MannKind Corporation (NASDAQ: MNKD) is a true cult stock in biotech with FDA communication and many skeptics over how safe or effective its product candidate is. Shares are trading higher this morning on news that the company has re-submitted its new drug application for AFREZZA and classified it as a Class 2 resubmission. The company also noted that the FDA accepted the resubmission.
The FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.
The FDA’s Complete Response Letter issued back in March had requested additional information from MannKind regarding AFREZZA. In the re-submission,the company says that it has provided clinical data from a recently completed efficacy study in patients with type 1 diabetes, The company also noted that it has provided an updated pooled safety data related to AFREZZA and information on the comparability of its delivery system used in pivotal clinical studies.
MannKind is not without its share of controversy. The inhaled insulin market is one that has never been fully developed because efficacy and safety issues elsewhere. Some critics blame the poor performance of predecessors while others blame MannKind for its own woes. The short interest below should show just how much controversy there is around MannKind:
- 6/30/2010 had S.I. of 17,236,299 shares.
- 6/15/2010 had S.I. of 16,753,981 shares.
- 5/28/2010 had S.I. of 15,357,935 shares.
- 5/14/2010 had S.I. of 15,107,662 shares.
So far we have shares up almost 9% at $6.76 on almost 700,000 shares as of 9:45 AM EST.
JON C. OGG
Cyberonics Inc. (NASDAQ: CBYX) a neuromodulation company specializing in surgically implanted devices used to treat neurological disorders is up nearly 12% to $20.89 after exceeding analyst estimates on fourth quarter earnings. Their primary product, a device which is uses vague nerve stimulation to treat epilepsy and depression, sold far better than expected.
Sequenom, Inc. (NASDAQ: SQNM) is trading lower in the after-hours session after the troubled diagnostics company reported its year-end earnings. Because of its recent woes of 2009, the earnings and revenue reports are a true side-show compared to what the company is updating over its pipeline and over its products.
We would note that actual trading could whip around significantly during the company’s conference call due to very speculative nature of the company and due to its trading history in 2009 and so far in 2010.
The company gave a T21 (Down syndrome) update, and it does not sound like the company is throwing in the towel here nor anything at all like it is backing off… This is the biggest issue, or has been, for the company. At least that is our take. Sequenom said that it “remains committed to the development, third party validation and launch of a noninvasive T21 test. R&D efforts focus on DNA based approaches using our MassARRAY platform and next-generation sequencing platforms. Collectively, the R&D and clinical sample collection costs that will be required to enable a pivotal third party T21 test validation study represent the single largest investment the company will make in 2010.”
More specifically, Paul V. Maier, interim chief financial officer, was quoted as saying, “With the completion of a strategic review in late 2009, we are now focused on funding priority projects in 2010, which includes continuing to make a major investment in T21 development and clinical studies. An additional project which will receive priority funding for 2010 includes development of the next generation of MassARRAY instrumentation.”
EDAP TMS SA (NASDAQ: EDAP) is a French company which makes medical devices for the treatment of urological diseases and the company’s stock is soaring after the company was granted marketing approval of its newly designed, high-end Sonolith I-Sys lithotripsy device by the Japanese Administration. Because this market is still under-served, we wanted to look into the news despite this not being a drug or biotech company.
The Japanese equivalent of the FDA in the US granted marketing approval of EDAP’s Sonolith I-Sys lithotripsy device. What makes this unique is that the lithotripsy market in Japan is supposed to rank as the number one market in the world in total lithotripsy sales volume and in the installed base. The company also noted that Japanese physicians have traditionally been fast adopters of products in this field.
The Sonolith I-Sys is an easy to use high-end system that the company called an effective tool to deliver benefits to both patients and physicians with integrated and robotized features. The company noted that the device successfully obtained marketing clearance by the U.S. FDA in August 2009.