Google Finance: MNKD
Mannkind Corp. Website
I am cautious about Mannkind's approval chances with the FDA in the next coming weeks (FDA delayed Dec 29th decision 4 weeks) but I am optimistic about its chances of an increase in stock price while the FDA reviews Mannkind's approval for Afrezza for Diabetes. Here are some news that has occurred for Mannkind in the past few weeks. Continued
MannKind (MNKD) CEO Alfred Mann Buys Another 700K Shares
January 12, 2011 2:28 PM EST
MannKind (Nasdaq: MNKD) CEO Alfred Mann discloses the purchase of another 700,000 shares on 1/12 at $8.71. This purchase and other recent purchases from Mann are part of an agreement dated 08/10/2010.
MannKind Updates Status of New Drug Application for AFREZZA®
December 28, 2010 6:30 AM EST
VALENCIA, Calif.--(BUSINESS WIRE)-- MannKind Corporation (Nasdaq: MNKD) today announced that it was informed on December 27, 2010 by the U.S. Food & Drug Administration (FDA) that the agency will not be able to complete the review of the New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.
AFREZZA® is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. It is a combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and delivered via a small, discreet and easy-to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the early release of mealtime insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both type 1 and type 2 diabetes.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes AFREZZA® and MKC253. MannKind has submitted a NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MKC253 is currently in phase 1 clinical trials. Other products in MannKind's pipeline include the cancer immunotherapy platform MKC1106, which is currently in phase 2 clinical trials. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Mannkind(MNKD), any news?"
Not a lot of news on Mannkind but tons of speculation and stock volatility as we get closer to the Dec. 29 FDA approval decision date for the company's inhaled insulin delivery device Afrezza.
Mannkind was trading for $6-plus around Thanksgiving but was up to $8.50 intraday Thursday. Wednesday was a particularly volatile day, with the stock trading as high as $9.23 and as low as $7.31.
On Wednesday, Mannkind founder Al Mann disclosed via an SEC filing that he purchased another 700,000 shares of the company, which a lot of investors interpreted as a sign of confidence so close to the FDA approval decision for Afrezza.
That's not entirely true, however. Mann's 700,000-share purchase was required under an equity financing agreement signed in August with an outfit known as Seaside 88. Mannkind has been selling discounted stock to Seaside 88 as a way to raise cash. Under the agreement, whenever Seaside buys and resells Mannkind shares, Mann has to buy an equal amount of Mannkind stock.
Meantime, the guessing game over the FDA's Afrezza decision continues. On Thursday, JMP Securities reiterated its buy rating and $11 price target on the grounds that there's a 40% chance for a full Afrezza approval on Dec. 29.
Furthermore, the JPM Securities note continues, "even should a second CRL [Complete Response Letter] be issued, we believe the most likely scenario would not involve a requirement for new, long-term clinical trials (30% probability), based on which we believe the stock would trade in the $8-10 range. We anticipate that the focus for a CRL would be on REMS [risk management plan] and/or the submission of the commercial delivery device and not pulmonary safety or efficacy concerns…"
Diabetic Investor's David Kliff told his newsletter subscribers that Afrezza has less than a 50% chance of getting FDA approval and he recommended banking trading profits ahead of the decision
MannKind: FDA Delay Leaves Future up in the Air
by: EP Vantage January 11, 2010
about: MNKD / MRK
The only certainty for MannKind (MNKD) is uncertainty now that the FDA has delayed an expected January 16 regulatory decision on its inhaled insulin product, Afrezza, formerly known as Afresa.
MannKind announced on January 8 that the FDA would not be able to meet the PDUFA deadline for the decision because the regulator had not completed the inspection of the manufacturing facilities of NV Organon, a Merck & Co (MRK) subsidiary that is supplying insulin to the company. With no news on when the product's review will conclude, the already volatile shares will continue to provide investors with a roller coaster ride.
Whilst a definitive decision was on the drug was not necessarily expected by January 16 (MannKind holding its breath over Afresa approval, January 5, 2010) , the announcement, with no clear signal on when the FDA will make up its mind, saw the stock slip slightly in after-hours trading from $8.05 after market close on January 8. In early trading today, MannKind shares were at $7.84, not a huge decline, reflecting the fact that the delay stems from the regulator missing a deadline rather than heightened concerns over approvability.
The market has been deeply divided over Afrezza, mindful of the withdrawal of Exubera from the market in 2007.
Supporters insist Afrezza is superior to Exubera, and expect a a positive decision from FDA and a successful partnership with a major pharmaceutical company. However, many investors remain sceptical, as reflected by the fact that 27% of MannKind's free-floating shares were held in short interest positions as of December 15, according to NASDAQ, suggesting a lot of people are betting the stock is heading for a fall.