MARKET CURRENTS
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MARKET CURRENTS
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Today - Wednesday, June 19
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4:05 PM Cytokinetics (CYTK -3.7%) gives back some of yesterday's gains made after the company announced that results from its Phase IIb clinical trial, ATOMIC-AHF, have been accepted for presentation during a Hot Line Late Breaking Trials Session at the European Society of Cardiology Congress 2013. Comment!
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3:12 PM Onglyza, a diabetes drug co-marketed by Bristol-Myers Squibb (BMY -1.3%) and AstraZeneca (AZN -1.2%), failed to reduce the risk of heart attacks and related disease compared with a placebo in a big clinical trial. The drug was approved by the FDA in 2009 to treat type 2 diabetes, but required a large clinical trial to assess its cardiovascular safety. The outcome disappointed those hoping for a boost to the market for type 2 diabetes pills, and could have implications for other companies with similar drugs, including Merck's (MRK) blockbuster Januvia. Comment!
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2:59 PM Lazard comes to the defense of Buy-rated Vanda Pharmaceuticals (VNDA -22%) after TheStreet's Adam Feuerstein tanks the stock with questions about the design of a Phase 3 trial for Tasimelteon (previous). Feuerstein's assessment is "surprisingly inflammatory," analyst Joshua Schimmer says, noting that the sell-off could be a buying opportunity given management's confidence in the drug. Comment!
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2:33 PM Shares of Agenus (AGEN +4.2%) rise for the second straight day bringing gains since around 1:30 Tuesday to nearly 7%. Maxim initiated the shares at Buy with a lofty $19 price target yesterday. Comment!
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2:17 PM Raptor Pharmaceutical (RPTP +1.1%) says its Procysbi delayed-release capsules for the treatment of nephropathic cystinosis are now available in the U.S. for shipment. Nephropathic cystinosis is a rare, life-threatening metabolic lysosomal storage disorder that causes toxic accumulation of cystine in all cells, tissues, and organs in the body. Comment!
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1:53 PM Neurocrine Biosciences (NBIX +2.7%) moves up today after being initiated by Oppenheimer with an Outperform rating. The firm says that its sees blockbuster potential for elagolix, with Phase 3 endometriosis results expected in H114 and Phase 2 results in H214. A secondary asset, NBI-98854, a Vesicular Mono-Amine Transporter 2 compound for treating tardive dyskinesia, is risky, but only modest value is baked in. Comment!
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1:35 PM Nektar Therapeutics (NKTR +8.8%) rises after saying NKTR-181 (basically an opioid which doesn't act like an opioid in terms of euphoric effects) "rated similar to placebo in 'drug liking' and 'feeling high' scores" compared to oxycodone. The drug's slow rate of entry into the brain is intended to reduce the euphoria that is often cited as a contributor to opioid analgesic addiction. (PR) Comment!
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1:33 PM Shares of Oxygen Biotherapeutics (OXBT +10.9%) extend yesterday's 2.6% closing gain after the company announced on yesterday that it's completed FDA requested studies on its Oxycyte, a treatment for traumatic brain injury and other brain conditions. The company says the results were positive overall, but it will continue to conduct more studies on the treatment. Comment!
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1:26 PM An AMA designation might have no legal standing but new legislation aimed at Medicare coverage for weight-loss drugs could change that. Sens. Tom Carper and Lisa Murkowski and Reps. Bill Cassidy, M.D. and Ron Kind have introduced The Treat and Reduce Obesity Act which would, among other things , "allow Medicare to cover additional obesity treatments (beyond surgery) such as prescription drugs for chronic weight management." Leerink's Marko Kozul says the news "could provide further upside to current estimates" for Arena (ARNA +2.7%), Orexigen (OREX +0.5%), and Vivus (VVUS +7.7%). 1 Comment
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1:16 PM Shares of clinical stage biopharmaceutical company Intercept Pharmaceuticals (ICPT) are now up over 13% after pricing its public offering of 1.73M shares at $33.01 per share in line with yesterday's close. Comment!
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1:07 PM MediciNova (MNOV +29.6%) soars after the company says its glial attenuator MN-166 may reduce methamphetamine's neurotoxic inflammation and might also "attenuate other actions contributing to methamphetamine dependence." The company plans to initiate a Phase 2 trial "later this summer." (PR) Comment!
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11:54 AM Danaher's (DHR -0.1%) subsidiary Beckman Coulter says the FDA has granted 510(k) clearance to its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system, designed to assist physicians with the diagnosis of heart attacks. Comment!
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11:35 AM Genetic Technologies (GENE -1.1%) says its subsidiary Phenogen Sciences has executed an agreement with FedMed to use its national provider network. FedMed's network includes more than 550K, 60K ancillary care providers and 4K hospitals nationwide, with more than 40M covered individuals. Comment!
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11:23 AM bluebird bio (BLUE) opens for trade at about $25, nearly 50% higher than the IPO price of $17. The IPO itself priced above the expected $14-$16 range and was upsized from 5M to 5.9M shares. Comment!
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10:58 AM Teva Pharmaceutical (TEVA -0.5%) says it's settled a a class action lawsuit in Israel resulting in the generic drug titan disclosing the compensation of senior executives and directors on an individual basis starting with this year's annual report. The drugmaker also agreed to reimburse $1.1M for the plaintiffs' legal fees and other expenses in the case, which aimed to increase transparency at the company. Teva also will pay $200K in compensation to the plaintiffs. Comment!
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10:43 AM Kyprolis sales update for Onyx Pharmaceuticals' (ONXX -3.1%) shareholders courtesy of Jefferies' Biren Amin: Data shows sales of ~$22M for May meaning the multiple myeloma treatment should meet Q2 estimates of $65-66M assuming sales in June do not surprise to the downside. The shares are reiterated at Buy (PT $104). Comment!
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10:12 AM In addition to the $1.75B public offering of common stock, Valeant Pharmaceuticals (VRX +0.1%) announces a $3.2B offering of senior unsecured notes by a wholly owned subsidiary. (PR) Comment!
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9:35 AM Jefferies' Biren Amin hikes the price target on Celldex Therapeutics (CLD +0.7%) to $19 from $15 citing potential royalties from rindopepimut and CDX-011. 1 Comment
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9:30 AM Pluristem Therapeutics (PSTI +2.15%) suspends trials in Germany for its placenta-based cell treatment for artery disease after the FDA halted Phase II testing in the U.S. earlier this month following "a serious allergic reaction" in one patient. To expedite the FDA's review, process, Pluristem has sent the agency information that it thinks might be relevant. (PR) Comment!
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9:24 AM More on J.P. Morgan's Keryx BioPharma (KERX) initiation: Zerenex (I, II) has "pharmacoeconomic advantages [that] could drive rapid uptake in the price sensitive end stage renal disease market," analyst Cory Kasimov says. Additionally a "deep dive" analysis has JPM "increasingly comfortable" with the issues that have weighed on the shares recently. Comment!
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9:07 AM Gene therapy company bluebird bio (BLUE) has raised $101M in its Nasdaq IPO by selling a greater-than-planned 5.9M shares at $17 each, above the expected range of $14-16. The price values the firm at $389M. What's unusual about the IPO is that bluebird has no significant, if any, clinical data behind it. (previous) Comment!
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8:38 AM Vanda Pharmaceuticals (VNDA) sinks 14% premarket after Adam Feuerstein raises questions about the design of the company's Phase 3 trial for Tasimelteon (previous) which he says has "changed numerous times." Specifically, Feuerstein notes that the company changed the primary endpoint to a measure it created which "has never been used before in sleep-drug clinical trials [and is not ] endorsed by the FDA." Comment!
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8:29 AM Vivus' (VVUS +4.3%) Stendra drug for erectile dysfunction demonstrated a statistically significant improvement vs a placebo a trial of 440 patients between the ages of 40 and 70, with the aim being for the medication to take effect within 15 minutes of being consumed. A major problem with other treatments is that patients are advised to wait 1-2 hours for the drugs take effect, or they have to be consumed daily. (PR) Comment!
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8:04 AM EU antitrust regulators have fined nine drug makers a combined €146M for blocking the supply of cheaper drugs through "pay-for-delay" deals in which brand name companies pay generic manufacturers not to enter the market with their products. Denmark's Lundbeck (HLUKF.PK) received the biggest penalty of €94M. The punishment highlights how authorities on both sides of the Atlantic are coming down on "pay for delay," with the U.S. Supreme Court recently ruling that the FTC can take action against such deals. Comment!
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5:50 AM The American Medical Association has voted to recognize obesity as a disease, a move that could prompt more insurers to pay for it - and define a third of Americans as being ill. SA author Spencer Osborne points out that companies that could benefit include Arena (ARNA), Vivus (VVUS) and Orexigen (OREX), whose prescription drugs are on the market or are in the FDA approval process. However, it's worth noting that the AMA's decision has no legal standing. 2 Comments
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5:34 AM The FDA is investigating the injectable form of Eli Lilly's (LLY) antipsychotic drug Zyprexa - which generated $1.7B in sales last year - after two patients died within four days of receiving the treatment. The patients had very high levels of the drug in their system, which can cause delirium, cardiac arrest and arrhythmias and coma or loss of consciousness. However, the agency isn't yet saying they received an overdose or an inappropriate amount. 2 Comments
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3:37 AM AstraZeneca's (AZN) and Bristol-Myers Squibb's (BMY) diabetes drug Onglyza doesn't reduce heart risks, a large-scale study shows, with patients who suffer from the Type 2 version of the disease not experiencing fewer strokes, heart attacks and other adverse events than those who took a placebo. Investors had hoped that a demonstrable cardiovascular benefit for Onglyza, which generated sales of $709M in 2012, would give it an edge over rival treatments and revive slowing demand. (PR) Comment!
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