Case Studies. With the setbacks, the stock slid backward for several years as DVAX worked to respond.
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1 California-based company Zogenix (NASDAQ:ZGNX) observed the drug fenfluramine, which had problematic side effects in obesity, and demonstrated it could work to prevent seizures. At a time when GW Pharmaceuticals (GWPH) and Insys Therapeutics (INSY) were advancing cannabidiol (CBD)-based drugs to treat childhood epilepsy, Zogenix launched a 5-year study of fenfluramine, also known as ZX008. The study goal was to reduce the frequency of seizures in childhood epilepsy. Like GW, Zogenix narrowed the patient pool by testing fenfluramine only in patients with either Dravet syndrome or Lennox Gastauts syndrome. ZX008, with a different mechanism of action, subsequently outperformed the GW drug, Epidiolex. SanaCurrents evaluated previous fenfluramine studies early last year through its analytics platform. On June 9, 2017, SanaCurrents forecast ZGNX s first phase III trial of ZX008 had a high probability for positive results. ZGNX shares traded at $14.63 on June 9. When ZGNX announced strong phase III results on September 29, 2017, its shares shot up to $35.29, reflecting a 141% return from a June 9 investment. SanaCurrents made an additional forecast in June this year that ZX008 again would post positive results in a second pivotal study completed on 12 July, ZGNX shares climbed to $62.23 on 13 July, up from $45.63 the day before.
2 In June 2018, the FDA approved GWPH s Epidiolex as a treatment for childhood epilepsy. Zogenix operated under the radar as GW and Inysys gained headlines for its novel cannabidiol approach, but the ZGNX study results validated the company s drug and yielded high returns for the investor who "removed the blindfold" in GWPH now has a $4.2 billion market cap, while ZGNX owns a $2.15 billion market cap. As ZX008 moves closer to approval and market launch, expect ZGNX to narrow the gap. What exactly did this mean for investors in ZGNX shares? In 13 months, they netted $32,000 on a mere $10,000 investment after SanaCurrents' initial forecast.
3 Dynavax's (NASDAQ:DVAX) BLA application for its Hepatitis B vaccine first received a complete response letter from the FDA in 2013 and then experienced further regulatory delays between Some of the FDA requests involved the vaccine s overall immunogenicity data, while others related to how the BLA was filed, not necessarily regarding the effectiveness of the vaccine. With the setbacks, the stock slid backward for several years as DVAX worked to respond. SanaCurrents identified on May 3, 2017 that DVAX and the FDA had ironed out their differences and forecast an advisory committee would recommend approval of the vaccine when it voted at a meeting scheduled for July 28, DVAX shares traded at $5.50 on May 3. After the 12-1 vote to approve the vaccine, shares climbed to $15.85, a 188% return. What exactly did this mean for investors in DVAX shares? In just 3 months, they netted $18,000 on a mere $10,000 investment after SanaCurrents' initial forecast.
4 MyoKardia (NASDAQ:MYOK), a leading precision cardiovascular medicine company, reported good data during on its drug, mavacamten, to treat hypertrophic cardiomyopathy (HCM), a condition that reduces the rate of heart contractions because of the thickening of surrounding heart muscles. Mavacamten, an oral, small molecule, modulates the function of cardiac myosin, the motor protein that drives heart muscle contraction. After MYOK initially proved the safety of mavacamten, the FDA in 2016 granted orphan drug designation for mavacamten to treat symptomatic ohcm, a subset of HCM. MYOK was set to report results of a phase II trial in the fall of 2017, which primarily needed to measure ventricular outflow in 12 patients. Previous studies indicated mavacamten could improve the outflow. SanaCurrents forecast a positive trial outcome on May 22, 2017 when MYOK shares were at $ The results were announced August 7, MYOK share rose to $ What exactly did this mean for investors in MYOK shares? In just 4 months, they netted at least $11,600 on a mere $10,000 investment after SanaCurrents' initial forecast.
5 Eiger Biopharmaceuticals (NASDAQ:EIGR), a company developing treatment for rare diseases, which often are reimbursed at a premium price, published a study on April 24, 2018, indicating the effectiveness of its drug, lonafarnib, to treat Hutchinson-Gilford Progeria Syndrome (HGPS). The disease is a rare and fatal genetic condition of accelerated aging in children. In anticipation of the study results, SanaCurrents had forecast further growth of the HGPS program at EIGR on March 21, when shares traded at $9.38. On May 16, 2018, Merck, a large global healthcare and drug manufacturing company, expanded its HGPS program with EIGR, contributing more capital and guidance for a phase III trial. EIGR shares increased to $16.38 on May 17, or 75% from SanaCurrents initial forecast. What exactly did this mean for investors in EIGR shares? In less than 3 months, they netted at least $7,500 on a mere $10,000 investment after SanaCurrents' initial forecast.
6 ARMO Biosciences [ARMO] listed in January 2018 at $17 per share. The company had a phase III pancreatic cancer drug in AMO010, a recombinant form of human interleukin 10 (IL-10). There is no effective drug to treat pancreatic cancer. AMO010 demonstrated the ability to activate anti-tumor CD8+ T cells in early clinical trials, an important action for cancer immunotherapies now in development at many drug companies. The company also was testing AMO010 in pancreatic cancer, one of the most aggressive forms of cancer. In a trial of 21 patients with advanced pancreatic cancer, ARMO said no tumor growth was observed in 74% of the patients and 43% experienced prolong survival. The impressive results pointed to a successful outcome of the phase III trial in the fourth quarter of ARMO shares rose as high as 50 in the first two months after it listed, partly because of the near term, late-stage trial results and also rumors that a buyer for ARMO could be looming. ARMO CEO Peter Van Vlasselaer had been part of several management teams at companies that were previously sold, most recently at True North Pharmaceuticals, which was purchased by Bioverative [BIVV] in May SanaCurrents forecast a successful outcome for the phase III trial on April 13, 2018, when the stock was at Eli Lilly agreed to purchase ARMO at $50 per share on May 10, reflecting a 72% return in less than one month. What exactly did this mean for investors in ARMO shares? In less than 1 month, they netted at least $7,200 on a mere $10,000 investment after SanaCurrents' initial forecast.
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