PhaseBio Pharmaceuticals, Inc. PHAS announced that the FDA has granted Breakthrough Therapy designation to its lead pipeline candidate, PB2452. The company is developing the candidate in an early stage study as a reversal agent for an antiplatelet drug, AstraZeneca’s AZN Brilinta (ticagrelor).
FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The designation also indicates that PB2452 can be eligible for accelerated approval and priority review depending upon certain criteria.
The designation was granted on the basis of positive data from a phase I study evaluating PB2452 for treating bleeding risk associated with antiplatelet drugs.
Shares of PhaseBio rallied 17.2% on Apr 8 following the news. Shares of the company have surged 306.8% so far this year, significantly outperforming the industry’s rise of 11.9%.
In March 2019, PhaseBio announced data from the above mentioned phase I study. The data showed that treatment with PB2452 has an immediate and sustained reversal effect on the antiplatelet effects of ticagrelor, which is prescribed to reduce risk of a cardiac event. Importantly, the benefit was observed without any drug-related serious adverse events.
The antiplatelet effects of Brilinta may lead to excessive bleeding, which can become life-threatening. Moreover, there is no approved drug to reverse the antiplatelet effects of Brilinta, which reflects significant growth opportunity for PB2452.
Data from the early-stage study demonstrated potential of the candidate as a treatment in emergency situations involving major bleeding and urgent surgeries.
The company is planning to initiate a phase IIa study on PB2452 in the first half of 2019, with data expected in the second half. Successful completion will be followed by initiation of phase IIb development of the candidate later this year.
Apart from PB2452, the company has a candidate — PB1046 — which is being evaluated in a phase IIb study for the treatment of pulmonary arterial hypertension (“PAH”).
PhaseBio has an exclusive license agreement with MedImmune Limited, a subsidiary of AstraZeneca, which grants PhaseBio license to develop drugs using certain patent rights owned by MedImmune. PhaseBio is liable to pay MedImmune milestone payments and royalties. However, there are no candidates in clinical-stage development under this license.
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Zacks Rank & Stocks to Consider
PhaseBio currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the same sector include ANI Pharmaceuticals, Inc. ANIP and Kamada Ltd. KMDA, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
ANI Pharmaceuticals’ earnings estimates have increased from $5.90 to $5.94 for 2019 and from $6.58 to $6.62 for 2020 over the past 60 days. The stock has rallied 55.1% so far this year.
Kamada’s earnings estimates have increased from 35 cents to 47 cents for 2019 and from 60 cents to 63 cents for 2020 over the past 60 days. The stock has rallied 20.6% so far this year.
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