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News Breaks
August 12, 2014
HIGHER: Intercept (ICPT), up 46% after upgraded at Leerink and Citigroup following OCA data. Conatus Pharmaceuticals (CNAT), which also develops treatments for liver disease, up 8.5%... Fontegra Financial (FRF), up 40% after Tiptree Financial (TIPT) to acquire the company for $10.00 per share in cash... Insys Therapeutics (INSY), up 15.4% after submiting NDA for new formula of Dronabinol Oral Solution, saying it is on track to submit at least four IND applications with the FDA in the second half of 2014... Exact Sciences (EXAS), up 8% after announcing FDA approved for Cologuard... Abercrombie & Fitch (ANF), up 2.7% after upgraded at Stifel. UP AFTER EARNINGS: Kate Spade (KATE), up 5.5%... Noah Holdings (NOAH), up 3%... ReneSola (SOL), up 5%... Supernus (SUPN), up 14%. LOWER: NII Holdings (NIHD), down 54.5% after warning it needs to make "key decisions" to address liquidity, "likely" to file a voluntary petition for relief under Chapter 11 of the Bankruptcy Code... Dendreon (DNDN), down 23.6% after warning that its alternatives could leave shareholders with no ownership... magicJack (CALL), down 10.3%, downgraded at Canaccord following Q2 results... Hi-Crush Partners (HCLP), down 4.7% after filing to sell 3.26M common units representing limited partners... Triangle Capital (TCAP), down 3.8% after filing to sell 4M shares of common stock. DOWN AFTER EARNINGS: Nuance (NUAN), down 9.4%... Flowers Foods (FLO), down 7.8%.
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November 18, 2015
08:14 EDTHCLPRBC Capital to hold a conference
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07:43 EDTINSYJefferies to hold a conference
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07:42 EDTICPTIntercept PBC treatment revenue likely to beat expectations, says Oppenheimer
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November 17, 2015
14:46 EDTANFAbercrombie & Fitch volatility elevated into Q3 and outlook
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10:11 EDTINSYOptions with decreasing implied volatility
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07:47 EDTTCAPWells Fargo to hold a forum
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07:35 EDTSOLReneSola sees Q4 revenue $275M-$295M, consensus $278.62M
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07:35 EDTSOLReneSola sold 35 MW of projects, project pipeline at 515 MW
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07:34 EDTSOLReneSola reports Q3 EPS 8c, consensus (2c)
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November 16, 2015
10:25 EDTINSYOptions with decreasing implied volatility
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09:06 EDTINSYDiplomat seen as compelling amid specialty pharmacy fallout
Shares of specialty pharmacy operator Diplomat Pharmacy (DPLO) and pharmacy benefit manager Express Scripts (ESRX) have each been knocked down by the negative news surrounding the sector amid the troubles faced by Valeant (VRX) and others, but an analyst at Leerink contends in a note to investors that the pullbacks in both stocks provide buying opportunities. BACKGROUND: Drugmaker Valeant and its prior specialty pharmacy partner, Philidor Rx Services, have been at the center of the firestorm engulfing the sector. Following claims that Philidor urged its employees to modify prescriptions to ensure more orders of Valeant-branded drugs rather than generics, as well as other allegations of wrongdoing, Express Scripts (ESRX) and peer CVS Health (CVS) terminated Philidor from their networks. The day after those termination announcements, Valeant said that it was severing all ties with Philidor and that the pharmacy planned to shut down operations as soon as possible, consistent with applicable laws. Valeant has subsequently said that Philidor has committed to cease operations by January 30, 2016, at the latest. More recently, Express Scripts, the nation's largest pharmacy benefit manager, announced that it stopped doing business with Linden Care, accusing it of being a "captive" pharmacy that dispenses mostly products made by Horizon Pharma (HZNP). In turn, Horizon called the idea that Linden Care is a captive pharmacy "entirely false," stating that "at best Express Scripts is being reckless in its allegations and at worse it is intentionally attempting to mislead investors." Express Scripts' move also impacted shares of Insys Therapeutics (INSY), which reportedly also used Linden Care to fulfill prescription for its drugs. DIPLOMAT LIKELY TO STAY IN-NETWORK: Leerink analyst David Larsen acknowledged that recent events indicate that Express Scripts appears to be evaluating certain retail pharmacies and their relationships with manufacturers, but he believes Diplomat's mix of drugs for diseases like multiple sclerosis, HIV, hepatitis C and cancer differentiate it as a "true" specialty pharmacy. Larsen does not think Diplomat is at risk of being excluded from the pharmacy networks of Express Scripts, CVS or UnitedHealth's (UNH) Optum, he tells investors. Larsen expects limited distribution agreements to stay an important channel strategy for drugmakers and believes these agreements are appropriate for high cost specialty drugs that require special handling and additional services to manage patient adherence. The analyst, who thinks Diplomat remains well positioned to deliver annual growth of over 30% in the next several years, keeps an Outperform rating on its shares. EXPRESS BUYING OPPORTUNITY: Larsen also thinks concerns around manufacturer and pharmacy relationships have put unwarranted pressure on shares of Express Scripts. He does not expect Express Scripts to disclose new lawsuits around rebate dollars owed over other manufacturer disputes and keeps an Outperform rating on the stock, which he views as having an "attractive" valuation. WHAT'S NOTABLE: Larsen also thinks that the specialty channel remains an opportunity for Walgreens Boots Alliance (WBA) and believes its proposed acquisition of Rite Aid (RAD) can strengthen its specialty offering. The analyst keeps an Outperform rating on Walgreens shares as well. PRICE ACTION: Over the last three months, Diplomat Pharmacy shares have declined 28%, Express Scripts has fallen 6% and Walgreens has dropped 14%.
07:24 EDTSUPNSalomon to hold a conference
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November 15, 2015
15:37 EDTCNATConatus says emricasan abstract selected as noteworthy, sees topline data 1H18
Conatus Pharmaceuticals announced that the company's late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Diseases -- entitled "Emricasan administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension" -- was selected as one of 16 key abstracts. Conatus CEO Steven Mento remarked, "Based in part on these encouraging clinical results, we recently introduced a strategy for the initial registration of emricasan involving multiple parallel Phase 2b clinical trials, the... ENCORE trials. We expect to initiate the ENCORE trials on a staggered basis over the next 15 months and expect top-line results to be available periodically beginning in 1H18."
15:08 EDTICPTIntercept reports analysis of Phase 3 obeticholic acid study, other data
Intercept announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis, for presentation at the American Academy for the Study of Liver Diseases annual meeting. The studies evaluate investigational use of obeticholic acid, Intercept's lead farnesoid X receptor agonist. In a presentation titled, "Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase," an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody test showed that, of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that 69% of those likely PBC patients continued to have elevated ALP two years after the first positive AMA test. Meanwhile, a presentation titled "A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis" includes an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase, albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA plus or minus ursodiol or placebo plus or minus ursodiol at the end of the POISE study. The UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo. Lastly, a presentation titled "Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" showed that patients may not be properly informed about their ALP scores and the nature of PBC symptoms.
14:38 EDTICPTIntercept reports analyses of OCA in fatty liver patients
Intercept Pharmaceuticals announced new results from the non-invasive evaluation of liver fibrosis in patients from the FLINT trial of obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. In the trial, treatment with once daily 25 mg OCA was shown to reverse fibrosis in a "significant proportion" of biopsy-proven NASH patients, as observed by repeat liver biopsy at the end of the double-blind treatment phase at week 72, according to the company. Post-hoc analysis evaluated the early predictive value of three known non-invasive fibrosis tests -- FIB-4, APRI and NFS -- in identifying patients who experienced improvement in fibrosis. Each was assessed at baseline and over the course of treatment and then correlated with histologic changes observed in the OCA and placebo patients. The analysis demonstrated that OCA treatment of NASH patients led to a statistically significant decrease in FIB-4 from baseline as compared to placebo. Further, a decline in FIB-4 of 10% after 24 weeks of treatment predicted improvement in fibrosis by at least one stage as assessed by biopsy at 72 weeks, according to Intercept. Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo, and a 34% reduction in APRI at 24 weeks predicted improvement in fibrosis by at least one stage at 72 weeks. On average, OCA treatment reduced the FIB-4 score to less than 1.3 and the APRI score to less than 0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs. While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis, the company said.
November 13, 2015
17:29 EDTCALLMan Group reports 5.26% passive stake in magicJack
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15:35 EDTICPTIntercept to host investor meeting
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08:28 EDTICPTAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
08:13 EDTFLOFlowers Foods pullback a buying opportunity, says Stephens
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November 12, 2015
12:02 EDTFLOOn The Fly: Top stock stories at midday
Stocks on Wall Street opened deep in negative territory but the averages began to pare their losses almost immediately. All eyes and ears were on Fed Chair Janet Yellen, who gave a welcoming speech at a Fed conference, though she did not discuss policy or the economy. Other Fed speakers talked about the lack of inflation as well as interest rate expectations, but their comments so far this morning have failed to clarify expectations for the December meeting. ECONOMIC EVENTS: In the U.S., initial jobless claims were unchanged at 276,000 in the week of November 7, versus expectations for 270,000 first-time claims. The JOLTS report showed job openings rebounded 149,000 to 5.53M in September. In Europe, European Central Bank president Mario Draghi, in remarks delivered in a hearing in the European Parliament, once again signaled that the bank is ready to boost stimulus at its December meeting as warranted. COMPANY NEWS: Shares of Angie's List (ANGI) jumped 12% after Barry Diller's IAC/InterActiveCorp (IACI), the parent company of HomeAdvisor, made public a $8.75 per share cash buyout offer. Yelp (YELP), which also connects people with local businesses via its web-based and mobile services, advanced 8% following the revelation of the takeout bid for Angie's List... Department store owner Kohl's (KSS), which was weak yesterday along with virtually every company in the space following Macy's (M) disappointing results, bounced back 6% after its third quarter report topped expectations on both the top and bottom lines... Advance Auto Parts (AAP) sunk 13% after its earnings missed the consensus forecast, its profit guidance was lowered, its CEO announced plans to retire and Starboard's CEO Jeff Smith was appointed to the company's board. MAJOR MOVERS: Among the notable gainers was Eros International (EROS), which rallied more than 8.5% after it called allegations of security laws violations "baseless and misleading." Also higher was Viacom (VIAB), which gained 2.5% after it quarterly earnings came in roughly in-line with consensus estimates. Among the noteworthy losers was Fairmount Santrol (FMSA), which fell 20% after reporting downbeat third quarter earnings and suspending its earnings guidance due to market uncertainty. Also lower was Flower Foods (FLO), which dropped 10% after it reported quarterly earnings and narrowed its fiscal 2015 guidance. INDEXES: Near midday, the Dow was down 147.82, or 0.84%, to 17,554.40, the Nasdaq was down 18.15, or 0.36%, to 5,048.87, and the S&P 500 was down 13.77, or 0.66%, to 2,061.23.
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