Portola Pharmaceuticals, Inc. PTLA announced that the FDA has granted an orphan drug designation to its investigational Syk/JAK inhibitor, cerdulatinib. The candidate is currently being evaluated for the treatment of peripheral T-cell lymphoma.
Cerdulatinib especially inhibits two key cell signaling pathways implicated in hematologic malignancies and autoimmune diseases.
Shares of Portola inched up 1.1% in after-hours trading following the above news on Tuesday. However, the stock has plunged 43.1% year to date versus the industry’s increase of 1.3%.
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Notably, the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. The status makes cerdulatinib eligible for seven years of marketing exclusivity in the United States following an approval for the given indication. The designation also makes the company entitled to certain other benefits including tax credits related to clinical trial expenses and exemption from the FDA-user fee.
Cerdulatinib is currently being assessed in a phase IIa study for treating relapsed/refractory B-cell and T-cell malignancies in patients, who previously did not respond to other therapies. Portola expects to provide additional data from the study at a scientific congress in early 2019. The company plans to meet with the FDA authorities/officials to expedite the approval process for cerdulatinib.
In June 2018, Portola presented data from the phase IIa study at the American Society of Clinical Oncology Annual Meeting and at the European Hematological Association Annual Congress.
Zacks Rank & Stocks to Consider
Portola currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Pacira Pharmaceuticals, Inc. PCRX, BioSpecifics Technologies Corp. BSTC and BioLineRx Ltd. BLRX. While both Pacira and BioSpecifics sport a Zacks Rank #1 (Strong Buy), BioLineRx carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Pacira’s earnings estimates have moved 60.1% north for 2018 over the past 60 days. The stock has gained 6.6% year to date.
BioSpecifics’ earnings estimates have been revised 9.1% upward for 2018 and 11.7% for 2019 over the past 60 days. The stock has surged 34.2% so far this year.
BioLineRx’s loss per share estimates have been narrowed 15.4% for 2018 and 14.3% for 2019 over the past 60 days.
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