Tue, Sep. 15, 12:41 PM
Mon, Jul. 6, 10:39 AM
- Thinly traded small cap Versartis (VSAR +19.5%) jumps on average volume in response to its announcement that the FDA removed the partial clinical hold on its 136-subject Phase 3 trial, called VELOCITY, assessing its lead product candidate, VRS-317, in pediatric patients with growth hormone deficiency. Patient recruitment can now proceed.
- Interim six-month height velocity data are expected by the end of 2016. Top-line data on 12-month mean height velocity are expected by mid-2017. If all goes well, FDA clearance could happen by late 2018.
- The primary endpoint of the study is non-inferiority of VRS-317 administered twice monthly to daily doses of Pfizer's (PFE +0.5%) Genotropin (somatropin [rDNA origin]) and Novo Nordisk's (NVO -0.3%) Norditropin (somatropin [rDNA origin]) as measured by 12-month mean height velocity.
Jul. 18, 2014, 12:45 PM
Mar. 21, 2014, 1:04 PM
- Investors stampede into IPO Versartis (VSAR). Recent prices are up 71% on 3.8M shares. The company raised $126M by offering 6M shares at $21, the high end of its range, but opened at $28.
- The company's lead product, VRS-317, is a recombinant growth hormone currently in a phase 2a clinical trial. Its value proposition is its longer half life versus current therapies. Injections are required once/month instead of daily.
- The firm has yet to generate sales. Operations burned $17M last year.
- Cash and equivalents at year end was $13.2M.
VSAR vs. ETF Alternatives
Other News & PR