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Apogee (APGE) Stock Rallies 95.6% in a Month: Here's Why
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Apogee Therapeutics Inc. (APGE - Free Report) , a clinical-stage company, is focused on developing novel therapies for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and related inflammatory and immunology (I&I) indications where there is a high unmet medical need.
Apogee’s clinical-stage pipeline comprises two investigational candidates, APG777 and APG808, which we are initially developing for the treatment of AD and COPD, respectively. The differentiated mechanisms of action are expected to enable these investigational candidates to overcome the limitations of existing standard-of-care therapies for these indications.
Shares of APGE have surged 95.6% in the past month against the industry’s 0.1% decline. The steep rise in the stock price has been observed after the company announced positive interim results from its phase I study for APG777 in the frontline treatment of moderate-to-severe AD in healthy volunteers earlier this month.
Image Source: Zacks Investment Research
APG777, one of the company’s lead product candidates, is a novel half-life extended anti-IL-13 antibody.
The phase I study enrolled 40 healthy adults who were randomized into three single-ascending dose and two multiple-ascending dose cohorts. The study evaluated three subcutaneous dosage strengths of APG777 (300mg, 600mg and 1,200mg).
The results from the study exceeded Apogee’s expectations as well as investors who were supporting the potential for APG777 to provide greater therapeutic benefit over the current standard of care treatments, thereby exceeding its study objectives ahead of schedule with a half-life of approximately 75 days.
Per pharmacokinetic data from the study, the candidate demonstrated potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing (once every three or six months) in maintenance compared with currently approved biologic therapies, which are dosed at every two to four weeks. This represents a potential breakthrough for patients with AD and other inflammatory diseases.
Furthermore, pharmacodynamic data from the study showed the achievement of deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for three months.
Apogee reported that treatment with all dose strengths of APG777 was well tolerated by the AD patients with a favorable safety profile consistent with the anti-IL-13 class.
The invasive nature of available treatments, involving frequent injection regimens, often leads to poor patient compliance, which hinders treatment efficacy. However, the less frequent injection regimens of APG777 to treat AD significantly reduce the treatment burden of patients, which will allow greater compliance.
Based on positive results from the early-stage study of APG777 to treat AD, the company is gearing up to initiate a phase II study in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
The planned phase II study will be conducted in two parts, Part A and Part B. Notably, Part A portion of the study will evaluate the efficacy and safety of a single dose of APG777 against placebo. Part B will evaluate the same for high, medium or low doses of APG777 against placebo.
The 16-week top-line data readout from Part A of the planned phase II study of APG777 for the AD indication is expected in the second half of 2025.
Recently, Apogee also announced initiating the dosing of healthy volunteers in its phase I study of APG808, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.
APG808 is a novel, subcutaneous extended half-life mAb targeting IL-4Rα. The ongoing phase I study will evaluate the safety, tolerability and pharmacokinetics of APG808 in healthy adults. Interim data readout is expected in the second half of 2024.
Subject to positive results from the early-stage study, and following investigational new drug application clearance by the FDA, Apogee plans to initiate a potential phase Ib study in asthma with a data readout in the first half of 2025 and a phase II study in patients with moderate-to-severe COPD in 2025.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past month, shares of ADMA have surged 25.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past month, shares of FGEN have gained 50.9%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past month, shares of ACET have lost 0.9%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.
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Apogee (APGE) Stock Rallies 95.6% in a Month: Here's Why
Apogee Therapeutics Inc. (APGE - Free Report) , a clinical-stage company, is focused on developing novel therapies for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and related inflammatory and immunology (I&I) indications where there is a high unmet medical need.
Apogee’s clinical-stage pipeline comprises two investigational candidates, APG777 and APG808, which we are initially developing for the treatment of AD and COPD, respectively. The differentiated mechanisms of action are expected to enable these investigational candidates to overcome the limitations of existing standard-of-care therapies for these indications.
Shares of APGE have surged 95.6% in the past month against the industry’s 0.1% decline. The steep rise in the stock price has been observed after the company announced positive interim results from its phase I study for APG777 in the frontline treatment of moderate-to-severe AD in healthy volunteers earlier this month.
Image Source: Zacks Investment Research
APG777, one of the company’s lead product candidates, is a novel half-life extended anti-IL-13 antibody.
The phase I study enrolled 40 healthy adults who were randomized into three single-ascending dose and two multiple-ascending dose cohorts. The study evaluated three subcutaneous dosage strengths of APG777 (300mg, 600mg and 1,200mg).
The results from the study exceeded Apogee’s expectations as well as investors who were supporting the potential for APG777 to provide greater therapeutic benefit over the current standard of care treatments, thereby exceeding its study objectives ahead of schedule with a half-life of approximately 75 days.
Per pharmacokinetic data from the study, the candidate demonstrated potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing (once every three or six months) in maintenance compared with currently approved biologic therapies, which are dosed at every two to four weeks. This represents a potential breakthrough for patients with AD and other inflammatory diseases.
Furthermore, pharmacodynamic data from the study showed the achievement of deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for three months.
Apogee reported that treatment with all dose strengths of APG777 was well tolerated by the AD patients with a favorable safety profile consistent with the anti-IL-13 class.
The invasive nature of available treatments, involving frequent injection regimens, often leads to poor patient compliance, which hinders treatment efficacy. However, the less frequent injection regimens of APG777 to treat AD significantly reduce the treatment burden of patients, which will allow greater compliance.
Based on positive results from the early-stage study of APG777 to treat AD, the company is gearing up to initiate a phase II study in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
The planned phase II study will be conducted in two parts, Part A and Part B. Notably, Part A portion of the study will evaluate the efficacy and safety of a single dose of APG777 against placebo. Part B will evaluate the same for high, medium or low doses of APG777 against placebo.
The 16-week top-line data readout from Part A of the planned phase II study of APG777 for the AD indication is expected in the second half of 2025.
Recently, Apogee also announced initiating the dosing of healthy volunteers in its phase I study of APG808, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.
APG808 is a novel, subcutaneous extended half-life mAb targeting IL-4Rα. The ongoing phase I study will evaluate the safety, tolerability and pharmacokinetics of APG808 in healthy adults. Interim data readout is expected in the second half of 2024.
Subject to positive results from the early-stage study, and following investigational new drug application clearance by the FDA, Apogee plans to initiate a potential phase Ib study in asthma with a data readout in the first half of 2025 and a phase II study in patients with moderate-to-severe COPD in 2025.
Apogee Therapeutics Inc. Price and Consensus
Apogee Therapeutics Inc. price-consensus-chart | Apogee Therapeutics Inc. Quote
Zacks Rank and Stocks to Consider
Apogee currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 (Buy) each 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 ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past month, shares of ADMA have surged 25.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past month, shares of FGEN have gained 50.9%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past month, shares of ACET have lost 0.9%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.