MannKind Corporation (NASDAQ: MNKD) is having an interesting day in the market this morning. Early on, the stock was up more than 3%, but it has fallen slightly into the red since. Nonetheless, there is some big news on the horizons, so we are excited that our partners at Trade Ideas brought this stock to our attention today. Currently (10:13), MNKD is trading at $1.93 per share after a gain of $0.01 per share (0.51%) thus far today.
MNKD May Fly Next Month
As mentioned above, MannKind Corporation is all over the place today. However, as we near the middle of next month, the stock could fly as the next clinical catalyst comes to light. That’s because the company is currently working on a Phase 4 clinical study that is coming to an end. In fact, it’s expected that investors will hear an update with regard to the trial on October 15th.
The Phase 4 clinical trial surrounds inhaled technosphere insulin in Diabetes Melitus, Type 1. The trial is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial that’s designed to evaluate the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with type 1 diabetes. TI (Technosphere Insulin) is already approved by the FDA for patients with diabetes.
The MNKD Phase 4 study is a multi-center study which follows 60 patients with Type 1 Diabetes A1c values between 6.5% and 10%. The patients included in the study are randomized in a 1:1 fashion to TI or NL. The patients that are randomized into the NL arm of the study will be using their usual prandial insulin dose before meals. However, patients that are randomized into the TI arm will be instructed to dose before meals and take necessary corrections at 1 and 2 hours after meals in order to optimize PPBG.
While technosphere insulin has already been approved by the FDA, it is hoped that this study will improve the labeling surrounding the treatment, leading to stronger sales. Also, MNKD is looking to prove several primary and secondary outcomes. Here are the results they are expecting:
- Improved time in range (70-180 mg/dl) with TI on CGM [Time Frame: 4 weeks]
- Better post-prandial glucose excursion (1-4 hours after meals) with TI [Time Frame: 4 weeks]
- Less glucose variability (GV) (standard deviation and/or coefficient variation) [Time Frame: 4 weeks]
- The area under the curve calculation (AUC) in the PPBG and PPGE [Time Frame: 4 weeks]
- Change in HbA1c in one-month treatment [Time Frame: 4 weeks]
- above the target time (>180 mg/dl) on CGM [Time Frame: 4 weeks]
- hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [Time Frame: 4 weeks]
For more information with regard to the clinical trial, click here!
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will keep a close eye on MNKD. In particular, we’re interested in learning the outcomes of the study mentioned above. We’re also interested in following the sales force along and excited for the potential new labeling to lead to stronger sales. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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