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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 EDT
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Price: $2.33 --0%

Rating Summary:
    1 Buy, 14 Hold, 0 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 20 | Down: 14 | New: 22
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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 measures.

Analyst Paul Matteis commented, "This morning CEMP announced top-line results from its phase III SOLITAIRE-IV study which compared V-to-oral regimens of Solithromycin and Moxifloxacin. The study demonstrated statistical noninferiority on both FDA and EMA primary endpoints, and with solid data on early clinical response (ECR), we believe approval in the much more important US market is very likely. However, unlike Solitaire-ORAL, in this study Solithromycin was numerically inferior on multiple key clinical measures, and notably was ~4-5% worse than Moxi on success at follow-up (SFU) on multiple data cuts, including an intent-to-treat (ITT) analysis and a clinically evaluable (CE) analysis that excluded 5 patients imputed as drug failures due to a drug supply issue. Thus, while we remain confident in both US approval and the unmet need presented by pneumonia, we are reducing our peak gross 2032 US sales estimate from ~$1B in 2032 to ~$600MM. This lowers our PT to $21 fr $31. Remain MP."

For an analyst ratings summary and ratings history on Cempra, Inc. click here. For more ratings news on Cempra, Inc. click here.

Shares of Cempra, Inc. closed at $26.78 yesterday.



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