Shares of Shire PLC (ADR) (NASDAQ:SHPG) ended Monday session in red amid volatile trading. The shares closed down -3.96 points or -1.95% at $199.09 with 824,917.00 shares getting traded. Post opening the session at $198.91, the shares hit an intraday low of $198.25 and an intraday high of $200.48 and the price vacillated in this range throughout the day. The company has a market cap of $59.87 billion and the numbers of outstanding shares have been calculated to be 906.90 million shares.
Shire PLC (ADR) (SHPG) on September 14, 2016 announced that the United States Food and Drug Administration (FDA) has granted approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. CUVITRU is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly; it affects up to six million people worldwide.
With the approval of CUVITRU, Shire now has the broadest portfolio of intravenous and subcutaneous immunolglobulin (IG) products, including the only once-a-month subcutaneous treatment option. CUVITRU is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments. Regardless of infusion rate or volume per site, CUVITRU was generally associated with a low incidence of local adverse and systemic reactions (0.022/infusion and 0.042/infusion, respectively) in the North American clinical study.
“In the clinical study, primary immunodeficiency patients tolerated CUVITRU favorably despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past,” said Richard L. Wasserman, M.D., Ph.D., Medical Director of Pediatric Allergy and Immunology at Medical City Children’s Hospital. “The availability of CUVITRU as a high concentration, subcutaneous IG provides primary immunodeficiency patients with the dosing flexibility that allows them to customize their therapy to best fit their individual needs.”
Shares of Chiasma Inc (NASDAQ:CHMA) ended Monday session in green amid volatile trading. The shares closed up +0.21 points or 7.39% at $3.05 with 814,205.00 shares getting traded. Post opening the session at $2.80, the shares hit an intraday low of $2.71 and an intraday high of $3.19 and the price vacillated in this range throughout the day. The company has a market cap of $78.72 million and the numbers of outstanding shares have been calculated to be 24.36 million shares.
Chiasma Inc (CHMA) on Aug. 16, 2016 announced that it is further reducing its workforce by approximately 44%, primarily in the company’s research and general and administrative functions, to lower its operating expenses and extend its cash runway. This action follows Chiasma’s announcement of a corporate restructuring plan in June 2016, which included an initial workforce reduction composed primarily of the company’s commercial personnel. Chiasma intends to focus its resources on the continued development of Mycapssa® (octreotide) capsules for the maintenance treatment of adult patients with acromegaly.
“We extend our sincere appreciation to those who will be leaving Chiasma for their contributions toward bringing new treatment options to patients,” said Mark Leuchtenberger, president and chief executive officer of Chiasma. “While this decision is extremely difficult, we believe it is the prudent course of action as we seek to conserve our cash and continue our dialogue with the U.S. Food and Drug Administration (FDA) regarding development of Mycapssa.”
Chiasma estimates that it will incur aggregate charges related to the headcount reduction of approximately $0.8 million to $1.0 million for one-time severance and related costs in the third quarter of 2016. These charges are expected to result in cash expenditures that will be substantially complete by the end of the first quarter of 2017. As of June 30, 2016, Chiasma had $115.6 million of cash, cash equivalents and marketable securities.