Regulatory bliss and clinical data gave a few biotech stocks a bounce on Monday.
said Monday that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) granted orphan drug designation to Camvia for cytomegalovirus (human herpesvirus 5) in patients with cell-mediated immunity.
The status is designed to promote development of drugs that could significantly benefit patients suffering from rare, life threatening diseases or serious conditions. And under EMEA guidelines, it gives the company 10 years of market exclusivity if the product is approved for marketing in the E.U. Also it may qualify for a reduction in regulatory fees or an E.U.-funded research grant.
Shares rose 67 cents, or 8.5%, to $8.53. The stock is a component of the Nasdaq biotechnology index, which was recently down 4.5, or 0.5%, to 841.06.
The Food and Drug Administration approved
lower strength Kaletra for pediatric HIV patients. The company said the drug will be available at the lower strength in the U.S. this month. Shares were trading up 99 cents, or 1.8%, to $55.11.
( ISTA), announced Monday afternoon that in a phase III trial, Xibrom QD, a new once-daily formulation of its ocular anti-inflammatory treatment for cataract surgery patients, met the primary and secondary efficacy endpoints of absence of ocular inflammation 15 days following surgery and elimination of ocular pain at one day. Shares rose 96 cents, or 17.4%, to $6.47.
The FDA also gave
( GORX) approval to manufacture and distribute Carprofen, its generic version of
Rimadyl, an anti-inflammatory used in orthopedic surgeries for dogs. Its shares initially rose but were recently down 4 cents, or 1.1%, at $3.55.
Another stock on the decline,
( AGIX), announced that after discussions with the FDA it has discontinued the highest dose in a dose-finding phase III study on its lead candidate for diabetes. Shares gave up 35 cents, or 25%, to $1.05.
reported a net loss of $9.7 million, or 34 cents a share, vs. a net loss of $4.9 million, or $5.57 a share, in the year-ago quarter. Analysts surveyed by Thomson Financial were expecting a loss of 31 cents a share. Shares rose 51 cents, or 3.4%, to $15.55.
reported a net loss of $12.7 million, or 85 cents a share, compared with a net loss of $6.4 million, or $4.76 a share, in the year-ago quarter. Revenue increased to $10.5 million from $4.1 million in the 2006 period, due to collaboration revenue from the company's partnership with Takeda Pharmaceutical for Affymax's lead compound Hematide, which stimulates red-blood-cell production. Quarterly results missed the Thomson Financial consensus of a loss of 79 cents a share on revenue of $14.3 million, and shares fell $1.35, or 4.6%, to $27.99.