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Biogen's (BIIB) FDA Filing for ALS Drug Gets 3 Months Extension
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Biogen (BIIB - Free Report) announced that the FDA extended the review period for its new drug application (NDA). The NDA seeks approval for antisense drug tofersen in patients with amyotrophic lateral sclerosis (“ALS”) with superoxide dismutase 1 (“SOD1”) mutation.
Following the extension in NDA review, a final decision from the FDA is expected by April 2023. Prior to the extension, the FDA had originally set a target action date of January 2023.
The decision to extend the review period comes after Biogen submitted additional data, which the FDA requested. Per the agency, the submitted data constitutes a major amendment to the earlier filed data and needs additional time to be reviewed.
Biogen’s NDA filing was supported by data from the phase III VALOR study and its open label extension (OLE) study.
Shares of Biogen have increased 12.4% so far this year against the industry’s 26.7% decline.
Image Source: Zacks Investment Research
ALS is a neurodegenerative disease whose progression leads to a steady decline in the ability to move, speak, eat and eventually breathe. The average life expectancy of people with ALS ranges from three to five years. SOD1-mutated ALS is a genetic form of ALS that currently accounts for 2% of the ALS population.
Currently, there are no genetically targeted treatment options for ALS. Though the VALOR study did not achieve statistical significance in primary endpoints, data from the same demonstrated that patients whostarted tofersen earlier reported signs of reduced disease progression across multiple measures. The signs included a reduction in SOD1 protein, a drop in neurofilament and an improvement in respiratory function compared with placebo.
Data from the VALOR study also showed that compared with delayed initiation of treatment with tofersen, earlier initiation of treatment with tofersen showed clinical benefit in study participants. An earlier start of treatment with tofersen led to a slowed decline in clinical function, respiratory function, muscle strength and quality of life.
Biogen in-licensed rights to tofersen from Ionis Pharmaceuticals (IONS - Free Report) under a collaborative development and license agreement entered in 2018. Apart from tofersen, Biogen is also collaborating with Ionis to develop ION541 for ALS (phase II) and ION859 for Parkinson’s disease (phase I/II).
Biogen and Ionis already have an existing marketed drug, Spinraza, which has now become the standard-of-care treatment for treating spinal muscular atrophy (SMA). While Biogen is responsible for Spinraza’s sales, Ionis receives royalties on the same.
Biogen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Aerie Pharmaceuticals and Morphic (MORF - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Aerie Pharmaceuticals’ 2022 loss per share have narrowed from $1.83 to $1.82. During the same period, the loss estimates per share for 2023 have narrowed from $1.01 to $0.96. Shares of Aerie Pharmaceuticals have gained 116.7% in the year-to-date period.
Earnings of Aerie Pharmaceuticals beat estimates in two of the last four quarters and missed the mark twice, witnessing a surprise of 70.27% on average. In the last reported quarter, AERI delivered an earnings surprise of 38.46%.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61. Shares of Morphic have lost 43.1% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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Biogen's (BIIB) FDA Filing for ALS Drug Gets 3 Months Extension
Biogen (BIIB - Free Report) announced that the FDA extended the review period for its new drug application (NDA). The NDA seeks approval for antisense drug tofersen in patients with amyotrophic lateral sclerosis (“ALS”) with superoxide dismutase 1 (“SOD1”) mutation.
Following the extension in NDA review, a final decision from the FDA is expected by April 2023. Prior to the extension, the FDA had originally set a target action date of January 2023.
The decision to extend the review period comes after Biogen submitted additional data, which the FDA requested. Per the agency, the submitted data constitutes a major amendment to the earlier filed data and needs additional time to be reviewed.
Biogen’s NDA filing was supported by data from the phase III VALOR study and its open label extension (OLE) study.
Shares of Biogen have increased 12.4% so far this year against the industry’s 26.7% decline.
Image Source: Zacks Investment Research
ALS is a neurodegenerative disease whose progression leads to a steady decline in the ability to move, speak, eat and eventually breathe. The average life expectancy of people with ALS ranges from three to five years. SOD1-mutated ALS is a genetic form of ALS that currently accounts for 2% of the ALS population.
Currently, there are no genetically targeted treatment options for ALS. Though the VALOR study did not achieve statistical significance in primary endpoints, data from the same demonstrated that patients whostarted tofersen earlier reported signs of reduced disease progression across multiple measures. The signs included a reduction in SOD1 protein, a drop in neurofilament and an improvement in respiratory function compared with placebo.
Data from the VALOR study also showed that compared with delayed initiation of treatment with tofersen, earlier initiation of treatment with tofersen showed clinical benefit in study participants. An earlier start of treatment with tofersen led to a slowed decline in clinical function, respiratory function, muscle strength and quality of life.
Biogen in-licensed rights to tofersen from Ionis Pharmaceuticals (IONS - Free Report) under a collaborative development and license agreement entered in 2018. Apart from tofersen, Biogen is also collaborating with Ionis to develop ION541 for ALS (phase II) and ION859 for Parkinson’s disease (phase I/II).
Biogen and Ionis already have an existing marketed drug, Spinraza, which has now become the standard-of-care treatment for treating spinal muscular atrophy (SMA). While Biogen is responsible for Spinraza’s sales, Ionis receives royalties on the same.
Biogen Inc. Price
Biogen Inc. price | Biogen Inc. Quote
Zacks Rank & Stocks to Consider
Biogen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Aerie Pharmaceuticals and Morphic (MORF - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Aerie Pharmaceuticals’ 2022 loss per share have narrowed from $1.83 to $1.82. During the same period, the loss estimates per share for 2023 have narrowed from $1.01 to $0.96. Shares of Aerie Pharmaceuticals have gained 116.7% in the year-to-date period.
Earnings of Aerie Pharmaceuticals beat estimates in two of the last four quarters and missed the mark twice, witnessing a surprise of 70.27% on average. In the last reported quarter, AERI delivered an earnings surprise of 38.46%.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61. Shares of Morphic have lost 43.1% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.