Key Developments For Discovery Laboratories, Inc.
Discovery Laboratories, Inc. (DSCO.O) (Consolidated Issue listed on NASDAQ Global Market)
Discovery Laboratories, Inc. Submits Lung Drug Trial Proposal To FDA-Reuters
Reuters reported that Discovery Laboratories, Inc. said it submitted a proposed protocol to U.S. health regulators to conduct a limited clinical trial for its drug to treat respiratory illness in infants, Surfaxin. The protocol submitted to the U.S. Food and Drug Administration incorporates a clinical trial design to assess the pharmacodynamic (PD) response, the physiologic responses to therapy, in preterm infants with respiratory distress syndrome after Surfaxin is administered. The Company said the FDA indicated its proposed concept of a PD trial design was acceptable and also provided direction regarding certain trial design specifics. The Company expects to receive the FDA's comments early in the first quarter of 2010.
Discovery Laboratories, Inc. Says FDA Agrees On Lung Drug Program-Reuters
Reuters reported that Discovery Laboratories, Inc. said U.S. health regulators agreed upon the Company's proposed program to resolve questions about its experimental lung drug Surfaxin. Discovery said the U.S. Food and Drug Administration indicated that the program to optimize and validate a quality control test was reasonable. The Company expects to finalize a protocol and submit it to the FDA in mid-fourth quarter. The Company has been trying to get the drug approved as a treatment for respiratory distress syndrome (RDS) in prematurely born infants since April 2004, but has been rejected four times by the FDA. The Company is also testing Surfaxin for the treatment of bronchopulmonary dysplasia, a chronic lung condition affecting newborn babies, and is developing an inhaled drug, Aerosurf, to treat infants with RDS.
Discovery Laboratories, Inc. To Meet FDA To Review Lung Drug Options-Reuters
Reuters reported that Discovery Laboratories, Inc. said it would meet U.S. health regulators on September 29 to review the options available to gain marketing approval for its lung drug surfaxin. The Company is currently developing surfaxin as a treatments for respiratory distress syndrome (RDS) in premature infants. The Company said it plans to discuss with the U.S. Food and Drug Administration (FDA) a limited surfaxin trial design, and whether conducting such trial could potentially address the key remaining requirement for an approval. In April, the FDA declined to approve the drug as a preventive treatment for RDS, and raised questions on certain aspects of a surfaxin biological activity test, a quality control stability and release test.
Discovery Laboratories, Inc. Announces Resignation Robert J. Capetola As CEO
Discovery Laboratories, Inc. announced the resignation of President and Chief Executive Officer Robert J. Capetola. Dr. Capetola has also resigned as a Director of Discovery Labs' Board of Directors. W. Thomas Amick, Chairman of the Board of Discovery Labs, has been appointed interim Chief Executive Officer. W. Thomas Amick, Chairman of the Board of Discovery Labs, has been appointed interim Chief Executive Officer.
Discovery Laboratories, Inc. Announces Completion Of $11.3 Million Registered Direct Offering
Discovery Laboratories, Inc. announced registered direct offering of 14 million shares of its common stock and warrants for 7 million shares of common stock. The shares were issued and sold to select institutional investors at a price of $0.81 for each share of common stock, together with a related warrant to purchase 0.5 shares of common stock. As a result of the offering, Discovery Labs has received gross proceeds of approximately $11.3 million, before deducting placement agent's fees and other offering expenses. Lazard Capital Markets LLC acted as the exclusive placement agent for the transaction.
