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Pieris (PIRS) Declines as AZN Halts Study of Asthma Candidate
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PierisPharmaceuticals’ shares plunged almost 70% on Jun 21 and 15% on Jun 22, as its partner AstraZeneca (AZN - Free Report) decided to discontinue and cease dosing in the ongoing mid-stage study of elarekibep.
This decision was based on the lung study findings from a non-clinical toxicology study that raised concerns about the long-term use and progression of the candidate.
Pieris’ lead candidate, elarekibep, is an inhaled IL-4 receptor alpha inhibitor under development for the treatment of asthma.
The non-clinical study was conducted over a period of 13 weeks on non-human primates that involved three active dose cohorts. Although AstraZeneca did not notice any clinical issue at different doses, it found significant problems in the respiratory tract. The study showed that the lungs suffered damaged due to inflammation, though it did not seem to be linked to the dosage of the candidate.
The results proved to be a setback for Pieris. The company had already initiated enrollment in the phase IIa study when AstraZeneca made its decision.
However, the findings from the toxicology study emphasized the need for supportive long-term non-clinical data before proceeding to late-stage development.
Shares of Pieris have nosedived 78.8% year to date compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
In light of AstraZeneca's decision and the new data, PIRS will conduct a comprehensive review of the implications for the elarekibep program. Pieris plans to reassess its priorities and determine the best course of action moving forward.
While AZN’s decisionis undoubtedly disappointing, it is not uncommon in the pharmaceutical industry. Drug development is a complex and challenging process that requires careful evaluation and consideration of safety and efficacy.
The companies were also co-developing a discovery-stage program with an undisclosed target. In the second quarter of 2023, they jointly discontinued the program in order to focus their resources on the other remaining and more advanced program.
Meanwhile, Pieris still maintains the option to co-develop and co-commercialize the remaining discovery-stage program in the United States.
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 5.1% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.51 per share to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 26.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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Pieris (PIRS) Declines as AZN Halts Study of Asthma Candidate
PierisPharmaceuticals’ shares plunged almost 70% on Jun 21 and 15% on Jun 22, as its partner AstraZeneca (AZN - Free Report) decided to discontinue and cease dosing in the ongoing mid-stage study of elarekibep.
This decision was based on the lung study findings from a non-clinical toxicology study that raised concerns about the long-term use and progression of the candidate.
Pieris’ lead candidate, elarekibep, is an inhaled IL-4 receptor alpha inhibitor under development for the treatment of asthma.
The non-clinical study was conducted over a period of 13 weeks on non-human primates that involved three active dose cohorts. Although AstraZeneca did not notice any clinical issue at different doses, it found significant problems in the respiratory tract. The study showed that the lungs suffered damaged due to inflammation, though it did not seem to be linked to the dosage of the candidate.
The results proved to be a setback for Pieris. The company had already initiated enrollment in the phase IIa study when AstraZeneca made its decision.
However, the findings from the toxicology study emphasized the need for supportive long-term non-clinical data before proceeding to late-stage development.
Shares of Pieris have nosedived 78.8% year to date compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
In light of AstraZeneca's decision and the new data, PIRS will conduct a comprehensive review of the implications for the elarekibep program. Pieris plans to reassess its priorities and determine the best course of action moving forward.
While AZN’s decisionis undoubtedly disappointing, it is not uncommon in the pharmaceutical industry. Drug development is a complex and challenging process that requires careful evaluation and consideration of safety and efficacy.
The companies were also co-developing a discovery-stage program with an undisclosed target. In the second quarter of 2023, they jointly discontinued the program in order to focus their resources on the other remaining and more advanced program.
Meanwhile, Pieris still maintains the option to co-develop and co-commercialize the remaining discovery-stage program in the United States.
Pieris Pharmaceuticals, Inc. Price and Consensus
Pieris Pharmaceuticals, Inc. price-consensus-chart | Pieris Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Pieris currently has a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) and Omega Therapeutics , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 5.1% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.51 per share to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 26.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.