Are investors hitting the brakes on biotech? The biotech sector's one of the most boom-or-bust areas for investors, where fortunes can be won or lost. For most of the first half of 2013, it seemed the former was true, as the Nasdaq Biotechnology Index soared by double-digit percentage growth.
Over the past five days, however, the index shed nearly 5%, part of a 7% drop over the past month. Should investors be worried about this volatile sector, or are the past week's losses a remote event you should discount? Let's look at why some of the biotech index's big names were on the move this week.
Even biotechs can't escape Bernanke
To be fair to biotech investors, the entire market took a beating this week behind Federal Reserve Chairman Ben Bernanke's announcement that the central bank could explore tapering back quantitative-easing bond buying later this year if the economy continues to improve. That won't affect the biotech market much, but in a classic overreaction from Wall Street, the sector fell with every other one on Wednesday and Thursday.
Best Biotech Stocks To Invest In 2015: Savient Pharmaceuticals Inc(SVNT)
Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing KRYSTEXXA, a biologic PEGylated uricase in the United States. The KRYSTEXXA is being developed as a treatment for chronic gout in patients refractory to conventional therapy. The company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. It sells its products directly to drug wholesalers. The company, formerly known as Bio-Technology General Corp. and changed its name to Savient Pharmaceuticals, Inc. in June 2003. Savient Pharmaceuticals, Inc. was founded in 1980 and is headquartered in East Brunswick, New Jersey.
Advisors' Opinion:- [By James E. Brumley]
It's still too soon to say Savient Pharmaceuticals Inc. (NASDAQ:SVNT) is off and running. In fact, the stock's decidedly NOT off and running yet. But, it's not too soon to put SVNT on your watchlist of potential breakout candidates, as it's much closer to a breakout than most anyone can see.
- [By James E. Brumley]
Since 2008's implosion from the stock, the interest in Savient Pharmaceuticals Inc. (NASDAQ:SVNT) has been waning. There was a brief burst of bullishness in September of last year, which stirred the bullish pot a little. But, when SVNT started to fade in October of that year - just as quickly as it had perked up - what lingering hopes there were for the stock finally started to melt away. By the middle of this year, pretty much everyone had written Savient Pharmaceuticals off as a lost cause. Big mistake. Over the last few days, SVNT has almost wiggled its way buck into a bullish zone.
Best Biotech Stocks To Invest In 2015: Gilead Sciences Inc.(GILD)
Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics for the treatment of life threatening diseases worldwide. Its products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems. The company?s products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular a ge-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Its products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a ?Quad? regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa. The company?s Phase II clinical trials products comprise Cicletanine, Ranolazine, and Aztreonam, as well as GS 9190, GS 9256, and GS 9451. Its Phase I clinical trial products include GS 7340, GS 5885, GS 6620, GS 9620, and GS 6624. The company was founded in 1987 and is headquartered in Fost er City, California.
Advisors' Opinion:- [By Keith Speights]
Gilead Sciences (NASDAQ: GILD ) shares have steadily risen more than 90% over the past year. The biotech announced first-quarter results after the market closed on Thursday, though, that weren't all that impressive. Will this be a problem for Gilead? I doubt it.
Top 5 Beverage Companies To Buy For 2015: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company�� other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company�� distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursuant to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA
LODOTRA is a programmed release formulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
Advisors' Opinion:- [By Jake L'Ecuyer]
Top losers in the sector included Horizon Pharma (NASDAQ: HZNP), off 9.5 percent, and Anacor Pharmaceuticals (NASDAQ: ANAC), down 8.2 percent.
Top Headline
The Greenbrier Companies (NYSE: GBX) reported a 13% gain in its fiscal second-quarter earnings. Greenbrier's quarterly profit surged to $15.6 million, or $0.50 per share, versus a year-ago profit of $13.8 million, or $0.45 per share. Excluding one-time items, it earned $0.51 per share. Its revenue climbed 88% to $502.2 million. However, analysts were expecting earnings of $0.60 per share on revenue of $508.69 million. - [By Jake L'Ecuyer]
Top losers in the sector included Horizon Pharma (NASDAQ: HZNP), off 9.5 percent, and Anacor Pharmaceuticals (NASDAQ: ANAC), down 8.2 percent.
Top Headline
The Greenbrier Companies (NYSE: GBX) reported a 13% gain in its fiscal second-quarter earnings. Greenbrier's quarterly profit surged to $15.6 million, or $0.50 per share, versus a year-ago profit of $13.8 million, or $0.45 per share. Excluding one-time items, it earned $0.51 per share. Its revenue climbed 88% to $502.2 million. However, analysts were expecting earnings of $0.60 per share on revenue of $508.69 million. - [By Bryan Murphy]
After a 16% rally on Tuesday, it would be understandable is a newcomer wanted to steer clear of Horizon Pharma Inc. (NASDAQ:HZNP). After all, how much more upside can there be for this fairly typical small cap biotech stock. Yet, HZNP may well be one of the rare exceptions to the "tough to follow-through" tendency.
For those not familiar, HZNP is a biopharma name with a couple of rheumatoid arthritis, COPD, and asthma drugs on the market... Duexis, and Rayos. There's a third drug in the pipeline - Lodotra, for polymyalgia rheumatica, though it's already approved as a treatment for RA.� Either way, Horizon Pharma Inc. is unique in the sense that though it's a small biopharma company, it's at least driving revenue with a handful of marketable products.
The pipeline and portfolio are secondary at this point, however. What matters most to traders now is whether or not there's actually any upside left to tap into with Horizon Pharma. The answer is, it depends.
Given just the nearby daily chart, no, it looks like HZNP has burned up all of its fuel. Aside from the fact that it's overextended now, Tuesday's volume spike also implies anybody who was thinking about buying went ahead and took the plunge. That may well mean nobody is left to keep buying tomorrow. There may well be, however, plenty of nervous-Nellie profit-takers ready to head for the exit.
The assessment changes quite a bit when you zoom out to a longer-term chart of Horizon Pharma, though.
While this won't allow the stock to sidestep a near-term pullback, Tuesday's pop was something a game-changer for the long-term chart. The move shook the stock out of a narrow range that had trapped the stock between $2.80 and $2.12 for the last ten months.
The proverbial "so what" is, with nearly a years' worth of pent-up energy finally being unleashed, we're nowhere near the end of the final resting place. Once we burn off this initial, knee-jerk reaction to the - [By Monica Gerson]
Horizon Pharma (NASDAQ: HZNP) shares dropped 5.29% to $12.90 in pre-market trading after the company reported Q4 results. Horizon Pharma posted a quarterly loss of $0.04 per share on revenue of $30.10 million. However, analysts were expecting a loss of $0.08 per share on revenue of $32.18 million.
Best Biotech Stocks To Invest In 2015: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company's clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton�� tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, the Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Company�� Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A multicenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
Advisors' Opinion:- [By Anders Bylund]
And then there's cancer drug developer Pharmacyclics (NASDAQ: PCYC ) . This stock had been trading like a roller coaster when the poison pill quietly got the kibosh, and continued to trade sideways for another couple of years. Then Pharmacyclics' cancer treatments made some headway in FDA proceedings led by leukemia drug Ibrutinib, sending the stock on a rocket ride. Pharmacyclics' returns of 2,500% since the plan change make the S&P 500's 45% jump look like dead money. And Pharmacyclics may work together with some big partners, but remains a separate business to this day.
Best Biotech Stocks To Invest In 2015: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion:- [By James E. Brumley]
At first glance, Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) doesn't look like anything particularly trade-worthy. The stock's now where it was in late October, and where it was in late September, and even where it was in late June. In other words, though RNN has been much higher and much lower than its current price of $0.46 over the course of the past several months, it doesn't look like it's going anywhere - on a net basis - anytime.
- [By Roberto Pedone]
One under-$10 biopharmaceutical player that's just starting to move into breakout territory is Rexahn Pharmaceuticals (RNN), which is engaged in the development of novel treatments for cancer to patients. This stock has been on fire so far in 2013, with shares up sharply by 62%.
If you take a look at the chart for Rexahn Pharmaceuticals, you'll notice that this stock has been uptrending strong for the last month, with shares moving higher from its low of 36 cents per share to its intraday high of 53 cents per share. During that uptrend, shares of RNN have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of RNN into breakout territory above some near-term overhead resistance levels at 49 cents to 50 cents per share. It's worth noting that volume today is tracking in extremely strong with over 3 million shares traded, versus its three-month average action of 1.22 million shares.
Traders should now look for long-biased trades in RNN if it manages to break out above Thursday's intraday high of 53 cents per share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 1.22 million shares. If that breakout hits soon, then RNN will set up to re-test or possibly take out its next major overhead resistance levels at 64 cents to its 52-week high at 66 cents per share. Any high-volume move above 66 cents to 67 cents per share could then send RNN towards its next major overhead resistance levels at 81 cents per share.
Traders can look to buy RNN off any weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average at 47 cents per share. One can also buy RNN off strength once it clears 53 cents per share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
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