Mar 10, 2011

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Best Biotech Stocks

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With summer almost at our back and autumn around the corner, October is approaching rather fast. When you filter in all the drug and drug delivery auditions infront of the FDA it will be here that much quicker. We have dissected below 5 spotlighted companies with pending FDA decisions that are on the calandar through the end of October, the main focus on small-cap companies with market caps of approximately $1 billion or less:

1) Amylin Pharma  (AMLN) $21.90 $3.1B

FDA Decision (NDA) Class 2 Resubmission

“If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible,” said Orville Kolterman, senior vice president of research and development, Amylin Pharmaceuticals.

BYDUREON (exenatide for extended-release injectable suspension) (once-weekly administration)

ALKS due to receive 8% royalties on first 40M units sold per year, then 5.5% royalties thereafter for its drug delivery technology

CRL reply submitted on 4/22/10 and accepted 5/6/10 for Class 2 (six-month) review and PDUFA action goal date of 10/22/10, addresses product labeling, clarification of manufacturing, and Risk Evaluation and Mitigation Strategy (REMS).

2) Biodel  (BIOD) $3.99 $105M

FDA Decision (NDA) for LINJETA (new proposed trade name) (rapid-acting insulin formulation)

On 8/24/10, SEC 8K filing indicated AMRI contract manufacturing site (one of two sites that made product vials for NDA) received FDA warning letter, BIOD plans to commercialize disposable pen version and expects to submit as sNDA early 2011 with different manufacturer (Wockhardt), PDUFA action goal date of 10/30/10.

3) Vivus  (VVUS) $6.31 $512M

Market Potential: Sales could peak $1.16 billion by 2015, according to Jefferies & Co. analyst.

Clinical Trial (Two-Year Data, SEQUEL study) (3Q10), FDA Decision (NDA) (10/28/10), MAA/EMA (Europe) New Filing

QNEXA (phentermine plus topiramate) (once-daily combo weight loss / obesity drug candidate)

On 7/15/10, Endocrinologic and Metabolic Drugs FDA Advisory Panel voted 10-6 against whether the overall risk-benefit of QNEXA is favorable to support approval, PDUFA action goal date is 10/28/10 under a standard 10-month review, SEQUELextension study results (subset of patients from 56-week pivotal CONQUER study) expected 3Q10 to provide long-term (two-year) safety / efficacy data and support MAA filing in Europe.

4) Avanir Pharma (AVNR) $2.77 $260M

Market Potential: Peak sales potential of $350 million, according to analysts.

FDA Decision (NDA) Class 2 Resubmission

ZENVIA (dextro-methorphan + quinidine)

Seeking approval for treatment of patients with neurological condition known as pseudobulbar affect (PBA), announced 5/17/10 that FDA accepted NDA resubmission with a Class 2 (six-month) review period and new PDUFA action goal date of 10/30/10.

5) ISTA Pharma  (ISTA) $3.14 $105M

Market Potential : ISTA expects sales from its Xibrom franchise, including XiDay, to be in the range of $95 million to $105 million.

FDA Decision (sNDA) XiDay (bromfenac) once-daily eye drops

Xibrom is currently marketed as an eye drop used twice-daily beginning 24 hours after cataract surgery, this sNDA filing is to request change to product label for once-daily use following cataract surgery as XiDay, expected FDA decision by 10/16/10 under standard 10-month review period.

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