Phase III
There are a few upcoming approval dates for several companies this week. Let’s take a look at the companies and their products awaiting approval.
Ansun Biopharma closed on a Series A financing round worth $85 million. The company plans to use the funds raised for a Phase III clinical trial of its experimental anti-viral drug, DAS181.
Shares of Ziopharm Oncology, Inc. are still sliding after the company announced it was pausing its planned Phase III trial for its lead gene therapy product designed to treat patients with recurrent glioblastoma (rGBM) as a monotherapy and in combination with an immune checkpoint inhibitor.
Akcea Therapeutics is preparing for the possible launch of its therapeutic for the treatment of the rare lipid disorder familial chylomicronemia syndrome (FCS) following the thumbs up from a U.S. Food and Drug Administration advisory committee.
AstraZeneca and its biologics research-and-development arm, MedImmune, indicated that its Fasenra (benralizumab) did not meet its primary endpoint in patients with moderate to very severe COPD.
As Boston-based Rhythm Pharmaceuticals moves its lead obesity treatment into a second Phase III trial, the company was bolstered by the publication of longer-term data from its Phase II study of setmelanotide in Nature Medicine.
North Carolina-based vTv Therapeutics revealed some potential hope for Alzheimer’s patients from its Phase III azeliragon study despite the drug failing to meet primary endpoints in April.
Genentech reported that its Phase III IMblaze370 trial of Tecentriq (atezolizumab) and Cotellic (cobimetinib) for difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) did not meet its primary endpoint of overall survival (OS) compared to Bayer’s Stivarga (regorafenib).
Shares of Armo BioSciences have soared more than 67 percent in premarket trading after Eli Lilly announced it had struck a deal to acquire the company for $1.6 billion in an all cash deal.
Not only does the company have to deal with the U.S. Food and Drug Administration’s three month PDUFA delay for elagolix, but now the watchdog organization, The Institute for Clinical and Economic Review (ICER), has released some disconcerting news over pricing.
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