Acrivon Therapeutics Submits Phase 3 Confirmatory Protocol for ACR-368
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 08 2026
0mins
Should l Buy ACRV?
Acrivon Therapeutics announced significant progress across its pipeline, including updates regarding the Phase 2 ACR-368 program, initial clinical data from the ACR-2316 Phase 1 study, and the nomination of Acrivon's next AP3-enabled preclinical development candidate, ACR-6840, a potential first-in-class, oral CDK11 inhibitor. Highlights; Electronic data capture extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive subjects with endometrial cancer showed 39% overall response rate and 44% in subjects with less than or equal to2 prior lines of therapy; Analysis of data from all-comer subjects with serous subtype and less than or equal to2 prior lines of therapy, a high unmet need population, showed a confirmed ORR of 52%, and within BM+ subjects cORR was 67%; Arm 3 is enrolling up to 90 subjects with serous subtype and less than or equal to2 prior lines of therapy, without requirement for a tumor biopsy, for treatment with ACR-368 plus ultra-low dose gemcitabine as a tumor sensitizer and enrollment completion expected in fourth quarter 2026; Based on preclinical AP3 data showing strong synergy between ACR-368 and anti-PD-L1, company has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 plus anti-PD-1 therapy in frontline EC subjects; Initial data from Phase 1 dose escalation for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, showed favorable tolerability; Tumor shrinkage was observed at greater than or equal to120 mg dose level in 9/20 subjects, including a confirmed PR in EC, and unconfirmed PRs in SCLC and sqNSCLC, two tumor types predicted sensitive by AP3; ACR-6840, a potential first-in-class AP3-derived oral CDK11 inhibitor, nominated as next preclinical development candidate, with IND submission planned for fourth quarter 2026
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Analyst Views on ACRV
Wall Street analysts forecast ACRV stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ACRV is 10.50 USD with a low forecast of 7.00 USD and a high forecast of 19.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
5 Buy
1 Hold
0 Sell
Strong Buy
Current: 1.600
Low
7.00
Averages
10.50
High
19.00
Current: 1.600
Low
7.00
Averages
10.50
High
19.00
About ACRV
Acrivon Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision oncology medicines. It uses its precision Generative Phosphoproteomics platform, Acrivon Predictive Precision Proteomics (AP3), to develop its pipeline of oncology drug candidates. Its lead candidate, ACR-368, is a selective small molecule inhibitor which targets CHK1 and CHK2 at sub single-digit nM and single-digit nM potency in intact cells, respectively, in a registrational Phase II trial across multiple solid tumor types. Using its AP3 platform, it has developed a predictive OncoSignature test for ACR-368, called ACR-368 OncoSignature, that can predict patient response to ACR-368 monotherapy and therefore improve the clinical overall response rate (ORR) and has the potential to enable drug development. Its preclinical program, ACR-2316, is advancing in investigational new drug-enabling studies. It is a novel, dual WEE1 and PKMYT1 inhibitor small molecule development candidate.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.
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- Clinical Results Analysis: Despite a promising overall confirmed response rate of 52% in patients with the serous subtype of endometrial cancer, mixed interpretations of the data led to shaken market confidence, adversely affecting stock performance.
- Trial Expansion Plans: Acrivon announced plans to expand the trial into the European Union to accelerate patient enrollment, a strategic move aimed at enhancing the trial's effectiveness and market acceptance, although the stock remains under pressure in the short term.
- Surge in Trading Volume: The trading volume significantly exceeded average levels, reflecting investors' strong reactions to the clinical results, highlighting the high volatility and uncertainty prevalent in the biotech sector.
See More
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- Targeted Strategy: Following the analysis of response rates in serous endometrial cancer patients, Arm 3 of the trial will focus exclusively on subjects with ≤2 prior treatments, aiming to enhance the trial's effectiveness and specificity.
- New Drug Development Update: Initial clinical data from ACR-2316 shows a tumor shrinkage rate of 45% in patients with small cell lung cancer and squamous non-small cell lung cancer at doses of 120 mg and above, providing a positive clinical basis for future treatment regimens.
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See More
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