FDA panels set to review ipilimumab, vandetanib, and sNDA for Avodart for prostate cancer risk reduction
This article was originally published in Scrip
The US FDA has called on its oncologic drugs advisory committee to review, on 2 December, Bristol-Myers Squibb's novel immunotherapy ipilimumab, to treat advanced melanoma in patients who have received prior therapy, and AstraZeneca's drug candidate, Zictifa (vandetanib), an oral multi-targeted kinase inhibitor, to treat patients with unresectable (nonoperable) locally advanced or metastatic medullary thyroid cancer. The day before, the panel will discuss a supplemental NDA (sNDA) for GlaxoSmithKline's Avodart (dutasteride) for the reduction in the risk of prostate cancer in men at increased risk of developing the disease; Merck & Co's Proscar (finasteride) will also be considered.
You may also be interested in...
ChemoCentryx has successfully completed its initial public offering on Nasdaq, raising $45 million to help support its multiple R&D programmes. It sold 4.5 million shares at $10, a somewhat less ambitious debut than it had originally planned in January when it wanted to sell four million shares at $14-$16. The reduced offer is a sign of the challenging nature of the IPO market, but ChemoCentryx's assessment of its own worth was at least closer to the market’s assessment that Cempra which got its IPO away on 6 February at valuation that was less than two-thirds of that implied by its initial prospectus (scripintelligence.com, 7 February 2012).
Ampio Pharmaceuticals, a development-stage company, initially raised $15 million which was boosted to $16.9 million by the exercise of overallotments by brokers. The shares were offered at $3.25, an 8.5% discount to the closing price of $3.66 on 12 July. The market pushed them down slightly further to 3.21 on 13 July.
Verastem, a cancer stem cells startup, has moved quickly to build its pipeline just five months after an initial public offering. Management at the Cambridge, Massachusetts firm believes that recent moves have accelerated Verastem's clinical development plans by a year.