|
|
News Breaks | | | | December 6, 2012 | | 16:02 EDT |  | CBST | FDA grants QIDP designation to two Cubist Phase 3 antibiotic candidates
Cubist Pharmaceuticals announced that the FDA has designated two of the company's Phase 3 antibiotic candidates, CXA-201 and CB-315, as Qualified Infectious Disease Products, or QIDP. The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa. The FDA's QIDP designation applies to CXA-201's treatment of complicated intra-abdominal infections. CB-315 is currently being investigated in Phase 3 trials as an oral therapy for Clostridium difficile-associated diarrhea, or CDAD. | |
|
News For CBST From The Last 14 Days Check below for free stories on CBST the last two weeks. |
|
|
| May 17, 2013 | | 05:51 EDT |  | CBST | Stocks with implied volatility movement; CBST CELG
 Subscribe for More Information | | | May 16, 2013 | | 07:29 EDT |  | CBST | Leerink to host a bus tour
Boston Biopharma Bus Tour travels throughout Boston on May 16-17. | | | May 15, 2013 | | 17:46 EDT | | CBST | SAC Capital gives quarterly update on stakes
NEW STAKES: Discovery (DISCA), Liberty Global (LBTYA), Liberty Media (LMCA), Norwegian Cruise Line (NCLH), and Cubist (CBST). INCREASED STAKES: Suncor (SU), EQT Corporation (EQT), Amazon.com (AMZN), Visa (V), and GNC Holdings (GNC). DECREASED STAKES: News Corp. (NWSA), Facebook (FB), Sherwin-Williams (SHW), and Avago (AVGO). LIQUIDATED STAKES: Coach (COH), Dover (DOV), and Virgin Media (VMED), . | | | 16:00 EDT | | CBST | Optimer calls active following takeover report
Optimer (OPTR) May and June 17 calls are active on 5,600 contracts (500 puts) according to Track Data. Traders are taking positions for large price movement on Cubist (CBST) offered to buy the company for $20 per share, Reuters says. | | | 15:54 EDT | | CBST | Optimer up 12.5%, to $16.03 after Reuters report Cubist offered $20 per share
Subscribe for More Information | | | 15:53 EDT | | CBST | Cubist offered to buy Optimer for $20 per share, Reuters says
Subscribe for More Information | | | May 13, 2013 | | 16:53 EDT |  | CBST | Optimer gets bids from AstraZeneca, Cubist, Astellas, Bloomberg says
Optimer (OPTR) has received first round bids from AstraZeneca (AZN), Cubist (CBST), and Astellas, reports Bloomberg, citing people familiar with the matter. Shares of Optimer spiked higher following the report, closing up $1.85, or 14.44%, to $14.66. The report notes the company disclosed almost three months ago it was exploring its strategic options. Reference Link | | | 15:55 EDT | | CBST | Optimer gets first round bids from AstraZeneca, Cubist, Bloomberg says
Subscribe for More Information | | | May 7, 2013 | | 08:34 EDT | | CBST | FDA grants fast track desingation for Cubist's late-stage antibiotic candidate
Subscribe for More Information | |
|
|
|
|
|
|
