Baird Remains Bullish as Market Reacts to Cempra's (CEMP) 2nd Phase 3 Study of Solithromycin

Roth Capital Cuts Price Target on Cempra (CEMP) as Solithromycin Misses High Expectations

Roth 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

Leerink 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

Unusual 11 Mid-Day Movers 10/16: (YOKU) (SFXE) (YGE) Higher; (ZFGN) (CEMP) (PWR) Lower

Zafgen (Nasdaq: ZFGN) 37.5% LOWER; announced that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts ongoing or planned clinical trials, including ZAF-311 and ZAF-312. A partial clinical hold is an order that the FDA issues to delay or suspend part of a sponsors clinical work requested under its investigational new drug (IND) application.

Cempra (Nasdaq: CEMP) 29.7% LOWER; announced... More

Pre-Open Stock Movers 10/16: (SFXE) (YOKU) (BOX) Higher; (ZFGN) (CEMP) (WYNN) Lower

Zafgen (NASDAQ: ZFGN) 34% LOWER; announced that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts... More

Cempra (CEMP) Announces Solitaire-IV Met All Endpoints in Phase 3

Cempra (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