|Amylin surges on analyst upgrade. BSD Medical hits 52 week high|
|By BioMedReports.com Staff|
|Wednesday, 27 October 2010 18:35|
Shares of Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) jumped more than 10% today after Leerink Swann analyst Joshua Schimmer bumped his grading on the stock from "market perform" to "outperform". Schimmer cited last week's sell-off of the stock as "overdone". Amylin's stock dropped nearly 50% last week after the FDA issued a CRL for its experimental drug Bydureon. The drug is designed as weekly injection to control diabetes is forecasted as a potential blockbuster for Amylin and its co-developers, Eli Lilly and Alkermes. Schimmer believes that Amylin should be able to provide FDA with the data it needs within the next 6 months. Amylin shares closed Wednesday's trading session at $13.21, up $1.21.
Shares of BSD Medical Corporation (NASDAQ:BSDM) shot up more than 20% today after rising more than 5% yesterday. On volume of nearly 4 Million shares, the stock rose 81 cents or 20.56% to close the day at $4.75. Early in the day the stock hit an intra-day 52 week high of $4.95. Shares are up 280% since the FDA provided 510 clearence on August 18th.
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which took place on September 14, 2010. At that meeting, agreement was reached on the BEMA Buprenorphine development plan for the treatment of chronic pain. As a result, the Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain will be initiated this quarter.
"We are very pleased with the outcome of our End-of-Phase 2 meeting with FDA where clear guidance was provided on our development requirements for BEMA Buprenorphine," stated Dr. David Wright, Vice President of Regulatory Affairs at BDSI. "There were no surprises, and we are moving forward into Phase 3."
IsoRay, Inc. (Amex:ISR) announced, today, it has completed an initial feasibility study, which demonstrates the ability to use its patented Cesium-131 (Cs-131) brachytherapy seeds (internal radiation therapy) in accelerated partial breast irradiation (APBI) for breast cancer treatment. APBI is one of the most exciting, emerging treatments available, today, for early stage, localized breast cancer.
Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has declared a special one-time cash distribution of $2.00 per share to shareholders, or an aggregate of about $85 million.
This nondividend distribution will be paid to shareholders of record as of the close of business on December 1, 2010 and they expect to pay shareholders on or around December 10, 2010. The nondividend distribution will be paid entirely from cash reserves. At September 30, 2010, Pain Therapeutics had cash and total investments of about $180 million, no debt and an expected net burn rate of under $5 million for 2010, before giving effect to the nondividend distribution.
Watson Pharmaceuticals, Inc. (NYSE:WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed a new drug application with the U.S. Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a new salt version of AstraZeneca's Crestor ® tablets which indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.
AstraZeneca filed suit against Watson on October 26, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. RE 37,314. AstraZeneca's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's NDA until March 30, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending June 30, 2010, Crestor had total U.S. sales of approximately $3.5 billion according to IMS Health data.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has entered into a pre-licensing feasibility agreement with a leading biopharmaceutical company to develop an oral formulation of an undisclosed prostate cancer compound utilizing its proprietary vitamin B-12-based CobOral Drug Delivery Technology.
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that Barry D. Quart, PharmD, president and chief executive officer, will present at the Oppenheimer 21st Annual Healthcare Conference in New York, NY.
Beckman Coulter, Inc. (NYSE:BEC), a leading developer, manufacturer, and marketer of products that simplify, automate, and innovate complex biomedical testing, announced today that Charlie Slacik, Beckman Coulter's senior vice president and chief financial officer will present at the Oppenheimer 21st Annual Healthcare Conference on Wednesday, November 3, 2010 at 2:45p ET.
Cardica, Inc. (Nasdaq:CRDC) today announced that its C-Port® Flex-A® Anastomosis System and its PAS-Port® Proximal Anastomosis System will be featured in several demonstration and wet lab presentations at the Advances in Robotic and Hybrid Coronary Revascularization conference, a meeting jointly developed by the International College of Robotic Surgery and Saint Joseph's Hospital in Atlanta, Georgia.
In conjunction with DURECT Corporation's (Nasdaq:DRRX) third quarter 2010 financial results press release, you are invited to listen to the conference call that will be broadcast live over the internet on Wednesday, November 3, 2010 at 4:30 pm Eastern Time (1:30 pm Pacific Time).
Endologix, Inc. (NASDAQ: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it has signed a definitive agreement to acquire Nellix Endovascular, Inc, a privately-held medical device company that has developed a revolutionary endograft for the treatment of Abdominal Aortic Aneurysms (AAAs).
Express Scripts, Inc. (Nasdaq:ESRX) announced 2010 third quarter net income from continuing operations of $307.1 million, or $0.57 per diluted share.
Global NuTech, Inc. (OTCBB:BOCL) announced today that it was unveiled its new website.
GeckoSystems Intl. Corp. (PINKSHEETS:GOSY) (PINKSHEETS: GCKO) announced today the change of its trading symbol from "GCKO" to "GOSY."
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has expanded its intellectual property portfolio in medical robotics with the recent issuance of 11 additional U.S. patents.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced today that the Company will hold an Analyst Day event during the upcoming 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) on Saturday, October 30, 2010 from 9:00 a.m. to 12:00 p.m. ET at the Mandarin Oriental, Boston.
InfuSystem Holdings, Inc. (OTCBB:INHI) (OTCBB: INHIW) (OTCBB: INHIU), a leading provider of infusion pumps and associated products and services, has appointed John Haggerty as Vice President of Biomedical Services.
INVO Bioscience, Inc. (OTC Bulletin Board:IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, announced today that Dr. Elkin Lucena of the Columbian Fertility and Sterility Center (CECOLFES LTDA) in Bogota, Colombia presented the results of the Center's first 95 fertility treatment cycles utilizing INVO Bioscience's INVOcell for couples with fertility issues at the 66th Annual Meeting of the American Society of Reproductive Medicine (ASRM) in Denver.
Medical Marijuana Inc (PINKSHEETS:MJNA) announces its preparation for the Prop 19 vote in California regarding the legalization of marijuana.
Mylan Inc. (Nasdaq:MYL) today announced that the Third Circuit Court of Appeals denied its motion for an interim injunction pending an on-going appeal of a recent New Jersey District Court decision relating to generic Paroxetine CR.
NMT Medical, Inc. (NASDAQ: NMTI) today announced that it will release its third-quarter 2010 financial results before the market opens on Tuesday, November 9, 2010.
PDL BioPharma, Inc. (PDL, the Company) (Nasdaq:PDLI) today announced that it has entered into separate privately negotiated exchange agreements under which it will retire $92.0 million in aggregate principal of the Company's outstanding 2.00% Convertible Senior Notes due February 15, 2012 (the 2012 Notes).
Regenicin, Inc. (OTC Bulletin Board:WDST), a development stage company focusing on next-generation tissue-engineered skin substitutes to restore the qualities of healthy human skin, announced today the appointment of Dr. Gervaise Gerstner to the company's Scientific Advisory Board.
Summer Infant, Inc. (NASDAQ: SUMR), a leading developer and distributor of juvenile health, safety, and wellness products, is proud to announce that 2010 marks its twenty-fifth anniversary.Since 1985, Summer Infant has been dedicated to delivering The Best Time of Your Life to parents and babies worldwide.
TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for cancer care, today released financial results for the third quarter ended September 30, 2010.
Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that it will report its unaudited financial results for the third quarter ended September 30, 2010 on Thursday, November 11, 2010, before the market opens in the United States.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today that Mr. Jacob Ho, Acting Chief Financial Officer, Ms. Vanessa Wu, Senior Financial Manager and Ms. Helen Yang, Investor Relations Manager, are scheduled to present at two upcoming investor conferences to be held in early November.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today that SOHM India has successfully executed a bulk purchase order and delivered the first 2 million tablets of the generic drug Sildenafil citrate-100 mg in West Africa.
Sun Healthcare Group, Inc. (NASDAQ: SUNH) today announced its operating results for the third quarter ended Sept. 30, 2010.
TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for cancer care, announced today that University Radiotherapy Center of Antwerp, Belgium, has begun installation of the world's first TomoTherapy® TomoHD treatment system, a comprehensive radiation therapy system that enables cancer centers to efficiently handle both common and complex tumors with a single device.
Unity Management Group, Inc. (PINKSHEETS:UYMG), a Health Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.
UV Flu Technologies, Inc. (OTCBB:UVFT) is pleased to announce that it has signed a Letter of Intent ("LOI") to acquire 100% of the ownership of a major US manufacturer of high quality air purification equipment designed for industrial applications and specializing in the medical and hospitality marketplace.