Pharmaceutical and biotech companies generally must endure the lengthy process that is getting their drug candidates to market through clinical trials. There is a fair amount to a great amount of risk involved, should a study come back negative or should a candidate not be approved. On the other hand, if a drug is approved or passes a clinical trial, there can be massive upside.
Suffice it to say, U.S. Food and Drug Administration (FDA) rulings and positive or negative trial results can make or break these companies.
24/7 Wall St. has collected several big FDA decisions and imminent clinical trial results that should be coming up in the June quarter. We have added some color, along with the trading range and price target.
Note that, due to many outside and internal factors, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters if a company is not deeply financed.
Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) is looking forward to an FDA approval in its late stage Orkambi study by the end of the second quarter. Specifically the Phase 3 study of Orkambi focuses on the treatment of cystic fibrosis in children ages 6 to 11. Currently the treatment is available for children aged 12 and up; this new demographic would add roughly 2,400 children eligible for the treatment in the United States. Orkambi was approved last July for treatment, but since that time it had sales totaling $351 million at the end of 2015. Shares of Vertex traded at $88.96 early Wednesday, with a consensus analyst price target of $109.55 and a 52-week trading range of $75.90 to $143.45.
Puma Biotechnology Inc. (NYSE: PBYI) is set to present data on its drug candidate PB272 (neratinib) at the American Society of Clinical Oncology (ASCO) Annual meeting at the beginning of June. Before the second quarter of 2016 is done, we can expect Puma to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) in the European Union. PB272 is for the extended adjuvant treatment of HER2-positive early stage breast cancer based on positive ExteNET Phase 3 study results. By the end of 2016, we can expect Phase 2 data from PB272 Summit trial and for HER2 non-amplified breast cancer. In either the fourth quarter of 2016 or the following quarter, Puma expects to present Phase 3 data of PB272 for third-line HER2-positive metastatic breast cancer. Its shares were last seen at $32.78. The consensus price target is $67.60, and the 52-week range is $19.74 to $201.49.
GW Pharmaceuticals PLC (NASDAQ: GWPH) reported positive initial results from its first Phase 3 trial of Epidiolex in Dravet syndrome early in May. However, there are many more trials associated with the Epidiolex orphan epilepsy program that are currently in the works. This Phase 3 Dravet syndrome trial is expecting a full publication of its results in the fourth quarter of this year. In the meantime, there are two LGS Phase 3 trials that are fully enrolled and data from the first trial is expected in June. Shares of GW Pharma traded at $87.11. The stock has a consensus price target of $147.67 and a 52-week range of $35.83 to $133.98.
Agios Pharmaceuticals Inc. (NASDAQ: AGIO) is gearing up to present data on its PKR Activators AG-348 and AG-519 in the upcoming European Hematology Association (EHA) Congress taking place between June 9 and 12. AG-348 is currently in an ongoing Phase 2 study (DRIVE PK) in adults with pyruvate kinase (PK) deficiency, while AG-519 is in an ongoing Phase 1 study in health volunteers. Shares of Agios were trading at $48.00, with a consensus price target of $54.00 and a 52-week range of $33.50 to $126.35.
Dermira Inc. (NASDAQ: DERM) expects to announce top-line data for the two DRM04 Phase 3 pivotal trials by the end of the second quarter for its treatment in patients with primary axillary hyperhidrosis. The company completed enrollment for this trial back in February, for DRM04 in its ATMOS-1 and ATMOS-1 Phase 3 trials, with a grand total of 697 patients. Previously in May, the company announced positive top-line data from its Phase 2b dose-ranging study evaluating the safety and efficacy of its DRM01 in patients with facial acne vulgaris. Shares of Dermira were trading at $31.86. The stock has a consensus price target of $41.60 and a 52-week range of $14.63 to $35.75.