Alder BioPharmaceuticals (ALDR -13.1%) regains the worldwide rights to its rheumatoid arthritis drug candidate clazakizumab and its migraine prevention candidate ADL403 from Bristol-Myers Squibb (NYSE:BMY) due to its focus on other therapeutic areas.
Clazakizumab is an IL-6 inhibitor which plays a key role in inflammation.
Although CEO Randall Schatzman is bullish about the prospects of bringing the product candidates back in-house, the market feels differently. Shares ended today's trading down 13% on a 3.5x surge in volume.
Ironwood Pharmaceuticals (NASDAQ:IRWD) appoints Thomas Graney as SVP of Finance and CFO replacing the departing Michael Higgins. Mr. Graney joins the company from J&J's Ethicon division where he was worldwide VP of Finance and CFO.
The company also appoints Lisa Adler as SVP of Corporate Communications. She joins the firm from Millennium: The Takeda Oncology Company where she was VP of Corporate Communications.
Clovis Oncology (CLVS +1.6%) intends to offer $200M aggregate principal amount of convertible senior notes due 2021 via private placement. Initial buyers will have a 30-day option to purchase up to an additional $30M aggregate principal amount.
Interest rate and conversion specifics will be determined at the time of pricing.
The FDA accepts Actavis' (ACT +0.8%) NDA for its priority review-tagged eluxadoline for the treatment of diarrhea and abdominal pain in adults with diarrhea predominant irritable bowel syndrome (IBS-D).
In a five-month crackdown on illegal pyramid schemes, Chinese authorities bust 1,446 pyramid operations involving 3.7B yuan ($607M). A total of 3,911 people are being investigated and 64.4M yuan has been seized. Severe punishments await core participants.
No word if U.S.-based multi-level marketers are in their crosshairs.
Shares of thinly traded nano cap Adamis Pharmaceuticals (ADMP +24.9%) jump on a 5x surge in volume albeit on turnover of only ~540K. Prices peaked at $5.27 earlier today representing a 100% gain from the August 15 low of $2.62. Shares are now poised to break the long-term downtrend line. Prices peaked at $18.70 almost two years ago.
There is no specific news today to account for the move. CEO Dennis Carlo reshuffled the BOD last week, though.
Nine mutual funds have positions, up from one a year ago.
The European Commission approves an expanded label for Allergan's (AGN +0.8%) Ozurdex (dexamethasone 700 mcg implant with applicator) to include adult patients with visual impairment due to diabetic macular edema (DME) who are pseudophakic (have an artificial lens implant) or who are considered insufficiently responsive to or unsuitable for non-corticosteroid therapy.
Medical Imaging Corp. (OTCQB:MEDD) acquires three diagnostic imaging companies in the Fort Myers, FL area for $1.8M. It expects to close the transaction by October 31, 2014 subject to securing financing.
Salix Pharmaceuticals (SLXP +0.5%) submits its response to the March 7, 2011 CRL it received from the FDA regarding its sNDA for Xifaxan (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
One of the required actions was a clinical trial to assess the safety and efficacy of rifaximin when administered beyond the first cycle of treatment. The company initiated the trial in February 2012. On July 1, 2014 Salix reported that rifaximin achieved the primary endpoint of a statistically significant greater proportion of refaximin-treated patients that responded to repeat treatment in the double-blind repeat treatment phase of the trial. On August 11, 2014 it reported acceptable safety data regarding repeat treatment with refaximin.
The FDA will have six months to respond to Salix's submission.
Roche (OTCQX:RHHBY -0.3%) debuts the molecular testing systems cobas 6800/8800 for blood and plasma donor screening in markets accepting the CE mark. The fully automated high throughput PCR analyzers can generate 96 results in less than 3.5 hours and up to 960 results in an eight-hour shift (8800) with substantial "walk-away" time and minimal operator interaction.