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April 11, 2012
Pharmaceutical Strategic Outlook: Biopharma Strategic Dealmaking Conference is being held in New York on April 11-13 with pre-conference workshops being held on April 11 and the conference starting on April 12 at 8 am.
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November 16, 2015
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%.
13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
13:08 EDTCELGCelgene defeats Bass challenege on Revlimid patent, Bloomberg reports
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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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November 13, 2015
11:02 EDTCELGCelgene calls active on renewed takeover chatter
Celgene November weekly 111 and 112 calls are active on total call volume of 9K contracts (3K puts) on renewed takeover chatter. November weekly call option implied volatility is at 82, November is at 42, December is at 35; compared to its 52-week range of 23 to 54. Active call volume suggests traders taking positions for large price movement.
10:58 EDTCELGRumor: Celgene moves up on renewed takeover chatter
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09:37 EDTAZNClovis down 3% after FDA approves AstraZeneca lung cancer drug
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09:34 EDTAZNFDA approves Roche's cobas EGFR Mutation Test
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09:31 EDTAZNFDA approves AstraZeneca non-small cell lung cancer treatment
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08:02 EDTMRKMerck: DMC recommends anacetrapib study continue with no changes
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November 12, 2015
17:02 EDTMRKMerck Animal Health to Acquire Harrisvaccines
Merck Animal Health and Harrisvaccines announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals. The terms of the agreement were not disclosed. The companies expect the transaction to close in the fourth quarter of 2015.
11:50 EDTMRKMerck issues statement regarding CUBICIN patent litigation
Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit: "The decision validated the patent for CUBICIN that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020. The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court."
08:42 EDTKFYSunTrust to hold a conference
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