"Approval of Tyvaso DPI Marks Significant Inflection Point", Shares Present "Upside From Current Levels" - Cantor Fitzgerald Bullish on MannKind (MNKD) with $6.50 Price Target

May 23, 2022 3:19 PM EDT
Get Alerts MNKD Hot Sheet
Price: $3.98 +4.46%

Rating Summary:
    8 Buy, 3 Hold, 6 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 1 | Down: 0 | New: 0
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Shares of MannKind (NASDAQ: MNKD) are gaining ~14% in heavy late day trading, following FDA's publication of a letter that seems to suggest approval of the company's Tyvaso DPI.

Cantor Fitzgerald analyst Brandon Folkes reiterates an Overweight rating and $6.50 price target on the company, noting that according to the letter, the "FDA has determined that the available data are sufficient to evaluate Tyvaso DPI’s potential pulmonary risks, including the risk of acute bronchospasm, and that these risks are appropriately addressed and mitigated through the product’s approved labeling."

The analyst further highlights that based on the FDA's comments, it appears Interstitial lung disease (ILD) indication will also be in the label - previously, one of key points of investors' debates.

The likely approval follows a previously issued Complete Response Letter (CRL), which the company has since been working to address. MNKD has expressed vocal confidence in the eventual approval of the drug, but the analyst notes the stock seemed to "had priced in another CRL."

Thus, he reiterates a view that "today's approval of Tyvaso DPI marks a significant inflection point for the company and MNKD stock." He believes "Irrespective of the conversion of patients to Tyvaso DPI, and the success of that from a UTHR (NC) standpoint, we believe there will be a meaningful portion of patients who convert, which in turn will benefit MNKD and present upside from the current stock levels."

For an analyst ratings summary and ratings history on MannKind click here. For more ratings news on MannKind click here.

By Vlad Schepkov



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