Betting on QURE Rebounding After Makary Steps Down

The core of the poster’s DD is an event-driven trade around uniQure (QURE) and turnover in FDA leadership: he believes that the FDA under Marty Makary has faced increasing pressure from the media, politicians, and patient groups over reviews of rare-disease and high-unmet-need drugs, especially after regulatory setbacks for uniQure’s Huntington's disease gene therapy AMT-130 and Replimune’s oncology therapy, leading the market to wrongly punish related stocks. The poster views Vinay Prasad as the key figure appointed by Makary to implement a stricter review approach, believes Prasad has already left over the AMT-130 controversy, and argues that Makary would also be forced out if he could not reverse course; based on news after the scrape and as of May 12, 2026, Makary has indeed resigned as FDA commissioner, which partially validates the poster’s directional view about leadership pressure after the fact. The post mainly targets QURE. The thesis is that previously released AMT-130 data attracted expert attention and sent the stock sharply higher, but the stock then plunged after the FDA refused to accept an external natural-history control and demanded a more rigorous randomized, double-blind study including sham surgery; the poster believes that once the regulatory stance shifts, QURE will “bounce back to $80.” The image shows the poster holding 986.41 shares of QURE, with a screenshot price around $21.15, market value around $20,862.65, and unrealized gain of 75.59%, indicating a real-money but not especially large high-volatility biotech bet. His valuation framework is very rough: it is basically not a DCF or probability-adjusted NPV, but rather directly anchors to an $80 price target near the prior high. The main catalysts are changes in FDA leadership, Prasad’s departure, Makary’s removal, and a potential easing in regulatory posture. The most important weakness is that the poster highly politicizes the regulatory dispute while downplaying the real scientific and review issues around AMT-130 itself, including the fact that it is an intracranially delivered gene therapy, trial sample size, safety, durability of efficacy, and acceptability of natural-history controls; meanwhile, the chain of “new FDA leadership = AMT-130 approval or a return to $80” does not necessarily follow. New FDA leaders could still require stronger evidence, and whether QURE’s stock can return to its prior high depends on meeting outcomes, trial design, overseas filings, financing needs, and progress by competing therapies, not only on whether Makary resigns.

The comment section sample is very small, with only 7 comments, so it cannot be treated as a broad WSB consensus. The most informative pushback comes from a user who says he previously made an 11x return on QURE by betting that Prasad would be removed; he acknowledges that AMT-130 “looks like it works” and also admits that the current FDA review stance has a political element in relitigating trial design, but emphasizes that this is not simply a MAHA-FDA or Prasad personal issue. Because AMT-130 requires brain surgery to deliver a gene therapy viral vector, safety and trial-design concerns may also come from FDA career scientists, and there are other Huntington's disease therapies in trials, so he currently has no position and does not want to hold it. Another comment uses the sarcasm of “pharma stock price goes up = saving lives” to question the simple equation of patient benefit with stock-price appreciation. Regarding ImmunityBio (IBRX), one comment says people on X are also criticizing Makary for continuing to delay Anktiva; OP personally responds that this situation is “unsustainable” because too much money and too many terminal patients are involved, reflecting OP’s broader framework that the current FDA leadership is a suppressive factor for biotech stocks. In that thread, another user supports IBRX from the perspective of his father’s cancer treatment and his investment, while adding emotionally charged accusations against the FDA and short sellers. Another TLDR-style comment essentially restates the poster’s trade: QURE up, waiting for an $80 rebound, with the catalyst being Makary getting fired, and uses “drilling holes in the placebo group” to meme-criticize the sham surgery design. Overall, the comments are not unanimously bullish: supporters agree that regulatory turnover could bring a rebound, while skeptics remind readers that AMT-130’s scientific and surgical risks are real and that not all review obstacles can be blamed on political figures. OP’s responses show that he is mainly betting that regulatory pressure is unsustainable, rather than giving detailed answers on efficacy, safety, or trial statistics.