The Food and Drug Administration has rejected a new antibiotic
planned to sell. Replidyne's stock plunged $4.86, or 47%, to $5.38, and Forest dropped $2.61, or 5.1%, to $48.86.
In rejecting the application for the drug faropenem, the FDA said the companies must conduct additional clinical trials for each of four indications that they were seeking. The extra testing will take a minimum of two years.
received U.S. regulatory approval for its Omnaris spray for nasal allergies. Shares of Altana were down 0.8% at $54.23.
The Food and Drug Administration cleared the drug to treat seasonal and perennial allergic rhinitis in patients 12 years of age and older. The agency also said the drug is approvable for the treatment of children aged 2 to 11.
rose 7% after the drug company said obese patients treated in a study with its Qnexa compound lost more weight than those taking a placebo. The company said significant reductions were also seen in lipid levels.
"Qnexa demonstrated significant weight loss and reduction in waist circumference in this study, coupled with excellent tolerability and a positive impact on certain factors pertaining to metabolic syndrome in obese patients," Vivus said. "This is the first time the Qnexa Phase 2 data has been presented in a medical forum and represents the beginning of our education process with practicing physicians on the potential of Qnexa." Shares rose 27 cents to $3.84.
shares were sinking after the Food and Drug Administration said the company needed to conduct another trial before its product Gestiva could be cleared for marketing.
Gestiva, which is meant for preventing preterm birth in women with a history of preterm delivery, is approvable subject to the completion of an additional animal study and certain other conditions, Adeza said, citing a letter from the FDA. Shares of Adeza were dropping $2.86, or 16%, to $15.07 on heavy volume.
Separately, the company reported product sales for the three months ended Sept. 30 of roughly $13.5 million, an increase of $2 million, or 17%, from the same period a year earlier. Based on the sales, Adeza expects to be profitable during the quarter.
, its chief executive and another company official were notified by the
Securities and Exchange Commission
that they might be facing regulatory actions.
The SEC issued Wells notices last week in connection with an investigation of a clinical trial of Inspire's dry-eye product candidate Prolacria. The Wells notices indicate that the SEC staff plans to recommend that the full commission bring a civil action against the company and the two officers regarding possible violations of securities laws.
Inspire, a biopharmaceutical company, and the officers will have the opportunity to respond in writing before the staff makes any formal recommendation. Inspire was losing 11% to $5.