Approval of Celgene's (CELG) Pomalyst Largely Expected by Street (ONXX)
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 8/22/2026
- Wall St rises on the day but falls for the week; bond yields and Iran in focus
- UBS says bull market has further to run
- S&P 500 may pull back before midterms, but Citi says buy the dip
- Global yield relief evaporates as U.S. rates push back toward multi-decade peaks
- BofA's Hartnett sees dollar slump, risk selloff if bond intervention fails
- Applied Optoelectronics sets up $600M at-the-market stock offering
- Fannie Mae loses at least 10 senior executives amid departures - WSJ
- Wall St rises on the day but falls for the week; bond yields and Iran in focus
- One killed, three injured when man attacks Swedish school with sword
- Morgan Stanley course-corrects their semiconductor equipment outlook on demand
Celgene (CELG) Affirms Approval of Pomalyst for Multiple Myeloma Patients
February 8, 2013 3:56 PM ESTCelgene Corporation (Nasdaq: CELG) announced the U.S. Food and Drug Administration (FDA) has approved POMALYST brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Supporting the approval were the results of MM-002, a phase II,... More
Celgene (CELG) Wins FDA Approval for Pomalyst in Multiple Myeloma
February 8, 2013 3:31 PM ESTCelgene Corp (NASDAQ: CELG) is said to have won FDA approval for pomalidomide in multiple myeloma.... More
Celgene (CELG) Issues FY13 Outlook; Guides Longer-Term Growth Expectations
January 7, 2013 11:32 AM ESTCelgene Corporation (NASDAQ: CELG) provided its financial outlook for 2013 at the JPMorgan 31st Annual Healthcare Conference. In 2013, total net product sales are expected to be approximately $6.0 billion, an 11.4% year-over-year increase. REVLIMID net sales are expected to be in the range of $4.1 billion to $4.2 billion, including approximately $90 million of negative year-over-year foreign exchange impact. Assuming constant foreign exchange, REVLIMID growth would be 11 to 14 percent. Adjusted diluted earnings per share (EPS) is expected in the range of $5.50 to $5.60, a 12 to 14 percent year-over-year increase. Based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected in the range of $4.67 to $4.79.
2012 Financial Results Year-Over-Year (Unaudited)
* Total net product sales are expected to be $5.4 billion, up 15% year-over-year; Total revenues are approximately $5.5 billion, up 14% year-over-year
* REVLIMID quarterly net product sales to surpass $1.0 billion for the fourth quarter of 2012
* Adjusted operating margin is expected to be ~48% for the full year, up 300 bps year-over-year;... More
Celgene (CELG) Reports Pomalidomide Phase III Met Primary Endpoint
October 23, 2012 7:44 AM EDTCelgene International SÃ rl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to... More
