Biogen Inc. (BIIB - Free Report) announced the initiation of phase III study – CHARM – to evaluate its pipeline candidate, BIIB093, for the prevention and treatment of severe cerebral edema in large hemispheric infarction (“LHI”). BIIB093 is an intravenous (“IV”) formulation of glibenclamide. LHI is a severe form of ischemic stroke, which results in swelling in brain. It may lead to death in 40-80% of cases and has no treatment options.
The company believes that BIIB093 has the potential to improve patient outcomes and reduce mortality risk.
Biogen’s stock has gained 8.8% this year so far against the industry’s 2.9% decrease.
The CHARM study will evaluate the efficacy and safety of BIIB093 within 10 hours of a cerebral stroke. The primary endpoint is the improvement in patients based on the modified Rankin Scale, a measurement of functional outcome or disability of a patient at 90 days.
Although the candidate failed to meet the primary endpoint in a phase II study, it demonstrated potential improvement in functional outcomes and mortality. With enrolment of first patient in the CHARM study, it is still a long way ahead for a successful development.
However, the FDA has granted Special Protocol Assessment to the CHARM study and BBIB093 enjoys orphan drug and fast track designation. The company acquired the candidate from Remedy Pharmaceuticals last year.
As competition in the multiple sclerosis (“MS”) market intensifies, Biogen is focusing on building a portfolio of other neurodegenerative disorders including stroke and acute neurology. In June, the company signed an option agreement with private biotech, TMS Co., Ltd. to acquire a phase II acute stroke candidate TMS-007 and backup compounds.
However in February 2018, Biogen faced a setback when its MS drug, Tysabri (natalizumab), failed in a phase IIb program evaluating it in acute ischemic stroke. Successful completion of clinical studies in these indications will be necessary for long-term growth of Biogen and offset competition in its key target market.
Zacks Rank & Stocks to Consider
Biogen currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the pharma space are Endo International plc (ENDP - Free Report) , BioSpecifics Technologies Corp (BSTC - Free Report) and Pacira Pharmaceuticals, Inc. (PCRX - Free Report) . While BioSpecifics and Pacira sport a Zacks Rank #1 (Strong Buy), Endo carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo’s earnings per share estimates have increased from $2.36 to $2.60 for 2018 and from $2.50 to $2.69 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 29.11%. The stock has rallied 121.1% so far this year.
BioSpecifics’ earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 22.9% so far this year.
Pacira’s earnings per share estimates have increased from 23 cents to 52 cents for 2018 and from 96 cents to $1.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 172.92%. The stock has gained 2.3% so far this year.
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