Avidity Biosciences Advances Groundbreaking AOC Therapies with Unprecedented Efficacy, Attracting Novartis Acquisition Interest

Aug 07, 2025 12:01 CST Updated 12:01

Avidity Biosciences

Antibody Oligonucleotide Conjugates Developer

Novartis

Drug Development and Manufacturing

Recently, according to the Financial Times,NovartisProposed AcquisitionAvidity Biosciences, Inc.。

The report said that Novartis has been evaluating a bid for Avidity Biosciences, Inc. in recent weeks,At the same time,Avidity Biosciences, Inc. is evaluating various options with advisors.. Currently,NovartisContacted Avidity Biosciences, Inc.。

Encouraged by this news,Avidity's Stock Price YesterdayRiseCompleted26%, to $48/Share。

Solve Liver-Targeted Delivery

Avidity is a pioneer in the field of Antibody-Oligonucleotide Conjugates (AOC), founded in 2013.

At the time of its establishment, the company's development focus was on the delivery of oligonucleotides using nanoparticles. The effect of oligonucleotides on liver targets has been widely confirmed, but due to delivery issues, tissue-specific targeting outside hepatocytes and some other tissues could not be achieved.

In order to further achieve tissue-specific delivery of siRNA nanoparticles, the company has turned to research on AOC.

The technical principle of AOC still draws inspiration from the ADC concept, achieving targeted delivery of oligonucleotides (siRNA, PMO, ASO) in a broader range of tissues beyond hepatocytes by conjugating oligonucleotide therapeutics with monoclonal antibodies.

Avidity mainly treats various rare muscle diseases by conjugating different siRNA molecules with TfR1 antibodies.

Among the partners who favor Avidity's technology are several major pharmaceutical companies, including Eli Lilly and Bristol-Myers Squibb (BMS). In November 2019, Eli Lilly invested $15 million in Avidity’s $100 million Series C financing. In November 2023, BMS expanded its collaboration with Avidity.With great momentum, a $100 million upfront payment was made. Additionally, last year, the company completed a massive $400 million private financing round.

AOCPipeline Ready to Launch

As a leading company in this field, after years of technical validation,AvidityAOC has now entered the harvest period. According to the company's disclosure, it plans to submit marketing applications for three AOC pipeline products within the next 12 months.

The nearest listing plan time isDel-zota，An AOC therapy targeting DMD exon 44, the company plans to submit to the FDA by the end of this year at the latest.Accelerated ApprovalApplication，Expected to be launched next year.

According to the previously released top-line data from the Phase I/II clinical trial EXPLORE44, Del-zota achieved a PMO (oligonucleotide) concentration of 200nM in the muscles of DMD patients with exon 44 mutations, and increased dystrophin production levels to 25% of normal levels. According to the company, this effect is unprecedented among therapies currently under development for DMD with exon 44 mutations.

If the regulatory process goes smoothly, Del-zota will be the first AOC drug to hit the market.

In terms of clinical progress, Del-desiran (Targeted DMPK)More advanced, this May, Avidity Biosciences, Inc. has already launchedDel-desiranThe Phase III clinical trial HARBOR for Type 1 Myotonic Dystrophy (DM1) is also the world's first AOC to enter Phase III clinical trials.

In July this year, HARBOR has completed patientEntryThe company expects to announce its top-line data in the second quarter of 2026 and begin submitting for market approval in the second half of 2026.

The Last OneListing PlanThe AOC is Del-brax, which targets DUX4 and is being developed for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Previously, the FDA had confirmed that it would use the FORTITUDE clinical data as the basis for accelerated approval. Patient recruitment for this clinical trial was completed in March 2025. Preliminary top-line data is expected to be released in the second quarter of 2026, with a market application submission planned for the second half of 2026.

In addition to the aforementioned products, Avidity Biosciences' pipeline also includes advancing AOC candidate pipelines.

Summary

AOC is a novel drug conjugation model derived from ADC., mainly to solve the challenge of targeted delivery of oligonucleotides.

After years of technical validation, AOC has also demonstrated its unique clinical value. In addition to Avidity, another leading AOC company, Dyne Therapeutics, has reported unprecedented clinical data (DYNE-251) and also disclosed the market launch plans for its two AOCs (Accelerated Approval Application), one is to submit—DYNE-251 to the FDA in early 2026, and the other isSubmit—DYNE-101 by the end of 2026.

As these AOC candidate pipelines successively reach their milestones, they are believed to attract significant attention from MNCs, further igniting market trading enthusiasm.

Reference Source:

https://investors.aviditybiosciences.com/2025-07-28-Avidity-Biosciences-Announces-Completion-of-Enrollment-for-HARBOR-TM-,-the-First-Global-Phase-3-Trial-of-Delpacibart-Etedesiran-del-desiran-for-Treatment-of-DM1-and-Provides-Guidance-on-Regulatory-Submission

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