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Cempra Inc (CEMP.O)

CEMP.O on Nasdaq

2.90USD
19 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Cempra and Melinta announce expiration of Hart-Scott-Rodino waiting period for proposed merger
Thursday, 28 Sep 2017 04:15pm EDT 

Sept 28 (Reuters) - Cempra Inc :Cempra and Melinta announce expiration of Hart-Scott-Rodino waiting period for proposed merger.Cempra Inc - ‍both companies expect transaction to be completed in Q4 of 2017​.Cempra inc - ‍waiting period under Hart-Scott-Rodino with respect to Melinta's pending merger with a subsidiary of Cempra has now expired​.  Full Article

Cempra and Melinta announce merger to form leading, vertically integrated commercial-stage anti-infectives company
Wednesday, 9 Aug 2017 08:00am EDT 

Aug 9 (Reuters) - Cempra Inc :Cempra and Melinta announce merger to form leading, vertically integrated commercial-stage anti-infectives company.Cempra Inc - ‍On a pro forma basis, current Cempra shareholders will own approximately 48 percent of combined company​.Says ‍on a pro forma basis, current Melinta shareholders will own approximately 52 percent of combined company​.Cempra Inc - ‍Board of directors of combined co will have 9 seats, with 4 appointed by Cempra, 4 appointed by Melinta, together with newly appointed CEO​.Says ‍combined company, which will be named Melinta Therapeutics​.Cempra Inc - ‍melinta will designate chairman of combined company board​.  Full Article

Cempra reports Q2 loss per share $0.23
Wednesday, 9 Aug 2017 08:00am EDT 

Aug 9 (Reuters) - Cempra Inc :Cempra provides corporate update and reports second quarter 2017 financial results.Q2 loss per share $0.23.Q2 earnings per share view $-0.32 -- Thomson Reuters I/B/E/S.Cempra Inc - ‍In Q1 of 2017, met with FDA to discuss solithromycin complete response letter (CRL)​.Cempra Inc - ‍FDA reiterated their request for additional clinical safety data prior to approval for solithromycin​.Cempra Inc - ‍FDA has stated that phase 3 trials provided evidence that oral and intravenous (IV) solithromycin are effective for treatment of CABP​.Cempra Inc - ‍FDA has not requested further efficacy data to support co's response to CRL for solithromycin​.Cempra Inc - ‍Continue to advance manufacturing activities for solithromycin at Uquifa.Cempra - Engaged with potential government and industry partners to identify non-dilutive funding to support execution of solithromycin study ​.Cempra Inc - ‍Expect to reduce second half 2017 expenses by more than 70 percent compared to second half of 2016​.  Full Article

Cempra Q1 loss per share $0.44
Friday, 28 Apr 2017 07:00am EDT 

April 28 (Reuters) - Cempra Inc :Cempra reports first quarter 2017 financial results and provides corporate update.Q1 loss per share $0.44.For quarter ended March 31, 2017, Cempra reported a net loss of $22.9 million, or $0.44 per share.As of March 31, 2017, Cempra had cash and equivalents of $202.8 million and 52.4 million shares outstanding.Expects research and corporate expenses to trend significantly downward beginning in Q2 of this year.  Full Article

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

BRIEF-Cempra and Melinta announce expiration of Hart-Scott-Rodino waiting period for proposed merger

* Cempra and Melinta announce expiration of Hart-Scott-Rodino waiting period for proposed merger