WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) sent shockwaves through the pharmaceutical industry today by suggesting that experimental drugs should, in fact, demonstrate a measurable benefit to patients before receiving market approval. The unprecedented demand came as the FDA called for uniQure’s Huntington’s disease asset, AMT-130, to undergo a Phase 3 clinical trial, causing the company’s stock to plummet.

“We understand this is a novel approach,” stated FDA spokesperson Dr. Evelyn Reed, adjusting her spectacles. “But after careful consideration, our committee concluded that patients, particularly those suffering from debilitating neurodegenerative diseases, might prefer treatments that actually, you know, work. And ideally, don’t make things worse.”

Industry analysts were quick to decry the FDA’s “overreach.” “This sets a dangerous precedent,” warned financial pundit Marcus Thorne from his yacht. “Are they going to start asking for *data* on every drug? Where does it end? Before you know it, companies will have to prove their products are safe and effective before they can charge exorbitant prices. It’s an attack on innovation, frankly.”

uniQure CEO, Dr. Adrian Finch, expressed his disappointment in an internal memo, later leaked, stating, “We had hoped the sheer audacity of our market valuation would be sufficient to sway regulators. Clearly, we overestimated the FDA’s commitment to shareholder value over, well, whatever it is they usually do.”

The FDA maintains that its primary goal is to ensure the safety and efficacy of drugs, a position that continues to baffle Wall Street.