Why This Colorectal Cancer Treatment Approval Is a Big Hit

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Exact Sciences Corp. (NASDAQ: EXAS) received a U.S. Food and Drug Administration (FDA) approval to start the week for its noninvasive colorectal cancer (CRC) screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older. While this is a positive move for the company, one analyst sees this tacking on another 30% to the stock.

Following the announcement, Canaccord Genuity reiterated a Buy rating with a $135 price target, implying upside of 30% from the most recent closing price of $103.77.

By Canaccord Genuity’s estimates, this adds an incremental $3 billion total addressable market cap for Exact Sciences, summing to a Cologuard total addressable market of $18 billion and about 106 million Americans.

The American Cancer Society in May 2018 updated its guidelines to recommend that average risk adults age 45 to 75 get screened for colon cancer, versus its prior recommendation of age 50 to 75. An American Cancer Society study demonstrated that 5.1% of all CRC deaths came from the age 45 to 49 cohort, which sadly is similar to the mortality rate of those in the age 50 to 54 cohort (7.6%).

Canaccord Genuity expected the FDA label expansion to hit as early as the year’s end, or in line with the Exact Sciences first half (2020) target, so this comes in about three to nine months ahead of expectations.

The company submitted its package to the FDA in April 2019, and approval came in before its 180-day comment period. Exact Sciences had indicated it did not have to do another large study and indicated it was able to submit enough evidence to prove Cologuard utility for individuals ages 45 to 49.

Note that CRC is considered the most preventable, yet least prevented form of cancer, and it is the second deadliest cancer in the United States. Regular screening is crucial because CRC is more treatable when detected in its earlier stages.

Shares of Exact Sciences traded at $103.56 on Tuesday, in a 52-week range of $53.06 to $123.99. The consensus price target is $133.10.


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