Shares of Axovant Sciences Ltd (NYSE:AXON) ended Monday session in red amid volatile trading. The shares closed down -0.57 points or -3.73% at $14.71 with 792,445.00 shares getting traded. Post opening the session at $15.76, the shares hit an intraday low of $14.50 and an intraday high of $15.77 and the price vacillated in this range throughout the day. The company has a market cap of $1.47 billion and the numbers of outstanding shares have been calculated to be 99.16 million shares.
Axovant Sciences Ltd (AXON) on Sept. 26, 2016 announced that the company has received Fast Track designation for its Investigational New Drug (IND) application for intepirdine in the treatment of dementia with Lewy bodies from the U.S. Food and Drug Administration (FDA).
“We are pleased that FDA has placed a high priority on the development of intepirdine as a potential treatment for dementia with Lewy bodies,” stated Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences. “Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States and currently there are no approved treatments for the disease in either the United States or Europe. We believe the HEADWAY-DLB study of intepirdine in dementia with Lewy bodies represents an important step to address the unmet need of patients with this condition.”
The ongoing HEADWAY-DLB study will evaluate over a 24-week treatment period the efficacy, safety and tolerability of intepirdine at doses of 70 mg and 35 mg daily in approximately 240 patients with dementia with Lewy bodies. The study permits patients currently receiving stable background therapy for dementia with Lewy bodies to participate.
The agency’s Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Shares of Cerus Corporation (NASDAQ:CERS) ended Monday session in green amid volatile trading. The shares closed up +0.07 points or 1.12% at $6.30 with 793,672.00 shares getting traded. Post opening the session at $6.18, the shares hit an intraday low of $6.13 and an intraday high of $6.32 and the price vacillated in this range throughout the day. The company has a market cap of $645.00 million and the numbers of outstanding shares have been calculated to be 102.71 million shares.
Cerus Corporation (CERS) on September 7, 2016 announced that it has granted stock options and restricted stock units to Vivek K. Jayaraman, Cerus’ newly appointed chief commercial officer. These awards were granted pursuant to the Cerus Corporation Inducement Plan, approved by the Compensation Committee of Cerus’ Board of Directors and granted as an inducement material to Mr. Jayaraman’s employment with Cerus, in accordance with NASDAQ Listing Rule 5635(c)(4).
Cerus granted Mr. Jayaraman an option to purchase 250,000 shares of Cerus’ common stock with an exercise price of $6.36 per share, the closing price of Cerus’ common stock on September 1, 2016, the date of grant. In addition, Cerus granted to Mr. Jayaraman an award in the form of 75,000 restricted stock units. The shares subject to the option will vest over a four-year term, with one-eighth of the shares subject to the option vesting after six months and the remaining shares vesting in equal monthly increments, and the restricted stock units will vest in equal annual installments over four years, in each case subject to Mr. Jayaraman’s continuous service to Cerus on each vesting date.
Cerus is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).