Health Winners & Losers: Amgen

Regulatory news injured a few biotech stocks on Monday, while others got a kick out of positive clinical news -- the balance a kind-of-down day for the sector.

Vanda (VNDA Quote) shares tanked after the Food and Drug Administration issued a non-approvable letter for its lead candidate, antipsychotic drug iloperidone. Shares gave up $2.46, or 73%, to 90 cents. The FDA requested an efficacy study that could take up to a year and a half and cost $35 million, as well as additional long-term safety data that could take two years to complete.

The company said in a conference call that under the capital available to the company today, it would not be able to conduct both the additional efficacy study and the additional safety exposures, but its first step is more discussions with the FDA to clarify the agency's thinking and any alternatives.

Meanwhile, Mylan (MYL Quote) said Monday that its subsidiary received final FDA approval for its abbreviated new-drug application (ANDA) for three strengths of the generic version of Sciele Pharma's (SCRX Quote) hypertension drug Sular. Sular, in the three strengths for which the generic was approved, generated U.S. sales of $94 million for the 12 months ended March 31, according to Mylan.

Mylan said it's shipping its Nisoldipine ER, the first generic version of Sular in the U.S., immediately. Sciele shares declined $3.45, or 16.8%, to $17.15. Mylan shares, incidentally, also lost ground, falling 52 cents, or 3.9%, to $12.74.

More regulatory news, Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (ONXX Quote) said Monday that the State Food and Drug Administration (SFDA) of China has approved Nexavar tablets for patients with unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer.