Avidity Biosciences (RNA) Company Report

Avidity Biosciences has initiated a U.S. Managed Access Program (MAP) for its investigational therapy delpacibart zotadirsen (del-zota), aimed at eligible individuals with Duchenne muscular dystrophy mutations amenable to exon 44 skipping (DMD44).
Enrollment for the MAP, which provides del-zota under an FDA-authorized treatment protocol, is anticipated to begin by year-end.
Avidity plans to submit a Biologics License Application (BLA) for del-zota for accelerated approval in 2026, following alignment with the FDA in an October 2025 pre-BLA meeting.
Clinical studies of del-zota have demonstrated unprecedented data, including robust increases in dystrophin production and reversal of disease progression, leading to multiple FDA designations such as Breakthrough Therapy.

Nov 19, 2025, 2:13 PM

Press Release

Avidity Biosciences Reports Q3 2025 Results and Announces Novartis Acquisition

RNA

M&A

Earnings

New Projects/Investments

Avidity Biosciences entered a definitive merger agreement with Novartis AG for an approximate $12 billion total equity value, with the acquisition expected to close in the first half of 2026 following the separation of early-stage precision cardiology programs into a new public company ("SpinCo").
For the third quarter ended September 30, 2025, the company reported $12.5 million in collaboration revenues and a net loss of $(174.4) million, or $(1.27) per share.
As of September 30, 2025, Avidity held approximately $1.9 billion in cash, cash equivalents, and marketable securities.
The company has a clear path forward with the FDA for del-zota, with a Biologics License Application (BLA) submission planned for 2026 for accelerated approval, supported by one-year data demonstrating sustained muscle protection and meaningful improvement.

Nov 10, 2025, 9:07 PM

8-K

Avidity Biosciences Announces Novartis Acquisition Agreement and Q3 2025 Results

RNA

M&A

Earnings

New Projects/Investments

Avidity Biosciences entered a definitive merger agreement with Novartis AG in October 2025, with Novartis acquiring Avidity for an approximate $12 billion total equity value, pending the separation of Avidity's early-stage precision cardiology programs into a new public company, SpinCo. The acquisition is expected to close in the first half of 2026.
For the third quarter ended September 30, 2025, Avidity reported $12.5 million in collaboration revenue and a net loss of $(174.4) million.
As of September 30, 2025, the company held approximately $1.9 billion in cash, cash equivalents, and marketable securities, which is projected to fund operations until mid-2028.
The company announced a clear path forward with the FDA for del-zota, with BLA submission planned for 2026, and completed enrollment for the Phase 3 HARBOR™ trial for del-desiran in July 2025.

Nov 10, 2025, 9:05 PM

Press Release

Novartis proposes to acquire Avidity Biosciences

RNA

M&A

Guidance Update

New Projects/Investments

Novartis proposes to acquire Avidity Biosciences for $72 per share, representing a 46% premium to the October 24th closing price.
The acquisition focuses on Avidity's neuromuscular franchise, including three late-stage assets (Delbisiran, Delbrac, Delzoda), and its Antibody Oligonucleotide Conjugates (AOCs™) platform for extrahepatic RNA delivery.
This deal is expected to enhance Novartis's 2024 to 2029 CAGR from +5% to +6% and is projected to close in the first half of 2026.
Novartis anticipates an initial 1% to 2% margin dilution, with a return to 40%+ core margin by 2029.

Oct 27, 2025, 12:00 PM

Transcript

Novartis Announces Acquisition of Avidity Biosciences

RNA

M&A

New Projects/Investments

Guidance Update

Novartis will acquire all outstanding shares of Avidity for USD 72.00 per share in cash, representing a 46% premium to its October 24 closing price.
The total transaction value is USD 12 billion on a fully diluted basis, with an enterprise value of approximately USD 11 billion at the expected closing date.
Avidity will separate its early-stage precision cardiology programs into a new SpinCo, while Novartis will acquire Avidity's neuromuscular franchise and platform rights.
The acquisition is expected to raise Novartis' 2024-2029 sales CAGR from +5% to +6% and result in a short-term 1-2%pts core margin dilution, returning to 40%+ core margin in 2029.
Closing is anticipated in H1 2026, pending the completion of the SpinCo separation and other customary conditions.

Oct 27, 2025, 12:00 PM

Presentation

Novartis to Acquire Avidity Biosciences

RNA

M&A

New Projects/Investments

Guidance Update

Novartis proposes to acquire Avidity Biosciences for $72 per share, representing a total transaction value of $12 billion on a fully diluted basis and a 46% premium to the October 24 closing price.
The acquisition is expected to close in 2026 and will strengthen Novartis's neuroscience franchise and exRNA strategy by adding three late-stage neuromuscular programs, including Delvisiran for DM1 and DELBRAX for FSHD, and a platform for extrahepatic delivery of XRNAs. Avidity will separate its early-stage precision cardiology programs into a new spin-co.
The deal is projected to raise Novartis's 2024-2029 CAGR from +5% to +6%, with a short-term margin dilution of 1-2% expected to return to 40%+ core margin by 2029. Key clinical readouts for Delvisiran and DELBRAX are expected in 2026.

Oct 27, 2025, 12:00 PM

Transcript

Novartis to Acquire Avidity's Neuromuscular Franchise

RNA

M&A

New Projects/Investments

Product Launch

Novartis will acquire Avidity's neuromuscular franchise and platform rights for USD 72.00 per share in cash, representing a 46% premium to its October 24 closing price.
The total transaction value is USD 12 billion on a fully diluted basis, with an enterprise value of approximately USD 11 billion.
Avidity will separate its early-stage precision cardiology programs into a new SpinCo prior to the acquisition.
The acquisition is expected to close in H1 2026, subject to the completion of the SpinCo separation and other customary closing conditions.
The deal is anticipated to raise Novartis' expected 2024-2029 sales CAGR from +5% to +6% and offers multi-billion-dollar peak sales opportunities in DM1 and FSHD.

Oct 27, 2025, 12:00 PM

Presentation

Novartis announces proposed acquisition of Avidity Biosciences

RNA

M&A

Guidance Update

New Projects/Investments

Novartis proposes to acquire Avidity Biosciences for $72 per share, representing a 46% premium to the October 24th closing price, with a total transaction value of $12 billion and an enterprise value of $11 billion.
The acquisition is expected to close in the first half of 2026 and will add three late-stage neuromuscular assets (Delbisiran for DM1, Delbrac for FSHD, and Delzoda for DMD exon 44 skipping) and an RNA technology platform.
This deal is projected to raise Novartis's 2024-2029 sales CAGR from +5% to +6% and is expected to result in a short-term margin dilution of 1% to 2%, with a return to 40%+ core margin by 2029.
The acquired assets include Delbisiran, with a Phase 3 readout in H2 2026 and regulatory submission in 2027 , Delbrac, with a Phase 3 readout and submission in 2028 , and Delzoda, on track for FDA submission for accelerated approval in 2026. These medicines have no LOEs before 2042 and are IRA exempt.

Oct 27, 2025, 12:00 PM

Transcript

Novartis Proposes Acquisition of Avidity Biosciences

RNA

M&A

New Projects/Investments

Guidance Update

Novartis proposes to acquire Avidity Biosciences for $72 per share, representing a 46% premium to the October 24th closing price, with an estimated total transaction value of $12 billion on a fully diluted basis.
The acquisition is expected to close in the first half of 2026, subject to Avidity separating its early-stage precision cardiology programs into a new SpinCo and other customary closing conditions.
The deal strengthens Novartis's neuroscience franchise and RNA technology platform by adding three late-stage neuromuscular programs (del-desiran for DM1, del-brax for FSHD, and del-zota for DMD44) and a platform for extrahepatic delivery of xRNAs.
Novartis expects the acquisition to raise its near-term sales guidance from +5% to +6% and bolster its growth profile beyond 2030, while anticipating a short-term dilution of 1%-2%.

Oct 27, 2025, 12:00 PM

Transcript

Avidity Biosciences to be Acquired by Novartis AG for $12.0 Billion

RNA

M&A

Takeover Bid

New Projects/Investments

Novartis AG has entered into a definitive merger agreement to acquire Avidity Biosciences, Inc. for $72.00 per share in cash, valuing the company at approximately $12.0 billion on a fully diluted basis. This price represents a 46% premium over Avidity's closing share price on October 24, 2025.
Prior to the acquisition, Avidity will separate its early-stage precision cardiology programs into a new company, SpinCo (Bryce Therapeutics, Inc.), which is expected to be publicly traded.
The closing of the acquisition is anticipated in the first half of 2026, subject to the completion of the SpinCo separation, regulatory approvals, and the adoption of the merger agreement by Avidity stockholders.
Novartis will acquire Avidity's neuroscience programs and pipeline, including three late-stage clinical development programs, and gain access to its differentiated RNA-targeting delivery platform.

Oct 27, 2025, 11:28 AM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Avidity Biosciences.

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