Exelixis, Inc. (NASDAQ:EXEL) announced that its partner Daiichi Sankyo Company, Limited(hereafter, Daiichi Sankyo) has initiated a phase 3 pivotal trial to evaluate CS-3150 (esaxerenone (r-INN)), an oral, non-steroidal, selective mineralocorticoid receptor antagonist, as a treatment for essential hypertension in Japanese patients. As a result ofDaiichi Sankyo enrolling the first patient in the program’s phase 3 pivotal trial, Exelixis is eligible for a $15 million milestone payment, which it expects to receive in the fourth quarter of 2016.
In March 2006, Daiichi Sankyo and Exelixis entered into a research collaboration agreement to discover, develop and commercialize novel therapies targeting the mineralocorticoid receptor. Under the terms of the agreement, Daiichi Sankyo has exclusive global development, manufacturing, and commercialization rights for the compounds. CS-3150 is one of the compounds identified during the research collaboration, and has subsequently been developed by Daiichi Sankyo.
The ESAX-HTN phase 3 pivotal trial is a randomized study of CS-3150 versus eplerenone in Japanese hypertensive patients. The trial will enroll an estimated 930 patients into three treatment arms: 2.5 mg and 5 mg doses of CS-3150, and 50 mg of eplerenone. The eighteen-week trial includes a four week washout period, twelve week study period and two week follow-up period. Among other inclusion criteria, to participate in the trial patients must be classified as hypertensive with systolic blood pressure between 140-180 mmHg, diastolic blood pressure between 90-110 mmHg and a mean 24-hour blood pressure reading greater than 130/80 mmHg. The primary objective is to evaluate the antihypertensive effect and safety of CS-3150 2.5 mg once daily compared to eplerenone; a secondary objective is to evaluate the effectiveness of the 2.5 and 5 mg doses of CS-3150.
In addition to ESAX-HTN, Daiichi Sankyo is sponsoring six smaller phase 3 clinical trials of CS-3150 in specific populations of patients with hypertension, either as monotherapy or in combination with other therapies used to treat the condition. The largest of these trials, Study J302, has been active since March 2016 and is a long-term, open-label study to evaluate the efficacy and safety of CS-3150 in 360 patients withessential hypertension, including forms that cannot be controlled by angiotensin II receptor blockers (ARB) or angiotensin converting enzyme (ACE) inhibitors. Another study in the program, J306, will evaluate the efficacy and safety of CS-3150 as an add-on to ARB or ACE inhibitor therapy in patients with hypertension and type 2 diabetes with albuminuria, a population for whom eplerenone is contraindicated.
“We are pleased to see our partner Daiichi Sankyo continue to advance CS-3150 through clinical development and into a well designed phase 3 pivotal trial in Japanese patients with essential hypertension,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “While our strategic partners devote their time and resources to progressing out-licensed Exelixis-discovered compounds, our internal team is focused on continuing to build a global franchise for cabozantinib and participating meaningfully in the commercialization of cobimetinib in the United States.”
Daiichi Sankyo’s decision to take CS-3150 into phase 3 clinical development was guided by results from multiple phase 2 trials, including data from a randomized, placebo-controlled double-blind trial evaluating doses of CS-3150, and open-label eplerenone in 400 patients with hypertension. Daiichi Sankyo is currently reviewing those data in advance of potential submission for publication or presentation at a scientific forum later this year. (Original Source)
Shares of Exelixis are currently trading at $15.25, up $0.36 or 2.42%. EXEL has a 1-year high of $15 and a 1-year low of $3.55. The stock’s 50-day moving average is $11.89 and its 200-day moving average is $7.61.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on September 19, Leerink analyst Michael Schmidt reiterated a Buy rating on EXEL, with a price target of $15, which represents a slight upside potential from current levels. Separately, on September 16, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and John Sonnier have a total average return of 25.1% and 14.5% respectively. Schmidt has a success rate of 68% and is ranked #34 out of 4183 analysts, while Sonnier has a success rate of 52% and is ranked #367.
The street is mostly Bullish on EXEL stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $15.00, which represents a slight upside potential from current levels.
Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib.