Alkermes Plc (NASDAQ:ALKS) investors have a smile on their faces Thursday evening, after the drug maker announced positive topline results from its FORWARD-5, the third core efficacy trial to read out from the FORWARD pivotal program for ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.
Alkermes shares reacted to the news, jumping nearly 40% to $61.50 in after-hours trading Thursday.
“We designed ALKS 5461 to have a novel mechanism of action for the treatment of MDD, a serious disease where new therapeutic options are highly sought after as millions of patients in the U.S. do not respond to standard courses of antidepressant therapy,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461, with a goal of bringing this important new medication to patients with MDD.”
“ALKS 5461 embodies our dedication to developing novel and safe CNS medicines that address compelling unmet needs faced by large numbers of patients,” said Richard Pops, Chief Executive Officer of Alkermes. “Major depressive disorder affects millions of people and their families, and represents one of the greatest burdens of suffering and cost of any disease today. New drug development in the field is challenging and we are excited to advance ALKS 5461 in this important indication.”
The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated. The most common adverse events observed for ALKS 5461 were nausea, dizziness and fatigue. Based on these results, along with the substantial data collected to date on the efficacy and safety of ALKS 5461 for the treatment of MDD, the company plans to request a meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.
In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores (p=0.018). ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in 10-item MADRS (MADRS-10) scores compared to placebo (p=0.026). The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo.
The most commonly reported adverse events for ALKS 5461 in the FORWARD-5 study were nausea, dizziness and fatigue. These findings are consistent with those observed in previously reported studies of ALKS 5461. Alkermes will present comprehensive data from FORWARD-5 at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal. (Original Source)
On the ratings front, Alkermes has been the subject of a number of recent research reports. In a report issued on October 4, Leerink analyst Paul Matteis reiterated a Buy rating on ALKS, with a price target of $57, which represents a potential upside of 31% from where the stock is currently trading. Separately, on September 27, Morgan Stanley’s David Risinger reiterated a Sell rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Paul Matteis and David Risinger have a total average return of 11.6% and -4.1% respectively. Matteis has a success rate of 59% and is ranked #408 out of 4180 analysts, while Risinger has a success rate of 43% and is ranked #3700.
The street is mostly Bullish on ALKS stock. Out of 8 analysts who cover the stock, 5 suggest a Buy rating , 2 suggest a Hold and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $56.80, which represents a potential upside of 30.5% from where the stock is currently trading.
Alkermes Plc is a biopharmaceutical company, which engages in the development, manufacturing and distribution of medicines. It operates through the United States and European Union segments.