Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. But the returns can be impressive irrespective of external headwinds such as the global economic concerns. For instance, the SPDR S&P Biotech ETF (XBI), which tracks returns performance of the S&P Biotechnology Select Industry Index, is up nearly 30 percent year-to-date. That is more than 9 times the 3.14 percent gain by Dow Jones over the same period.
What follows is a bunch of our biotech stock picks that touched new highs this year. Read on to find out what's moving the stock prices...
Raptor Pharmaceutical Corp. (RPTP) was trading around $3.46 when we alerted readers to the stock in April 2011, and it touched a 52-week high of $7.90 on February 9, 2012, which was an increase of 128%. RPTP closed Thursday's trading at $5.56, down 4.96%.
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.
Raptor's New Drug Application for RP103 for the potential treatment of nephropathic cystinosis has a decision date set for January 30, 2013. RP103 is also under review in Europe for the potential treatment of nephropathic cystinosis, and a decision from EMA is anticipated in the first half of 2013.
Earlier this week, the company began dosing in its phase 2b clinical trial evaluating RP103 as a potential treatment of non-alcoholic steatohepatitis, or "NASH", an advanced form of non-alcoholic fatty liver disease, or "NAFLD", in children.
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Lexicon Pharmaceuticals Inc. (LXRX) was trading around $1.42 when we alerted readers to the stock last May, and it touched a 52-week high of $2.36 on June 26, 2012, implying a return of 66%. LXRX closed Thursday's trading at $2.30, up 0.44%.
The company has a pipeline of diverse drug candidates in various stages of development. Earlier this week, Lexicon reported positive results from a phase 2b trial of LX4211 for type 2 diabetes. LX4211 showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c) in patients diagnosed with poorly-controlled type 2 diabetes. A phase III trial of LX4211 is planned for initiation in the first half of 2013.
Preparations are underway for phase III registrational trials of telotristat etiprate (LX1032) in patients with carcinoid syndrome.
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Regeneron Pharmaceuticals Inc. (REGN) was trading around $57.95 when we alerted readers to the stock last June. In the months that followed, REGN had a stellar run and went on to touch a 52-week high of $145.04 on April 26, 2012, returning a gain of 150%. REGN closed Thursday's trading at $110.66, down 2.67%.
On July 30, 2012, the company faces the FDA decision on the expanded use of Arcalyst (rilonacept) Injection for subcutaneous use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy. Last month, an FDA panel voted against recommending approval of Arcalyst for that indication.
Arcalyst is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.
Yet another drug of the company under FDA review is Zaltrap for the proposed indication of metastatic colorectal cancer. The decision date is set for August 4, 2012.
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BioDelivery Sciences International Inc. (BDSI) was trading around $3.42 when it was profiled on our site last June, and it touched a 52-week high of $4.54 on May 14, 2012, representing an increase of 32.7%. BDSI closed Thursday's trading at $4.43, up 3.02%.
Following the reconstitution of the Russell U.S. and global equity indexes, the company was added to the Russell 3000 and Russell 2000 Indexes on June 25, 2012.
BioDelivery Sciences has a worldwide license and development agreement with Endo Pharmaceuticals, Inc. (ENDP) for BEMA Buprenorphine for the treatment of chronic pain. In the third quarter of 2012, the companies expect to initiate two phase III efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups.
The registration studies of BNX for the treatment of opioid dependence are progressing as planned and data from the pivotal pharmacokinetic study is anticipated in late third quarter of 2012. BioDelivery Sciences is targeting a potential NDA submission for BNX (BEMA Buprenorphine/Naloxone) in the first half of 2013.
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Dynavax Technologies Corp. (DVAX) was trading around $2.52 when we alerted readers to the stock last June, and it touched a 52-week high of $5.34 on May 2, 2012, which was an increase of 112%. DVAX closed Thursday's trading at $4.06, down 6.67%.
The company's lead product candidate Heplisav is under FDA review for the proposed indication of immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age. The regulatory agency's decision date is set for February 24, 2013.
Dynavax anticipates seeking approval for Heplisav in Europe in the third quarter of 2012. Upon approval of the HEPLISAV BLA, Dynavax plans to submit a supplemental BLA for an indication in patients with chronic kidney disease.
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Ariad Pharmaceuticals Inc. (ARIA) was trading around $9.32 when it was profiled on our site last June, and it touched a 52-week high of $18.10 on June 19, 2012, implying a return of 94%. ARIA closed Thursday's trading at $16.89, down 3.15%.
Last week, the company presented updated results from a pivotal trial of its oncology product candidate Ponatinib, which is being evaluated as a potential treatment for CML (chronic myeloid leukemia) and Philadelphia positive acute lymphoblastic leukemia. The trial, dubbed PACE, demonstrated robust anti-leukaemic activity of Ponatinib in patients with CML at all stages, who are resistant or intolerant to dasatinib or nilotinib, or who have the T315I mutation, a rare form of CML which has no available treatment options, according to the company.
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Seattle Genetics Inc. (SGEN) was trading around $19.83 when we alerted readers to the stock last June, and it touched a 52-week high of $26.02 on June 18, 2012, which was an increase of 31%. SGEN closed Thursday's trading at $25.39, down 0.70%.
In August of 2011, the company's lead product Adectris was granted accelerated approval by the FDA for two indications namely, treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.
Adectris is also under review in Canada for proposed indication of relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. If all goes well as planned, the drug is expected to be available to patients in Canada by early 2013.
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Pharmacyclics Inc. (PCYC) was trading around $10.94 when we alerted readers to the stock last July. The stock has had a remarkable run since then and it touched a 52-week high of $53.03 on June 26, 2012, implying a gain of 385%. PCYC closed Thursday's trading at $52.48, down 3.19%.
The company's lead clinical candidate is Ibrutinib (PCI-32765), an inhibitor of Bruton's tyrosine kinase (Btk). Ibrutinib PCI-32765, which is under phase II development, is being evaluated for various indications including, chronic lymphocytic leukemia, mantle cell lymphoma, multiple myeloma and diffuse large B-cell lymphoma.
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QLT Inc. (QLTI) (QLT.TO) was trading around $6.67 when we alerted readers to the stock last July. The stock touched a 52-week high of $8.10 on June 6, 2012, which represents a gain of 21%. QLTI closed Thursday's trading at $7.73, down 0.51%.
The company is in discussions with the FDA and the European Medicines Agency regarding the design and protocol requirements for a potential pivotal trial of QLT091001 for the treatment of LCA ( Leber Congenital Amaurosis). The initiation of a pivotal trial in LCA patients is targeted later in 2012. A pivotal trial of QLT091001 for Retinitis Pigmentosa is anticipated to be initiated next year.
A phase I proof-of-concept study with the travoprost punctal plug delivery system for glaucoma is expected to be initiated prior to year-end.
If the ongoing phase II latanoprost punctal plug delivery system studies are successful, QLT plans to commence phase III clinical development activities in the second half of 2013.
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Array BioPharma Inc. (ARRY) was trading around $2.11 when we alerted readers to the stock last August. The stock touched a 52-week high of $4.10 on May 17, 2012, returning a gain of 94%. ARRY closed Thursday's trading at $3.38, down 3.43%.
Earlier this month, results from a phase II study comparing Selumetinib (AZD6244/ARRY-886) in combination with Docetaxel versus Docetaxel alone in advanced or metastatic non-small cell lung cancer, which were reported, showed statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as a trend for improvement in overall survival in favor of Selumetinib in combination with Docetaxel.
Array has a partnership in place with AstraZeneca plc (AZN) for the development of Selumetinib.
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Amarin Corp (AMRN) was trading around $10.44 when it was profiled on our site last August. The stock, which has had a good run up since then, touched a 52-week high of $15.40 on June 27, 2012, implying an increase of 47%. AMRN closed Thursday's trading at $14.17, down 0.84%.
The company's drug candidate - AMR101, for the proposed indication of treatment of patients with very high triglycerides, is currently under FDA review, with a decision date set for July 26, 2012.
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Infinity Pharmaceuticals Inc. (INFI) was trading around $7.03 when we alerted readers to the stock last August. The stock touched a 52-week high of $14.15 on June 15, 2012, representing an increase of 101%. INFI closed Thursday's trading at $13.40, down 0.22%.
Underscoring the strength of its pipeline, Infinity Pharma was included in the NASDAQ Biotechnology Index effective May 21, 2012.
Last week, the company announced that it is discontinuing phase II trials of its investigational drug Saridegib, also known as IPI-926, which was being evaluated in chondrosarcoma, a common type of bone cancer, and in myelofibrosis, an incurable malignancy of the bone marrow, based on the trials' interim data.
The company's compounds in clinical development now include, IPI-504 (retaspimycin HCl) and IPI-145. IPI-504 is under phase II development for non-small cell lung cancer while IPI-145 is under phase I study in patients with advanced hematologic malignancies. The company anticipates reporting results from the two trials in the second half of 2012. A phase II development of IPI-145 in inflammation is expected to begin in the second half of 2012.
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Idenix Pharmaceuticals Inc. (IDIX) was trading around $5.04 when it was profiled on our site last September. The stock touched a 52-week high of $15.25 on January 19, 2012, which was an increase of 202%. IDIX closed Thursday's trading at $10.04, down 4.65%.
The company is focused on building a pipeline of drug candidates for Hepatitis C virus, a market with high levels of unmet need.
Earlier in the month, the company reported positive results from an ongoing phase IIb trial of HCV drug candidate IDX184 and positive data from a three-day proof-of-concept study evaluating yet another investigational HCV drug IDX719. A phase II combination study of IDX719 with IDX184 is expected to be initiated by the end of this year.
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Pacira Pharmaceuticals Inc. (PCRX) was trading around $7.92 when it was profiled on our site last September. The stock touched a 52-week high of $16.50 on June 28, 2012, implying a gain of 108%. PCRX closed Thursday's trading at $16.35, up 0.62%.
The company was included in the NASDAQ Biotechnology Index beginning May of this year.
Last October, the FDA approved the company's non-opioid local analgesic - EXPAREL, for postsurgical pain management. The product was launched in the U.S. in April of this year.
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NovaBay Pharmaceuticals Inc. (NBY) was trading around $0.86 when we alerted readers to the stock last September, and it hit a 52-week high of $1.72 on January 19, 2012, representing a gain of 100%. NBY closed Thursday's trading at $1.28, up 7.56%.
The company expects to initiate a global phase IIb study of its investigational drug NVC-422 for impetigo, a highly contagious skin infection affecting millions of children and adults worldwide, in the third quarter of this year.
NovaBay has an agreement in place with dermatological company Galderma S.A. to develop and commercialize NVC-422 for acne and impetigo and potentially other major dermatological conditions, excluding onychomycosis and orphan drug indications.
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Vivus Inc. (VVUS) was trading around $8.75 when it was profiled on our site last September. The stock has had an impressive run since then, and it touched a 52-week high of $29.42 on June 27, 2012, representing a gain of 236%. VVUS closed Thursday's trading at $28.52, up 0.67%.
The company's obesity drug Qnexa is currently under FDA review with a decision date set for July 17, 2012.
Arena Pharmaceuticals Inc.'s (ARNA) obesity drug Lorcaserin was approved by the FDA on June 27, 2012, making it the first new drug therapy in nearly ten years to treat obesity.
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BioCryst Pharmaceuticals Inc. (BCRX) was trading around $2.76 when it was profiled on our site last September. The stock touched a 52-week high of $5.95 on March 7, 2012, representing a gain of 115%. BCRX closed Thursday's trading at $3.82, down 3.29%.
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Ligand Pharmaceuticals Inc. (LGND) was trading around $13.14 when it was profiled on our site last October. The stock touched a 52-week high of $18.74 on March 27, 2012, which was an increase of 42%. LGND closed Thursday's trading at $16.33, up 4.55%.
Ligand has multiple partnerships and its list of partners reads like a Who's Who of pharmaceutical companies.
The company's most valued revenue asset is Promacta, an oral drug approved for chronic ITP (idiopathic thrombocytopenic purpura), a rare blood disorder, developed in collaboration with British drug giant GlaxoSmithKline.
Last month, GlaxoSmithKline submitted regulatory applications in the United States and European Union, seeking approval for additional indication of Promacta in increasing platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia).
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Achillion Pharmaceuticals Inc. (ACHN), which is focused on building a pipeline of drug candidates for hepatitis C virus, was trading around $4.37 when it was profiled on our site last October. The stock had an impressive run in the months that followed and it touched a 52-week high of $12.95 on January 13, 2012, implying a gain of 196%. ACHN closed Thursday's trading at $6.18, down 0.32%.
The company's most advanced clinical drug candidate for the treatment of chronic hepatitis C infection is ACH-1625, a proprietary potent, once-daily NS3 protease inhibitor currently in phase II clinical development.
Achillion looks forward to combine ACH-1625 and another HCV investigational drug ACH-3102, which is currently under phase 1 clinical trial, into a potent, oral, interferon-free regimen for the treatment of HCV which is expected to begin during the third quarter of this year.
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Incyte Corp. (INCY) was trading around $15.87 when we alerted readers to the stock last October. The stock touched a 52-week high of $24.30 on May 11, 2012, which was an increase of 42%. INCY closed Thursday's trading at $22.35, down 3.46%.
Last November, the FDA approved the company's Jakafi (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis, becoming the first and only approved treatment for a potentially life-threatening blood cancer.
Ruxolitinib is tested for other indications like polycythemia vera, hematologic malignancies and solid tumors. A global phase III registration study, dubbed RESPONSE, is studying Ruxolitinib in patients with advanced polycythemia vera. The trial continues to enroll patients and is targeted to complete recruitment this year. Results from the RESPONSE trial are expected in the second half of 2013.
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Alnylam Pharmaceuticals Inc. (ALNY) was trading around $7.06 when it was profiled on our site last October. The stock touched a 52-week high of $13.75 on February 27, 2012, implying a return of 95%. ALNY closed Thursday's trading at $11.49, down 4.33%.
The company expects to reports results from a phase I study of ALN-TTR02 for Transthyretin (TTR)-mediated amyloidosis early in the third quarter.
ALN-TTR02 was provided Orphan Drug status for the treatment of Transthyretin (TTR)-mediated amyloidosis last week.
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Threshold Pharmaceuticals Inc. (THLD) was trading around $1.66 when we alerted readers to the stock last October and it touched a 52-week high of $9.07 on March 30, 2012. That represents an increase of 446%. THLD closed Thursday's trading at $7.28, down 3.96%.
Threshold Pharma's lead product candidate is TH-302, an anticancer agent. A number of key events related to TH-302 are lined up for the coming months.
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Curis Inc. (CRIS) was trading around $3.42 when we alerted readers to the stock last October. The stock touched a 52-week high of $5.65 on January 30, 2012, representing a gain of 65%. CRIS closed Thursday's trading at $5.39, up 0.19%.
Earlier in the year, the FDA approved the company's Erivedge (vismodegib) capsule for the treatment of adults with a type of skin cancer, called basal cell carcinoma. Erivedge is currently under review by the European Medicines Agency. Approval for Erivedge is also being sought in Australia, Canada and Switzerland.
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Questcor Pharmaceuticals Inc. (QCOR) was initially profiled on our site in November of 2010 when it was trading around $14. We again alerted readers to the stock when it was trading around $41. The stock touched a new 52-week high of $54.31 on June 26, 2012. QCOR closed Thursday's trading at $51.85, down 2.21%.
The key driver of the stock price has been the growing sales of the company's flagship product H.P. Acthar Gel, also called Acthar, a repository corticotropin injection. Acthar is an injectable drug that is approved by the FDA for the treatment of 19 indications.
Of these 19 indications, Questcor currently generates substantially all of its net sales from three indications namely, the treatment of acute exacerbations of multiple sclerosis in adults, the treatment of nephrotic syndrome, and the treatment of infantile spasms in children under two years of age.
Since Questcor believes that there are significant opportunities to enter markets where Acthar has FDA approval beyond the three key markets, the company plans to commercialize Acthar for rheumatology indications in late 2012.
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Affymax Inc. (AFFY: Quote) was trading around $4.68 when we alerted readers to the stock last November. The stock has had an impressive rally since then and it touched a 52-week high of $16.25 on March 27, 2012. AFFY closed Thursday's trading at $12.61, down 5.33%.
It was as recently as March 27th of this year, did the FDA approve OMONTYS (peginesatide) Injection, co-developed by Affymax and Takeda Pharmaceutical Co., for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.
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Santarus Inc. (SNTS) was trading around $2.72 when it was profiled on our site last November. The stock touched a 52-week high of $7.42 on June 20, 2012, which was an increase of 173%. SNTS closed Thursday's trading at $7.00, down 0.85%.
The company's investigational drug for ulcerative colitis - UCERIS, is under FDA review with a decision date set for October 16, 2012. If approved, Santarus expects UCERIS to garner peak sales of around $300 million.
Santarus generates revenue from sales of Glumetza and Cycloset, both of which are indicated to improve glycemic control in adult patients with type 2 diabetes, and Fenoglide, which is prescribed to treat high triglycerides and unhealthy cholesterol levels.
For full year 2012, the company expects revenue to increase by about 68% to $200 million compared to 2011.
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Spectrum Pharmaceuticals Inc. (SPPI) was trading around $12.05 when we alerted readers to the stock last November and it touched a 52-week high of $16.00 on January 12, 2012, marking a gain of 33%. SPPI closed Thursday's trading at $15.31, up 1.86%.
In April of this year, Spectrum Pharma announced its offer to acquire Allos Therapeutics Inc. (ALTH) for $1.82 per share in cash, in addition to one contingent value right. The upfront portion of the transaction is valued at up to $206 million on a fully-diluted basis. The buyout offer, which was scheduled to expire on June 22, 2012, now runs till July 9, 2012.
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NewLink Genetics Corp. (NLNK) was trading around $7 when it was profiled on our site last November. The stock touched a 52-week high of $18 on June 27, 2012, which was an increase of 157%. NLNK closed Thursday's trading at $15.84, down 8.76%.
The company expects its pivotal phase III hyperacute pancreas immunotherapy trial to be fully enrolled before the end of 2013. The first interval look at the trial is anticpated to occur at the end of 2012 or early 2013.
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Sucampo Pharmaceuticals Inc. (SCMP) was trading around $3.73 when we alerted readers to the stock last December. The stock touched a 52-week high of $8.50 on April 27, 2012, implying a return of 128%. SCMP closed Thursday's trading at $6.76, down 4.65%.
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Amylin Pharmaceuticals Inc. (AMLN) was trading around $10.48 when we alerted readers to the stock last December, and it touched a 52-week high of $28.45 on May 29, 2012. AMLN closed Thursday's trading at $28.03, down 0.04%.
Earlier in the year, Amylin received FDA approval for Bydureon, a once-weekly version of the injectable diabetes medication Byetta, which has been available in the U.S. since June 2005. In March, Amylin rejected a $3.5 billion unsolicited takeover offer from Bristol-Myers Squibb Co. (BMY).
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ImmunoGen Inc. (IMGN) was trading around $12.01 when it was profiled on our site last December. The stock touched a 52-week high of $16.60 on June 28, 2012, an increase of 38%. IMGN closed Thursday's trading at $16.17, up 0.06%.
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Omeros Corp. (OMER) was trading around $3.94 when we alerted readers to the stock in December 2011, and it set a 52-week high of $13.45 on June 25, 2012. That represents a return of 241%. OMER closed Thursday's trading at $10.34, down 2.50%.
In March of this year, Omeros reported positive data from its first phase 3 OMS302 trial. The company remains on track to announce data from its second phase 3 OMS302 clinical trial in the second half of 2012. OMS302 is being evaluated for use during ophthalmological procedures, including cataract and other lens replacement surgery, to induce dilation of pupils (mydriasis) and reduce postoperative pain.
On June 27, the company priced an underwritten public offering of 2.9 million shares of its common stock at a price to the public of $10.25 per share.
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Isis Pharmaceuticals Inc. (ISIS) was trading around $7.17 when we alerted readers to the stock in January of this year, and it touched a 52-week high of $12.00 on June 28, 2012. That represents a return of 67%. ISIS closed Thursday's trading at $11.64, down 1.36%.
The company's New Drug Application for KYNAMRO (Mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia is under FDA review. The regulatory agency's decision is expected on January 29, 2013.
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Anika Therapeutics Inc. (ANIK) was trading around $9.43 when it was profiled on our site in January of this year. The stock touched a 52-week high of $17.70 on May 2, 2012, which was an increase of 87%. ANIK closed Thursday's trading at $13.14, down 2.59%.
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Repros Therapeutics Inc. (RPRX) was trading around $4.17 when we alerted readers to the stock in April of this year. The stock touched a 52-week high of $9.88 on June 26, 2012, which was an increase of 87%. RPRX closed Thursday's trading at $8.67, down 5.45%.
Last month, the company met with the FDA and discussed the design of pivotal phase III efficacy studies for its investigational drug Androxal for male reproductive health. The company resubmitted the Special Protocol Assessment to the FDA for its pivotal studies for Androxal on May 22. The FDA is slated to respond within 45 calendar days of submission.
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Onyx Pharmaceuticals Inc. (ONXX) was trading around $45.85 when we alerted readers to the stock last month. The stock touched an all-time high of $67.62 on June 28, 2012, implying an increase of 47% in just 1 month. ONXX closed Thursday's trading at $63.97, down 3.65%.
The company's investigational drug Kyprolis for multiple myeloma is under FDA review. Last week, an FDA panel voted 11-0 (with 1 abstention), recommending approval of Kyprolis. The final decision of the regulatory agency is set for July 27, 2012.
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Supernus Pharmaceuticals Inc. (SUPN: Quote) was trading around $4.63 when we alerted readers to the stock earlier this month. The stock touched an all-time high of $15.20 on June 27, 2012, implying an increase of 228%. SUPN closed Thursday's trading at $10.30, down 10.28.
Earlier in the week, the company's epilepsy drug Trokendi XR, a once-daily extended release formulation of topiramate (formerly known as SPN-538), received tentative approval from the FDA. The FDA's decision was originally scheduled for next month.
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by RTT Staff Writer
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