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March 28, 2014
08:58 EDTECYT, AZN, MRK, RHHBYAnalysts see Endocyte as potential target, Bloomberg says
Analysts at RBC believe Endocyte (ECYT) could see takeover interest from partner Merck (MRK), while Cowen thinks AstraZeneca (AZN) or Roche (RHHBY) could be potentially interested based on the strong results for the company's experimental cancer treatment, according to Bloomberg's "Real M&A" column.
News For ECYT;MRK;AZN;RHHBY From The Last 14 Days
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November 18, 2015
08:11 EDTAZN, RHHBY, MRKIMS 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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07:01 EDTMRKThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.
November 17, 2015
08:04 EDTMRKMerck to present new KEYTRUDA findings at upcoming congresses
Merck announced that data investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research 2015 Congress in San Francisco, Nov. 18 - 21; the 57th American Society of Hematology Annual Meeting in Orlando, Florida, Dec. 5 - 8; the San Antonio Breast Cancer Symposium, Dec. 8 - 12; and the European Society for Medical Oncology Asia 2015 Congress in Singapore, Dec. 18 - 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. "The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."
07:34 EDTRHHBYOphthotech to hold a conference call
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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.
06:08 EDTRHHBYRoche subsidiary to participate in Ophthotech and Novartis agreement
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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.
08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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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 EDTMRKSalomon to hold a conference
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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
15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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