The FDA PDUFA date for Alimera Sciences' (ALIM -0.8%) NDA for Iluvien (190 mcg fluocinolone acetonide intravitreal implant in applicator) is September 26, 2014. The company resubmitted its application in April after addressing the issues cited in the FDA's October 2013 CRL that questioned Iluvien's benefit-to-risk and safety profiles.
The company licensed Iluvien from pSivida (PSDV +0.5%) for the U.S. Regulatory clearance will trigger a $25M milestone payment from Alimera to pSivida.
The Stock Split Index Fund (NYSE:TOFR) began trading yesterday, marking a break from United States Commodity Funds' historical focus on commodity ETFs.
TOFR seeks to capture the price appreciation that can follow stock splits, using the 2 for 1 Index.
"Investors and investment professionals have both been taught that stock splits really shouldn't impact a stock's performance, but there has been a lot of material published that demonstrates that stock splits, do in fact, matter" stated John Hyland in a press release.
NASDAQ halts trading in nano cap Lipocine (LPCN) citing pending news. A joint meeting is being held today between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the appropriate treatment population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes.
Lipocine's product candidate LPCN 1021 is an oral formulation of testosterone undecanoate.
Mobile Telesystems (MBT -4.5%) falls for a second day after Sistema chairman Vladimir Yevtushenkov was placed under house arrest for suspicion of money laundering connected to his company's acquisition of oil producer Bashneft.
MBT says the investigation is not interfering with its operational activities, but Sistema owns a 53.46% stake in the Russian telecom, giving it an effective ownership stake in the company.
The case is reminiscent of the 2003 arrest of Mikhail Khodorkovsky, at the time the head of Yukos Oil, which was absorbed in a series of forced sales by Rosneft.
The move percolated somewhat positively through Asian equity markets overnight, but fell short of something more sweeping - say a cut in interest rates - out of Beijing. Some warn the move won't do a whole lot as bank liquidity isn't the issue, but instead slow loan demand from businesses and consumers.
The PBOC's action is in the form of 3-month, low-rate loans to banks, according to a bank executive briefed on the action. While there are no explicit conditions attached to the money, says the executive, the PBOC wants to see credit channeled into areas Beijing's central planners have deemed important to the economy.
Among the recent evidence pointing to a slowing economy: Industrial production growth hit a six-year low in August, and foreign direct investment hit a four-year low.
Occidental Petroleum (OXY -0.2%) is in talks to sell at least one-fifth of its 24.5% stake in Dolphin Energy to Abu Dhabi-owned Mubadala Development, WSJ reports.
Qatar would need to approve the deal because Dolphin Energy's assets include upstream gas projects and a pipeline with the capacity to transport up to 3.2B cf/day of gas from Qatar to the United Arab Emirates and Oman.
Mubadala already owns 51% of the pipeline project, valued at $3.5B, while Total (NYSE:TOT) holds a 24.5% stake.
OXY also is said to be in talks to sell as much as a 30% stake in the $10B Shah natural gas project in the UAE to Mubadala.
Continuing a leadership shakeup at Pimco (OTCQX:AZSEY, OTCPK:ALIZF), the company's London-based emerging markets equities chief Masha Gordon has left "to pursue other interests." Deputy CIO and Global Head of Equities Virginie Maisonneuve is running emerging markets following the departure.
Gordon joined Pimco in 2010 from Goldman Sachs where she had worked on emerging markets equities strategy since 2003.
"Nike (NYSE:NKE) in no way condones child abuse or domestic violence of any kind and has shared our concerns with the NFL," says the company in a statement. "We have suspended our contract with Adrian Peterson."
Motivated by feedback from U.S. and European regulators, ImmunoCellular Therapeutics (IMUC +7.8%) plans to advance ICT-107 to two Phase 3 clinical trials in patients with newly-diagnosed glioblastoma (GBM). Patients will be selected based on their HLA-A2 status. Positives will be in one trial and negatives in the other. The two populations of GBM patients are evenly distributed.
The company hopes to initial the trials in mid-2015.
Complicating matters is the FDA's position that Overall Survival (OS) is the appropriate primary endpoint. ICT-107 failed to achieve this endpoint in Phase 2.
In a case relating to the Gulf of Mexico oil spill, BP's lawyers were allowed to submit a response of up to 35 pages double-spaced, but the judge discovered the company had abused the page limit to fit in six additional pages of text; Barbier castigated BP, warning that any future briefs using similar tactics would be dismissed.
Earlier this month, the judge ruled that BP had been grossly negligent over the Gulf of Mexico disaster, leaving it facing up to $17.6B in potential civil fines.