Friday, March 7, 2014
- The FDA requests that Regeneron (REGN) and Sanofi (SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor.
- Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol.
- Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.
- Pfizer (PFE) and Amgen (AMGN) are also working on PCSK9 inhibitors.
- Robbins Arroyo LLP investigates Medbox (MDBX) to determine if management breached its fiduciary duties to shareholders.
- The shareholder rights firm initiates its inquiry on the basis of a report by Citron Research published on February 18 alleging inaccurate financial statements. In a follow-on article published on February 24, Citron accused certain individuals of improper stock sales.
- AstraZeneca's (AZN) virtual iMed Oncology division signs an R&D deal with Korea Health Industry to identify early stage projects suitable for funding. The twelve most promising proposals will be chosen for development.
- The company formed iMed in 2012 as it eliminated 2,200 R&D jobs in an effort to cut costs and increase efficiency. Replacing the large centrally-located bureaucratic structure is a small in-house staff that interacts remotely with collaborators and contractors around the world.
- iMed's initial success in neuroscience prompted the move into oncology.
- North Carolina surgeon Stuart Meloy may have discovered a game changer for some women: a device that produces "orgasms on demand". He decided to pursue developing the product after witnessing a female patient's intense stimulation after he placed electrodes in her lower back for an undisclosed condition.
- The device consists of two electrodes that will be surgically inserted into certain nerves in the spinal column and a cigarette pack-size signal generator implanted in the upper buttock. The user presses a remote control button for stimulation.
- The device will be studied for women who have serious cases of orgasmic dysfunction where some women's brains interpret arousal as a fear response.
- Medtronic (MDT) has signed on to conduct tests.
- No decision on developing a mass market version has been disclosed.
- Market buzz remains high about several pharmaceutical companies' interest in the orphan drug maker.
- InterMune (ITMN) considered selling itself three years ago but no deals were reached due to uncertainty with pirfenidone data.
- On February 25, the company disclosed positive trial data showing significant slowing of disease progression versus placebo. Shares gapped up 170% on a 17-fold increase in volume.
- Shares are up 14% on heavy volume in today's trading.
- 250 mutual funds have positions.
10:23 AM| Comment!
- AstraZeneca (AZN) says Nexium is safe despite an FDA-imposed ban on US shipments on a key ingredient's manufacturer.
- Ranbaxy Laboratories was slapped with the ban in January because it was allegedly retesting QC-failed products in order to get acceptable results. AZN switched suppliers to Minakem SAS in France shortly thereafter.
- It has no plans to withdraw the $4B product from the marketplace.
- Mindray Medical International Ltd (MR) will pay its recently-declared $.50/share dividend on or around April 8 to shareholders of record March 8.
- Columbia Laboratories (CBRX) purchases 1.4M shares of its common stock from Actavis (ACT) at $6.08/share, a 10.75% discount to yesterday's closing price.
- The CEO calls it a "unique opportunity to acquire Actavis' large block of shares at an advantageous price." No word on shareholder reaction to this once-in-a-lifetime use of 41% of the company's $20.7M of cash and equivalents.
- Consensus 2014 estimates are earnings of $0.33/share on revenues of $32M.
- EPS for 2013 was $0.73 on revenues of $29.2M.
9:06 AM| Comment!
- Shares of Northwest Biotherapeutics (NWBO) are poised for a strong up move at the open in response to its announcement that the Data Safety Monitoring Board recommends the continuation of its DCVax-L Phase 3 GBM trial.
- The unblinded review was conducted in response to shareholder inquiries.
- Prices have been on a roller coaster of late. In November, shares doubled, retraced, then shot up almost 150% to a February 27 peak of $7.92 before correcting. Shares closed yesterday at $5.96.