Top Biotech Stocks To Buy For 2014

Summer doesn't officially arrive for a few more weeks, but the first week of June packed some real heat. That's especially true for three biotech stocks that rank as our most humongous of the week.

Give me a double
The Motley Fool's David Williamson summed up the great week for Clovis Oncology (NASDAQ: CLVS  ) perfectly in his headline a few days ago: "1 Biotech + 2 Cancer Drugs = 100% Pop." While that 100% pop drifted down to 96% by the end of the week, Dave hit the nail on the head.

Clovis blew everyone away at the ASCO conference earlier this week, when it announced phase 1 results for cancer drug�rucaparib. The drug showed a disease control rate of 89% for ovarian cancer patients across all dose levels. Clovis also said that the safety profile for rucaparib looked good.

The second set of results presented at ASCO centered on experimental drug�CO-1686. Phase 1 findings for the drug in treating patients with non-small-cell lung cancer were generally positive but weren't as dazzling as those for rcaparib. Clovis shareholders aren't complaining a bit, though.���

Top Biotech Stocks To Buy For 2014: ViroPharma Incorporated(VPHM)

ViroPharma Incorporated, a biotechnology company, develops and commercializes therapeutic products that address serious diseases in the United States and internationally. It focuses on developing products used by physician specialists or in hospital settings. The company markets and sells Cinryze, a C1 esterase inhibitor therapy for the routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, a life-threatening genetic disorder; and Vancocin HCl capsule, an oral capsule formulation for the treatment of C. difficile-associated diarrhea (CDAD) and to treat enterocolitis caused by staphylococcus aureus, including methicillin-resistant strains. It also offers Plenadren, an orphan drug for treatment of adrenal insufficiency in adults; Buccolam, a oromucosal solution for treatment of prolonged, acute, and convulsive seizures in infants, toddlers, children, and adolescents; and maribavir, an antiviral compound for the treatment o f CMV disease through a license agreement with GlaxoSmithKline. The company?s primary development programs include Cinryze, a C1 esterase inhibitor for management of hereditary angioedema; and VP 20621, a non-toxigenic strain of C. difficile. Its clinical stage drug candidate comprises VP-20629 for the treatment of Friedreich?s Ataxia. The company sells its products directly to wholesale drug distributors and specialty pharmacies/distributors. ViroPharma Incorporated was founded in 1994 and is headquartered in Exton, Pennsylvania.

Advisors' Opinion:

• [By Paul Ausick]

  Stocks on the Move: ViroPharma Inc. (NASDAQ: VPHM) is up 25.4% at $49.38 on a $4.2 billion buyout offer from London-listed Shire. Zalicus Inc. (NASDAQ: ZLCS) is down 72.3% at $1.30 on a failed drug trial.

• [By Sean Williams]

  What: Shares of ViroPharma (NASDAQ: VPHM  ) , a biotechnology company specializing in treating rare diseases, rose as much as 14% after a report from Reuters noted preliminary buyout interest in the company.

• [By John Udovich]

  Small cap orphan drug stocks Zalicus Inc (NASDAQ: ZLCS), Omeros Corporation (NASDAQ: OMER) and Viropharma Inc (NASDAQ: VPHM) have been active lately thanks to good news about their orphan drug treatments. In case you aren�� familiar with the term, orphan drug designation by the FDA is granted for drugs targeting conditions affecting 200,000 or fewer US patients annually that are expected to provide significant therapeutic advantage over existing treatments. The designation will also qualify companies for benefits across all stages of drug development, such as�accelerated approval processes, seven years of market exclusivity�after marketing approval, tax credits on�any US�clinical trials, grants and waiver of certain administrative fees.

• [By Max Macaluso and David Williamson]

  At the end of last week, a Bloomberg article revealed that Shire (NASDAQ: SHPG  ) and pharmaceutical giant Sanofi� (NYSE: SNY  ) may be circling ViroPharma� (NASDAQ: VPHM  ) . The the following video, from The Motley Fool's health care show Market Checkup, analysts David Williamson and Max Macaluso take a close look at ViroPharma and discuss the recent interest in this small biotech company.

Top Biotech Stocks To Buy For 2014: 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 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.

• [By James E. Brumley]

  With just a quick glance at a chart of Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), it would be easy to conclude it's nothing but a volatile mess. When you take a step back and look at a long-term weekly chart of RNN, however, it starts to become clear that this small cap biopharma name is on the verge of a monster-sized breakout. First things first, however.

Best Warren Buffett Stocks For 2014: Organovo Holdings Inc (ONVO)

Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.

The Company has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.

The Company�� NovoGen MMX Bioprinter is an automate! d device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.

The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.

Advisors' Opinion:

• [By Steve Symington]

  To answer that question, remember what our fellow Fool Isaac Pino reminded us a few weeks ago:�high-end production 3-D printers from companies like 3D Systems, Stratasys (NASDAQ: SSYS  ) , and ExOne (NASDAQ: XONE  ) are capable of using dozens of materials to print infinitely more complicated items including shoes, saws, guitar bodies, and other functioning tools with moving parts.�Heck, 3-D bioprinting specialist�Organovo (NYSEMKT: ONVO  ) is currently working feverishly on perfecting the process of designing and creating functional human tissue which -- putting inevitable regulatory hurdles for using the technology aside -- could obviously change the health care world as we know it.

• [By James E. Brumley]

  It's certainly not the way I would have likes for things to shake out with Organovo Holdings Inc. (NYSEMKT:ONVO), but I'm not going to complain - it's pointed in the right direction. More important, for anybody who's been wanting into an ONVO trade but wasn't sure where the right entry spot was, today's move is it, with just one little caveat.

• [By Harry Boxer]

  HARRY:  It is.  More than 10 years, I visited 3-D systems and saw a demo, and it was like whoa.  They weren’t even public then.  Of late, SSYS (Stratasys), Proto Labs (PRLB), EX1; those are the four big ones in the industry.  There is a little buy-out tech company called Orvganovo (ONVO) that is now bio-printing organs for testing.

• [By James E. Brumley]

  I'll warn you now that if you a fan of or shareholder in Organovo Holdings Inc. (NYSEMKT:ONVO), you're not going to like what you're about to hear. Sorry, but I have to call 'em like I see 'em. And what I see with ONVO is an overbought stock ripe for a big tumble.

Top Biotech Stocks To Buy For 2014: AMAG Pharmaceuticals Inc.(AMAG)

AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.

Top Biotech Stocks To Buy For 2014: Telik Inc (TELK)

Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.

Clinical Product Development

TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tolerated. In June 2011, the Company initiated a Phase II clinical ! trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '

The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transfusions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.

TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolerability of the combinations was similar to that expected of each! drug alo! ne.

Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.

Preclinical Drug Product Development

The Company has a small molecule compound, TLK60404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.

The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multiple, standard preclinical models of cancer. TLK60596, a potent VG! FR kinase! inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.