Friday’s biggest gaining and declining stocks

Atlanta, GA 6/22/12 (StreetBeat) -- Here are some of the most active stocks in U.S. trading Friday:

Gainers

Alexza Pharmaceuticals (Nasdaq:ALXA) rose 40% on Friday, rallying after the company said that it has resubmitted a new drug application for its Adasuve candidate with the Food and Drug Administration.

Harvest Natural Resources Inc. (NYSE:HNR) shares jumped 75%, Late Thursday, the energy company reached an agreement to sell some Venezuelan assets for about $725 million.

NPS Pharmaceuticals Inc. (Nasdaq:NPSP) shares added 11% after the company said it and partner Takeda Pharmaceutical have won support from a European regulatory committee recommending the companies’ treatment for short bowel syndrome.

U.S.-listed shares of Sony Corp. (NYSE:SNE) climbed 6%. The electronics and entertainment conglomerate reportedly is considering making an investment in fellow Japanese company Olympus.

Decliners

Protalix Biotherapeutics (AMEX:PLX) shares shed 7% after the company said that European medical authorities have ruled against recommending taliglucerase alfa, a treatment for Gaucher disease that Pfizer Inc. (NYSE:PFE) and Protalix have partnered on.

Repligen (Nasdaq:RGEN) shares fell 9% on Friday. Earlier, the company said that the FDA has requested more data on one of its drugs used for the treatment of pancreatitis.

Ryder System Inc. (NYSE:R) shares fell 11%. On Thursday the company issued a lowered outlook for its fiscal second quarter and full-year earnings.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

StreetBeat Disclaimer

Distributed by Viestly

Alexza (Nasdaq: ALXA) resubmits drug application, shares soar

Atlanta, GA 6/22/12 (StreetBeat) -- Alexza Pharmaceuticals Inc (Nasdaq: ALXA) said it resubmitted the approval application for its drug to calm patients with schizophrenia or bipolar disorder, sending its shares up as much as 47 percent.

The company said it was awaiting the U.S. health regulators' decision on a potential review date for Adasuve.

Typically, the U.S. Food and Drug Administration classifies a resubmission as a class 1 or class 2 response, signifying a review time of 2 months and 6 months, respectively.

Early last month, the FDA declined approval to Adasuve, for the second time, saying it found certain deficiencies at the company's Mountain View, California manufacturing facility during an inspection.

The company's shares were at $4.10 in morning trade on the Nasdaq.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

StreetBeat Disclaimer

Distributed by Viestly

Alexza Pharmaceuticals (Nasdaq: ALXA): FDA Committee Recommends Approval of ADASUVE™

Palm Beach, FL 12/13/11 (StreetBeat) -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE™ (Staccato® loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain).

"We view the recommendations by the PDAC today as another step forward in the development of ADASUVE," stated Thomas B. King , President and Chief Executive Officer of Alexza Pharmaceuticals. "We appreciate the Advisory Committee's recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder. If approved, we believe ADASUVE represents a valuable treatment option for patients and physicians alike. We look forward to continuing to work toward our goal of bringing ADASUVE to market in 2012."

As previously announced, the ADASUVE NDA Prescription Drug User Fee Act (PDUFA) goal date is February 4 , 2012. In Europe, a Marketing Authorization Application (MAA) for ADASUVE is currently under review by the European Medicines Agency (EMA) and the application will follow the Centralized Procedure.

Summary of Advisory Committee Voting

The FDA takes the committee's advice into consideration as part of its review of a New Drug Application, but is not bound by an advisory committee's recommendations. After reviewing and discussing the ADASUVE data, the committee voted on the following questions:
Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be effective as a treatment for agitation in patients with schizophrenia or bipolar mania? The resulting vote was: 17/1/0 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be acceptably safe for use as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by the sponsor? The resulting vote was: 1/17/0 (yes/no/abstain).
b. When used in conjunction with the REMS proposed by the FDA? The resulting vote was: 5/12/1 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder would be acceptably safe for use as a single dose in 24 hours as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by FDA? The resulting vote was: 11/5/2 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder should be approved for use as a single dose in 24 hours when used with the FDA recommended REMS, for the treatment for agitation in patients with schizophrenia or bipolar mania. The resulting vote was: 9/8/1 (yes/no/abstain).

Shares of Alexza are currently trading at $0.86, up $0.24 or 37%.

StreetBeat Disclaimer

Distributed by Viestly