Response to our Durect survey so far, Ultragenyx and Dicerna have strong debuts, Regado raises, CytRx raises, Abbvie reports HCV data, Vanda gets approval. Lets go over the stories we've been watching, commenting upon and trading this week.
Durect Corporation (NASDAQ:DRRX)
We polled readers regarding the upcoming POSIDUR PDUFA decision. While the poll is non-scientific and the number of respondents is still fairly low, the sentiment seems contrary to what the street in general believes. Sixty-nine percent (69%) of respondents say that POSIDUR will be approved. Just 30% suggest that a CRL is forthcoming. If this were reflective of the overall market's thinking, DRRX would be trading much higher than the low $2's. This tells us that perhaps our audience on this issue is slanted towards long-biased investors. Or, perhaps that in general long-biased investors tend to participate in such surveys and polls to a larger extent than neutral or short biased investors.
To gain a more representative sample, we need more respondents. Feel free to pass along this weekly review with the link to the poll to your friends and colleagues. The more responses we get, the more accurately the poll will reflect true sentiment. We will leave the poll open until the PDUFA results are out.
We are long DRRX.
Ultragenyx Pharmaceutical (NASDAQ:RARE) and Dicerna Pharmaceuticals (NASDAQ:DRNA)
Two new biotechs had initial public offerings this week. first, on Thursday, Dicerna went public selling 6 million shares to the public at an initial price of $15. The stock opened at $30 and closed it's first trading day at $46. On Friday, Ultragenyx went public, selling 5.76 million shares at $21. The stock opened at $45.80 and closed at $42.25 after trading as high as $47.99.
We have no position in RARE or DRNA
Cytrx Corporation (NASDAQ:CYTR) and Regado Biosciences (NASDAQ:RGDO)
Cytrx and regado both raised funds this week. On Friday, CYTR did a $75 million spot-secondary priced at $6.50. This was nearly $1.50 below Thursday's closing price of $7.98. Meanwhile, Regado did a $20 million PIPE transaction priced at $5 to raise some cash. Neither of these moves is surprising, we expect Cytrx will have to raise even more cash going forward to properly mount their phase 3 trials of aldoxorubicin. Regado will also have to raise again to be able to complete their phase 3 trials.
We have no position in CYTR or RGDO.
AbbVie (NYSE:ABBV)
AbbVie reported strong data from it's all-oral Hepatitis C regimen. Sustained Viral Response rates at 12 weeks were all above 90% and most were above 95%. The company expects to file with these data in the early part of 2014 with an anticipated approval before years' end. Gilead Sciences (NASDAQ:GILD) still appears to have a slight edge in that it's all-oral ribavarin free regimen has a lower pill burden, but GILD will see competition in the HCV space next year.
We have no position in ABBV
Vanda Pharmaceuticals (NASDAQ:VNDA)
The FDA approved VNDA's HETLIOZ (tasimelteon) for non-24 hour sleep-wake disorder in completely blind patients. This is the second controversial FDA approval VNDA has managed to secure against the odds. Their high-paid regulatory consultant seems to be worth the money.
We have no position in VNDA.
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