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Annexon (ANNX) Stock Rallies 156% in 3 Months: Here's How
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Annexon, Inc. (ANNX - Free Report) , a clinical-stage company, is focused on developing novel therapies to treat patients suffering from serious complement-mediated autoimmune, neurodegenerative and ophthalmic disorders.
The company has channeled its resources to prioritize the development of three candidates in its pipeline, such as ANX005 for Guillain-Barré syndrome, ANX007 for geographic atrophy (GA) and first-in-kind oral complement small molecule, and ANX1502 for several autoimmune indications.
Over the past three months, shares of Annexon have skyrocketed 156.4% compared with the industry’s 12.3% rise. The massive uptick in the stock price was observed after the company shared its plans regarding the global registrational program for ANX007, a fragment antigen-bindingantibody, in GA after reaching an alignment with the FDA regarding the late-stage study’s primary endpoint.
Image Source: Zacks Investment Research
The alignment with the FDA regarding the registration program was reached around the end of 2023. The alignment includes using, for the first time, the prevention of ≥15-letter loss of best corrected visual acuity (BCVA) as the primary outcome measure, followed by a head-to-head comparison of ANX007 with Apellis Pharmaceuticals’ (APLS - Free Report) Syfovre (pegcetacoplan injection).
BCVA is a popular and widely used functional endpoint of vision preservation. It has been the basis for numerous ophthalmology drug approvals by the FDA and EU’s European Medicines Agency.
It is important to note that the FDA has not mandated Annexon to study the slowing of lesion growth as measured by fundus autofluorescence, an anatomical endpoint used for the approval of other GA programs.
Per Annexon, positive results from its phase II ARCHER study of ANX007 in GA were the basis for reaching alignment with the FDA regarding the registrational program of the candidate for the same indication. In the mid-stage study, treatment with the candidate resulted in statistically significant and dose-dependent visual protection in GA patients.
Per the company, current FDA-approved treatments have not shown a meaningful functional benefit after years of treatment, representing an unmet medical need for the GA patient population.
Notably, the planned registration program for ANX007 in GA is two-fold. The late-stage program will begin with a phase III ARCHER II study, designed to confirm the results from the phase II ARCHER study and potentially expedite the path to regulatory approval in the EU. Per Annexon, there are approximately 2.5 million people in the EU living with GA.
The second portion of the registration program will include the planned injection-controlled head-to-head ARROW study against Apellis’ Syfovre, given the availability of FDA-approved GA treatments in the United States. The ARROW study aims to potentially throw the spotlight on ANX007’s unique mechanism of action and critical differentiation on visual function.
ANNX expects to begin enrollment in the phase III ARCHER II study in mid-2024, followed by ARROW in late 2024.
We remind the investors that ANX007 currently enjoys the PRIME designation in the EU.
Apellis received FDA approval for Syfovre in February 2023 as the first and only treatment for GA secondary to age-related macular degeneration. The drug has been witnessing robust initial uptake since its commercial launch in March 2023.
APLS has also filed for a marketing authorization application seeking approval of intravitreal pegcetacoplan for the treatment of GA in the EU and several other countries, which is currently under review.
In December 2023, Annexon also reported positive results from the phase I single ascending dose and multiple ascending dose study of ANX1502, which could have also contributed to the stock price movement.
Per the results from the study, ANX1502 achieved target serum levels and demonstrated PK measures that support the initiation of a proof-of-concept clinical study on a tablet formulation of the candidate to assess PD and efficacy in patients with cold agglutinin disease in 2024.
Annexon plans to evaluate ANX1502 in serious complement-mediated autoimmune diseases to provide enhanced efficacy and offer convenient dosing administration for the long-term treatment of chronic conditions.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past three months, shares of PBYI have gained 123%.
PBYI 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 ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past three months, shares of ADMA have gained 48.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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Annexon (ANNX) Stock Rallies 156% in 3 Months: Here's How
Annexon, Inc. (ANNX - Free Report) , a clinical-stage company, is focused on developing novel therapies to treat patients suffering from serious complement-mediated autoimmune, neurodegenerative and ophthalmic disorders.
The company has channeled its resources to prioritize the development of three candidates in its pipeline, such as ANX005 for Guillain-Barré syndrome, ANX007 for geographic atrophy (GA) and first-in-kind oral complement small molecule, and ANX1502 for several autoimmune indications.
Over the past three months, shares of Annexon have skyrocketed 156.4% compared with the industry’s 12.3% rise. The massive uptick in the stock price was observed after the company shared its plans regarding the global registrational program for ANX007, a fragment antigen-bindingantibody, in GA after reaching an alignment with the FDA regarding the late-stage study’s primary endpoint.
Image Source: Zacks Investment Research
The alignment with the FDA regarding the registration program was reached around the end of 2023. The alignment includes using, for the first time, the prevention of ≥15-letter loss of best corrected visual acuity (BCVA) as the primary outcome measure, followed by a head-to-head comparison of ANX007 with Apellis Pharmaceuticals’ (APLS - Free Report) Syfovre (pegcetacoplan injection).
BCVA is a popular and widely used functional endpoint of vision preservation. It has been the basis for numerous ophthalmology drug approvals by the FDA and EU’s European Medicines Agency.
It is important to note that the FDA has not mandated Annexon to study the slowing of lesion growth as measured by fundus autofluorescence, an anatomical endpoint used for the approval of other GA programs.
Per Annexon, positive results from its phase II ARCHER study of ANX007 in GA were the basis for reaching alignment with the FDA regarding the registrational program of the candidate for the same indication. In the mid-stage study, treatment with the candidate resulted in statistically significant and dose-dependent visual protection in GA patients.
Per the company, current FDA-approved treatments have not shown a meaningful functional benefit after years of treatment, representing an unmet medical need for the GA patient population.
Notably, the planned registration program for ANX007 in GA is two-fold. The late-stage program will begin with a phase III ARCHER II study, designed to confirm the results from the phase II ARCHER study and potentially expedite the path to regulatory approval in the EU. Per Annexon, there are approximately 2.5 million people in the EU living with GA.
The second portion of the registration program will include the planned injection-controlled head-to-head ARROW study against Apellis’ Syfovre, given the availability of FDA-approved GA treatments in the United States. The ARROW study aims to potentially throw the spotlight on ANX007’s unique mechanism of action and critical differentiation on visual function.
ANNX expects to begin enrollment in the phase III ARCHER II study in mid-2024, followed by ARROW in late 2024.
We remind the investors that ANX007 currently enjoys the PRIME designation in the EU.
Apellis received FDA approval for Syfovre in February 2023 as the first and only treatment for GA secondary to age-related macular degeneration. The drug has been witnessing robust initial uptake since its commercial launch in March 2023.
APLS has also filed for a marketing authorization application seeking approval of intravitreal pegcetacoplan for the treatment of GA in the EU and several other countries, which is currently under review.
In December 2023, Annexon also reported positive results from the phase I single ascending dose and multiple ascending dose study of ANX1502, which could have also contributed to the stock price movement.
Per the results from the study, ANX1502 achieved target serum levels and demonstrated PK measures that support the initiation of a proof-of-concept clinical study on a tablet formulation of the candidate to assess PD and efficacy in patients with cold agglutinin disease in 2024.
Annexon plans to evaluate ANX1502 in serious complement-mediated autoimmune diseases to provide enhanced efficacy and offer convenient dosing administration for the long-term treatment of chronic conditions.
Annexon, Inc. Price and Consensus
Annexon, Inc. price-consensus-chart | Annexon, Inc. Quote
Zacks Rank and Other Stocks to Consider
Annexon currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the same industry are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 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 (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past three months, shares of PBYI have gained 123%.
PBYI 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 ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past three months, shares of ADMA have gained 48.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.