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May 14, 2014
05:38 EDTAZN, INCYIncyte, MedImmune collaborate on immuno-oncology combination clinical trial
Incyte (INCY) and MedImmune, the global biologics research and development arm of AstraZeneca (AZN), announced that they have entered into a clinical study collaboration. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte’s oral indoleamine dioxygenase-1 inhibitor, INCB24360. Under the terms of the agreement, MedImmune and Incyte will collaborate on a non-exclusive basis on the study, to evaluate the combination in multiple solid tumors including metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer. The Phase I part of the trial is expected to establish a recommended dose regimen of both MEDI4736 and INCB24360 and the Phase II part of the study will assess the safety and efficacy of the combination. Results from the study will be used to determine whether further clinical development of this combination is warranted. The study will be co-funded equally by Incyte and MedImmune and conducted by Incyte.
News For INCY;AZN From The Last 14 Days
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November 23, 2015
06:00 EDTAZNAstraZeneca sells U.S. Entocort drug rights to Perrigo for $380M
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November 22, 2015
15:03 EDTINCYMerck reports multiple data sets from Keytruda combination studies
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November 20, 2015
07:31 EDTAZNLabcyte, AstraZeneca partner to develop acoustic liquid handling system
Labcyte announced a partnership with AstraZeneca to develop a state-of-the-art automated pharmaceutical compound management system based on its revolutionary Echo acoustic liquid handling technology. The new system, which will employ storage tubes compatible with acoustic liquid handling, will be deployed at the AstraZeneca MRC UK Centre for Lead Discovery in Cambridge.
06:09 EDTAZNSanofi, AstraZeneca to exchange more than 210,000 compounds
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November 18, 2015
16:43 EDTAZNBIND Therapeutics gets $4M milestone payment from AstraZeneca
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10:02 EDTINCYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Align Technology (ALGN) initiated with an Overweight at Piper Jaffray... Allegion (ALLE) initiated with a Buy at BofA/Merrill... Atara Biotherapeutics (ATRA) assumed with a Neutral at Goldman... Bankrate (RATE) initiated with a Buy at Topeka... Boulder Brands (BDBD) initiated with a Buy at Wunderlich... (CRCM) initiated with a Hold at Topeka... Coeur Mining (CDE) initiated with a Hold at Noble Financial... E.W. Scripps (SSP) initiated with an Equal Weight at Stephens... Etsy (ETSY) initiated with a Hold at Topeka... Euronet (EEFT) initiated with a Hold at Feltl... Fulton Financial (FULT) initiated with a Neutral at JPMorgan... Gray Television (GTN) initiated with an Overweight at Stephens... HP Enterprise (HPE) initiated with a Market Perform at Raymond James... Halozyme (HALO) initiated with a Buy at Citi... Incyte (INCY) initiated with a Buy at Goldman... Inventure Foods (SNAK) initiated with a Buy at Wunderlich... Isis Pharmaceuticals (ISIS) initiated with a Neutral at Goldman... Kite Pharma (KITE) initiated with a Buy at Goldman... Landec (LNDC) initiated with a Buy at Wunderlich... Lendingtree (TREE) initiated with a Buy at Topeka... Media General (MEG) initiated with an Equal Weight at Stephens... Meredith (MDP) initiated with an Equal Weight at Stephens... Nexstar (NXST) initiated with an Overweight at Stephens... OSI Systems (OSIS) initiated with a Buy at BB&T... PriceSmart (PSMT) initiated with an Outperform at Scotia Howard Weil... Qorvo (QRVO) initiated with an Outperform at JMP Securities... Seattle Genetics (SGEN) initiated with a Sell at Goldman... Sinclair Broadcast (SBGI) initiated with an Equal Weight at Stephens... TEGNA (TGNA) initiated with an Overweight at Stephens... Tribune Media (TRCO) initiated with an Equal Weight at Stephens... Xenia Hotels & Resorts (XHR) initiated with an Outperform at JMP Securities... bluebird bio (BLUE) initiated with a Buy at Goldman.
08:32 EDTINCYGoldman sees bluebird shares doubling on 'one-shot' gene therapy
Following a three and a half year rally for biotech stocks, and a more recent sector pullback from July's record high levels, Goldman Sachs analyst Salveen Richter said in a new note to investors that he has a Neutral view of the small- to mid-cap biotech space. Richter believes select small- to mid-cap biotech stocks should continue to outperform the broader market, but thinks stock picking is essential and laid out for investors who he thinks the winning and losing stocks in the space are likely to be. BUY BLUEBIRD: bluebird bio's (BLUE) innovative platform, which is designed to cure genetic diseases by introducing functional gene copies into a patient, makes it the "leading gene therapy play," contends Richter. bluebird's key value driver is LentiGlobin, a gene therapy for rare blood disorders, beta-thalassemia major and sickle cell disease, the analyst points out. Richter, who notes that bluebird has a major upcoming catalyst in the form of clinical updates from three Phase I/II studies of LentiGlobin in beta-thalassemia and sickle cell disease, set a 12-month price target of $165 on the stock, giving it 107% upside from current levels if his target is achieved. OTHERS TO BUY: Richter also recommends that investors own leading names in three areas of innovation, namely orphan diseases, gene therapy/editing, and immuno-oncology. In those areas, he identifies BioMarin (BMRN) as an orphan drug stock to buy, Incyte (INCY) as the best-positioned biotech immuno-oncology play for 2016 and Kite Pharma as a stock to own for the company's engineered T-cell platform focused on cancer. He set Buy rating on each of the three aforementioned names. SELL SEATTLE GENETICS: The only stock in the small- to mid-cap biotech space that Richter initiated coverage of with a Sell rating is Seattle Genetics (SGEN). The analyst acknowledges that the company is currently a leader in the antibody drug conjugate field, but thinks the consensus view of future competition for its Adcetris drug is "optimistic" and that the outlook for the rest of its pipeline is unclear. Richter set a 12-month price target of $33 on the stock, giving it 27% downside from current levels if his target is achieved. The analyst also began coverage of Atara Biotherapeutics (ATRA), Isis Pharmaceuticals (ISIS) and Juno Therapeutics (JUNO) with Neutral ratings, as he sees them all as having interesting drug platforms, but also believes their prospects are appropriately reflected in current valuations of their stocks. PRICE ACTION: Over the last six month, bluebird bio shares have fallen nearly 50%, but the stock has still more than doubled from where it was one year ago. In the last six months Seattle Genetics has risen 13%, bringing its gains over a one year timeframe to 28%.
08:11 EDTAZNIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:02 EDTAZNBIND says AstraZeneca initiates patient dosing in AZD2811 Phase 1 trial
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07:26 EDTAZNZS Pharma downgraded to Neutral from Buy at Citi
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06:25 EDTINCYIncyte initiated with a Buy at Goldman
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November 17, 2015
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
16:00 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.
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.
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
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