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March 3, 2014
07:19 EDTBAX, TEVA, AZN, NBS, MNTA, INO, PTLA, ICPT, AMAG, IRWD, SNY, GILD, ACHN, EBSCowen to host a conference
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 3 at 1:30 pm; not all company presentations may be webcasted. Webcast Link
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November 17, 2015
10:47 EDTGILDBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
07:47 EDTTEVALeerink sees M&A accelerating for central nervous system assets
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07:03 EDTAZNCerulean, AstraZeneca partner to evaluate LYNPARZA, CRLX101 combo
Cerulean (CERU) announced that it has entered into a collaboration with AstraZeneca (AZN) and the National Cancer Institute, part of the National Institutes of Health, to study LYNPARZA and CRLX101. The collaboration will explore the synergistic effects of AstraZeneca's LYNPARZA, a poly ADP ribose polymerase inhibitor, and CRLX101, Cerulean's inhibitor of topoisomerase 1. The NCI will conduct a combination Phase I/IIa trial in the Branch led by Yves Pommier, M.D., Ph.D., Chief of the Developmental Therapeutics Branch.
06:02 EDTAZNAstraZeneca drug to cost over $12K for a month's supply, Reuters reports
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05:37 EDTAZNClovis downgraded to Neutral from Conviction Buy at Goldman
Goldman Sachs analyst Terence Flynn downgraded Clovis Oncology (CLVS) to Neutral from Conviction Buy citing limited visibility on the path to FDA approval following yesterday's update on the company's lung cancer drug Roci. The drug now has a less compelling profile relative to AstraZeneca's (AZN) Tagrisso, Flynn tells investors in a research note. He cut his price target for shares to $23 from $123. Clovis closed yesterday down $66.19, or 70%, to $30.24.
November 16, 2015
16:53 EDTTEVAPaulson reduced stake in Valeant
Paulson & Co. gave a quarterly update on its stakes in a filing this afternoon. NEW STAKES: Perrigo (PRGO), CIT Group (CIT), Precision Castparts (PCP), Cameron (CAM), and Altera (ALTR). INCREASED STAKES: Teva (TEVA), Post Holdings (POST), Starwood Hotels (HOT), LivaNova (LIVN), and Synergy Pharmaceuticals (SGYP). DECREASED STAKES: Valeant (VRX), Shire (SHPG), Whiting Petroleum (WLL), Computer Sciences (CSC), and Oasis Petroleum (OAS). LIQUIDATED STAKES: Houghton Mifflin Harcourt (HMHC), Broadcom (BRCM), and Sprint (S).
16:00 EDTAZNDiplomat Pharmacy to dispense TAGRISSO
Diplomat Pharmacy (DPLO) announced that it will offer TAGRISSO (osimertinib), recently approved by the U.S. Food and Drug Administration as an oral therapy for a specific type of metastatic non-small cell lung cancer. TAGRISSO is distributed by AstraZeneca (AZN).
14:07 EDTAZNClovis plunges after lung cancer drug response rate misses expectations
Shares of Clovis Oncology (CLVS) plunged more than 70% after the drugmaker reported new details regarding its cancer drug candidate rociletinib, with new, confirmed data showing an unexpected drop in effectiveness. SURPRISING DRUG RESULTS: Clovis announced this morning new details regarding its rociletinib drug, which is being studied for the treatment of non-small cell lung cancer. According to the company, the Food and Drug Administration is now requesting additional clinical data on the drug, with a renewed focus on so-called confirmed treatment responses. Clovis explained that previous applications submitted to the FDA -- as well as early data on the drug publicized at medical conferences and elsewhere -- contained some immature and unconfirmed results. Perhaps most notably, the company disclosed that "as the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected," with the current confirmed response rate for rociletinib now standing at 28% for the 500mg dose and 34% for the 625mg group. The primary driver of the low conversion to confirmed responses was due to ineffective tumor shrinkage as well as general disease progression, including brain metastasis, said the company. APPROVAL DELAY: In the wake of this morning's update, Piper Jaffray's Charles Duncan cut his price target on Clovis shares to $28 from $92 while reiterating a Neutral rating. Duncan explained that Clovis had previously reported a 54%-60% unconfirmed response rate for rociletinib, a significant change from today's confirmed numbers. The analyst had previously speculated that rociletinib might further differentiate itself in the market by demonstrating a meaningful impact on brain metastasis, but Monday's commentary from Clovis seems to specifically downplay that possibility. Though the new data "may still ultimately be approvable," Duncan envisions an approval delay of three to six months given what was revealed, and he pushed anticipated first U.S. sales of the drug to the fourth quarter of 2016 while cutting his expected second-line market penetration to just 25% from 45%. RETHINKING CLOVIS: Goldman Sachs analyst Terence Flynn said he views the news as a "significant setback" for rociletinib, especially given that the updated responses rates come in below that of Tagrisso, AstraZeneca's (AZN) recently-approved rival treatment option. As a result, Flynn put his Conviction Buy rating and $123 price target on Clovis "under review." IMMUNOGEN PRESSURED: Weighing in on the news, RBC's Simos Simeonidis speculated that Monday's selloff in ImmunoGen (IMGN) shares could be related to the Clovis update, as investors may be drawing a parallel between the company's IMGN853 and rociletinib. IMGN853 saw a similar drop in efficacy when adjusting data for confirmed responses, but the drug looks outright potent when limiting results to just key patient groups, the analyst contended. Though IMGN853 will still have to prove itself in larger trials, Simeonidis nevertheless sees the current weakness in ImmunoGen as a buying opportunity. PRICE ACTION: Shares of Clovis have dived more than $71, or 71.5%, to $28.35 in afternoon trading, while ImmunoGen has fallen 7% to $11.62. AstraZeneca, meanwhile, is up better than 4%.
10:27 EDTAZNGoldman puts Conviction Buy-rated Clovis under review
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10:23 EDTAZNClovis price target cut to $28 from $92 at Piper Jaffray
Piper Jaffray analyst Charles Duncan cut his price target for shares of Clovis Oncology (CLVS) to $28 from $92 after the company announced that rociletinib efficacy data matured and the number of patients with a confirmed response is lower than expected. The updated response rate may still ultimately be approvable, but it further hinders rociletinib's competitive positioning compared to AstraZeneca's (AZN) Targrisso, Duncan tells investors in a research note. The analyst pushed back his first rociletinib sales estimate to Q4 of 2016 and lowered the drug's peak penetration of the second line market from 25% to 45%. He reiterates a Neutral rating on Clovis. The stock is down 67%, or $66.93, to $32.50 in morning trading.
09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
08:32 EDTAZNClovis reopens, down 64% after FDA requests added data for rociletinib
AstraZeneca (AZN), which is at work on a drug similar to rociletinib, is up 2.5% in pre-market trading.
07:24 EDTINOSalomon to hold a conference
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07:22 EDTINOBrean Capital to hold a summit
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06:11 EDTBAXBaxter resumed with a Neutral from Overweight at Piper Jaffray
Piper Jaffray analyst Brooks West downgraded Baxter (BAX) to Neutral after resuming coverage of the name. The company, post the spin of Baxalta (BXLT), "has a number of moving pieces that need to be addressed," West tells investors in a research note. He lowered his price target for shares to $39 from $90.
05:57 EDTAZNAstraZeneca urges UK for antibiotics investment shake-up, Financial Time says
AstraZeneca has urged the U.K. government to develop a new model for incentivizing investment in antibiotics, reports the Financial Times. In a letter to the Financial Times, the company said it has joined other "leading voices" in the life sciences sectory to implore Britain to go ahead with a new system rather than waiting for an international agreement. The company said a new payment model was needed that would reward companies' investments but without encouraging the over-use of antibiotics. Reference Link
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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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.
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