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• BridgeBio's Attruby has outperformed expectations, with second-quarter US sales reaching $222 million, beating Wall Street's projections by 6%.

  • Jefferies analysts predict it may achieve over $1 billion in global sales this year.

• Meanwhile, Alnylam's Amvuttra sales fell short despite significant growth. Both companies target first-line ATTR-cardiomyopathy patients, as the debate between silencer and stabilizer drugs continues.

• BridgeBio's CEO, Neil Kumar, suggests the market is leaning towards stabilizers, especially after AstraZeneca and Ionis' silencer Wainua failed a major trial. The ATTR-CM market saw a 19% growth in the second quarter, with stabilizers gaining more market share. (Fierce Pharma)

• The FDA approved Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment.

• The FDA’s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its advisers voted in support of the treatment.

• Even though FDA staff expressed concerns about the design and conduct of Replimune’s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.

• The list price of Tudriqev will be $450,000 per course of therapy before customary rebates and discounts, Replimune said. (STAT)

• Epicrispr Biotechnologies has raised $90 million in a series C round backed by investors including Sanofi Ventures, positioning the biotech to advance a pipeline of epigenetic medicines led by an early-phase facioscapulohumeral muscular dystrophy (FSHD) prospect.

• San Francisco-based Epicrispr began a phase 1/2 trial of the FSHD drug candidate, EPI-321, last year.

• A recent look at data from the trial showed increases in lean muscle mass in three patients with FSHD, a rare muscle degeneration disease. Six months after receiving a single intravenous infusion of EPI-321, the patients had gained between 0.5 and 1.3 pounds of lean muscle mass.

• The interim readout provided preliminary clinical support for Epicrispr’s theory that suppressing DUX4 expression will improve outcomes in FSHD. (Fierce Biotech)

• Up to 10 years, to be exact, a Merck spokesperson said in a statement.

“Manufacturers would need dedicated formulations, manufacturing processes, and clinical packages, to support FDA review and eventual approval,” he said. “This means significant investment and even under accelerated conditions would likely take years.”

The Merck spokesperson echoed this and said that “these would be considered three new, investigational, separately licensed vaccines and would require full clinical trial testing and regulatory review for each new product.”

• Almost two-thirds of Americans are extremely or very confident that childhood vaccines are highly effective at preventing serious illness, according to Pew Research data from last year.

“The real story is the pressure that tech capital puts on biopharma leadership to fix their failure rates,” Tyrone Lam, chief business officer at GATC Health, said.

• Lam noted that there has been a big influx of tech money into biopharma. These new investors, he added, “fundamentally understand the value of a ‘fail-fast’ process”—a strategy that puts a premium on figuring out quickly where a product might fail.

• There is outreach from the machine learning sector, too: In April, AI frontrunner Anthropic named Novartis CEO Vas Narasimhan to its board of directors.

• Late last month, the tech company launched Claude Science, an AI workbench designed specifically for the life sciences.

• This mammoth round, the second-largest in biotech history, came despite the company having no disclosed candidate yet.

• That could free up resources for more clinical studies and possibly lower the high failure rate for new drugs.

• The efficiencies increase with the number of tumors a drug can target: An experimental treatment with 50 active uses could see net benefits of as much as $565 million, Tufts found.

• Tufts applied a clinical monitoring agent from Medable, which provides a platform to support clinical trials, to an unspecified oncology drug development program in phase 2 and 3 trials.

"To our knowledge, this is the first time that [predictive] modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution in a drug development program," he said.