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Avalo (AVTX) Fails to Meet Goal in Asthma Study, Stock Down 89%
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Avalo Therapeutics, Inc. (AVTX - Free Report) announced dismal top-line results from its phase II PEAK study of AVTX-002, a fully human, anti-LIGHT mAb, for treating patients with poorly controlled non-eosinophilic asthma (NEA). Per the data readout, the study failed to meet its primary endpoint of reduction in asthma-related events.
The stock of the company plunged 89% on Monday in response to the study failure.
Year to date, shares of Avalo have plunged 90.1% compared with the industry’s fall of 2%.
Image Source: Zacks Investment Research
The mid-stage PEAK study was evaluating the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA in 91 patients. The enrolled patients were divided into two cohorts, receiving either a 600 mg dose of AVTX-002 or placebo subcutaneously at days 0, 28 and 56. After 12 weeks of treatment, the efficacy and safety of AVTX-002 were evaluated in comparison with treatment with placebo through week 14.
The primary endpoint of the study constituted a reduction in several pre-defined asthma-related events associated with NEA.
It was observed that AVTX-002 exhibited a favorable safety and tolerability profile. Despite failing to meet the primary endpoint of the study, an additional exploratory analysis demonstrated a positive trend in the reduction of asthma-related events in patients treated with AVTX-002 as compared with placebo within a substantial sub-population of patients with elevated baseline LIGHT levels. AVTX-002 provided the proof of target engagement by significantly reducing LIGHT levels for the study duration.
Per Avalo, reducing LIGHT levels could potentially moderate immune dysregulation in many acute and chronic inflammatory disorders. Avalo also reported that its NEA candidate drug, AVTX-002, had previously demonstrated proof of concept in COVID-19-induced acute respiratory distress syndrome, including a reduction in mortality and respiratory failure, as well as a positive signal in Crohn’s Disease.
In the past 90 days, the Zacks Consensus Estimate for Akebia Therapeutics’ 2023 loss per share has narrowed from 45 cents to 28 cents. During the same period, the estimate for Akebia Therapeutics’ 2024 loss per share has narrowed from 25 cents to 16 cents. Year to date, shares of the company have gained by 57.7%.
AKBA beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 41.41%.
In the past 90 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 loss per share has narrowed from 80 cents to 53 cents. During the same period, the estimate for ImmunoGen’s 2024 loss per share has narrowed from 53 cents to 27 cents. Year to date, shares of the company have rallied by 281.5%.
IMGN beat estimates in two of the trailing four quarters and missed twice, delivering an average earnings surprise of 7.09%.
In the past 90 days, the Zacks Consensus Estimate for Iterum Therapeutics’ 2023 loss per share has narrowed from $5.91 to $3.31. During the same period, the estimate for Iterum Therapeutics’ 2024 loss per share has narrowed from $4.95 to $3.08. Year to date, shares of the company have risen by 27.4%.
ITRM beat estimates in three of the trailing four quarters and missed the mark once, delivering a negative average earnings surprise of 6.56%.
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Avalo (AVTX) Fails to Meet Goal in Asthma Study, Stock Down 89%
Avalo Therapeutics, Inc. (AVTX - Free Report) announced dismal top-line results from its phase II PEAK study of AVTX-002, a fully human, anti-LIGHT mAb, for treating patients with poorly controlled non-eosinophilic asthma (NEA). Per the data readout, the study failed to meet its primary endpoint of reduction in asthma-related events.
The stock of the company plunged 89% on Monday in response to the study failure.
Year to date, shares of Avalo have plunged 90.1% compared with the industry’s fall of 2%.
Image Source: Zacks Investment Research
The mid-stage PEAK study was evaluating the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA in 91 patients. The enrolled patients were divided into two cohorts, receiving either a 600 mg dose of AVTX-002 or placebo subcutaneously at days 0, 28 and 56. After 12 weeks of treatment, the efficacy and safety of AVTX-002 were evaluated in comparison with treatment with placebo through week 14.
The primary endpoint of the study constituted a reduction in several pre-defined asthma-related events associated with NEA.
It was observed that AVTX-002 exhibited a favorable safety and tolerability profile. Despite failing to meet the primary endpoint of the study, an additional exploratory analysis demonstrated a positive trend in the reduction of asthma-related events in patients treated with AVTX-002 as compared with placebo within a substantial sub-population of patients with elevated baseline LIGHT levels. AVTX-002 provided the proof of target engagement by significantly reducing LIGHT levels for the study duration.
Per Avalo, reducing LIGHT levels could potentially moderate immune dysregulation in many acute and chronic inflammatory disorders. Avalo also reported that its NEA candidate drug, AVTX-002, had previously demonstrated proof of concept in COVID-19-induced acute respiratory distress syndrome, including a reduction in mortality and respiratory failure, as well as a positive signal in Crohn’s Disease.
Avalo Therapeutics, Inc. Price and Consensus
Avalo Therapeutics, Inc. price-consensus-chart | Avalo Therapeutics, Inc. Quote
Zacks Rank and Other Stocks to Consider
Avalo currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the same industry are Akebia Therapeutics (AKBA - Free Report) , Immunogen and Iterum Therapeutics (ITRM - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Akebia Therapeutics’ 2023 loss per share has narrowed from 45 cents to 28 cents. During the same period, the estimate for Akebia Therapeutics’ 2024 loss per share has narrowed from 25 cents to 16 cents. Year to date, shares of the company have gained by 57.7%.
AKBA beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 41.41%.
In the past 90 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 loss per share has narrowed from 80 cents to 53 cents. During the same period, the estimate for ImmunoGen’s 2024 loss per share has narrowed from 53 cents to 27 cents. Year to date, shares of the company have rallied by 281.5%.
IMGN beat estimates in two of the trailing four quarters and missed twice, delivering an average earnings surprise of 7.09%.
In the past 90 days, the Zacks Consensus Estimate for Iterum Therapeutics’ 2023 loss per share has narrowed from $5.91 to $3.31. During the same period, the estimate for Iterum Therapeutics’ 2024 loss per share has narrowed from $4.95 to $3.08. Year to date, shares of the company have risen by 27.4%.
ITRM beat estimates in three of the trailing four quarters and missed the mark once, delivering a negative average earnings surprise of 6.56%.