Regeneron Pharmaceuticals

Regeneron Pharmaceuticals Inc. reported second-quarter profit of $1.3 billion with adjusted earnings of $14.29 per share, surpassing Wall Street's expectation of $10 per share. The company also posted revenue of $4.29 billion, exceeding forecasts of $3.84 billion.

Regeneron Pharmaceuticals faces investor claims of inflating stock prices by overstating the potential of a skin cancer treatment's clinical trial, which later failed to meet approval benchmarks. Investors allege the company minimized risks of trial delays while describing the drug combination as a 'potential blockbuster,' leading to significant stock price declines after the trial's failure was disclosed.

The FDA's shifts are a top concern for the gene therapy field, even at a meeting in Rome. Recent approvals of rare disease treatments have been highlighted as reasons for optimism. The departure of Vinay Prasad, the FDA's vaccine chief, is also seen as potentially promising.

President Donald Trump announced a deal with Regeneron Pharmaceuticals to lower drug prices under the most-favored-nation initiative, including discounted Medicaid pricing and a $225 price for cholesterol drug Praluent on the TrumpRx website. The agreement, part of broader efforts to reduce healthcare costs ahead of midterms, also includes $27 billion in U.S. R&D investments and expedited FDA approval for Regeneron's gene therapy.

The FDA has approved the first gene therapy for deafness, developed by Regeneron Pharmaceuticals, marking a significant medical milestone for treating a rare form of the condition.

President Trump is hosting a White House event to address health care affordability and is expected to announce a new agreement with pharmaceutical company Regeneron under his 'Most Favored Nation' initiative. This marks the 17th such agreement by the administration.