Protocols

Loxo raising $227M in post-ASCO score; Bavarian Nordic reports data delay; Sonar and Stratus ordered to cease production

→  Loxo shared some impressive data at ASCO, and the biotech isn’t about to let that pass without raising more cash. The company announced a public offering of 3,150,000 shares of common stock at of $72.00 per share. They’re expecting $226.8 million in proceeds when they close on June 20.

 Bavarian Nordic has announced a delay in reporting data from its PROSPECT study, a Phase III trial to test the efficacy of PROSTVAC on the survival of men with metastatic castration-resistant prostate cancer. The company says the delay is due to a decrease in average monthly events in the study. Results are still expected this year.

→  After US Marshalls seized more than $16 million worth of unapproved and misbranded prescription drugs from a Stratus facility and investigators found microbial levels that were “too numerous to count,” a South Florida judge ordered Status and Sonar to cease production of drugs that are unapproved, mislabeled or contaminated. Miami-based Stratus and New Jersey-based Sonar reportedly have histories of violating CGMPs.


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RAPS Regulatory Convergence 2017