FDA Panel Grants Market Approval of MannKind Corp.'s Inhalable Insulin


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NASDAQ:MNKD / NASDAQ:PRAN / NASDAQ:WTSL / NASDAQ:GALE
04/02/2014 [ACCESSWIRE]

On Apr. 1, MannKind Corp. (NASDAQ:MNKD) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that Afrezza, its inhalable insulin,  be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes.

MannKind added that the FDA panel also voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.

If it is approved, Afrezza will be the first ultra-rapid-acting mealtime insulin therapy available in the United States.

Recap of the Valencia, Calf.-based Pharmaceutical Company's 2013 Financial Results

For the fourth quarter of 2013, total operating expenses were $46.6 million, compared to $33.5 million for the fourth quarter of 2012, an increase of $13.1 million.

Research and development expenses were $29.0 million for the fourth quarter of 2013, compared to $25.3 million for the corresponding quarter in 2012, due to an increase in non-cash stock compensation expense of $4.3 million that was offset by a decrease in clinical trial related expenses of $1.3 million.

General and administrative expenses increased by $9.4 million to $17.6 million for the fourth quarter of 2013, compared to $8.2 million in the fourth quarter of 2012. The increase in G&A expenses was due to an increase in non-cash stock compensation expense of $6.0 million and increased professional legal and financing fees of $2.2 million as compared to the corresponding quarter of the prior year.

For fiscal year 2013, operating expenses totaled $169.4 million, compared to $147.0 million for fiscal year 2012. Total R&D expenses for fiscal year 2013 increased by $8.2 million, or 8.1%, to $109.7 million for fiscal year 2013 as compared to $101.5 million for fiscal year 2012, due to an increase in non-cash stock compensation expense of $14.2 million that was offset by a decrease in clinical trial related expense in 2013.

G&A expenses increased by $14.2 million, or 31.2%, to $59.7 million for fiscal year 2013 as compared to $45.5 million in fiscal year 2012, due to increased non-cash stock compensation expense of $17.7 million and increased professional legal and financing fees of $2.3 million in 2013 that was offset by the $6.5 million litigation settlement accrual recorded in 2012.

The net loss applicable to common stockholders for fiscal year 2013 was $(191.5) million, or $(0.64) per share based on 299.6 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $(169.4) million, or $(0.94) per share based on 180.9 million weighted average shares outstanding for fiscal year 2012. The number of common shares outstanding at December 31, 2013 was 369,391,972.

Cash and cash equivalents were $70.8 million at December 31, 2013 and $61.8 million at December 31, 2012. Currently, there is $30.1 million of available borrowings under the amended loan arrangement with The Mann Group.

Analysts' Consensus

Of the 5 analyst firms covering MNKD, 1 rates it a "strong buy," 3 a "hold" and 1 an "underperform."

On Mar. 31, MNKD's share price closed at $4.02 down 81 cents from the previous day's close of $4.83 cents a share.

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Prana Biotechnology Reports Disappointing Test Results

Meanwhile, Prana Biotechnology (NASDAQ:PRAN) stock volume skyrocketed Apr. 1, with 13,818,296 shares changing hands, more than five times its three-month average volume of 2,695,070 shares.

The high stock volume is being spurred in part by the disappointing results the Australian biotech company released on clinical trial of a drug it's developing to treat Alzheimer's Disease.

Prana said based on draft results, Prana's PBT2 did not meet its primary endpoint of a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer's disease patients, as measured using PiB-PET Standardized Uptake Value Ratio (SUVR).

Plaques Not Reduced

While there was a reduction in the overall levels of the PiB PET signal in patients treated with PBT2, the results were confounded by an atypical reduction of levels of the PiB PET signal in the placebo group as well.

Commenting on the result, Geoffrey Kempler, chief executive of Prana Biotechnology said: "This is the first time that Prana has looked at PiB-PET in a study with PBT2 to measure its effect on insoluble amyloid plaques. In our previous Alzheimer's study (EURO)1, we looked at levels of unaggregated soluble Abeta peptides in spinal fluid, and they were significantly reduced with PBT2 treatment. So in the IMAGINE trial we looked for an impact on the insoluble plaques as well, but did not see it differ significantly from the placebo."

On Apr.1, PRAN's share price closed at $2.30, down 50 cents from its close of $2.80 the previous day.

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The Wet Seal Inc. Reports $27.3-million Operating Loss

In other news, The Wet Seal, Inc.'s (NASDAQ:WTSL) stock volume soared Apr. 1, with 2,710,071 shares changing hands, more than double its three-month average volume of 1,263,256 shares.

The upsurge in volume is being fueled in part by the release of the Foothill Ranch, Calif-based specialty retailer's recent financial report for its 4Q and Fiscal 2013.

Here are the highlights:

Fourth Quarter 2013

-- Net sales for the 13-week fourth quarter were $124.8 million compared to net sales of $161.7 million for the 14-week fourth quarter in fiscal 2012.

-- Consolidated comparable store sales declined 16.5%, including a comparable store sales decline of 15.4% at Wet Seal and 25.0% at Arden B. Comparable store sales for the current year quarter are versus the comparable thirteen weeks from the prior year. Versus the comparable thirteen week period from prior year, net sales for the fourth quarter of fiscal 2013 declined approximately 14% at Wet Seal, 43% at Arden B and 18% on a consolidated basis.

-- Gross profit was $23.4 million, or 18.8% of sales, compared to $40.1 million, or 24.8% of sales, in the fourth quarter of fiscal 2012.

-- Operating loss was $27.3 million compared to operating loss of $25.5 million in the prior year quarter.

Analysts' Consensus

Of the 5 analyst firms that cover WTSL 1 recommends a "strong buy," 1 a "buy" and three a "hold."

On Apr.1, WTSL's share price closed at $1.27, down 5 cents from its close of $1.32 the previous day.

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Galena Biopharma Inc.'s Share Value Loses Ground amid Shareholder Lawsuits

Finally, Galena Biopharma Inc.'s (NASDAQ:GALE) share value has lost substantial ground in the last 30 days as a result in part the Worcester, Mass-based company's revelation that it is being investigated by the Securities and Exchange Commission.

Here is the company's statement:

"In February 2014, we learned that the SEC is investigating certain matters relating to our company and an outside investor-relations firm that we retained in 2013. We have been in contact with the SEC staff through our counsel and are cooperating with the investigation," the company stated in its 10-K filing dated Mar. 17.

Class-Acton Lawsuits

In addition to this bad news, the company is facing a slew of class action lawsuits from stockholders that allege Galena and certain of its executives issued a series of materially false and misleading statements during the Class Period, violating federal securities laws. However, it should be noted that none of these allegations have been proven.

Moreover, Galena's results for its fourth quarter were less than comforting to shareholders. Its earnings per share loss of 46 cents on revenue of $1.32 million as compared to estimates of  9 cents and $1.62 million, respectively. The company pointed out that the Q4 net loss of $48.5 million included $38.9M in non-cash charges. On the positive side, Galena lifted its 2014 Abstral net revenue estimates to $11 million to $15 million as compared to prior guidance of $8 million to $12 million.

Analysts' Consensus

Of the 9 analyst firms that cover Galena, 7 rate it a "strong buy," 1 a "buy" and 1 a "sell."

On Apr.1, GALE's share price closed at $2.56, up 6 cents from its close of $2.50 the previous day.

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