Today - Thursday, December 5, 2013
3:35 PMEU high court questions injunctions blocking disclosure of trial data
- The EU court of justice says a lower court "erred" in some instances in the course of imposing injunctions preventing the EMA from releasing data from clinical trials of AbbVie's (ABBV +0.4%) Humira and from trials conducted by InterMune (ITMN -2.7%).
- The case has been sent back to the EU General Court and, as Reuters notes, the potentially "sensitive data ... will remain under wraps for now."
- The EMA discloses information about clinical studies upon request in an effort to support transparency and satisfy public demand for less secrecy regarding the data.
- Related: Pfizer to broaden access to clinical trial data
3:11 PMDyax scores Orphan designation for HAE treatment
- Dyax (DYAX -1.2%) gets an Orphan designation from the FDA for DX-2930 in hereditary angioedema.
- The plasma kallikrein inhibitor is in Phase 1 testing with results planned for Q1 of next year.
- The company (which makes Kalbitor for acute HAE attacks) says the designation "is an important element of [the drug's] development strategy." (PR)
- Other plasma kallikrein inhibitors include BioCryst's BCX-4161.
2:50 PMSanofi, Zealand diabetes treatment meets primary endpoint
- Sanofi's (SNY -0.4%) GLP-1 analogue lixisenatide "exerts similar glucose lowering effect whether administered before breakfast or before the main meal," Zealand Pharma (ZLDPF) reports.
- SNY licenses the drug from Zealand.
- The data (from a Phase 3 study presented at the World Diabetes Congress) "could make the drug more appealing to patients given its flexibility of administration, especially for injectable diabetes therapies," Reuters notes.
2:20 PMAfter big rally, Oculus falls on offering announcement| Comment!
1:50 PMNoble Financial likes TherapeuticsMD's CSO appointment
- Noble Financial analyst Nathan Cali is excited about TherapeuticsMD's (TXMD +2.6%) move to appoint Joel Krasnow as CSO and head of regulatory development.
- Dr. Krasnow's experience provides TXMD with a well rounded clinical team to execute Phase 3 studies towards FDA approval for three late stage compounds; potential FDA approvals expected to start in 2015, Cali says.
- Buy rating maintained.
- Price target is $7.25.
1:30 PMHealth Management shares fully reflect Community Health deal: Wells| Comment!
12:40 PMPfizer to broaden access to clinical trial data
- "We are proud to be, I think, the first company to take this step," Reuters quotes Pfizer's (PFE -0.1%) Mikael Dolsten as saying, regarding a move by the company to make clinical trial data available to study participants.
- The company's move to be more transparent with its data comes as the industry faces pressure to broaden access to information about clinical trials.
- PFE will also attempt to simplify some of the language in the trial results for those patients who elect to view the data and will "give them access to personal medical information tracked by researchers over the course of the trial."
- PFE's head of medicines development Steve Romano hopes the initiative will change "the mindset of patients getting involved in clinical trials."
12:16 PMUBS upgrade lifts Celgene
- Shares of Celgene (CELG +3.3%) are moving notably higher in morning trading.
- Likely behind the move is UBS, where analyst Matthew Roden has upgraded the stock to Buy from Neutral.
- "We find CELG compares favorably to other names in healthcare and the broader markets on the basis of EPS growth (26% vs 16% HC and 13% S&P500), and operating margin (49% vs 13% and 16% in Q3 2013, and 60% achievable for CELG by 2017)," Roden notes.
- Price target is $200.
10:03 AMReceptos to move RPC1063 into Phase 3
- Receptos (RCPT +22.7%) soars after saying the DMC for its Phase 2/3 trial of RPC1063 in RMS has recommended both the continuation of the Phase 2 portion of the study and the initiation of the Phase 3 component.
- The company says data from an interim analysis "support the RPC1063 differentiation profile and [is] consistent with data from prior RPC1063 studies."
- Expect top-line data from Phase 2 in mid-2014. (PR)
9:52 AMQuestcor possibly hit by Acthar coverage worries
- In addition to a hangover from the latest Citron bear call, shares of Questcor Pharmaceuticals (QCOR -1.4%) appear to be suffering from market chatter surrounding HealthNet's coverage of Acthar in infantile spasms. (document is here)
- Although the weakness looks to be attributable to coverage worries, it isn't immediately clear that any change has been effectuated.
- See also: Citron back on offensive in QCOR debate
9:43 AMBoston Scientific fairly valued: Benchmark
- Benchmark starts coverage of Boston Scientific (BSX) at Hold.
- Analyst Jan Wald thinks "the company is making good progress on major efforts to drive improved leverage and growth," but says the shares adequately reflect these efforts.
- "We would look for either improvements in reported results, new efforts not yet appreciated by the Street, or a pullback in the stock before seeing upside," Wald concludes.
9:29 AMSummer Street out with bearish commentary on Auxilium
- "The sell-off is not surprising to us and we continue to warn investors that the market for Testim will disappear in the foreseeable future," Summer Street says, regarding Auxilium Pharmaceuticals (AUXL) and Wednesday's news regarding an unfavorable district court ruling.
- Analyst Bart Classen also warns that when AndroGel goes generic in 2015, "almost no one will pay a premium for branded Testim."
- As for the December 6 PDUFA for Xiaflex, Classen is "skeptical that the FDA will approve [it] for Peyronies disease without an Ad Com."
9:15 AMWedbush sees big upside for MEI Pharma
- Wedbush thinks MEI Pharma's (MEIP) pracinostat "has the potential to be a best-in-class HDAC inhibitor, with synergistic potential in combination with approved hypomethylating agents such as azacitidine (Vidaza) that are standard-of-care in MDS and in elderly AML patients."
- Analyst David Nierengarten starts the shares at Outperform.
- Price target is $12, representing upside of around 50% from Wednesday's close.
9:11 AMBenchmark initiates bullish coverage on Covidien
- Covidien (COV) is initiated at Buy at Benchmark.
- Analyst Jan Wald likes the company's "deep commitment to ROIC" and thinks the strategy of "using acquisitions as a proxy for R&D" is working out well.
- Wald also says COV's EM strategy is "paying off" and thinks margins look "much stronger" than competitors.
- Price target is $82.
8:53 AMPuma Biotechnology rises on neratinib update
- Puma Biotechnology (PBYI) rallies 20% in premarket trading.
- Investors appear pleased with top-line data from a Phase 2 study of neratinib in breast cancer (data released Wednesday evening).
- BofA has lifted the price target on the shares to $87 from $71, saying "much awaited I-SPY2 top-line results show PBYI's next generation HER2 kinase inhibitor is superior to Herceptin in the neoadjuvant breast cancer setting in a Taxol containing regimen."
- Meanwhile, FierceBiotech's John Carroll calls the study "anything but traditional" in a story that carries the rather colorful headline, "I-SPY a controversy over Puma's positive Phase 2 test of neratinib."
- See: Puma releases "positive" results from neratinib trial
8:37 AMCombiMatrix jumps on ACOG CMA recommendation
- CombiMatrix (CBMX) soars 38% in premarket trading.
- The company says the American College of Obstetricians and Gynecologists is now recommending chromosomal microarray analysis as the "first-line genetic test in pregnancies showing fetal abnormalities on an ultrasound screen."
- Further, CBMX says the ACOG's "guidelines also indicate that microarray testing is recommended as the preferred genetic test to help identify the cause of death in stillbirths and intrauterine fetal demise when further cytogenetic analysis is desired." (PR)