Cempra Announces Positive Topline Phase 3 Clinical Results for Intravenous Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia
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Baird Remains Bullish as Market Reacts to Cempra's (CEMP) 2nd Phase 3 Study of Solithromycin
October 19, 2015 10:17 AM EDTBaird reiterated an Outperform rating and $38.00 price target on Cempra, Inc. (NASDAQ: CEMP) following the company's second Phase 3 study of solithromycin.
Analyst Brian Skorney commented, "While the market is clearly reacting to potential signals about safety, we believe that the second Phase 3 study of... More
Roth Capital Cuts Price Target on Cempra (CEMP) as Solithromycin Misses High Expectations
October 19, 2015 8:53 AM EDTRoth Capital maintained a Buy rating on Cempra, Inc. (NASDAQ: CEMP), and cut the price target to $40.00 (from $56.00), after succumbing to high expectations for solithromycin. While solithromycin is expected to be approved for the treatment of CAP, lack of numerical superiority in older patients... More
SOLITAIRE-IV Data Not as Strong as ORAL; Leerink Partners Cuts Price Target on Cempra's (CEMP) to $21
October 16, 2015 1:13 PM EDTLeerink Partners maintains a Market Perform rating on Cempra, Inc. (NASDAQ: CEMP), and cut the price target to $21.00 (from $31.00), following this mornings announced SOLITAIRE-IV Phase III results. The study demonstrated statistical non-inferiority on both FDA and EMA primary endpoints. However, unlike Solitaire-ORAL, in this study Solithromycin was numerically inferior on multiple key clinical... More
Cempra (CEMP) Announces Solitaire-IV Met All Endpoints in Phase 3
October 16, 2015 7:01 AM EDTCempra (NASDAQ: CEMP) announced positive topline results from a global, pivotal Phase 3 clinical trial of intravenous (IV) to oral solithromycin (Solitaire-IV) in the treatment of patients with community-acquired bacterial pneumonia (CABP).
In the intent-to-treat population (ITT, all randomized patients), solithromycin met the FDA primary objective of statistical non-inferiority (NI, 10% non-inferiority margin) compared to moxifloxacin at the early clinical response (ECR, 72 [-12/+36] hours after initiation of therapy). The point estimates for the primary endpoint of early clinical response were 79.3% for solithromycin and 79.7% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper... More
