CEMP
Cempra, Inc.NASDAQ
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  • Mon, Dec. 5, 8:28 AM
    • Cempra (NASDAQ:CEMP) is up 8% premarket on modest volume in response to its announcement that licensee Toyama Chemical Co., Ltd., has initiated a Phase 3 study in Japan evaluating solithromycin compared to levofloxacin in patients with community-acquired bacterial pneumonia and other respiratory infections.
    • Toyama owns exclusive development and commercialization rights to solithromycin in Japan. Cempra has received $40M in upfront and milestone payments to date from Toyama and can earn an additional $30M in milestones in addition to tiered royalties if solithromycin is approved for sale there.
    | Mon, Dec. 5, 8:28 AM | 24 Comments
  • Fri, Dec. 2, 5:36 PM
    | Fri, Dec. 2, 5:36 PM | 7 Comments
  • Mon, Nov. 21, 1:11 PM
    • Cempra (CEMP -7.9%) bulls among analysts just lost one of their own. Cowen and Company's Ritu Baral just downgraded the stock to Market Perform citing the lack of clarity with lead product candidate solithromycin.
    • Since the close 7-6 Ad Comm vote several weeks ago, there have been a rash of downgrades. According to MarketBeat, there are three Buy ratings on the stock and eight Hold/Underweight ratings. Before the Ad Comm, 10 of 11 analysts rated the stock a Buy.
    | Mon, Nov. 21, 1:11 PM | 29 Comments
  • Tue, Nov. 8, 12:03 PM
    • Unsurprisingly, analysts have a range of opinions regarding Cempra (CEMP -12.4%) after Friday's close Ad Comm vote on solithromycin.
    • On the bullish side, WBB Securities, RBC Capital Markets and Needham all rate the stock a Buy with price targets of $40 (567% upside), $27.50 (358% upside) and $15 (150% upside) (from $36), respectively.
    • Three shops downgraded: Morgan Stanley from Overweight to Underweight with a $5 (17% downside risk) price target (from $35); Jefferies from Buy to Hold with a $10 (67% upside) price target (from $36) and Gabelli from Buy to Hold.
    • The day before the Ad Comm review, Stifel Nicolaus and JPMorgan downgraded it to Hold and Neutral, respectively, with price targets of $8 (33% upside)(from $37) and $6 (0% upside)(from $25), respectively.
    • Shares have lost 67% of their value since last week.
    | Tue, Nov. 8, 12:03 PM | 36 Comments
  • Mon, Nov. 7, 9:17 AM
    | Mon, Nov. 7, 9:17 AM | 4 Comments
  • Mon, Nov. 7, 8:18 AM
    • Cempra (NASDAQ:CEMP) is up 31% premarket on robust volume in response to Friday's Ad Comm vote on solithromycin. The vote on whether its benefits outweigh the risks was close, 7 - 6, due to potential liver injury but investors expect approval considering the acute need for new antibiotics.
    • Solithromycin is a next-generation antibiotic called a fluoroketolide, a member of a class of drugs that has shown effectiveness against drug-resistant bacteria because of their ability to bind to two sites on the bacterial ribosome.
    • Read now Cempra, Inc.: Out Take On FDA;s Question On Liver Enzyme Elevation Due To Solithromycin 
    | Mon, Nov. 7, 8:18 AM | 58 Comments
  • Fri, Nov. 4, 4:06 PM
    • The FDA's Antimicrobial Drugs Advisory Committee voted today on Cempra's (CEMP) New Drug Application (NDA) seeking approval of solithromycin. The outcome:
    • Question #1: Is there sufficient evidence of efficacy? 13 - Yes, 0 - No.
    • Question #2: Has the risk of hepatotoxicity been adequately characterized? 1 - Yes, 12 - No.
    • Question #3: Does the efficacy outweigh the risks? 7 - Yes, 6 - No.
    • If the FDA approves solithromycin, it is a certainty some form of post-approval study/surveillance will be required considering the liver risk.
    • Previously: Cempra slumps 30% premarket on solithromycin liver injury comments in FDA briefing material ahead of Ad Comm review (Nov. 2)
    | Fri, Nov. 4, 4:06 PM | 202 Comments
  • Fri, Nov. 4, 8:16 AM
    • Almost Family (NASDAQ:AFAM) upgraded to Outperform from Neutral by Baird. Price target raised to $55 (35% upside) from $44.
    • Gilead Sciences (NASDAQ:GILD) upgraded to Outperform from Market Perform by BMO Capital. Price target lowered to $84 (17% upside) from $98.
    • Dentsply Sirona (NASDAQ:XRAY) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $69 (16% upside) from $65.
    • Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Strong Buy from Buy by Needham. Price target lowered to $148 (44% upside) from $150.
    • Stryker (NYSE:SYK) upgraded to Market Perform from Underperform with a $125 (8% upside) price target by BMO Capital.
    • Teva Pharmaceutical Industries (NASDAQ:TEVA) upgraded to Outperform from Neutral by Credit Suisse. Price target lowered to $52 (33% upside) from $59.
    • Cempra (NASDAQ:CEMP) downgraded to Hold from Buy by Stifel Nicolaus. Price target lowered to $8 (6% upside) from $37. Downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $6 (21% downside risk) from $25. Downgraded to Underperform from Outperform by Baird. Price target lowered to $6 (21% downside risk) from $33.
    • Diplomat Pharmacy (NYSE:DPLO) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $18 (39% upside) from $35. Downgraded to Market Perform by Citigroup and Avondale Partners.
    • WebMD (NASDAQ:WBMD) downgraded to Neutral from Buy by Mizuho Securities. Price target lowered to $52 (5% upside) from $63.
    • Pfizer (NYSE:PFE) downgraded to Market Perform from Outperform by BMO Capital. Price target lowered to $33 (10% upside) from $40. Downgraded to Hold from Buy by Argus.
    • Adeptus Health (NYSE:ADPT) downgraded to Underperform from Buy by Bank of America. Downgraded to Hold from Buy by Jefferies. Price target lowered to $13 (48% upside) from $77.
    • Sangamo BioSciences (NASDAQ:SGMO) downgraded to Neutral from Overweight by Wedbush and Piper Jaffray. Price targets lowered to $4 (25% upside) from $30 and $5 (56% upside) from $9, respectively.
    • Novo Nordisk (NYSE:NVO) downgraded to Neutral from Buy by Citigroup and to Hold from Buy by DNB Markets.
    • AbbVie (NYSE:ABBV) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $60 (7% upside) from $70.
    | Fri, Nov. 4, 8:16 AM | 18 Comments
  • Wed, Nov. 2, 12:42 PM
    | Wed, Nov. 2, 12:42 PM
  • Wed, Nov. 2, 11:01 AM
    | Wed, Nov. 2, 11:01 AM
  • Wed, Nov. 2, 9:20 AM
    • Cempra (NASDAQ:CEMP) slumps 30% premarket on robust volume in response to the FDA's briefing doc for Friday's Ad Comm review of solithromycin. On page 34, the reviewer states that these findings (clinical studies) comprise a "genuine liver injury signal." The reviewer adds that "the likelihood of serious idiosyncratic hepatic liver injury in a larger population and the impact of prior sensitization to macrolides on solithromycin-induced liver injury are unknown," clearly implying a need for additional clinical studies.
    • FDA briefing doc
    • Company briefing doc
    | Wed, Nov. 2, 9:20 AM | 115 Comments
  • Wed, Nov. 2, 8:28 AM
  • Tue, Nov. 1, 9:36 AM
    • Cempra (CEMP -0.1%) receives a $10M milestone payment from FUJIFILM subsidiary Toyama Chemical Co. triggered by the advancement of solithromycin to Phase 3 development in Japan. Toyama has exclusive rights there for respiratory tract infections and certain other indications in adult and pediatric patients.
    • Cempra can earn up to $70M ($40M already earned) in milestones from Toyama based on achieving certain objectives. It will earn tiered royalties on net sales of solithromycin once commercially available.
    | Tue, Nov. 1, 9:36 AM
  • Fri, Oct. 28, 11:01 AM
    | Fri, Oct. 28, 11:01 AM
  • Fri, Oct. 28, 9:20 AM
    | Fri, Oct. 28, 9:20 AM | 24 Comments
  • Thu, Oct. 27, 6:02 PM
    • Cempra (NASDAQ:CEMP) Q3 results ($M): Revenues: 4.0 (+59.1%).
    • Net Loss: (32.3) (-17.0%); Loss Per Share: (0.62) (+1.6%).
    • Shares are down 15% after hours on robust volume in apparent reaction to statements made during the earnings call that appeared to imply that the India-based manufacturing facility that will make solithromycin may not be ready for an early Q1 U.S. market launch. The FDA's action dates are in late December.
    | Thu, Oct. 27, 6:02 PM | 59 Comments