News today... 08:41 TRGT Targacept trading 7% higher premarket; Hearing report suggesting pipeline drug could be potential Alzheimer's treatment (4.31 )
08:36 BMTI Biomimetic Therapeutics discusses results of a study conducted on becaplermin (Regranex); results indicated no difference in either cancer incidence or cancer mortality between patients who received Regranex and those who did not (4.32 )
Announced in an 8-K this morning, BMTI has amended its Augment Bone Graft PMA which was previously filed with the U.S. Food and Drug Administration (the "FDA") to include the results of a study conducted on becaplermin (Regranex) to evaluate cancer mortality. The results of the study, presented at the Second Annual Meeting of The American College of Wound & Tissue Repair, indicated no difference in either cancer incidence or cancer mortality between patients who received Regranex and those who did not.
The retrospective follow-up analyses were conducted using patient records of 6,429 Regranex patients compared to a matched group of patient records of 6,429 similar patients without Regranex treatment (12,858 total patients). Patients with foot ulcers and no prior cancer were followed for up to eleven years (1998 through 2009) to identify new malignancies and cancer-related deaths recorded in the Veterans Affairs and Medicare patient records.
08:29 SUMRX Gapping up/down: DOLE +9.5%, LNG +2.1%... FDX -1.7% following earnings, Financial related names lower
Gapping up:
In reaction to strong earnings/guidance: SHF +3.8%.
M&A news: DITC halted (Ditech to be acquired by NUAN for $1.45/share in cash).
Select drug related names showing strength: AZN +0.6%, SNY +0.4%.
Other news: OXGN +40.3% (announces agreement with FDA on special protocol assessment for a Phase 3 trial of ZYBRESTAT in anaplastic thyroid cancer), DOLE +9.5% (Dole Food will sell two of its businsses to Itochu for $1.7 bln in cash), LNG +2.1% (Reuters discusses news that Japan's Tokyo Electric is in talks to secure LNG supplies from North America),NBS +3.6% (files to withdraw Registration Statement on Form S-3/A), OCZ +2.0% (appoints Alex Mei as Interim CEO; accepts Ryan Petersen's resignation), VOD +1.4% (still checking), TYC +1.1% (Barron's profiles positive view on Tyco).
Analyst comments: DEO +1.6% (seeing modest strength; Hearing attributed to positive comments at a tier 1 firm), BRCM +0.3% (light volume, Broadcom upgraded to Outperform from Sector Perform at RBC Capital).
Gapping down:
In reaction to disappointing earnings/guidance: HNI -12%, FDX -1.7%.
Financial related names showing weakness: BCS -3.8%, DB -3.2%, UBS -3%, ING -1.5%, SAN -1.5%, CS -1.2%, BAC -1.1%, MS -1.1%, RBS -1%.
Select oil/gas related names showing early weakness: RIG -1.2% (Transocean: Brazil Oil Regulator has appealed decision to ban RIG and Chevron from operating in Brazil following spills, according to reports), SLB -1.1%, E -1.0%, BP -0.6% (wins dismissal of Norex lawsuit over Yugraneft stake, according to reports).
Other news: AMD -6.5% (AMD Announces Chief Financial Officer Transition), CLWR -5.2% (Time Warner Cable to sell its 7.8% stake in CLWR), FRO -3.5% (still checking), CLF -2.9% (still checking), ANR -1% (announces strategic repositioning plan; organizational streamlining will red
08:01 SVA Sinovac Biotech receives GMP certification for mumps vaccine production facility; On track to commence commercial production in Q3 2012 (2.25 )
Co announced today that it has received GMP certification from the China State Food and Drug Administration (SFDA) for the Company's dedicated mumps vaccine production plant at its Sinovac Dalian facility. The SFDA issued a public announcement on September 12, 2012, stating that the Good Manufacturing Practices certification was issued to Sinovac with the certificate number CN20120080.
The SFDA issued a public notification in July 2012 stating that Sinovac Dalian's mumps vaccine production plant is in compliance with the new GMP guidelines (2010 version) following the site inspection and documentation review. The Co obtained the production license from the SFDA for its mumps vaccine in Dec 2011. Sinovac continues to anticipate that it will be in a position to commence commercial production of the mumps vaccine in Q3 2012 and is on track to launch the mumps vaccine in China following the batch release process
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