12:00 AM
Jun 17, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Alimera Sciences Inc. (NASDAQ:ALIM) was up $0.56 (12%) to $5.05 last week after the U.K.'s NICE issued draft guidance recommending Iluvien fluocinolone acetonide intravitreal implant for chronic diabetic macular edema (DME) patients considered insufficiently responsive to available therapies and who have had their natural lens replaced with an intraocular lens.

The recommendation, which reverses final guidance issued in January, is contingent on Alimera providing Iluvien at an undisclosed discount under a patient access scheme.

Iluvien has an Oct. 17 PDUFA date in the U.S. Alimera has worldwide rights from pSivida Corp. (NASDAQ:PSDV; ASX:PVA), which was up $0.03 to $3.43 for the week on NASDAQ. In Australia, the stock was up A$0.13 to A$3.62.

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) gained $0.26 (11%) to $2.60 last week after FDA recommended in a complete response letter that the company conduct an additional clinical trial of tivozanib to support approval to treat advanced renal cell carcinoma (RCC). The complete response follows a 13-1 vote by FDA's Oncologic Drugs Advisory Committee that the benefit-risk profile of tivozanib does not support approval.

The stock still is off 186% since April 29, before briefing documents for the panel were released, leaving it with a market cap of $133.3 million. At March 31, Aveo had $191.6 million in cash.

Dynavax Technologies Corp. (NASDAQ:DVAX) fell $1.07 (43%) to $1.40 on Monday after announcing a further delay for Heplisav. According to Dynavax, FDA said the safety database for the adjuvanted HBV vaccine needs additional subjects.

The company had been hoping to avoid conducting another trial by seeking approval in a narrower patient population. But the agency said that analyzing benefit-risk in "discrete patient populations did not fundamentally address the shortfall in the safety database" and would "unnecessarily restrict" the population that could benefit from approval.

Dynavax, which received a complete response letter in February, further fell to close the week down $1.32 (53%) to $1.15.

Exact Sciences Corp. (NASDAQ:EXAS) was off $0.57...

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