The S&P 500 Biotech Index has nearly tripled in the past three years. The index had stalled and moved sideways for much of the past spring, leading some to wonder whether the rally was spent. Several factors have been fueling the biotech rally of the past three years. For one thing, the U.S. Food and Drug Administration has been pushing to speed up approvals. According to Ernst & Young, the FDA approved 41 new drugs in 2014, up from 27 a year earlier.
Meanwhile, the genomics-based insights that emerged in the early 2000s are finally delivering on new drug therapies. That in turn has led biotech firms to increase their research and development spending by 20% a year. After a decade or more of few promising drugs, the new generation is finally bearing financial fruit. Revenue at U.S. and European biotech firms rose 24% last year, while net income rose 231%, Ernst & Young reckons.
On the trading floor, shares of Omeros Corporation (NASDAQ:OMER) gained 72.03% to close at $25.03. The $551.24M company on August 18, 2015 announced additional positive data in the company’s Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body’s organs, most commonly the kidney and brain. OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of TMAs, including atypical hemolytic uremic syndrome (aHUS).
The Phase 2 trial is designed to enroll primarily aHUS patients but can also enroll patients with thrombotic thrombocytopenic purpura (TTP) and hematopoietic stem cell transplant (HSCT)-related TMA. The trial has fully enrolled the first and second cohorts and is currently completing the third and final planned cohort of its dose-ranging stage. In each three-patient cohort, OMS721 is dosed for four weeks. Data from the first (low-dose) cohort were released on February 19, 2015. Today the company is releasing data from its second (mid-dose) cohort and data to date from its third (high-dose) cohort.
AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) closed at $0.121 with an increase of 5.40%. The $21.59M company on August 13, 2015 reported financial and operating results as at and for the second quarter ended June 30, 2015.
Net loss for the three-month period ended June 30, 2015 was $15.1 million or $0.14 per basic and diluted share, as compared to $5.0 million or $0.09 per basic and diluted share for the same period in 2014. This increase is predominantly due to higher comparative net finance costs and to higher comparative selling expenses, partially offset by lower comparative R&D costs.
At the opening of the second quarter, the Company had 93.6 million issued and outstanding common shares. On June 30 and August 12, 2015, the Company had 139.9 million and 182.3 million issued and outstanding common shares, respectively. The increase in the Company’s outstanding shares during the quarter and subsequent to quarter-end through August 12, 2015, results from the issuance of 31.6 million common shares upon exercise of pre-funded Series C warrants and 56.8 million common shares upon the alternate cashless exercise of Series B warrants issued as part of our previously disclosed March 2015 $37 million public equity financing. As of August 12, 2015, all pre-funded Series C Warrants had been exercised and of the 29.8 million Series B warrants initially issued, there remain an additional 20.9 million Series B warrants available for exercise into common shares, including through the alternate cashless exercise feature.
Cash and cash equivalents were $45.5 million as at June 30, 2015, compared to $34.9 million as at December 31, 2014.
Gilead Sciences, Inc.(NASDAQ:GILD) ended at $117.06by gaining 0.55%. The $170.86B company on July 27, 2015 announced the promotion of William Lee, PhD to Executive Vice President, Research, and Brett Pletcher to Executive Vice President and General Counsel. Dr. Lee and Mr. Pletcher will both join Gilead’s senior leadership committee.
Dr. Lee joined Gilead in 1991 and was promoted to Senior Vice President, Research in 2000. He has led the expansion of the company’s research activities across a range of therapeutic areas, including HIV, liver diseases, hematology/oncology, inflammation and respiratory diseases and cardiovascular conditions. He reports to Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer. Prior to joining Gilead, Dr. Lee worked at California Biotechnology, Inc. and Syntex. He received his BS in Chemistry from the University of Massachusetts, PhD in Chemistry from the University of California at San Diego and did postdoctoral work at the Ecole Polytech Federal Lausanne and the University of California at Santa Barbara.