MannKind Corporation (NASDAQ:MNKD) Spikes On Afrezza New Insulin Label

MannKind Corporation (NASDAQ:MNKD)

MannKind Corporation (NASDAQ:MNKD) shares gained 40.1% after the U.S. Food and Drug Administration approved a favorable label change for Afrezza. Human Insulin, Afrezza, is now approved for glycemic control in adult patients with type 1 and type 2 diabetes. According to the company, it is the only inhaled rapid-acting mealtime insulin available in the United States.

The biopharmaceutical company has also confirmed that it successfully exchanged new common stock for outstanding warrants issued last year. The exchange strengthened investors’ confidence as it showed the company’s commitment to cleaning up opportunities for capital flexibility.

MNKD Stock Performance

MannKind Corporation (NASDAQ:MNKD) has gained more than 100% since the start of the month. However, the stock is up by more than 30% for the year. The stock is currently trading at 14-month high and traders are waiting to see if it will continue to rise after registering a new 52 week high of $6.51 a share.

MannKind Corporation (NASDAQ:MNKD)

Afrezza’s new label has revitalized investor confidence on the stock. The biotech company has been under pressure as investors reacted negatively to anemic sales reports. However, the label change should unlock the product’s blockbuster potential.

Afrezza New Label

The new label update includes data that describes the action profile by dosage strength as well as clarity on starting and adjusting mealtime dosage. To conform with current FDA guidance, the label also includes updated pregnancy lactation section.

“These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” said Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) – University of Colorado.

Mannkind’s Financial Woes

MannKind Corporation (NASDAQ:MNKD) needs to capitalize on the new label if it is to continue rising higher in the market. The company still faces a string of changes after exiting the recent quarter with only $44 million in cash. Observers question if that amount will be sufficient to support operations going forward.

The company may have to look for additional funds to be able to ramp up the Afrezza commercial launch. Investors may wish to consider bracing themselves for secondary offerings given the spike in MNKD stock.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Cymabay Therapeutics, Inc. (NASDAQ:CBAY) Hits Highs with Strength in Pipeline

Cymabay Therapeutics, Inc. (NASDAQ:CBAY)

Cymabay Therapeutics, Inc. (NASDAQ:CBAY) was upgraded by H.C. Wainwright from “Neutral” to “Buy” at the end of January. However CBAY had already delivered some spectacular performance prior to that announcement. Last week CBAY shares gained over 37%, and YTD the stock is up over 85%. On Friday shares gained over 15%, on four times their average daily volumes, and the Relative Strength Indicator (RSI) was sitting at over 85 – overbought by most standards. Still, analysts have a price target of over $5.65 on CBAY.

SanFancisco, CA-based Cymabay Therapeutics, Inc. (NASDAQ:CBAY) is a clinical-stage biopharmaceutical company that develops therapies to treat metabolic diseases with high unmet medical need or serious rare and orphan diseases. Cymabay Therapeutics, Inc. (NASDAQ:CBAY) was seeded with the assets from an earlier biotechnology company that had a pipeline which was the result of over $120 million in development expenses. Their pipeline is more mature than many other firms in the biotech space.

 

According to the centers for Disease Control, 8.3 million U.S. adults are afflicted by this disease and gout’s prevalence grew by 1.2% over the previous two decades. MBX-8025 addresses aspects of metabolic syndrome, including improvements in insulin sensitivity and trends toward decreased waist circumference and body fat. Over half of the patients that entered the Phase 2 study meeting the criteria for metabolic syndrome no longer met the criteria at the end of the study. MBX-2982 demonstrated dose-dependent increases in drug exposure with a profile supporting once daily oral dosing that was safe and well tolerated with no serious adverse events, adverse event trends or dose-limiting toxicities. These results may provide clinical validation for the potential therapeutic benefits of MBX-2982 as a type 2 diabetes treatment.

Three firms follow Cymabay Therapeutics, Inc. (NASDAQ:CBAY) – one rates CAY as a “Buy”, while the other two rate the shares as a “Strong Buy”.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

2/17/2017
Ticker Symbol CBAY
Last Price a/o 8:00 PM EST  $                      3.24
Average Volume                    402,850
Market Cap (mlns)  $                    75.73
Sales (mlns) $0.00
Shares Outstanding (mlns) 23.45
Share Float (mlns) 23.13
Shortable Yes
Optionable No
Inside Ownership 0.10%
Short Float 1.53%
Short Interest Ratio 0.88
Quarterly Return 57.56%
YTD Return 86.71%
Year Return 180.87%

Tandem Diabetes Inc. (Nasdaq: TNDM) Up >15% in Mid-Day Trading

Tandem Diabetes Care, Inc. – Nasdaq: TNDM

San Diego, CA-based Tandem Diabetes Care, Inc. shares are up over 15% in mid-day trading. The shares, traded on the Nasdaq under ticker symbol TNDM, closed Friday at $2.40 and have reached as high as $2.85 on heavy volumes.

Tandem Diabetes Care, Inc. designs, develops, and commercializes various products for people with insulin-dependent diabetes in the United States. The company’s flagship product is the t:slim insulin delivery system that comprises t:slim pump, its disposable insulin cartridge, and an infusion set.

Sales have been consistently higher year-on-year. In 2012 Tandem Diabetes reported sales of $2.5 million and in 2015 they reported sales of $72.9 million. However, EPS for TNDM shares have not been so easy on the eyes. In 2011 Tandem Diabetes Inc. reported and EPS loss of $1.24. In 2013, there was a whopping $21.46 loss, but in 2015 Tandem Diabetes narrowed the loss to $2.50. Eleven firms follow Tandem Diabetes Inc and five rate TNDM as a “Strong Buy”, one rates the shares a “Buy” four rate TNDM as a “Hold”, and one rates TNDM as an “Underperform”.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/17/2017
Ticker Symbol TNDM
Last Price a/o 1:41 PM EST  $                      2.78
Average Volume 550,000
Market Cap $67.4 million
Sales $84.5 million
Shares Outstanding 28.08 million
Share Float 20.44 million
Shortable Yes
Optionable Yes
Inside Ownership 32.00%
Short Float 9.26%
Short Interest Ratio 3.46
Quarterly Return -65.76%
YTD Return 11.63%
Year Return -70.19%