Pharmaceutical Industry Update: Novartis' Major Acquisition, Q3 Earnings, and FDA Operations Amid Shutdown

Novartis Makes Waves with $12B Avidity Biosciences Acquisition

In a significant move that marks the second-largest acquisition in the pharmaceutical industry this year, Novartis announced its purchase of neuromuscular drug developer Avidity Biosciences for $12 billion. This strategic acquisition, revealed on a Sunday afternoon, positions Novartis to expand its presence in the RNA-targeting therapies market, particularly for neuromuscular ailments.

The deal has had a ripple effect across the industry, with shares of Dyne Therapeutics, a company also focused on RNA-targeting therapies for neuromuscular diseases, nearly doubling over the past month. The market reacted positively to the news, with Dyne's stock jumping approximately 40% following Novartis' announcement.

Q3 Earnings and Strategic Moves

As third-quarter earnings reports continue to roll out, several pharmaceutical giants are making strategic decisions that could shape the industry's landscape:

• Eli Lilly has reinforced its commitment to gene therapy by acquiring Adverum Biotechnologies, which focuses on treatments for wet age-related macular degeneration.

• Roche, following its recent $3.5 billion acquisition of 89bio centered on a MASH candidate, hinted at the possibility of more deals in the future during its Q3 earnings call.

• BioMarin announced plans to divest its hemophilia gene therapy, Roctavian, signaling a shift in its portfolio strategy.

• Regeneron faced questions about its Eylea product and regulatory application issues stemming from problems at a Novo Nordisk plant. The company also quietly dropped a CAR T asset acquired from 2seventy bio, reflecting ongoing challenges in the cell and gene therapy space.

Industry Developments and Clinical Progress

Amid the flurry of financial activity, significant clinical advancements are also making headlines:

BridgeBio reported positive results from a Phase III trial for an investigational substrate supplementation therapy targeting limb-girdle muscular dystrophy. Analysts predict that the company could submit the asset for FDA review later this year or in early 2026.

FDA Operations During Government Shutdown

As the U.S. government shutdown enters its fourth week, the pharmaceutical industry is closely monitoring its impact on regulatory processes. BioSpace has conducted an analysis of how the FDA is functioning during this period, highlighting the agency's efforts to maintain critical operations despite the challenging circumstances.

The extended shutdown raises questions about potential delays in drug approvals and regulatory decisions, adding another layer of uncertainty to an already complex industry landscape.