Investors have been flocking to biotech stocks this year, with the IBB, the ETF that tracks biotech stocks, making noteworthy gains. So far in 2015, several industries have either underperformed or provided mixed results, leading to a rather ho-hum showpiece for U.S. blue-chip indices.
Biotech stocks, on the other hand, have consistently returned positive results in the markets over the past seven years. On paper, there’s very little evidence to suggest that the magical rally in biotech stocks will abate any time soon.
Since 2010, the annualized average of the month-over-month performance rate for the exchange-traded fund iShares NASDAQ Biotechnology Index (IBB) has outpaced the benchmark S&P 500, often with a wide margin averaging a 1.64% difference. In addition, both indicators peaked in performance in 2011, but the subsequent decline in blue-chip stocks was heavily pronounced. However, biotech stocks bucked the trend, continuing to make strong inroads.
On the trading floor, shares of Esperion Therapeutics Inc (NASDAQ:ESPR) dropped 10.33% to close at $57.54. The $1.44B company on August 17, 2015 provided an update from the ETC-1002 (bempedoic acid) End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) last week.
The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD), who are already taking maximally tolerated statins yet require additional LDL-C reduction and where there is a positive benefit/risk ratio. Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT). The Company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.
Novavax, Inc. (NASDAQ:NVAX) closed at $13.12 with a decrease of 2.74%. The $3.64B company on August 10, 2015 announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older). The RSV F Vaccine was well-tolerated and fulfilled the Company’s expectations of the primary, secondary and exploratory objectives of the trial.
The Novavax trial was a randomized, observer-blinded, placebo-controlled Phase 2 trial of 1,600 older adult participants conducted at 10 sites in the United States. The trial was designed to prospectively examine the incidence of all symptomatic respiratory illnesses associated with RSV, in community-living older adults who were treated with placebo. The trial also evaluated safety and immunogenicity of the unadjuvanted, 135 microgram dose of the RSV F Vaccine compared to placebo. Finally, the trial estimated the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illness due to RSV.
ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) ended at $9.32 by losing 4.80%. The $1.28B company on July 24, 2015 announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Ad-RTS-hIL-12 + veledimex in the treatment of patients with malignant glioma. Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.
The FDA’s Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.