Biogen Inc BIIB shares, which suffered a severe setback in early 2019 after the company's Alzheimer's program flopped, were seeing a resurgence Tuesday.
The stock fell under the psychological barrier of $300 March 21, when the company and its development partner Eisai Co., Ltd ESALY announced their decision to shelve two late-stage studies dubbed ENGAGE and EMERGE that evaluated the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.
After moving roughly sideways in a range of $215.78-$246.99, Biogen stock has reclaimed the $300 level, with the catalyst being a startling about-face with respect to its Alzheimer's program.
Alzheimer's Program Revived
Biogen said Tuesday it plans to file a BLA for aducanumab for the treatment of early Alzheimer's disease following consultation with the FDA.
The decision was based on a new analysis conducted by Biogen in consultation with the FDA of a larger dataset from the Phase 3 clinical studies that were discontinued in March following a futility analysis.
The positive results of the new analysis were due to a greater exposure to high-dose aducanumab in the larger dataset as compared to data available at the time of futility analysis.
Elaborating on the results, Biogen said the Phase 3 EMERGE study met the primary endpoint, showing a significant reduction in clinical decline, and the patients in the Phase 3 ENGAGE study who received sufficient exposure to high-dose aducanumab supported the findings from EMERGE.
"We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer's disease and the potential implication of these results for similar approaches targeting amyloid beta," Biogen CEO Michel Vounatsos said in a statement.
Mid-2020 Filing Targeted
The company said it plans to file a BLA in early 2020 while it continues dialogue with regulatory agencies in international markets, including Europe and Japan.
"Biogen will work towards this goal with regulatory authorities and principal investigators with a sense of urgency," according to the company.
Alzheimer's drug development has the highest failure rate of all drug research. If aducanumab is successful in crossing the regulatory hurdle, it could gain a huge first-mover advantage and potentially add billions to Biogen's top line.
Q3 Print Outpaces Estimates
Biogen also reported third-quarter results that exceeded estimates. Revenue rose 5% year-over-year to $3.6 billion, with the multiple sclerosis franchise raking in $2.35 billion, a 2% increase, the company said in a separate statement.
The spinal muscular dystrophy drug Spinraza and biosimilars also contributed to the upside.
Non-GAAP earnings per share, or EPS, climbed 24% to $9.17, as cost of sales fell 7%.
Analysts, on average, estimated EPS of $8.27 and revenue of $3.54 billion.
The stock was rallying by 38% to $308.47 in Tuesday's premarket session.
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