After a roller coaster of a year for Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics Inc. looks to focus on the efficacy narrative in 2026, starting with newly unveiled three-year data showing durable efficacy across all key motor function assessments. Notably, patients in the study were on average 9 years of age, a point at which functional decline typically is accelerating for untreated patients, according to Louise Rodino-Klapac, president of R&D and technical operations at Sarepta. Compared to external controls, Elevidys-treated DMD patients showed a 70% or greater reduction in the rate of decline. Shares of Sarepta (NASDAQ:SRPT) were up 10% in midmorning trading.

Drug, device companies could still be liable for terrorist claims

In a lawsuit that’s been creeping through the courts for nearly a decade, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for hundreds of terrorist attacks against Americans in Iraq. The opinion in Johsua Atchley v. Astrazeneca, handed down Friday, made it clear that while “liability does not attach to those who … passively and tangentially aid terrorists in the ordinary course of their business,” this complaint described conduct that is far from “business as usual.”

Dealmaking set for upward trajectory in 2026, says EY report

Despite pressure on drug pricing, an ongoing threat of tariffs and rising geopolitical tension, the outlook for dealmaking in 2026 is strong. Balanced against the fog of uncertainty, which the industry is navigating, is the stark reality of the coming patent cliff and the fact that the big pharma companies have access to $1.619 trillion with which to replenish their pipelines. As a result, dealmaking fundamentals are sound and the momentum of 2025 – when biopharma M&A accelerated and the deal size doubled – will be maintained, according to the EY Firepower M&A report 2026. “Dealmaking remains essential for growth, and despite headwinds … we anticipate a strong 2026,” said Subin Baral, EY’s global life sciences deals leader.

1st Biotherapeutics closes $22M series D, preps for IPO

1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion (US$22 million) series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases. The round was co-led by existing major investor, Smilegate Investment, and new investors, Groom Investment and Double Capital. Eleven in total joined the financing. Participation by Korea Investment & Securities, 1st Biotherapeutics’ lead IPO book-running manager, formally signaled the company’s preparations for public listing, according to the firm.

US FDA caps 2025 with December high of 27 drug approvals

The U.S. FDA approved 27 drugs in December, the highest month of 2025, bringing the full year total to 226.Three new molecular entities gained U.S. approval in December: Innoviva Inc.'s Nuzolvence (zoliflodacin) to treat the sexually transmitted infection gonorrhea, Milestone Pharmaceuticals Inc.'s Cardamyst (etripamil) for paroxysmal supraventricular tachycardia, and Cytokinetics Inc.'s Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy.

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