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Alexion's sBLA for Soliris Receives FDA Acknowledgement
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Alexion Pharmaceuticals, Inc. announced that the FDA, on Mar 9, has accepted the supplemental Biologics License Application (sBLA) to expand the indication for Soliris for the potential treatment of patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) and antibody-positive.
We note that Alexion’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry in the last one year. The stock declined 7.5% compared to the industry’s gain of 1.4% over the same time frame.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of Oct 23.
Soliris enjoys Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and EU. Soliris is alreday approved in the U.S., EU, and Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The drug is also approved for atypical hemolytic uremic syndrome (aHUS).
We note that Soliris is the key drug for Alexion. However, as Soliris accounts for majority of revenues at Alexion, the company relies on the drug heavily for growth. The drug is witnessing access challenges in Latin America. Soliris quarter-to-quarter revenues growth will be impacted by the enrolment ramp-up of trials on ALXN1210 (by $70 million–$110 million).
Meanwhile, the company is currently evaluating ALXN1210 (a longer-acting anti-C5 antibody that inhibits terminal complement) in phase III studies for both PNH and aHUS. Patients are currently being dosed in a phase III trial which compares ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH.
Further, the company is also initiating a phase III PNH switch study on ALXN1210 which compares the candidate administered intravenously every eight weeks to patients currently treated with Soliris. Enrolment in both the studies is expected to be completed in 2017.
Meanwhile, recruitment is ongoing in a phase III trial on ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrolment is expected to be complete in 2017. Alexion expects to initiate a phase III trial on ALXN1210 in pediatric patients with aHUS in the second quarter of 2017.
Sunesis’ loss estimates narrowed 8.8% for 2017 over the past 60 days. The company recorded positive earnings surprises in three of the last four quarters, the average being 0.54%.
Celgene’s earnings estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
GlaxoSmithKline’s earnings estimates increased from $2.66 to $2.76 for 2017 and from $2.80 to $2.85 for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.03%. Its share price increased 6.7% year to date.
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Alexion's sBLA for Soliris Receives FDA Acknowledgement
Alexion Pharmaceuticals, Inc. announced that the FDA, on Mar 9, has accepted the supplemental Biologics License Application (sBLA) to expand the indication for Soliris for the potential treatment of patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) and antibody-positive.
We note that Alexion’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry in the last one year. The stock declined 7.5% compared to the industry’s gain of 1.4% over the same time frame.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of Oct 23.
Soliris enjoys Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and EU. Soliris is alreday approved in the U.S., EU, and Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The drug is also approved for atypical hemolytic uremic syndrome (aHUS).
We note that Soliris is the key drug for Alexion. However, as Soliris accounts for majority of revenues at Alexion, the company relies on the drug heavily for growth. The drug is witnessing access challenges in Latin America. Soliris quarter-to-quarter revenues growth will be impacted by the enrolment ramp-up of trials on ALXN1210 (by $70 million–$110 million).
Meanwhile, the company is currently evaluating ALXN1210 (a longer-acting anti-C5 antibody that inhibits terminal complement) in phase III studies for both PNH and aHUS. Patients are currently being dosed in a phase III trial which compares ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH.
Further, the company is also initiating a phase III PNH switch study on ALXN1210 which compares the candidate administered intravenously every eight weeks to patients currently treated with Soliris. Enrolment in both the studies is expected to be completed in 2017.
Meanwhile, recruitment is ongoing in a phase III trial on ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrolment is expected to be complete in 2017. Alexion expects to initiate a phase III trial on ALXN1210 in pediatric patients with aHUS in the second quarter of 2017.
Zacks Rank & Stocks to Consider
Alexion currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the health care sector include Sunesis Pharmaceuticals , Celgene Corp. and GlaxoSmithKline plc (GSK - Free Report) . All the three stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sunesis’ loss estimates narrowed 8.8% for 2017 over the past 60 days. The company recorded positive earnings surprises in three of the last four quarters, the average being 0.54%.
Celgene’s earnings estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
GlaxoSmithKline’s earnings estimates increased from $2.66 to $2.76 for 2017 and from $2.80 to $2.85 for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.03%. Its share price increased 6.7% year to date.
Just Released – Driverless Cars: Your Roadmap to Mega-Profits Today
In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>