A Happy New Year to all readers of BioPharmCatalyst.
Since its inception in 2010, BioPharmCatalyst has striven to provide freely available tools for investors of biotech stocks. A significant revamp was released in late August (2016) and 2017 is already shaping up as another year to look forward to with more tools in the pipeline to be released. More details will be made available during 1Q 2017.
As we look back at the last week of 2016 a number of events dominated biotech headlines, all of which had severe negative impact on shares of the respective companies.
Seattle Genetics, Inc. (Nasdaq:SGEN) started the biotech rout when it announced its Phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients was placed on full clinical hold. This was followed by Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) which saw its shares collapse on Wednesday following notice that it did not meet the primary endpoint in its Phase 3 SOLUTION trial of Sollpura, while on Thursday the FDA released decisions that saw shares of both Cempra, Inc. (Nasdaq:CEMP) and Innocoll (NASDAQ:INNL) tumbling.
Not only did the FDA present Cempra with a Complete Response Letter (CRL) for its New Drug Applications (NDAs) for oral and intravenous solithromycin but it also requested the company to conduct a safety trial of approximately 9,000 patients.
In the after-hours session on Thursday the FDA delivered further bad news when it informed Innocoll that it would not even accept for filing its NDA for XARACOLL for the treatment of postsurgical pain and instead issued a Refusal to File (RTF) letter.
To round out the week of disappointing news, Opko Health Inc (NASDAQ:OPK) announced on Friday that it did not meet the primary endpoint in its Phase 3 trial of hGH-CTP in adults with growth hormone deficiency (GHD). Although the company noted that it identified one or more outliers that may have affected the primary outcome the stock still closed down 19%.
As we look forward to binary events scheduled for January 2017, there are still a handful of companies that gave guidance of various releases by the end of 2016. While delays are not uncommon, investors will be hoping for news in early January.
This week’s Biotech Stock Watch List focuses on stocks with early January catalysts:
|Phase 3||CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but reconfirmed April 11, 2017 its intention to reflile NDA 2Q 2017.|
|Phase 3||Phase 3 top-line data released January 3, 2017. Primary endpoint not met.|
|Phase 2||Phase 2 interim data released January 3, 2017. Full data released April 12, 2017. Company noted data were positive but results showed efficacy down on January data.|
|Phase 3||Phase 3 top line data released January 31, 2017 - primary endpoints not met.|