American Renal Associates says Audit Committee review is continuing

As previously disclosed, in October 2018, the Staff of the Securities and Exchange Commission requested that the Company voluntarily provide documents and information relating to certain revenue recognition, collections and related matters. Following receipt of the SEC request, the Company responded by producing documents and information to the Staff and expects to continue to cooperate with the SEC by providing additional documents and information to the Staff in the future. In addition, the Audit Committee of the Board of Directors of the Company began an examination of the Company’s revenue recognition methodology and related accounting matters, such as internal control over financial reporting related to revenue recognition and related matters, with the assistance of legal counsel that reports to the Audit Committee, as well as independent accounting advisors retained by the Audit Committee’s counsel. The Audit Committee’s review is continuing. With the assistance of its advisors, the Audit Committee is examining reserve computations and other accounting practices that could have an impact on accounts receivable and revenue for the fiscal year ended December 31, 2018, as well as the previously reported fiscal years ended December 31, 2014, 2015, 2016 and 2017, the fiscal quarters within those fiscal years and the first three fiscal quarters of 2018. The Audit Committee is continuing to evaluate whether and how any such adjustments will affect individual quarters and years during the affected period, and the Company does not expect to comment further on the Audit Committee’s review until it is completed. However, the Company currently believes that the filing of its 2018 Form 10-K will be delayed and has informed the Company’s independent registered public accounting firm and the Staff of the SEC accordingly. The Audit Committee and the Board are continuing to evaluate these matters and are working diligently to complete their review so that the Company can file its 2018 Form 10-K and make any related disclosures as promptly as practicable.
https://thefly.com/landingPageNews.php?id=2876469

Insys falls after hiring banker to advise on Subsys divestment

Drug maker Insys Therapeutics has enlisted investment banking firm Lazard to advise on its intentions “to explore strategic options and is in talks to divest its fentanyl sublingual spray Subsys, sending the company’s shares down 15% percent in after-hours trading, according to a report out of Reuters.
https://thefly.com/landingPageNews.php?id=2876473

Rhythm Pharmaceuticals reports Q4 EPS (74c), consensus (57c)

As of December 31, 2018, cash, cash equivalents and short-term investments were $252.1M, as compared to $148.1M as of December 31, 2017.
https://thefly.com/landingPageNews.php?id=2876501

Jazz target lowered to $135 from $168 at Morgan Stanley

Morgan Stanley analyst David Risinger lowered his multiple on Jazz Pharmaceuticals shares and cut his price target to $135 from $168 given that Xyrem is one year closer to initial generics in 2023 and he is uncertain about Xyrem-related newsflow in 2019. He sees the risk-reward for next-gen Xyrem JZP-258’s Phase3 readout as skewed to the downside, given that he thinks success is unlikely to move shares up and he cannot rule out potential efficacy or safety issues. Risinger also thinks the potential approval of competitor pitolisant could impact investor perception about Xyrem, he noted. He maintains an Equal Weight rating on Jazz shares.
https://thefly.com/landingPageNews.php?id=2876519

Arena Pharmaceuticals presents new Phase 2 data for etrasimod and olorinab

Arena Pharmaceuticals presented new Phase 2 data from its investigative drug candidates etrasimod and olorinab at the 14th Congress of European Crohn’s and Colitis Organisation. “The new data presented from the Phase 2 trial of etrasimod demonstrate that both mucosal healing and histological remission were seen in patients with moderate to severe ulcerative colitis following just 12 weeks of treatment,” said Laurent Peyrin-Biroulet, MD PhD, Professor of Medicine and Head of the Inflammatory Bowel Disease Unit, Inserm, University Hospital of Nancy, France. “These results continue to support etrasimod’s potential as an important future therapy and we look forward to further validating these data in the soon to be initiated ELEVATE Phase 3 clinical program for etrasimod in UC.”
https://thefly.com/landingPageNews.php?id=2876523

Elevated risk of cardiovascular disease in young women

New research published in Diabetologia (the journal of the European Association for Study of Diabetes [EASD]) shows that, in women who develop gestational diabetes (GDM) during pregnancy, the risk of cardiovascular disease (CVD) in the years following childbirth is doubled compared to women who do not develop GDM. This increased risk remains even if women who had GDM do not go on to develop full blown type 2 diabetes, concludes the study by Dr Caroline Kramer, Dr Sara Campbell and Dr Ravi Retnakaran, Mount Sinai Hospital, Toronto, and University of Toronto, ON, Canada.

Women who develop GDM have an elevated lifetime risk of going on to develop type 2 diabetes, at least seven times higher than women without a history of GDM. Recently, various studies have suggested that women with GDM also have an increased risk of CVD. However, it is unclear if this increased CVD risk is dependent on the development of T2D. In this study, the authors did a systematic review and meta-analysis to determine if and how these conditions were related.

Their analysis of studies in the PubMed and EMBASE databases from 1950 to 2018 provided nine eligible studies (all published in the past six years) providing data from 5,390,591 women and 101,424 cardiovascular events. Compared with those who did not have GDM, women with GDM had a doubled risk of future cardiovascular events.

Further analysis of the data showed that rates of incident T2D across the studies did not affect this risk. Moreover, when restricted to women who did not go on to develop T2D, GDM remained associated with a 56% higher risk of future cardiovascular events. GDM also conferred a 2.3 times increased risk of cardiovascular events in the first decade following delivery.

The authors say: “The diagnosis of GDM identifies young women who have double the risk of cardiovascular events after birth compared with their peers who did not develop GDM. This risk is not dependent upon development of T2D and is apparent within the first decade after pregnancy. Thus, even without progressing to type 2 diabetes, women with GDM are an at-risk population for CVD and hence a potential opportunity for early risk factor surveillance and risk modification.”

They add it is notable that the association between GDM and CVD is consistently apparent across study populations of varying sizes from different countries (USA, Canada, UK, France, Israel and Sweden). They also say that, since the higher risk of CVD in women who have had GDM is not dependent on T2D, it could be related to one or more other risk factors, including increased inflammatory markers such as C-reactive protein, higher levels of blood fats, low levels of HDL (good) cholesterol and higher levels of LDL (bad) cholesterol. The authors say: “Each of these features has been shown to be present as early as 3 months after delivery, suggesting that women with GDM may experience long-term exposure to this enhanced risk factor profile.”

They add: “Taken together, these data support the emerging concept that women who develop GDM actually have a chronic metabolic disorder that comes to clinical attention during gestation, although it exists before, during and after the pregnancy. In this way, the diagnosis of GDM may be seen as identifying women who have a long-standing, high-risk cardiometabolic profile that would otherwise escape clinical detection during the relative youth of their childbearing years, if not for the screening that they undergo during pregnancy that will diagnose GDM.”

They conclude: “The diagnosis of GDM should be recognised as providing a unique window into a woman ‘s future risk of CVD, and hence an opportunity for early risk modification and possibly prevention of what remains a leading cause of mortality in women worldwide in 2019.”

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Story Source:

Materials provided by Diabetologia. Note: Content may be edited for style and length.

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Journal Reference:

1. Caroline K. Kramer, Sara Campbell, Ravi Retnakaran. Gestational diabetes and the risk of cardiovascular disease in women: a systematic review and meta-analysis. Diabetologia, 2019; DOI: 10.1007/s00125-019-4840-2

https://www.sciencedaily.com/releases/2019/03/190307195720.htm

U.S. Physical Therapy initiated with an Outperform at William Blair

William Blair analyst Matt Larew started U.S. Physical Therapy with an Outperform rating saying the company is a “best-in-class” operator that offers “pure-play” access to physical therapy.

https://thefly.com/landingPageNews.php?id=2876256