GW Pharmaceuticals (NASDAQ:GWPH)
On March 14, 2016 shares of GW Pharmaceutical were up 124% after the company announced that it had obtained positive phase 3 results for its drug, known as Epidiolex. The drug was able to meet the primary endpoint of the study, which was a reduction of seizures compared to the placebo. The drug was statistically significant because it had obtained a p-value of p = .01. What should be taken away here is that any p-value below .01 should be taken as a positive.
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The patients recruited are those with a rare-form of epilepsy known as Dravet Syndrome. Patients with this disease experience seizure events with certain triggers. Such triggers are extremely hot temperatures or getting a fever. It is devastating to go through seizures every time because of these triggers, and a drug that can help reduce seizures is a welcomed component. After all, there are no FDA approved drugs to treat Dravet Syndrome.
There were a total of 120 patients who were randomized into two different dose groups. One group took 20 mg/kg/day of Epidiolex, and the other group took the placebo compound instead. The trial results were not only positive, but the Epidiolex treatment was safe and well tolerated in all patients. The next action is for GW Pharmaceuticals to have a pre-NDA meeting with the FDA to determine possible marketing approval for Epidioldex in patients with Dravet Syndrome.
Celator Pharmaceuticals (NASDAQ:CPXX)
In after-hours trading on March 14, 2016 shares of Celator Pharmaceuticals rocketed 300% after the company announced positive phase 3 results in patients with high-risk acute Myeloid Leukemia — AML. The company’s drug is known as VYXEOS and was being compared in the trial against the current standard of care regimens cytarabine and daunorubicin. Celator’s drug met on the primary endpoint of the study which was improved overall survival.
The median survival in the VYEXOS group was 9.56 months compared to 5.95 months in the placebo group. This means that VYXEOS reduced the risk of death in patients with high-risk AML by 31%. The company now expects that it will file an NDA to the FDA later in the year for marketing approval of the drug. It also states that it will file a Marketing Authorization Application — MAA – by the first quarter of 2017 for the same indication.
The drug was safe and well tolerated in all patients that were tested. There are some minor grade 3 adverse events in the VYXEOS group, which is similar to the current standard of care drugs. Despite these minor adverse events VYXEOS was able to improve overall survival for these patients, which is no small feat. Considering the market cap of the company is still low, there is a possibility that it could run once the NDA is filed.
Vitae Pharmaceuticals (NASDAQ:VTAE)
On Wednesday March 16, 2016 shares of Vitae Pharmaceuticals were up by 50% after the company announced positive phase 2a results in patients with moderate-to-severe psorasis. The company’s drug used to treat these patients with psoriasis is known as VTP-43742. Psoriasis is a disease of the skin characterized by scaly patches that itch. The results were not only great but both dose groups of VTP-43742 were positive relative to placebo.
The higher dose group of 700 mg achieved a 30% reduction of PASI score compared to placebo, and the 350 mg dose group achieved a 24% reduction in PASI compared to placebo. PASI is an index that measures the amount of area affected by psoriasis.
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Vitae’s next step is to start another phase 2 trial that will test VTP-43742 over a 16-week period to confirm initial efficacy. If the company can replicate the same results in this extended trial, then it will see a higher share price in the coming year. Although, on the other hand if it doesn’t meet the primary endpoint for positive efficacy it could see quite a huge tumble. Investors should only risk what they can afford to lose, because it will still be a risky bet.
[Image Courtesy of Public Domain Pictures]