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Actionable news in DVAX: Dynavax Technologies Corporation,

10 Upcoming PDUFA dates for small-cap biotech stocks

Weekly watchlist

The latest BioPharmCatalyst watch list takes a look at upcoming PDUFA dates all due within the next four months for small cap biotech stocks. Recent FDA regulatory news in favor of Puma Biotechnology Inc (NASDAQ:PBYI) but against Ocular Therapeutix Inc (NASDAQ:OCUL) has put the spotlight back on companies expecting upcoming decisions from the FDA. In a rarity in the biotech space, next week sees TWO FDA Advisory Committee Meetings for small cap biotech stocks, IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) and Dynavax Technologies Corporation (NASDAQ:DVAX).

First let's review the week that was with five key events that made headlines.

Puma Biotechnology, Inc. (Nasdaq: PBYI) won FDA approval for Nerlynx (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on an invasive disease-free survival (iDFS) rate of 94.2% in its ExteNET trial compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares closed the week up 5.3% to $94.30.

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares closed the week up 23% to $43.41 following better than expected revenue reported in its 2Q earnings release. Sales from Exondys 51, approved by the FDA in 2016 for the treatment of Duchenne muscular dystrophy, were $35m in 2Q 2017, above market estimates of around $22m. Guidance was also raised...


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