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Dianthus (DNTH) Gains 18% in the Past Month: Here's Why
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Dianthus Therapeutics (DNTH - Free Report) is a clinical-stage company, developing next-generation complement therapies to treat severe autoimmune diseases.
Its lead investigational candidate is DNTH103, which is being developed for several autoimmune indications, like generalized Myasthenia Gravis (gMG), multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Dianthus’ stock gained 17.5% in the past month after the company announced the FDA clearance of its investigational new drug application to begin a phase II study called MoMeNtum of DNTH103 in patients with MMN, around mid-June. MMN is a rare, progressive neurological disorder characterized by muscle weakness and wasting in the limbs due to immune system attacks on motor nerves.
DNTH103 is a monoclonal antibody in clinical development. It is designed to selectively inhibit the active form of the C1s protein, a vital component of the classical complement pathway, which has been clinically validated as a therapeutic target for autoimmune diseases. Dianthus believes the investigational candidate has best-in-class potential across various autoimmune disorders with high unmet needs.
The company believes that current treatments for MMN are limited to intravenous or subcutaneous infusions of immunoglobin (Ig), which are often inconvenient and challenging for patients to tolerate. Treatment with an active C1s inhibitor like DNTH103 could significantly improve the quality of life for these patients as it is much easier to use. This is expected to increase patient compliance.
Year to date, shares of Dianthus have skyrocketed 142.5% against the industry’s 6.9% decline.
Image Source: Zacks Investment Research
The planned global phase II MoMeNtum study will evaluate the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN. After assessing Ig dependency and responsiveness, the enrolled patients will be randomly assigned to receive either a placebo or DNTH103 subcutaneously every two weeks.
The initial treatment period will last 17 weeks, followed by a 52-week open-label extension. The primary goal is to evaluate safety and tolerability, while secondary goals include measuring the time to IVIg retreatment, time to relapse, and muscle and grip strength. Initial top-line results are expected in the second half of 2026.
Per Dianthus, approximately 5,000 to 10,000 people in the United States live with MMN, the majority of whom are not adequately managed by current standard-of-care treatment. In the absence of approved targeted biologic therapies for MMN, there is a significant market opportunity for Dianthus.
Please note that the company has also initiated a phase II study evaluating DNTH103 for the treatment of gMG. Topline data from this study is expected in the second half of 2025. Additionally, Dianthus is also gearing up to initiate a separate phase II study to evaluate DNTH103 for the CIDP indication in the second half of 2024.
In the first quarter of 2024 earnings release, the company reported having cash, cash equivalents and short-term investments worth $377.0 million, which it expects to be sufficient to fund operations into the second half of 2027. This indicates that the company enjoys a favorable cash position.
However, it is important to note that several other players in this market are also developing novel therapies for several autoimmune indications, an example is Immunovant (IMVT - Free Report) . Immunovant is currently developing its lead investigational candidate, IMVT-1402, also a monoclonal antibody, across several autoimmune indications, including Graves’ disease, MG, CIDP and thyroid eye disease.
Last year, Immunovant reported positive topline data from a phase I study evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered IMVT-1402. Based on such results, the company is gearing up to potentially initiate several registrational studies on the candidate for the above-mentioned indications.
Immunovant believes that IMVT-1402, if developed successfully, would be differentiated from the currently available, more invasive treatments, enabling it to capture market share. IMVT-1402’s best-in-class features are expected to maximize efficacy in treating autoimmune indications.
Zacks Rank and Stocks to Consider
Dianthus currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 63.4%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 21.2%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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Dianthus (DNTH) Gains 18% in the Past Month: Here's Why
Dianthus Therapeutics (DNTH - Free Report) is a clinical-stage company, developing next-generation complement therapies to treat severe autoimmune diseases.
Its lead investigational candidate is DNTH103, which is being developed for several autoimmune indications, like generalized Myasthenia Gravis (gMG), multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Dianthus’ stock gained 17.5% in the past month after the company announced the FDA clearance of its investigational new drug application to begin a phase II study called MoMeNtum of DNTH103 in patients with MMN, around mid-June. MMN is a rare, progressive neurological disorder characterized by muscle weakness and wasting in the limbs due to immune system attacks on motor nerves.
DNTH103 is a monoclonal antibody in clinical development. It is designed to selectively inhibit the active form of the C1s protein, a vital component of the classical complement pathway, which has been clinically validated as a therapeutic target for autoimmune diseases. Dianthus believes the investigational candidate has best-in-class potential across various autoimmune disorders with high unmet needs.
The company believes that current treatments for MMN are limited to intravenous or subcutaneous infusions of immunoglobin (Ig), which are often inconvenient and challenging for patients to tolerate. Treatment with an active C1s inhibitor like DNTH103 could significantly improve the quality of life for these patients as it is much easier to use. This is expected to increase patient compliance.
Year to date, shares of Dianthus have skyrocketed 142.5% against the industry’s 6.9% decline.
Image Source: Zacks Investment Research
The planned global phase II MoMeNtum study will evaluate the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN. After assessing Ig dependency and responsiveness, the enrolled patients will be randomly assigned to receive either a placebo or DNTH103 subcutaneously every two weeks.
The initial treatment period will last 17 weeks, followed by a 52-week open-label extension. The primary goal is to evaluate safety and tolerability, while secondary goals include measuring the time to IVIg retreatment, time to relapse, and muscle and grip strength. Initial top-line results are expected in the second half of 2026.
Per Dianthus, approximately 5,000 to 10,000 people in the United States live with MMN, the majority of whom are not adequately managed by current standard-of-care treatment. In the absence of approved targeted biologic therapies for MMN, there is a significant market opportunity for Dianthus.
Please note that the company has also initiated a phase II study evaluating DNTH103 for the treatment of gMG. Topline data from this study is expected in the second half of 2025. Additionally, Dianthus is also gearing up to initiate a separate phase II study to evaluate DNTH103 for the CIDP indication in the second half of 2024.
In the first quarter of 2024 earnings release, the company reported having cash, cash equivalents and short-term investments worth $377.0 million, which it expects to be sufficient to fund operations into the second half of 2027. This indicates that the company enjoys a favorable cash position.
However, it is important to note that several other players in this market are also developing novel therapies for several autoimmune indications, an example is Immunovant (IMVT - Free Report) . Immunovant is currently developing its lead investigational candidate, IMVT-1402, also a monoclonal antibody, across several autoimmune indications, including Graves’ disease, MG, CIDP and thyroid eye disease.
Last year, Immunovant reported positive topline data from a phase I study evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered IMVT-1402. Based on such results, the company is gearing up to potentially initiate several registrational studies on the candidate for the above-mentioned indications.
Immunovant believes that IMVT-1402, if developed successfully, would be differentiated from the currently available, more invasive treatments, enabling it to capture market share. IMVT-1402’s best-in-class features are expected to maximize efficacy in treating autoimmune indications.
Zacks Rank and Stocks to Consider
Dianthus currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the drug/biotech industryworth mentioning are ALX Oncology Holdings (ALXO - Free Report) and Compugen (CGEN - Free Report) . Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 63.4%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 21.2%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.