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Cempra Inc (CEMP.O)

CEMP.O on Nasdaq

3.90USD
29 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Cempra withdraws solithromycin marketing authorization application in Europe
Tuesday, 28 Mar 2017 07:00am EDT 

Cempra Inc : Cempra withdraws solithromycin marketing authorization application in Europe . Based on day 120 questions Cempra received from EMA, company believes additional data would be required .Cempra - by withdrawing MAA at this time, it will allow co to align strategy to provide additional data to EMA, U.S. FDA to support potential approval.  Full Article

Cempra Q4 loss per share $0.60
Tuesday, 28 Feb 2017 06:45am EST 

Cempra Inc : Cempra provides corporate update and reports fourth quarter and full year 2016 financial results . Qtrly loss per share $0.60 . Qtrly revenues $7.945 million versus $5.794 million .Cempra Inc - delay of potential approval of solithromycin, have resulted in an approximately 67 percent reduction in our workforce.  Full Article

Cempra’s fusidic acid achieves primary endpoint in phase 3 study of Absssi
Friday, 24 Feb 2017 07:00am EST 

Cempra Inc : Cempra’s fusidic acid achieves primary endpoint in phase 3 study of Absssi . Fusidic acid met primary endpoint and secondary efficacy endpoints . Fusidic acid well tolerated in study ."Look forward to meeting with fda to discuss next steps required to bring fusidic acid to patients in United States".  Full Article

Cempra receives complete response letter from FDA for solithromycin NDAs
Thursday, 29 Dec 2016 07:16am EST 

Cempra Inc : Cempra receives complete response letter from FDA for solithromycin NDAs . FDA did not request any further information on solithromycin efficacy for CABP in CRL . Says plans to request a meeting with FDA as soon as possible to discuss issues identified in a complete response letter . Comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance program would also be required . To address the deficiency, FDA is recommending a comparative study to evaluate safety of solithromycin in patients with CABP . During inspections of Wockhardt Limited and Hospira manufacturing facilities, FDA field investigator conveyed deficiencies to representatives . CRL states that FDA cannot approve NDAs in their present form . CRL notes that additional clinical safety information and satisfactory resolution of manufacturing facility inspection deficiencies required . Based on their review of NDAs, CRL stated that FDA determined risk of hepatotoxicity had not been adequately characterized. . Says plans to provide FDA with an update on manufacturing progress at Uquifia . Details on the deficiencies were not provided in CRL . Cempra inc says "is committed to working with FDA to achieve approval of solithromycin as quickly as possible".  Full Article

Cempra stock trading halted today FDA advisory committee to discuss Solithromycin
Friday, 4 Nov 2016 07:05am EDT 

Cempra Inc : Cempra stock trading halted today; FDA advisory committee to discuss solithromycin . Fda amdac meeting on Friday to discuss safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia .Cempra Inc - FDA advisory committee meeting is scheduled to begin at 8:30 a.m. Et and is scheduled to end at 5:00 p.m. Et.  Full Article

Cempra says FDA scheduled meeting to discuss safety, efficacy of solithromycin
Tuesday, 30 Aug 2016 09:15am EDT 

Cempra Inc :FDA scheduled meeting of Antimicrobial Drugs Advisory Committee on Nov. 4 to discuss safety, efficacy of solithromycin.  Full Article

Cempra says current cash, equivalents sufficient to fund ongoing operations through 2017
Monday, 1 Aug 2016 04:05pm EDT 

Cempra Inc : Cempra reports second quarter 2016 financial results and provides corporate update . Q2 earnings per share view $-0.67 -- Thomson Reuters I/B/E/S . Q2 loss per share $0.51 .Cempra Inc says current cash and equivalents are expected to be sufficient to fund ongoing operations through 2017.  Full Article

Cempra announces positive data from Japenese study on solithromycin
Wednesday, 25 May 2016 04:30pm EDT 

Cempra Inc :Cempra announces successful results in the phase 2 community acquired bacterial pneumonia (cabp) trial conducted by japanese partner, toyama chemical (a subsidiary of fujifilm holdings corporation).  Full Article

Cempra Announces Proposed Public Offering of $175 Million of Common Stock
Tuesday, 5 Jan 2016 04:11pm EST 

Cempra, Inc:Says its intention to offer and sell shares of its common stock with an aggregate public offering price of approximately $175 million in an underwritten public offering pursuant to its existing shelf registration statement.The company also intends to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the public offering with an aggregate public offering price of $26.25 million.intends to use net proceeds from offering to fund commercial launch of solithromycin in community acquired bacterial pneumonia in U.S., including continued clinical and regulatory development of solithromycin in CABP and gonorrhea and Taksta in acute bacterial skin and skin structure infections.and also for the chronic oral treatment of refractory infections in bones and joints, working capital and general corporate and administrative expenses.J.P. Morgan Securities LLC is acting as lead active book-running manager and Jefferies LLC is acting as joint active book-running manager for the offering.  Full Article

Cempra, Inc Cempra announces positive topline phase 3 clinical results for Intravenous Solithromycin
Friday, 16 Oct 2015 07:00am EDT 

Cempra, Inc:Announces positive topline phase 3 clinical results for intravenous solithromycin in the treatment of community-acquired bacterial pneumonia.Says rolling nda submission expected to begin 4q 2015.Solithromycin met the secondary endpoint of ni compared to moxifloxacin in the mitt population at the ecr time point from solitaire-IV alone.Says solithromycin met all FDA primary objectives of non-inferiority compared to moxifloxacin.Says two phase 3 trials required by the FDA and the ema for cabp regulatory filings now complete.  Full Article

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BRIEF-Cempra retains Morgan Stanley to lead review of strategic business options

* Cempra retains Morgan Stanley to lead review of strategic business options