(RTTNews.com) - As the year draws to a close, it's time to walk you through some of our biotech stock picks of 2013 that have returned decent gains, and the reasons behind their moves. We profiled 150 stocks this year, of which 39 have delivered triple-digit returns.
Here's our Top 10 list for 2013.
Inovio Pharmaceuticals Inc. (INO), focused on the development and delivery of a new generation of vaccines, called DNA vaccines.
INO was trading at $0.53 when we alerted it on March 18.
On June 14, the company reported that in a preclinical study of its influenza DNA vaccine against the newly emergent, virulent H7N9 flu virus it achieved immune response levels exceeding what are considered protective levels in other common influenza subtypes.
On July 24, it was announced that the investigational hTERT (human telomerase reverse transcriptase) DNA cancer vaccine - INO-1400 - showed potential to reduce tumors and prevent tumor recurrence in a preclinical study with two animal models.
On August 15, the company announced that its malaria DNA vaccine, SynCon, demonstrated robust immune responses in animal models. The following month, Inovio entered into a partnership with Roche for its DNA-based vaccines INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B).
INO touched a high of $3.03 on August 6, which reflects a gain of 461 percent from our published price. The stock is currently trading at $2.81.
Galectin Therapeutics Inc. (GALT), a developer of two major classes of galectin inhibiting carbohydrate polymers namely, the GM-CT and GR-MD series. GM-CT-01 is the company's lead product candidate for cancer therapy while GR-MD-02 is its lead compound for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis.
GALT was trading at $2.46 when we alerted it on Jan.16.
On Jan.30, the company submitted an Investigational New Drug application to FDA FOR GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis.
On March 5, the FDA gave a green signal to proceed with the first human clinical trial for GR-MD-02. The phase I trial of GR-MD-02 in patients with fatty liver disease with advanced fibrosis was initiated in July. The following month, Galectin received FDA Fast Track status for GR-MD-02 for fatty liver disease with advanced fibrosis.
Last month, the company completed enrollment of the first five of eight patients in the phase I clinical trial of GR-MD-02. If all goes as expected, the clinical data from the first cohort are expected to be available early in 2014.
GALT recorded a high of $13.21 on Sep.12, representing a gain of 437 percent from our published price. The stock is currently trading at $8.10.
Arrowhead Research Corp. ( ARWR ), a biopharmaceutical company developing targeted RNAi therapeutics. The lead product candidate is ARC-520, an RNAi-based compound, for chronic hepatitis B virus infection.
ARWR was trading at $2.22 when we alerted it on June 3.
On July 23, the company announced the initiation of a phase I trial of ARC-520 for the treatment of chronic hepatitis B infection. Enrollment in the study was completed in October - with 36 subjects in Melbourne, Australia.
Last month, the company filed an application for approval to begin a phase IIa clinical trial of ARC-520 for the potential treatment of chronic hepatitis B virus infection.
On Dec.9, Arrowhead presented phase I data which demonstrated that a single intravenous administration of ARC-520 was found to be safe and well tolerated up to and including a dose of 2 mg/kg, the highest dose tested.
ARWR hit a high of $11.12 on Dec.26, reflecting an increase of 400 percent from our published price. The stock is currently trading at $10.76.
Rockwell Medical Inc. (RMTI), a biopharmaceutical company that is developing a novel iron-replacement therapy for anemia in kidney disease patients.
RMTI was trading at $3.45 when we alerted it on May 17.
On May 29, the company announced that a phase III efficacy study evaluating its drug candidate - Triferic (Soluble Ferric Pyrophosphate, or SFP) - for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis, dubbed CRUISE-1, completed patient dosing.
On July 11, Rockwell reported that the CRUISE-1 study of Triferic met primary and key secondary endpoints.
On July 22, the company announced that another phase III trial of Triferic, dubbed CRUISE-2, completed patient dosing.
On Sep.4, Rockwell announced that CRUISE-2 study of Triferic also met primary and key secondary endpoints.
RMTI touched a high of $15.85 on Nov.22, which represents a gain of 359 percent from our published price. The stock is currently trading at $10.95.
BioCryst Pharmaceuticals Inc. ( BCRX ), developing novel small-molecule drugs that block key enzymes involved in infectious and inflammatory diseases.
BCRX was trading at $1.71 when we alerted it on May 15.
On July 22, BioCryst announced that it successfully completed a phase I trial of BCX4161 for the treatment of hereditary angioedema.
On Sep.17, the company was awarded a contract by the National Institute of Allergy and Infectious Diseases to develop BCX4430 for the treatment of Marburg virus disease.
Last month, the company initiated a phase IIa study of BCX4161 in patients with hereditary angioedema. The trial, dubbed OPuS-1, is being conducted at up to four centers in Germany.
On Dec.20, BioCryst announced that it submitted a New Drug Application filing for intravenous Peramivir to FDA for the treatment of acute uncomplicated influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.
BCRX recorded a high of $7.84 on Dec.26, which reflects a gain of 358 percent from our published price. The stock is currently trading at $7.50.
Alimera Sciences Inc. ( ALIM ), a company working persistently to get Iluvien, thrice rejected by FDA, approved by the U.S. regulatory agency.
Iluvien is an intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for the treatment of diabetic macular edema, or DME. Alimera licensed Iluvien from pSivida Corp in 2005.
ALIM was trading at $1.69 when we alerted it on Jan.4.
On Jan.17, Iluvien received marketing authorization in Spain for the treatment of chronic diabetic macular edema.
Alimera received a Complete Response Letter for Iluvien from the FDA for the third time on Oct.18, 2013, and was asked to submit results from a new clinical trial to address the clinical and statistical deficiencies identified. The same day - Oct.18, Alimera was notified by the FDA that an Advisory Committee meeting would be convened on January 27, 2014, which would be of assistance in addressing the deficiencies identified in the Complete Response Letter.
However, following labeling discussions with the FDA this month, it has been concluded that Alimera need not conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval. It has also been decided that the Advisory Committee meeting is no longer necessary.
Accordingly, Alimera will be addressing the remaining issues that were raised in the Complete Response Letter and will submit its response in the first quarter of 2014, which will include recent safety data gathered from patients in Europe.
ALIM recorded a high of $5.69 on June 17, representing a gain of 236 percent from our published price. The stock is currently trading at $4.47.
Prana Biotechnology Ltd. (PRAN), an Australian biotechnology company, developing a drug for Alzheimer's and Huntington's diseases.
PRAN was trading at $2.36 when we alerted it on June 11.
The company's lead drug candidate PBT2 is under phase II testing in Alzheimer's and Huntington's diseases.
On July 23, Prana announced that it successfully completed the phase II trial of PBT2 in early-to-mid stage Huntington's disease patients, dubbed REACH 2HD, scheduling results to be announced in October.
On July 29, the company dosed the first patient in a 12-month open-label extension study of PBT2 in Alzheimer's disease patients, dubbed IMAGINE Extension trial.
On Sep.13, Prana said that phase II trial results of PBT2 in Huntington's disease are expected to be reported early in 2014, and not originally as anticipated in the last quarter of 2013 due to a delay in finalising the database to achieve 'database lock', required before statistical analysis of the data.
On Nov.18, the company announced that 29 of the 42 patients originally enrolled in its phase II trial of PBT2 in Alzheimer's disease patients, dubbed IMAGINE, completed treatment. The results of this trial are expected in March 2014.
On Dec.9, Prana announced that a total of 40 patients in the IMAGINE trial completed the planned 12 months of treatment with PBT2, or placebo, bringing the treatment phase of the trial to a close.
PRAN hit a high of $7.87 on Dec.19, which represents a gain of 233 percent from our published price. The stock is currently trading at $6.88.
FONAR Corp. ( FONR ), a medical device company that introduced the world's first Upright Multi-Positional MRI scanning.
FONR was trading at $7.03 when we alerted it on Oct.3.
On Nov.15, the company reported its first fiscal 2014 quarter results, reporting 104% percent increase in net income and 77 percent growth in net revenues compared to the year-ago quarter.
FONR touched a high of $22.34 on Nov.25, which represents a gain of 217 percent from our published price. The stock is currently trading at $17.52.
Anika Therapeutics Inc. ( ANIK ), a developer of therapeutic products for tissue protection, healing and repair, based on hyaluronic acid, or HA, a naturally occurring, biocompatible polymer in the body.
ANIK was trading at $12.50 when we alerted it on March 1, highlighting its growing revenue, increasing margins and improving operational efficiency.
On May 1, the company reported Q1, 2013 financial results of 60 percent growth in net income and 6 percent increase of revenue. Product gross margin for the quarter of 2013 improved to 66.6% from 52.9% in the first quarter last year.
On July 1, Anika announced Q2 results - delivering 58 percent increase in net income and 6.1 percent growth in revenue. Product gross margin for the second quarter of 2013 improved to 68.5% from 57.2% in the second quarter last year.
On Oct.30, the company reported strong quarterly results, with Q3 net income growing three-fold and revenue rising 20 percent over the year-ago quarter. Product gross margin for the third quarter of 2013 improved to 68% from 49% in the third quarter last year.
ANIK hit a high of $38.68 on Dec.26, which represents a gain of 209 percent from our published price. The stock is currently trading at $36.84.
Insmed Inc. (INSM), a biopharmaceutical company focused on developing targeted inhaled therapies for patients battling serious orphan lung diseases.
The company's lead product candidate is ARIKACE, an inhaled liposomal formulation of the commonly used antibiotic Amikacin. ARIKACE is delivered by an investigational eFlow Nebulizer System developed by PARI Pharma GmbH.
INSM was trading at $5.83 when we alerted it on Feb.9.
On March 28, the FDA granted orphan drug designation for ARIKACE for the treatment of infections caused by non-tuberculous mycobacteria.
On July 1, Insmed reported that ARIKACE met the primary endpoint of non-inferiority to TOBI in a phase III trial in Europe and Canada to treat pseudomonas aeruginosa in cystic fibrosis patients.
On Oct.15, the company reported that it completed patient enrollment in its phase II clinical study of ARIKACE for patients with recalcitrant nontuberculous mycobacterial (NTM) lung disease in the U.S. and Canada.
INSM touched a high of $17.60 on Dec.4, which represents a gain of 201 percent from our published price. The stock is currently trading at $17.05
Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.
Visit Emerging Biostocks (http://www.rttnews.com/Products/EBSService.aspx) for a complete list of our biotech stock picks.
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