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ABSI Stock Up on Initiating Dosing in Androgenetic Alopecia Study
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Key Takeaways
Absci Corporation began dosing in its phase I/IIa study of ABS-201 for androgenetic alopecia.
The HEADLINE study will assess safety, tolerability, PK, PD and early efficacy measures in healthy volunteers.
Positive MAD results could advance ABS-201 to accelerated development as a potential new AGA therapy.
Shares of Absci Corporation (ABSI - Free Report) jumped 13.4% on Thursday after the company initiated dosing in an early-to-mid-stage study evaluating its investigational candidate, ABS-201, for androgenetic alopecia (AGA). ABS-201 is ABSI’s novel anti-PRLR antibody developed using the company’s generative AI platform.
Absci Corporation’s phase I/IIa HEADLINE study will evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ABS-201 in AGA patients. The company anticipates reporting interim data from the study in the second half of 2026.
ABSI’s Alopecia Study Design for ABS-201 in Detail
The phase I/IIa HEADLINE study is a randomized, first-in-human study evaluating ABS-201 in up to 227 healthy volunteers, both with and without AGA. The study will evaluate the candidate's safety and tolerability as its primary endpoints. The study’s secondary endpoints include PK, PD, immunogenicity, and multiple early efficacy indicators, such as hair count, hair width, pigmentation, and patient- and investigator-reported outcomes.
The HEADLINE study begins with a single-ascending-dose (SAD) stage assessing 4-6 intravenous dose groups of ABS-201 for safety, tolerability, PK and PD, before progressing to a multiple-ascending-dose (MAD) stage, which will evaluate 3-4 subcutaneous dosing groups in healthy volunteers with AGA. This latter phase is designed to demonstrate human proof-of-concept for the use of ABS-201 to treat AGA by stimulating significant hair regrowth.
If the MAD portion delivers positive efficacy signals, Absci Corporation expects the program to advance into accelerated registrational development, positioning ABS-201 as a potential new therapeutic option in the AGA treatment landscape.
In the past year, ABSI shares have gained 20% compared with the industry’s 10.1% growth.
Image Source: Zacks Investment Research
Last month, Absci Corporation expanded its development strategy for ABS-201 to include endometriosis as a second indication. The phase I/IIa AGA study of the candidate is expected to generate safety, tolerability, and PK data that would support moving the program into phase II development for the endometriosis indication. The company aims to initiate phase II clinical development of ABS-201 for endometriosis in the fourth quarter of 2026, using insights from the SAD portion of the AGA study, and anticipates an interim readout in the second half of 2027.
AGA, better known as male- or female-pattern hair loss, affects roughly 80 million people in the United States, leading to crown balding and receding hairlines in men and gradual hair thinning in women. Endometriosis, on the other hand, is a chronic inflammatory condition affecting an estimated 5-10% of women of reproductive age, including roughly nine million in the United States, with no curative medical or surgical options. Both conditions represent large, underserved markets with significant unmet need.
Absci Corporation is positioning ABS-201 as a differentiated therapeutic approach for AGA and endometriosis, where current treatment options often fall short on efficacy or carry meaningful side-effect burdens. With prolactin recognized as an important biological driver in both diseases, targeting the prolactin receptor offers a novel and potentially more effective pathway for intervention. ABSI believes that ABS-201 could become a safer, more effective, and longer-lasting alternative for these patients who remain underserved by existing standards of care.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 12% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have rallied 151.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have gained 45.2%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
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ABSI Stock Up on Initiating Dosing in Androgenetic Alopecia Study
Key Takeaways
Shares of Absci Corporation (ABSI - Free Report) jumped 13.4% on Thursday after the company initiated dosing in an early-to-mid-stage study evaluating its investigational candidate, ABS-201, for androgenetic alopecia (AGA). ABS-201 is ABSI’s novel anti-PRLR antibody developed using the company’s generative AI platform.
Absci Corporation’s phase I/IIa HEADLINE study will evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ABS-201 in AGA patients. The company anticipates reporting interim data from the study in the second half of 2026.
ABSI’s Alopecia Study Design for ABS-201 in Detail
The phase I/IIa HEADLINE study is a randomized, first-in-human study evaluating ABS-201 in up to 227 healthy volunteers, both with and without AGA. The study will evaluate the candidate's safety and tolerability as its primary endpoints. The study’s secondary endpoints include PK, PD, immunogenicity, and multiple early efficacy indicators, such as hair count, hair width, pigmentation, and patient- and investigator-reported outcomes.
The HEADLINE study begins with a single-ascending-dose (SAD) stage assessing 4-6 intravenous dose groups of ABS-201 for safety, tolerability, PK and PD, before progressing to a multiple-ascending-dose (MAD) stage, which will evaluate 3-4 subcutaneous dosing groups in healthy volunteers with AGA. This latter phase is designed to demonstrate human proof-of-concept for the use of ABS-201 to treat AGA by stimulating significant hair regrowth.
If the MAD portion delivers positive efficacy signals, Absci Corporation expects the program to advance into accelerated registrational development, positioning ABS-201 as a potential new therapeutic option in the AGA treatment landscape.
In the past year, ABSI shares have gained 20% compared with the industry’s 10.1% growth.
Image Source: Zacks Investment Research
Last month, Absci Corporation expanded its development strategy for ABS-201 to include endometriosis as a second indication. The phase I/IIa AGA study of the candidate is expected to generate safety, tolerability, and PK data that would support moving the program into phase II development for the endometriosis indication. The company aims to initiate phase II clinical development of ABS-201 for endometriosis in the fourth quarter of 2026, using insights from the SAD portion of the AGA study, and anticipates an interim readout in the second half of 2027.
AGA, better known as male- or female-pattern hair loss, affects roughly 80 million people in the United States, leading to crown balding and receding hairlines in men and gradual hair thinning in women. Endometriosis, on the other hand, is a chronic inflammatory condition affecting an estimated 5-10% of women of reproductive age, including roughly nine million in the United States, with no curative medical or surgical options. Both conditions represent large, underserved markets with significant unmet need.
Absci Corporation is positioning ABS-201 as a differentiated therapeutic approach for AGA and endometriosis, where current treatment options often fall short on efficacy or carry meaningful side-effect burdens. With prolactin recognized as an important biological driver in both diseases, targeting the prolactin receptor offers a novel and potentially more effective pathway for intervention. ABSI believes that ABS-201 could become a safer, more effective, and longer-lasting alternative for these patients who remain underserved by existing standards of care.
Absci Corporation Price and Consensus
Absci Corporation price-consensus-chart | Absci Corporation Quote
ABSI's Zacks Rank & Stocks to Consider
Absci Corporation currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector include CorMedix (CRMD - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 12% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have rallied 151.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have gained 45.2%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.