Alcobra Ltd. (ADHD) Expects Topline MDX Phase III Clinical Trial Data in Two Weeks Sep 19, 2014 04:35PM

Alcobra Ltd. (Nasdaq: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that all scheduled follow-up visits have been completed for patients enrolled in the company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.

"Completion of this Phase III clinical trial is a major milestone in the development of MDX, as we are one step closer to a potential new treatment alternative for Adult ADHD," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."

The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were randomized to receive either 1400 mg MDX or placebo over 6 weeks followed by a 2-week safety follow-up and preceded by a 2-week screening period. The primary endpoint measure is the Conners' Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms, and the same endpoint utilized in the company's successful Phase IIb study. Secondary endpoints include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase II studies, as well as safety assessments and additional exploratory endpoints.

American Spectrum Realty (AQQ) Submits New Plan of Compliance to NYSE MKT Sep 19, 2014 03:54PM

American Spectrum Realty (NYSE: AQQ) announced that it had submitted a new plan of compliance to the NYSE MKT LLC (the “Exchange”) to address how it intended to regain compliance with Sections 134 and 1101 of the NYSE MKT Company Guide (the “Company Guide”).

On August 19, 2014, the Company received correspondence from the Exchange notifying the Company that it was not in compliance with certain of the Exchange’s continued listing standards based on the Company’s stockholders’ equity and net losses, and failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31, 2013 (“2013 Form 10-K“) and Form 10-Q for the fiscal quarters ended March 31 and June 30, 2014.

On September 15, 2014, the Company received additional correspondence from the Exchange stating that although the Company did not meet the deadlines provided in its earlier plan of compliance, the Company had made a reasonable demonstration of its ability to regain compliance with Sections 134 and 1101 of the Company Guide, and, in accordance with Section 1009 of the Company Guide, the Exchange had agreed to the Company’s revised plan period. The Exchange has agreed to an extension of time until October 31, 2014 for the filing of the Company’s 2013 Form 10-K, and if that deadline is met, an extension to December 31, 2014 to file the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended and ending March 31, June 30 and September 30, 2014 ("Revised Plan Period").

On September 18, 2014, the Company submitted to the Exchange its required compliance plan addressing deficiencies with respect to the Company’s stockholders’ equity and net losses. The compliance plan outlined the company’s initiatives to regain compliance with the applicable continued listing standards within the timeframe specified in Section 1009.

The Company continues to work towards compliance under the Revised Plan Period and intends to file the 2013 Form 10-K and Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31 and June 30, 2014 as soon as practicable.

Akorn (AKRX) Needs to Divest Generic Injectable Rifampin ANDA in VersaPharm Deal - FTC Sep 19, 2014 02:12PM

Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Akorn's (NASDAQ: AKRX) acquisition of VersaPharm Inc. and its parent company, VPI Holdings Corp., would have likely been anticompetitive.

Under the order, first announced in August 2014, Akorn is required to divest its Abbreviated New Drug Application for generic injectable rifampin – which is currently pending before the Food and Drug Administration – to Watson Laboratories, Inc.

According to the FTC’s complaint, only VersaPharm and two other firms currently have FDA approval to sell generic injectable rifampin. There are no viable substitutes for rifampin as a course of treatment for tuberculosis. The FTC alleged that if Akorn had consummated its acquisition of VersaPharm as originally proposed, the combined company would have been likely to delay or cancel the introduction of Akorn’s generic injectable rifampin.

The Commission vote approving the final order was 5-0. (FTC File No. 1410162; the staff contact Jasmine Y. Rosner, Bureau of Competition, 202-326-3558)

Tesla Motors (TSLA) Releases Software v6.0 Update Sep 19, 2014 02:05PM

Tesla Motors (NASDAQ: TSLA) made the following announcement on its blog today:

Today, we’re announcing details about new software being delivered to Model S customers through an over-the-air update. The new features further personalize the Model S ownership experience and help make the car smarter about owners’ individual preferences. This is the latest in a series of software updates issued since we launched Model S in 2012, enabling new features such as hill start assist, smart suspension controls, and energy saving sleep mode.

The Software v6.0 update introduces traffic-based navigation and commute advice, provides an in-car view of daily schedules, enables location-based air suspension settings, and allows owners to name their Model S and start it remotely using their mobile phone.

New features include:

Traffic-Based Navigation (BETA)

The Model S navigation system will be a lot smarter. Navigation will now provide route suggestions based on real-time traffic and calculate estimated travel times accordingly. It will also update dynamically as traffic conditions change throughout your trip. This feature will also take into account traffic data shared by other Tesla vehicles on the road.

Commute Advice

Navigation isn’t particularly useful when commuting between home and work because most of us usually know the way. But if traffic has an effect on a typical route, it’s helpful to know in advance. Now, Model S will monitor traffic before you even start your weekday commute and alert you with a pop-up message on the 17-inch touchscreen when a faster route is available.

Calendar (BETA)

Model S will synch with your smartphone to bring you a large in-car view of your daily schedule. If you’ve already set locations for particular events, you don’t have to worry about re-entering the details into your car’s navigation system. Instead, you can just tap on the event in your calendar to bring up route directions.

Remote Start

You will have the ability to start your Model S using only your smartphone. This function, which is particularly useful if you forget your key fob, will be accessible through the Tesla mobile app and requires you to input your password for each use.

Location-Based Air Suspension

If you regularly drive on roads or driveways that require higher than normal clearance, your Model S will remember where you previously selected high ride heights and automatically adjust the air suspension at those locations. This feature will be especially handy for people who have steep driveways. (Model S must be equipped with air suspension for this function to work.)

Name Your Car

You can now make your Model S nickname official. The car’s name will appear in the Tesla mobile app and in the About Your Tesla section on the touchscreen.

Power Management Options

A new power management option will put Model S into energy saving mode at night to help maximize available energy. There’ll also be an option that allows the Tesla mobile app to always connect immediately to the car, while still saving power.

This software update represents Tesla’s commitment to improving Model S for customers even long after it has left the assembly line. With each update, Model S becomes more attuned and responsive to its owner’s needs without requiring excessive user input. We will continuously fine-tune the software and work on new features in response to customer feedback.

ExxonMobil (XOM) Issues Statement on Russia Sanctions Sep 19, 2014 11:52AM

ExxonMobil (NYSE: XOM) is complying with all U.S. sanctions," it said in a statement.

"The U.S. Treasury Department, recognizing the complexity of the University-1 well and the sensitive Kara Sea arctic environment, has granted a license to ExxonMobil and other U.S. contractors and persons involved to enable the safe and responsible winding down of operations related to this exploration well. The license recognizes the need to protect the safety of the individuals involved in these operations as well as the risk to the environment. All activities related to the wind down will proceed as safely and expeditiously as possible."

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