|Chelsea Notes 'Abnormal Trading Activity' Surrounding Today's PDUFA Action; Teleflex launches the Rusch® DispoLED™ Laryngoscope Handle|
|By Staff and Wire Reports|
|Friday, 14 February 2014 19:17|
Shares of Chelsea Therapeutics International (NASDAQ: CHTP) have been volatile throughout Friday, halting three times on a circuit breaker before 11:35 a.m. EST. Investors are positioning themselves ahead of a very important PDUFA date for Northera (droxidopa), expected out sometime Friday afternoon.
The PDUFA action for a candidate like Northera is extremely important the FDA will decide if the pharma company will make-it or break-it, so to speak, with the pending drug for the short-term. According to fda.gov, the PDUFA allows the FDA to "collect fees from companies that produce certain human drug and biological products."
Overwhelming Support from FDA Advisory Panel -- In a press release on January 14, Chelsea announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend the approval of Northera. Even though the FDA is not bound by this recommendation, as noted in the release, the Food and Drug Administration will "take it into consideration."
Wild Price Action -- Heading into the last hour of the morning session, shares slowly rose to a session high at $5.63 (up about 11 percent), before plunging around 14 percent to a low at $3.65. Shares were halted by a circuit breaker over the course of this sharp move lower. Trading was halted again almost immediately after resumption as shares dipped another 15 percent. At the low, the stock was down more than 26 percent from Thursday's close. Chelsea Therapeutics shares were halted once again around 11:29 a.m. EST -- this time on the upside.
Given the above price action, many traders assumed a decision had been released. Such action, however, is often seen in the stock's of company's awaiting a PDUFA decision. The term "bear raid" comes to mind: bears who believe an unfavorable decision is coming will start moving the stock in an attempt to shake out the bulls.
Chelsea Responds in 8-K Filing -- Chelsea Therapeutics released an 8-K filing on its response to the "Abnormal Trading Activity." The company reported that no decision regarding Northera has been received as of 11:45 a.m. EST.
Northera Drug History -- Chelsea's Northera is an experimental drug for the treatment of neurogenic orthostatic hypotension (NOH), a disease characterized by low blood pressure. Although the drug has been received favorably by the FDA, the reviewer has concerns surrounding Northera's clinical trials. Chelsea Therapeutics and its investors also remain concerned over the possible FDA label that would limit the drug's use to 1-2 weeks.
Interim CEO of Chelsea Therapeutics Joseph G. Oliveto previously commented, "Chelsea is committed to improving the lives of patients with nOH, a debilitating disorder which often severely limits a person's ability to perform routine daily activities. We are appreciative of the FDA bringing our Northera NDA before the Cardiovascular and Renal Drugs Advisory Committee, and for the Committee's thoughtful discussion of the application."
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced the launch of the Rusch® DispoLED™ Single-Use Fiber Optic Laryngoscope Handle — a cost-neutral* way to combat cross-contamination infection risk during intubation.
"We believe no one should be concerned about cross-contamination during intubation," said Cary Vance, President, Teleflex Anesthesia and Respiratory. "This technology is designed to help remove the financial barrier to reducing the risk of cross-contamination during intubation and focus instead on improving patient safety."
The Rusch DispoLED Laryngoscope Handle is the latest addition to Teleflex’s broad single-use anesthesia product portfolio — a product category that is playing an increasingly important role in clinicians’ practice since the October 2011 publication of Joint Commission laryngoscope cleaning guidelines1.
"This disposable handle exemplifies our commitment to meet the ever-evolving practices of the modern healthcare community,” said Vance. "The cost of adopting this single-use handle is typically offset by the costs associated with the cleaning, sterilization and handling of reusable laryngoscope handles between patients."
The Rusch DispoLED Laryngoscope Handle features sturdy construction, ergonomic grip, and optimal light output for intubation, all designed to inspire clinician confidence during critical procedures. The disposable design helps reduce the risk of cross-contamination and eliminate the hidden costs associated with reusable products.
The Rusch DispoLED Laryngoscope Handle is packaged individually in a preformed tray to protect the integrity of the light source and preloaded batteries. With a validated 3-year shelf life, the Rusch DispoLED Laryngoscope Handle can be safely stored for long periods and is ready to use out of the package.
Teleflex is proud to continue a more than 125 year partnership between our Rusch brand and clinicians to develop laryngoscopes that make intubation as simple, convenient, and safe as possible. The result is one of the broadest ranges of laryngoscopes available, with each product precisely engineered to meet the needs of Anesthesia professionals.
The Rusch DispoLED Handle joins an already extensive line of disposable laryngoscopes, including Green Rusch Lite™ Laryngoscope Blades, each offering the performance of reusable products, while reducing the risk for cross contamination.
Align Technology, Inc. (NASDAQ: ALGN) today announced the 2014 Invisalign Gallery University Challenge. This is the second year Align is hosting this competitive program that encourages Invisalign-integrated orthodontic residency programs in North America to submit their best Invisalign treatment outcomes in one of four clinical categories: Class I, Class II, Class III, and multidiscipline.
AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced the companies will end their worldwide collaboration and license agreement for the development and commercialization of investigational agent tivozanib.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved VIMIZIM™ (elosulfase alfa) for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) action date for the Company's NORTHERA™ (droxidopa) New Drug Application (NDA): "As a result of severe weather conditions leading to an office closure, FDA today notified Chelsea Therapeutics that the goal date for the Company's NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014."
Coastal Contacts Inc. (Nasdaq:COA) (TSX:COA), the leading global manufacturer and digital retailer of eyewear, today announced that it has entered an agreement with DreamWorks Animation's Mr. Peabody & Sherman.
Decision Diagnostics Corp. (OTCQB: DECN), the exclusive worldwide sales, service and regulatory processes agent for the popular Shasta GenStrip™, the unique Green Glucose Test Strip, specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today announced that that the Company has executed a Terms Agreement with a major east coast based litigation prosecution fund for the financing of the prosecution of DECN's countersuits brought against LifeScan, Inc., a division of Johnson and Johnson, Inc. DECN has asserted claims for anti-trust violations and false advertising.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today issued a letter to its shareholders in response to recent media attention stemming from an article by TheStreet.com.
Greater New York Hospital Association (GNYHA), one of the nation's most influential healthcare trade associations, expanded its partnership with Premier, Inc. (Nasdaq:PINC) to implement new population health analytics and advisory services across its membership base.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research, will announce results for its fourth quarter and year ended December 31, 2013 before market trading hours on Thursday, February 27, 2014.
HealthTalk Live, Inc. (OTCQB: HLTK) is proud to announce the start of active trading on the OTCQB under the ticker symbol HLTK.
Intelligent Living Inc. (OTCQB: ILIV) announced the immediate availability of its newest intelligent digital pillbox app, "apPill Box XL™," which is now available for download to users of Android smartphones via Google Play Store at https://play.google.com/store/apps/details?id=appillboxxl.iliv.eng&hl=en
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of Inogen, Inc (Nasdaq:INGN), a leading medical technology company that develops, manufactures and markets innovative portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions, commenced on The NASDAQ Global Select Market on February 14, 2014.
NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced the closing of its initial public offering of 3,100,000 shares of common stock at a public offering price of $12.00 per share for total gross proceeds of $37,200,000 before underwriting discounts.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) and Acasti Pharma Inc. ("Acasti") (Nasdaq:ACST) (TSX-V:APO), a Neptune subsidiary, announce that a settlement agreement has not been finalized with Enzymotec Ltd. and Enzymotec USA, Inc. (collectively, "Enzymotec") that would resolve the International Trade Commission ("ITC") investigation into infringement of Neptune's composition of matter patents, as well as related federal court actions initiated by Neptune against Enzymotec and its distributors.
Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it will hold a conference call and audio webcast to discuss financial results for its fourth quarter and full year ended December 31, 2013 after the NASDAQ Market closes on Thursday, February 20, 2014 at 4:30 p.m. ET.
Stereotaxis, Inc. (Nasdaq:STXS) announced today that its board of directors has appointed Chairman William C. Mills III to Chief Executive Officer, effective February 12, 2014.
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today reported financial results for the second quarter of fiscal 2014.
Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced that its common stock has commenced trading under new ticker symbol "XBIO" on the OTC Bulletin Board (OTCBB).