Absci (Nasdaq: ABSI) shows favorable Phase 1 ABS-201 safety profile
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Absci Corporation reported positive interim Phase 1 results for ABS-201 from its HEADLINE trial in healthy adults with and without androgenetic alopecia. In four single ascending dose cohorts totaling 32 participants, intravenous ABS-201 at 150, 450, 900, and 1800 mg appeared well tolerated with no serious adverse events reported.
Most treatment-emergent adverse events were mild; one moderate headache was assessed as unlikely related to treatment. Interim pharmacokinetic data indicate an estimated half-life of at least 65 days, supporting a potential dosing schedule of two or three injections over six months. The study has advanced into a subcutaneous multiple ascending dose phase in androgenetic alopecia participants, with interim proof-of-concept data expected in the second half of 2026 and full proof-of-concept data in early 2027.
Positive
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Negative
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Insights
Early ABS-201 safety and PK look encouraging, but efficacy proof still lies ahead.
Absci released interim Phase 1 data for ABS-201, an anti-PRLR antibody for androgenetic alopecia and potentially endometriosis. In 32 participants across four single ascending IV dose cohorts up to 1800 mg, blinded data suggest a favorable safety profile with no serious adverse events.
The estimated ABS-201 half-life of at least 65 days supports infrequent dosing, potentially two or three injections over six months, which could be attractive in hair-loss and chronic gynecologic indications. The trial has progressed into subcutaneous multiple ascending dosing in androgenetic alopecia participants, an important step toward assessing real-world dosing routes.
Key value inflection points are the planned interim proof-of-concept readout in the second half of 2026 and full proof-of-concept data in early 2027. These future datasets, focused on hair growth endpoints like target area hair count and width, will be critical for assessing ABS-201’s commercial potential beyond the current early-stage safety and pharmacokinetic signals.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Phase 1 SAD participants: 32 participants
IV dose levels: 150, 450, 900, 1800 mg
Estimated half-life: At least 65 days
+4 more
7 metrics
Phase 1 SAD participants
32 participants
Healthy adults across four single ascending dose cohorts
IV dose levels
150, 450, 900, 1800 mg
Single ascending IV doses of ABS-201 in Phase 1
Estimated half-life
At least 65 days
Interim pharmacokinetic data across all SAD cohorts
Planned trial enrollment
Up to 227 volunteers
HEADLINE Phase 1/2a SAD and MAD cohorts
MAD SC doses
300, 600, 1200 mg
Subcutaneous multiple ascending dose phase in AGA
Interim proof-of-concept timing
Second half of 2026
Planned ABS-201 HEADLINE data readout
Full proof-of-concept timing
Early 2027
Planned ABS-201 HEADLINE data readout
Key Terms
single ascending dose (SAD), multiple ascending dose (MAD), androgenetic alopecia, anti-prolactin receptor (PRLR) antibody, +2 more
6 terms
single ascending dose (SAD) medical
"These data comprise 32 healthy adult participants enrolled into four planned single ascending dose (SAD) cohorts."
A single ascending dose (SAD) is a type of test where a new medicine is given to a small group of people in increasing amounts to see how the body responds. This process helps determine the safest and most effective dose for future use. For investors, understanding SAD studies can provide insight into a drug's development progress and potential approval prospects.
multiple ascending dose (MAD) medical
"the study has advanced into the subcutaneous multiple ascending dose (MAD) portion in participants with AGA."
Multiple ascending dose (MAD) is a research process used to test how a new medicine affects the body when given in increasing amounts over several doses. It helps researchers find the safest and most effective dose before the drug is widely used. For investors, understanding MAD studies is important because successful results can signal progress toward new treatments and potential future profits.
androgenetic alopecia medical
"First multiple ascending dose (MAD) of ABS-201 in cohort of androgenetic alopecia (AGA) participants has been initiated"
Androgenetic alopecia is a common form of hair loss characterized by gradual thinning and receding of hair, often following a predictable pattern. It results from a combination of genetic factors and hormone influences, similar to how certain plants are more susceptible to environmental stress. For investors, understanding trends in health and wellness, including conditions like this, can highlight shifts in consumer demand for related products and treatments.
anti-prolactin receptor (PRLR) antibody medical
"ABS-201, an investigational anti-prolactin receptor (PRLR) antibody."
target area hair count (TAHC) medical
"Secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, target area hair count (TAHC)"
forward-looking statements regulatory
"Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements”"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 24, 2026
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of principal executive offices, including zip code)
(360 ) 949-1041
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On June 24, 2026, Absci Corporation issued a press release announcing Interim Phase 1 Data from the HEADLINE™ Trial of ABS-201. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | ||||||||||
| 99.1 | Press release, dated June 24, 2026 | ||||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | ||||||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Absci Corporation | ||||||||
Date: June 24, 2026 | By: | /s/ Shelby Walker | ||||||
| Shelby Walker | ||||||||
| Chief Legal Officer | ||||||||
Exhibit 99.1
Absci Announces Positive Interim Phase 1 Data from the HEADLINE™ Trial of ABS-201, a Novel Antibody Targeting the Prolactin Receptor (PRLR)
Study medication appears well tolerated, with favorable safety data across all blinded single ascending dose (SAD) cohorts
Estimated half-life of at least 65 days supports potential for ABS-201 targeted dosing interval of two or three injections over six-month period
First multiple ascending dose (MAD) of ABS-201 in cohort of androgenetic alopecia (AGA) participants has been initiated
Interim proof-of-concept data anticipated in the second half of 2026, with full proof-of-concept data in early 2027
VANCOUVER, Wash. and NEW YORK, June 24, 2026 -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today reported positive interim Phase 1 data from its first-in-human trial of ABS-201, an investigational anti-prolactin receptor (PRLR) antibody.
“We are particularly encouraged by the emerging safety, pharmacokinetic, and immunogenicity profile observed to date," said Ransi Somaratne, MD, Chief Medical Officer of Absci. "We look forward to further characterizing ABS-201’s clinical profile and potential in the ongoing MAD portion of the HEADLINE trial for AGA, and to initiating a Phase 2 trial for endometriosis later this year.”
Key Phase 1 Interim Findings
The ABS-201 Phase 1 trial (NCT07317544) is an ongoing, first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate the safety and pharmacokinetics (PK) of ABS-201 in healthy volunteers with and without androgenetic alopecia (AGA). These data comprise 32 healthy adult participants enrolled into four planned single ascending dose (SAD) cohorts. Dose levels evaluated were 150 mg, 450 mg, 900 mg and 1800 mg administered intravenously (IV). Interim blinded safety data from these cohorts as of the June 8, 2026 data cutoff are summarized below. Following review of blinded SAD safety and PK data by the trial’s Safety Review Committee, the study has advanced into the subcutaneous multiple ascending dose (MAD) portion in participants with AGA.
Safety: Blinded, aggregate interim data suggest study drug was well tolerated and exhibited a favorable safety and tolerability profile. No serious adverse events were reported as of the data cutoff date. All treatment-emergent adverse events (TEAEs) were mild in severity except for a single moderate TEAE (headache) in SAD cohort 3, which was assessed as unlikely related to study treatment. Treatment-related TEAEs were reported in 5 participants and were all mild. The most frequently reported TEAE across cohorts was headache (4 participants). The interim safety data as of the data cutoff date are summarized as follows.
Exhibit 99.1
PK: Based on available interim pharmacokinetic data across all four SAD cohorts, including Day 56 follow-up in the lower-dose cohorts, half-life for ABS-201 is estimated to be at least 65 days. These results support the potential for dosing two or three times over a six month period, pending confirmation through continued follow-up across all cohorts. The following graph depicts drug concentrations by dosing group over time.
Immunogenicity: No apparent impact of anti-drug antibodies (ADAs) on PK was observed based on interim data in the SAD cohorts.
About ABS-201 and Androgenetic Alopecia
Androgenetic alopecia, commonly known as male-pattern or female-pattern hair loss, affects approximately 80 million Americans. The condition causes crown balding and receding hairlines in men, and progressive hair thinning in women. Currently, the only FDA-approved treatments – minoxidil and
Exhibit 99.1
finasteride – show limited efficacy and notable side effects, leaving patients with limited therapeutic options.
ABS-201 represents a novel therapeutic approach targeting prolactin receptors to stimulate hair follicle regeneration and promote durable hair regrowth as demonstrated in in vivo studies. In preclinical studies, the antibody demonstrated statistically significant superior hair regrowth compared to minoxidil in a preclinical mouse model. Absci anticipates interim proof-of-concept data from its ongoing HEADLINE™ study in the second half of 2026, with full proof-of-concept data in early 2027.
About the ABS-201 HEADLINE Trial
The HEADLINE trial (NCT07317544) is a Phase 1/2a, randomized, double-blind, placebo-controlled, first-in-human trial evaluating the safety, tolerability, and preliminary proof-of-concept of an investigational treatment in participants with or without AGA. The trial is designed to enroll up to 227 healthy adult volunteers across SAD and MAD cohorts. In the SAD phase, participants received IV doses of 150 mg, 450 mg, 900 mg, or 1800 mg of ABS-201 or placebo. The MAD phase is evaluating doses of 300 mg, 600 mg, and 1200 mg SC (subcutaneous), or matching placebo. The primary endpoints are safety and tolerability. Secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, target area hair count (TAHC), target area hair width (TAHW), target area darkening/pigmentation (TAHD), and patient/investigator-reported outcomes. Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027.
About Absci
Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci’s approach leverages a continuous feedback loop between advanced AI algorithms and wet lab validation. Each cycle refines our data and strengthens our models, facilitating rapid innovation and enhancing the precision of our therapeutic designs. Alongside collaborations with top pharmaceutical, biotech, tech, and academic leaders, Absci is advancing its own pipeline of AI designed therapeutics including ABS-201™, a novel approach in hair regrowth with the potential to redefine treatment possibilities for androgenetic alopecia, commonly known as male and female pattern hair-loss. ABS-201 is also being investigated as a potential “best-in-class” therapeutic for endometriosis, a condition with significant unmet medical need and market potential. Absci is headquartered in Vancouver, WA, with AI Research Labs in New York City and Serbia, and an Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube.
Absci® standard character mark, ABS-201™, and Integrated Drug Creation™ are trademarks and registered trademarks of Absci Corporation.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding any or all of the following: development and clinical progress of Absci's pipeline programs, including ABS-201, the design, enrollment, conduct, and timelines of our ongoing Phase 1/2a HEADLINE™ trial of ABS-201 for androgenetic alopecia; the anticipated timing of an interim proof-of-concept data readout for ABS-201 in the second half of 2026 and full proof-of-concept data in early 2027; the potential advancement of ABS-201 into Phase 3 development; the therapeutic potential of ABS-201 as a treatment for endometriosis, the anticipated characteristics and product profile of ABS-201 as a drug product; projections regarding potential market opportunity based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual addressable market to differ materially from these projections; and Absci’s strategy and goals; and expected benefits of its collaborations with partners. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risk that the Company’s research and development programs and product candidates, including those product candidates under clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates or that interim or preliminary clinical data may not be predictive of final clinical trial results, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the enrollment of patients in the Company’s ongoing and
Exhibit 99.1
planned clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce expected therapeutic benefits or may cause unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, please refer to those under the heading “Risk Factors” in Absci Corporation’s most recent quarterly report on Form 10-Q and in any other subsequent filings made by Absci Corporation with the U.S. Securities and Exchange Commission. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Investor Contact
Alexander D.H. Khan
Corporate Vice President
Head of Investor Relations
investors@absci.com
Media Contact
press@absci.com
FAQ
What did Absci (ABSI) report in its ABS-201 Phase 1 interim data?
Absci reported positive interim Phase 1 data for ABS-201 in 32 healthy adults. The drug appeared well tolerated across four single ascending IV dose cohorts, with no serious adverse events and mainly mild side effects, supporting continued development in androgenetic alopecia and endometriosis.
How well tolerated was ABS-201 in Absci’s HEADLINE Phase 1 trial?
ABS-201 appeared well tolerated, with no serious adverse events reported across four single ascending dose cohorts. Most treatment-emergent adverse events were mild, and a single moderate headache was deemed unlikely related to treatment, supporting further evaluation in multiple ascending dose cohorts.
What dosing and half-life data did Absci provide for ABS-201?
Absci tested ABS-201 at 150, 450, 900, and 1800 mg IV in 32 participants and reported an estimated half-life of at least 65 days. This pharmacokinetic profile supports potential dosing of two or three injections over a six-month period, pending further confirmation.
What are the next steps in Absci’s HEADLINE trial for ABS-201?
Following review of single ascending dose data, the trial advanced into a subcutaneous multiple ascending dose phase in androgenetic alopecia participants. Absci expects interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027, focusing on hair-growth endpoints.
How many participants may enroll in Absci’s ABS-201 HEADLINE trial?
The HEADLINE trial is designed to enroll up to 227 healthy adult volunteers across single and multiple ascending dose cohorts. It includes both participants with and without androgenetic alopecia, enabling broader safety, pharmacokinetic, and preliminary efficacy assessments for ABS-201.
What endpoints is Absci using to assess ABS-201 in androgenetic alopecia?
Primary endpoints are safety and tolerability, while secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, target area hair count, target area hair width, target area darkening or pigmentation, and patient and investigator-reported outcomes, providing a detailed view of hair-growth effects.