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Ladenburg Downgrades Cempra Following FDA's Complete Response Letter
Thursday, December 29, 2016 - 3:41pm | 372Ladenburg Thalmann has downgraded Cempra Inc (NASDAQ: CEMP) to Neutral from Buy following the complete response letter from the FDA for Solithromycin for treatment of Community Acquired Bacterial Pneumonia (CABP). The letter cites both manufacturing deficiencies at contract manufacturer Wockhardt...
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What Happened To Cempra's PDUFA Dates?
Thursday, December 29, 2016 - 9:30am | 332Cempra Inc (NASDAQ: CEMP) investors, whose shares had taken a pounding in early November, were waiting for a couple of big catalysts that could drive a rebound this week. The FDA had set two target dates to take action on solithromycin under the PDUFA: On Tuesday, it would make a decision for...
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What You Need To Know About Cempra's 2 PDUFA Dates This Week
Tuesday, December 27, 2016 - 12:08pm | 484Cempra Inc (NASDAQ: CEMP) has two upcoming catalysts this week, and the company may have too much riding on these, as its stock, which took a pounding in early November, is looking to bounce back. Stock Tanks On FDA's Prelim. Review Cempra stock fell about 61 percent on November 2 after its drug...
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Why The Last Week Of 2016 Could Be Big For Biotech Catalysts
Tuesday, December 27, 2016 - 10:02am | 481Many traders are stepping away from the market in the last week of the year to celebrate the holiday season with friends and family. However, biotech traders know the market never takes a vacation. In fact, there are a number of major biotech catalysts expected out in the near future. Here’s...
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Can Cempra Clear Solithera Hurdle After FDA Reveal?
Wednesday, November 2, 2016 - 2:55pm | 479Shares of Cempra Inc (NASDAQ: CEMP) plunged 60 percent to a new 52-week low of $7.35 after FDA briefing documents questioned whether solithromycin has some of the same safety risks as Ketek and potential for liver toxicity. The FDA issue came on the heels of company announcing the receipt of a $10...