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Dr. Reddy's (RDY), COYA Ink Deal to Develop COYA 302 for ALS
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Dr. Reddy's Laboratories (RDY - Free Report) announced entering into a licensing agreement with Coya Therapeutics, Inc. (COYA - Free Report) for the development and commercialization of the latter’s investigational combination therapy, COYA 302, for the treatment of Amyotrophic Lateral Sclerosis (ALS).
ALS is a neurodegenerative disease that causes progressive muscle weakness and paralysis due to the death of nerve cells in the brain and spinal cord. ALS seriously affects the quality of life of patients suffering from it as it leads to progressive loss of voluntary muscle movement required for speaking, walking, swallowing and breathing.
Coya Therapeutics’ COYA 302 is a proprietary combination product of low-dose IL-2 and CTLA-4 Ig (abatacept), being developed for subcutaneous administration for the treatment of ALS patients.
This novel investigational candidate has a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells and suppress the inflammation produced by activated monocytes and macrophages.
COYA 302 is yet to be approved by the FDA or any other regulatory agency.
Year to date, shares of Dr. Reddy’s have rallied 34.2% compared with the industry’s 30.5% growth.
Image Source: Zacks Investment Research
The collaboration grants Dr. Reddy’s an exclusive license to commercialize COYA 302 in the United States, Canada, EU and UK for ALS. However, Coya retains the commercialization rights for COYA 302 in Japan, Mexico, and each country in South America in the ALS indication.
Per the terms of this agreement, Coya is responsible for clinical development of COYA 302 and for seeking U.S. regulatory approval for this drug in the treatment of ALS. On the other hand, RDY is liable to make an upfront payment of $7.5 million for the licensing agreement and several other milestone payments to Coya during the development process of COYA 302.
Dr. Reddy’s will make the first milestone payment of $4.2 million to Coya upon the first FDA acceptance of an investigational new drug application (IND) for COYA 302 in ALS. Once Coya has completed dosing the first patient in the first mid-stage study of COYA 302 for ALS treatment in the United States, the company will make an additional payment of $4.2 million.
Coya Therapeutics expects the IND filing for COYA 302 in ALS to be made in the first half of 2024.
In totality, Dr. Reddy’s is liable to pay up to $40 million to Coya in milestone payments, subject to the achievement of all development and regulatory milestones.
If COYA 302 is successfully commercialized, the company will be further liable to pay Coya sales-based milestone payments of up to $677.25 million linked to tiers of cumulative net sales being achieved over several years. Additionally, RDY will also have to pay Coya royalties based on a percentage of net sales of COYA 302 ranging from low to middle teens.
The press release states that this current agreement signed for COYA 302 is in addition to the in-licensing agreement with Dr. Reddy’s signed in early 2023. The March 2023 agreement granted Coya the license to RDY’s proposed biosimilar for Orencia (abatacept) for the development and commercialization of COYA 302 for neurodegenerative diseases.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 67.4%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Dr. Reddy's (RDY), COYA Ink Deal to Develop COYA 302 for ALS
Dr. Reddy's Laboratories (RDY - Free Report) announced entering into a licensing agreement with Coya Therapeutics, Inc. (COYA - Free Report) for the development and commercialization of the latter’s investigational combination therapy, COYA 302, for the treatment of Amyotrophic Lateral Sclerosis (ALS).
ALS is a neurodegenerative disease that causes progressive muscle weakness and paralysis due to the death of nerve cells in the brain and spinal cord. ALS seriously affects the quality of life of patients suffering from it as it leads to progressive loss of voluntary muscle movement required for speaking, walking, swallowing and breathing.
Coya Therapeutics’ COYA 302 is a proprietary combination product of low-dose IL-2 and CTLA-4 Ig (abatacept), being developed for subcutaneous administration for the treatment of ALS patients.
This novel investigational candidate has a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells and suppress the inflammation produced by activated monocytes and macrophages.
COYA 302 is yet to be approved by the FDA or any other regulatory agency.
Year to date, shares of Dr. Reddy’s have rallied 34.2% compared with the industry’s 30.5% growth.
Image Source: Zacks Investment Research
The collaboration grants Dr. Reddy’s an exclusive license to commercialize COYA 302 in the United States, Canada, EU and UK for ALS. However, Coya retains the commercialization rights for COYA 302 in Japan, Mexico, and each country in South America in the ALS indication.
Per the terms of this agreement, Coya is responsible for clinical development of COYA 302 and for seeking U.S. regulatory approval for this drug in the treatment of ALS. On the other hand, RDY is liable to make an upfront payment of $7.5 million for the licensing agreement and several other milestone payments to Coya during the development process of COYA 302.
Dr. Reddy’s will make the first milestone payment of $4.2 million to Coya upon the first FDA acceptance of an investigational new drug application (IND) for COYA 302 in ALS. Once Coya has completed dosing the first patient in the first mid-stage study of COYA 302 for ALS treatment in the United States, the company will make an additional payment of $4.2 million.
Coya Therapeutics expects the IND filing for COYA 302 in ALS to be made in the first half of 2024.
In totality, Dr. Reddy’s is liable to pay up to $40 million to Coya in milestone payments, subject to the achievement of all development and regulatory milestones.
If COYA 302 is successfully commercialized, the company will be further liable to pay Coya sales-based milestone payments of up to $677.25 million linked to tiers of cumulative net sales being achieved over several years. Additionally, RDY will also have to pay Coya royalties based on a percentage of net sales of COYA 302 ranging from low to middle teens.
The press release states that this current agreement signed for COYA 302 is in addition to the in-licensing agreement with Dr. Reddy’s signed in early 2023. The March 2023 agreement granted Coya the license to RDY’s proposed biosimilar for Orencia (abatacept) for the development and commercialization of COYA 302 for neurodegenerative diseases.
Dr. Reddy's Laboratories Ltd Price and Consensus
Dr. Reddy's Laboratories Ltd price-consensus-chart | Dr. Reddy's Laboratories Ltd Quote
Zacks Rank and Stocks to Consider
RDY currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), AGEN carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 67.4%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.