Goldman Sachs’ Jay Olson downgraded the rating on Portola Pharmaceuticals Inc PTLA from Buy to Neutral, while reducing the price target from $65 to $30.
APEX Study Miss
Removing the stock from Goldman Sachs’ Americas Buy List, Olson mentioned that the topline results show that the APEX study had missed the first step in the primary analysis plan.
“This Phase 3 pivotal study for betrixaban in acute medically ill patients at risk for blood clots was intended to support a single study regulatory filing, per the agreement with the FDA,” Olson explained.
Olson also expressed concern regarding the near term miss, saying that this would prevent progression to the next two analysis levels, although the company did achieve statistical significance in those levels.
Estimates Lowered
The analyst has lowest the probability estimate for regulatory/commercial success of betrixaban from 60 percent to 20 percent based on the topline results for APEX.
The sales estimate for the drug has also accordingly been lowered from $360 million to $130 million in 2020.
Potential For Andexanet
“While we think PTLA’s unique antidote (andexanet) for bleeding in Factor Xa patients is poised to deliver on significant unmet medical need, we expect this scenario to take over a year to materialize,” Olson went on to point out.
The analyst expressed optimism regarding the August PDUFA for andexanet, given the robust Phase 3 data, although it is likely to take time for Portola Pharma to ramp up its manufacturing capacity.
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