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders.
U.S. midterm elections seen as potential positive for cannabis sector
Shares of cannabis stocks are in focus ahead of the United States’ midterm elections on Tuesday. ‘POSITIVE DRIVER’: In a research note on Thursday, Canaccord analyst Bobby Burleson said he views the elections as a positive near-term catalyst for the U.S. cannabis sector as the midterms are likely to benefit Democrats and see the approval of several state legalization measures. The analyst said Michigan and North Dakota are considering legalization of recreational use, while Missouri and Utah are considering legalization of medical use and recent polling points to the likely passage of the Michigan, Missouri and Utah measures. Burleson also said he expects gains for Democratic governerships during the midterms as well as the federal advance toward legalization to progress. The analyst contended that qualitatively, a Democratically controlled House shifts political capital toward federal legalization, while indirectly, the potential of a coming Democratic-led House could rouse efforts toward compromise on the stalled House version of the Farm Bill. In addition, Burleson noted that is widely expected that Attorney General Jeff Sessions will step down after the elections, which would be significant given his rescission of the Cole memo and his general hostility toward legalization. The departure may also create the opportunity for rescheduling of marijuana on the Controlled Substances Act, the analyst said. Burleson said he believes the midterms will be positive for the entire U.S. cannabis sector, but expects a lift for specific names including 1933 Industries, Charlotte’s Web, Ianthus/MPX Bioceutical, Liberty Health Sciences, MedMen Enterprises, Planet 13 and Trulieve Cannabis Corp. CANNABIS STOCKS: Publicly traded companies in the space include Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC) and Tilray (TLRY). PRICE ACTION: CV Sciences rose 7.2% to $6.23, CannTrust Holdings fell 1.2% to $6.85, Cronos Group was down 1.4% to $7.95 and Tilray dropped 4% to $95.52 in late morning
FDA finds more issues at Akorn in new inspection report, STAT says
The FDA has released “another in an ongoing stream of inspection reports that have found quality control problems” at Akorn, according to STAT.
AcelRx price target raised to $9 from $8 at Cantor Fitzgerald
Cantor Fitzgerald analyst Brandon reiterated an Overweight rating on AcelRx and raised his price target to $9 from $8 after the approval of Dsuvia and the company’s Q3 earnings results. Folkes believes the approval of Dsuvia remained discounted in the stock’s price, given the opioid crisis, and now that an overhang has been removed, investors can look forward to the commercial potential of Dsuvia. Additionally, the analyst believes AcelRx’s second product, Zalviso, has the potential to gain approval in the U.S. over the next 12 months.
Pacira price target raised to $90 from $85 at Wedbush
Wedbush analyst Liana Moussatos raised her price target for Pacira to $90 from $85 citing Exparel sales that continued to climb in Q3. Moussatos keeps an Outperform rating on Pacira shares.
https://thefly.com/landingPageNews.php?id=2817619
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