Citing a higher-than-expected placebo response and pointing to “encouraging” data in a subset of Crohn’s disease patients did little to assuage investor fears Monday as Coronado Biosciences Inc. reported that CNDO-201, its pig whipworm egg-based candidate, missed its endpoint in the Phase II TRUST-1 study.
When it comes to breast cancer treatment, there’s no shortage of drugs in development. Cortellis, the database run by BioWorld’s new parent Thomson Reuters, shows more than 3,500 drugs in development in the space.
In another piece of good news for the biotech initial public offering (IPO) market, Macrogenics Inc. priced its IPO as expected Thursday, selling 5 million shares at $16 apiece, and then watched as shares (NASDAQ:MGNX) opened 53 percent higher on the first day of trading.
Shares of Ariad Pharmaceuticals lost two-thirds of their value Wednesday after follow-up safety data showing increased incidents of arterial blood clots in patients treated with Iclusig (ponatinib) prompted an FDA partial clinical hold and left analysts worrying about how the news will affect the drug’s position as a potential blockbuster.
Two months after shares of Neostem Inc. made the leap to Nasdaq, the New York-based firm added some much-needed capital, raising $35 million to support its expanding cell therapy business, including a lead therapeutic candidate aimed at heart attack patients.
Mention autologous cell therapy and Dendreon Corp.’s commercially challenged prostate cancer vaccine Provenge (sipuleucel-T) usually comes first to mind. Despite an innovative scientific approach – using a patient’s own cells in a personalized treatment – the product’s sales have been hampered by manufacturing complexity, reimbursement issues and increasing competition in the prostate cancer space, so much so that even the much-awaited European approval provoked little excitement. (See BioWorld Today, Sept. 18, 2013.)
Following disappointing results from Arqule Inc.’s Phase III study in non-small-cell lung cancer (NSCLC) a year ago, analysts had all but written off tivantinib in that indication. But detailed data reported at this week’s European Cancer Congress in Amsterdam suggested the oral MET inhibitor might have an opportunity in NSCLC after all.
In its fourth substantial public offering in two years, Synageva Biopharma Corp. padded its balance sheet with a $155.7 million to accelerate its aspirations of becoming a global rare disease company replete with burgeoning pipeline programs, manufacturing and commercial infrastructure.
Less than three months after the FDA rejected insomnia candidate suvorexant, the agency issued a complete response letter (CRL) for another Merck & Co. Inc. drug, giving analysts and investors additional ammunition in the call for a “major restructuring” in the company’s R&D division.
