Needham analyst Serge Belanger lowered his price target on Flexion to $36 after its yesterday’s guidance for FY19 Zilretta sales of $65M-$80M came in below the Street consensus of $97.8M. The analyst states that although the outlook may appear disappointing at first, investors may welcome the “expectation reset” that should yield a “more accurate guidepost” for Zilretta growth. The analyst also lowered his FY19 EPS view to ($3.89) from ($2.63) to reflect the slower launch ramp but kept his Buy rating on the shares based on the company’s potential for its product to serve as the front-line treatment for Osteoarthritis knee pain.
Friday, January 4, 2019
Catalyst Pharmaceuticals announces publication of Firdapse trial data
Catalyst Pharmaceuticals announced the online publication in Sage Open Medicine of the results of an investigator-sponsored Phase IIb clinical trial evaluating Firdapse for the treatment of MuSK antibody positive Myasthenia Gravis, or MuSK-MG. The positive topline results from this trial were previously announced, but the full results of safety, efficacy and other clinical data are now available. The MSK-001 trial was a randomized, double-blind, placebo-controlled, double crossover design. The co-primary endpoints were statistically met as well as the secondary endpoints. The study provided evidence that amifampridine phosphate was safe and effective in treating MuSK-MG patients. The study was conducted in Milan, Italy.
MannKind to host conference call
Conference call to discuss company developments will be held on January 4 at 9 am.
Morgan Stanley: dental survey negative for Align, positive for Straumann
Morgan Stanley analyst Steve Beuchaw noted that the firm surveyed 30 dentists and 42 orthodontists in the U.S. and said the results points to slower aligner mix shift and emerging share movements, both of which he said are negative for Align Technology (ALGN). He further points out that the survey was run during 4Q, in advance of the full launch of competing products from 3M (MMM), Danaher (DHR) and Dentsply Sirona (XRAY). Given the survey findings, Beuchaw cut his U.S. volume estimates for Align by 400bps for 2019 and lowered his price target on the stock to $210 from $300 to account for lower estimates and a lower market multiple. He maintains an Equal Weight rating on Align Technology shares. Beuchaw added that the survey was positive for Straumann (STMN), which is covered by Michael Jungling. While investors tend to focus on new entrants from the other three mentioned above, ClearCorrect with support from Straumann was the bigger share winner prospectively in the survey, Beuchaw tells investors.
Rite Aid receives NYSE notice of non-compliance
Rite Aid Corporation announced today that the New York Stock Exchange has notified the company that it is no longer in compliance with NYSE continued listing standard rules because the per share trading price of its common stock has fallen below the NYSE’s share price rule. The NYSE requires the average closing price of a listed company’s common stock to be at least $1.00 per share over a consecutive 30 trading-day period. Rite Aid said it received written notification of the non-compliance on Jan. 3, 2019. In accordance with the NYSE’s rules, Rite Aid has six months from the receipt of the notice to regain compliance with the NYSE’s price condition or until the company’s next annual meeting of stockholders if stockholder approval is required, as would be the case to effectuate a reverse stock split, to cure the share price non-compliance. During this time period, Rite Aid’s common stock will continue to be listed and trade on the NYSE as usual. Rite Aid is in compliance with all other NYSE continued listing standard rules. Rite Aid intends to pursue measures to cure the share price non-compliance, including through a reverse stock split of the company’s common stock, subject to stockholder approval no later than at Rite Aid’s next annual meeting, if such action is necessary to cure the share price non-compliance. Under NYSE rules, Rite Aid can regain compliance at any time during the six-month cure period if on the last trading day of any calendar month during the cure period Rite Aid has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month or on the last day of the cure period.
https://thefly.com/landingPageNews.php?id=2843817
Jefferies more cautious on Healthcare Services group for 2019
Jefferies more cautious on Healthcare Services group for 2019. After strong performance in 2018, analyst Brian Tanquilut is more cautious on the Healthcare Services group for 2019 given his belief that sales growth will be “tepid” for most providers as overall utilization flattens out and increased market volatility drives greater scrutiny of debt levels. Given this backdrop, companies that can deliver positive organic or acquisition-driven growth with solid balance sheets should outperform, Tanquilut tells investors in a research note. His top picks in the space are Addus HomeCare (ADUS), Amedisys (AMED), AMN Healthcare (AMN), Encompass Health (EHC), HCA Healthcare (HCA), LHC Group (LHCG) and RadNet (RDNT).
https://thefly.com/landingPageNews.php?id=2843823
Endologix to ensure Nellix System used only within current indications
Endologix announced that in order to ensure optimal outcomes for patients, unrestricted sales and use of the Nellix System will cease immediately, and the product will only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. To ensure optimal clinical outcomes, the Nellix System will, for the foreseeable future, only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. All cases will be pre-screened by a physician panel and supported by Endologix clinical specialists to ensure adherence to protocol. Compassionate use requests will be reviewed in accordance with the process established by the Company and associated national competent authorities. The existing inventory will be voluntarily recalled. These actions are described in a Field Safety Notification issued today. This decision is one of several actions taken by Endologix following a new management mandate in August 2018 to ensure the most appropriate use of each of its devices and is in alignment with a recent publication by the European Society for Vascular Surgery. Endologix has been in contact with regulatory authorities regarding the Nellix System recall and related matters to help ensure patient safety and continued appropriate access to the Nellix System.
https://thefly.com/landingPageNews.php?id=2843825
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