The year gone by has been disappointing - marred by eurozone debt turmoil, Japan's catastrophic earthquake and tsunami, and revolts in the Middle East and North Africa, all of which had adversely affected the financial markets. Now that a new year has just begun, it's time to revisit our 2011 bio stock picks that continue to trade up a minimum 50% since we profiled them on our site. The near-term catalysts of the highlighted stocks are also mentioned in this report.
Raptor Pharmaceutical Corp. (RPTP) is a biotechnology company focused on developing medicines that improve life for patients with severe, rare disorders. RPTP was trading around $3.46 when we alerted readers to the stock in April 2011, and based on Thursday's (Jan.12) closing price of $6.25, it is up nearly 81%.
The company's lead investigational compound is RP103, also known as Delayed-Release or DR Cysteamine which is being evaluated for potential indications, including Nephropathic Cystinosis, Non-alcoholic Steatohepatitis and Huntington's Disease.
A pivotal phase III clinical trial of RP103 for the potential treatment of nephropathic cystinosis was completed last July. The company is on track to submit marketing applications for RP103 as potential treatment of nephropathic cystinosis in both the U.S. and E.U in the first calendar quarter of 2012.
Raptor plans to file for "Priority Review" in the US and "Accelerated Approval" in the EU. If granted, RP103 could be approved for the treatment of nephropathic cystinosis in both the U.S. and the EU in the fourth calendar quarter of 2012. In anticipation of the potential approval in 2012, Raptor is actively building its US and European commercial infrastructure and pre-commercial programs to market RP103.
Dynavax Technologies Corp. (DVAX) is a clinical-stage biopharmaceutical company developing products to prevent and treat infectious and inflammatory diseases. DVAX was trading around $2.52 when we alerted readers to the stock in May 2011, and based on Thursday's (Jan.12) closing price of $3.80, it is up 51%.
The company's lead product candidate is Heplisav, a late-stage investigational adult hepatitis B prophylactic vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines.
The company plans to submit a Biologics License Application for Heplisav for persons over 40 years of age , followed by a supplemental BLA for licensure of a specific regimen for vaccinating chronic kidney disease patients against hepatitis B infection at the time the initial application is approved. Dynavax' first BLA submission is expected to be submitted in the first quarter of 2012.
ARIAD Pharmaceuticals Inc. (ARIA) is an emerging global oncology company focused on developing breakthrough cancer medicines. The company was upgraded to trade on the NASDAQ Global Select Market from NASDAQ Global Market on January 3, 2012. ARIA was trading around $9.32 when we alerted readers to the stock in June 2011, and based on Thursday's (Jan.12) closing price of $13.88, it is up nearly 49%.
Ariad's out-licensed product candidate Ridaforolimus is under development for multiple oncology indications, including soft tissue/bone sarcomas, endometrial cancer, breast cancer, lung and colon cancers, ovarian cancers and kidney cancer. Ariad collaborates with Merck & Co. Inc. (MRK) in developing Ridaforolimus. Merck is responsible for clinical trials and regulatory filings of Ridaforolimus.
The regulatory filing seeking approval for Ridaforolimus in metastatic soft-tissue or bone sarcomas is under review by the FDA and European Medicines Agency. The FDA is expected to make a decision on Ridaforolimus in mid-June of this year.
Yet another oncology product candidate of Ariad is Ponatinib, which is being evaluated as a potential treatment for CML (chronic myeloid leukemia) and Philadelphia positive acute lymphoblastic leukemia in a pivotal phase II trial dubbed PACE. Last December, the company reported encouraging results from the PACE trial.
Ariad anticipates filing for marketing approval of Ponatinib in the U.S. and EU in the third quarter of 2012.
The company's third internally discovered small-molecule oncology-drug candidate is AP26113 for lung cancer. AP26113 entered clinical development in a phase I/II trial in the third quarter of 2011.
Pharmacyclics Inc. (PCYC) is a clinical-stage biopharmaceutical company focused on developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. PCYC was trading around $10.94 when we alerted readers to the stock in July 2011, and based on Thursday's (Jan.12) closing price of $17.56, it is up 60%.
The company's lead clinical candidate is PCI-32765, an inhibitor of Bruton's tyrosine kinase (Btk). A number of Phase 1 and 2 studies with PCI-32765 are ongoing across a panel of B-cell malignancy disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma.
In December of 2011, Pharmacyclics inked a deal worth $975 million with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) to develop and commercialize PCI-32765.
Idenix Pharmaceuticals Inc. (IDIX) is a biopharmaceutical company building a pipeline of drug candidates for hepatitis C, a market with high levels of unmet need. IDIX was trading around $5.04 when we alerted readers to the stock in July 2011, and based on Thursday's (Jan.12) closing price of $12.71, it is up 152%.
IDX184, a once-daily, oral HCV nucleotide polymerase inhibitor, is the company's lead product candidate. Earlier this week, Idenix reported positive interim data from a 12-week phase IIb clinical trial of IDX184.
NovaBay Pharmaceuticals Inc. (NBY) is a clinical-stage biotechnology company with a focus on four distinct fields, namely dermatology, ophthalmology, urology and hospital infections. NBY was trading around $0.86 when we alerted readers to the stock in September 2011, and based on Thursday's (Jan.12) closing price of $1.31, it is up 52%.
The company is preparing for the launch of NeutroPhase, a wound cleanser and debriding agent, early this year. A commercial partnership agreement was signed by NovoBay on January 9, 2012 for the commercialization of NeutroPhase China. The company is also seeking strategic partners for additional global territories.
Transcept Pharmaceuticals Inc. (TSPT) is a specialty pharmaceutical company, focused on the development of proprietary products that address therapeutic needs in the field of neuroscience. TSPT was trading around $5.29 when we alerted readers to the stock in September 2011, and based on Thursday's (Jan.12) closing price of $8.44, it is up 59%.
Last November, the company's sleep drug Intermezzo won FDA approval for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Transcept has an agreement in place with Purdue Pharma L.P. for the commercialization of Intermezzo in the United States. Purdue plans to launch Intermezzo in the second quarter of 2012 and to invest about $100 million to support sales and marketing during the first year of commercialization.
Achillion Pharmaceuticals Inc. (ACHN) is a biopharmaceutical company focused on the development of antivirals for the treatment of chronic hepatitis C; and the development of antibacterials for the treatment of resistant bacterial infections. ACHN was trading around $4.37 when we alerted readers to the stock in October 2011, and based on Thursday's (Jan.12) closing price of $11.76, it is up 169%.
Last week, the company secured a Fast Track designation from the FDA for its phase II investigational drug for the treatment of chronic hepatitis C virus.
During the second half of 2012, Achillion plans to initiate an interferon-free, all-oral combination clinical study evaluating a protease inhibitor and a NS5A inhibitor, with or without ribavirin, for the treatment of HCV. The company's protease inhibitors include ACH-1625 and ACH-2684, and its NS5A inhibitors include ACH-2928 and ACH-3102.
Affymax Inc. (AFFY) is a biopharmaceutical company, engaged in the development of drugs for the treatment of serious and life-threatening conditions. AFFY was trading around $4.68 when we alerted readers to the stock in November 2011, and based on Thursday's (Jan.12) closing price of $6.95, it is up 48%.
Affymax is co-developing Peginesatide with Takeda Pharmaceutical Co. Ltd. for the treatment of anemia in chronic kidney disease patients on dialysis. The drug candidate is under FDA review.
Last month, an FDA panel voted in favor of benefit/risk profile for Peginesatide, and the regulatory agency's final decision is set for March 27, 2012.
The company is also preparing for regulatory filing for Peginesatide in Europe.
Amicus Therapeutics Inc. (FOLD) is a pioneer in developing small-molecule drugs called pharmacological chaperones to address human genetic diseases resulting from misfolded proteins. FOLD was trading around $2.86 when we alerted readers to the stock in November 2011, and based on Thursday's (Jan.12) closing price of $4.54, it is up 59%.
The most advanced candidate drug in the company's pipeline is Amigal (migalastat HCl), currently in phase III for the treatment of Fabry disease, a rare inherited disorder. Two phase III studies , dubbed Study 011 and Study 012, are underway evaluating Amigal as a monotherapy for Fabry disease.
The company completed enrollment in the first Phase 3 global registration study - Study 011 of Amigal for Fabry disease and results from this trial are expected in the third quarter of 2012.
Amicus has a strategic collaboration with GlaxoSmithKline plc (GSK) for the development of Amigal that was inked in October 2010.
Santarus Inc. (SNTS) is a specialty biopharmaceutical company developing a drug to treat patients with mild or moderate active ulcerative colitis. SNTS was trading around $2.72 when we alerted readers to the stock in November 2011, and based on Thursday's (Jan.12) closing price of $4.47, it is up 64%.
The company submitted a New Drug Application for Uceris (budesonide) Tablets 9 mg, its investigational medication for ulcerative colitis, to the FDA on December 20, 2011. The regulatory agency evaluates the application within the first 60 days of its receipt to determine if it is sufficiently complete to conduct a full review.
Uceris is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. Upon acceptance for review of the NDA for Uceris tablets, $4 million is payable to Cosmo Technologies Limited. The milestone is payable in cash or Santarus common stock, at Cosmo's option.
Insys Therapeutics Inc. , formerly NeoPharm, Inc., (NEOL.PK), is a specialty pharmaceutical company with a focus on cancer-supportive care. NEOL.PK was trading at $8 when we alerted readers to the stock in December 2011, and based on Thursday's (Jan.12) closing price of $12, it is up 50%.
The company received FDA approval for its proprietary product Subsys for the treatment of breakthrough cancer pain as recently as January 5, 2012. Insys intends to launch Subsys later this quarter.
Delcath Systems Inc. (DCTH) is a development stage specialty pharmaceutical and medical device company focused on oncology. DCTH was trading around $2.76 when we alerted readers to the stock in December 2011, and based on Thursday's (Jan.12) closing price of $4.21, it is up 52%.
The company's pre-NDA meeting with the FDA related to its chemosaturation system for use in the treatment of patients with metastatic melanoma in the liver is scheduled in in mid-January 2012.
Delcath's proprietary chemosaturation therapy involves a percutaneous hepatic perfusion, or PHP, procedure that allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug, thereby limiting the toxic side-effects due to chemotherapy treatments. Besides being minimally invasive, PHP, is a repeatable procedure.
The following are the stocks that continue to trade up a minimum 20% since we profiled them on our site.
Micromet Inc.(MITI) is a biopharmaceutical company developing BiTE or Bispecific T cell Engager antibody-based therapies for the treatment of cancer. MITI was trading around $6.05 when we alerted readers to the stock in May 2011, and based on Thursday's (Jan.12) closing price of $8.83, it is up 46%.
Regeneron Pharmaceuticals Inc. (REGN) is a biopharmaceutical company, having two marketed products, Arcalyst injection for treatment of Cryopyrin-Associated Periodic Syndromes and Eylea for the treatment of Wet Age-Related Macular Degeneration. REGN was trading around $57.95 when we alerted readers to the stock in June 2011, and based on Thursday's (Jan.12) closing price of $78.26, it is up 35%.
Infinity Pharmaceuticals Inc. (INFI) is an innovative drug discovery and development company with a therapeutic focus on oncology and difficult-to-treat diseases. INFI was trading around $7.03 when we alerted readers to the stock in August 2011, and based on Thursday's (Jan.12) closing price of $9.08, it is up 29%.
Vivus Inc. (VVUS) is one of the companies in the race to find a cure for obesity. VVUS was trading around $8.75 when we alerted readers to the stock in September 2011, and based on Thursday's (Jan.12) closing price of $12.23, it is up nearly 40%. The company's investigational drug to treat obesity - Qnexa, is under FDA review with a decision date set for April 17, 2012.
Cell Therapeutics Inc. (CTIC) is a biopharmaceutical company involved in developing cancer drugs. CTIC was trading around $0.93 when we alerted readers to the stock in October 2011, and based on Thursday's (Jan.12) closing price of $1.19, it is up 28%.
Alnylam Pharmaceuticals Inc. (ALNY) is a biopharmaceutical firm focused on developing novel therapeutics based on RNA interference, or RNAi. ALNY was trading around $7.06 when we alerted readers to the stock in October 2011, and based on Thursday's (Jan.12) closing price of $10.08, it is up nearly 43%.
Curis Inc. (CRIS) is a drug discovery and development company engaged in the development of cancer therapeutics. CRIS was trading around $3.42 when we alerted readers to the stock in October 2011, and based on Thursday's (Jan.12) closing price of $4.55, it is up nearly 33%. The company's most-advanced drug candidate is Vismodegib, being developed in collaboration with Roche subsidiary Genentech, for the treatment of advanced basal cell carcinoma, also known as BCC. Vismodegib is now under review for approval in both the United States and Europe, with an FDA decision date set for March 8, 2012.
Spectrum Pharmaceuticals Inc.'s (SPPI) is a commercial-stage biotechnology company, focusing on oncology and hematology. SPPI was trading around $12.05 when we alerted readers to the stock in November 2011, and based on Thursday's (Jan.12) closing price of $15.67, it is up 30%. Last November, the FDA approved the removal of pre-treatment biodistribution evaluation requirement before administering the company's Zevalin therapeutic dose.
Zevalin was approved by the FDA in 2002 for the treatment of adults with relapsed or refractory low-grade, follicular B-cell lymphoma. In September 2009, the FDA approved expanded use of Zevalin as a first-line treatment for follicular B-cell non-Hodgkin's lymphoma. The drug is currently approved in more than 40 countries.
Omeros Corp. (OMER) is a biopharmaceutical company focused on developing products for inflammation, bleeding and disorders of the central nervous system. OMER was trading around $3.94 when we alerted readers to the stock in December 2011, and based on Thursday's (Jan.12) closing price of $5.61, it is up 42%. The company is scheduled to announce data from the initial phase 3 trial of OMS302 in the first quarter of 2012. OMS302 is being tested for use during ophthalmological procedures, including cataract and other lens replacement surgery.
Binary events like clinical trial results and FDA decisions are typical in biotech companies, and can cause significant swings in share price.
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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.