Regulatory volatility returns after FDA’s reversal on uniQure’s AMT-130, raising questions about accelerated-approval consistency.

Gene & RNA data flow: new immunotherapy and fibrosis readouts keep investor attention on next-gen modalities.

Earnings season: strong prints from Krystal Biotech and Cogent Biosciences highlight commercial momentum amid wider losses.

Legal front: Pfizer escalates its obesity-drug battle with Novo Nordisk and Metsera.

Events: BIO-Europe (Vienna, Nov 3-5) begins; Guggenheim Healthcare Innovation (Boston, Nov 10-12) to follow next week.

uniQure plunges 49 % after FDA reversal on AMT-130:
The agency ruled that Phase I/II Huntington’s data are insufficient for accelerated-approval consideration, reversing prior guidance and stunning the HD community. Shares fell to $34.29, with calls for FDA accountability across patient forums. 👉 Read more
A sharp reminder that regulatory tone can swing overnight, even for late-stage rare-disease programs.

Phio Pharmaceuticals’ PH-762 delivers >90 % tumor clearance in skin-cancer study:
In the final dose cohort, one patient saw 100 % clearance, a second >90 %, a third >50 %, with no DLTs or serious AEs. Shares rose ~21 %. 👉 Read more
Validates RNA-based immunotherapy’s potential in solid-tumor microenvironments.

Krystal Biotech beats Q3 estimates:
Revenue $97.8 M (+4.6 M vs consensus), EPS $2.66, driven by VYJUVEK demand; FY guidance reaffirmed. 👉 Read more
Strong execution reinforces Krystal as the gene-therapy commercial benchmark.

Cogent Biosciences widens loss but maintains runway:
Net loss $80.9 M; cash $390.9 M (runway to 2027). Continues Phase 3 PEAK enrollment for GIST with top-line data expected late 2025. 👉 Read more

Pfizer files second Delaware suit against Novo Nordisk and Metsera:
The new antitrust complaint seeks to block Novo’s $9 B+ counter-bid for Metsera after Pfizer’s initial offer. 👉 Read more
Escalates the metabolic-drug power struggle dominating 2025.

Rein Therapeutics regains momentum:
FDA lifted the clinical hold on LTI-03 (Phase 2 IPF), allowing re-enrollment by year-end with top-line expected Q3 2026. 👉 Read more
Positive signal for pulmonary-fibrosis space after months of safety scrutiny.

Regulatory whiplash: uniQure’s reversal jolts confidence in accelerated pathways; expect lobbying for clearer FDA endpoints.

RNA immuno-oncology ascends: Phio’s localized delivery model offers clinical and cost advantages over systemic checkpoint strategies.

Commercial gene therapy matures: Krystal’s steady growth contrasts with new-entrant volatility.

Capital discipline: Cogent’s long runway and Rein’s non-dilutive progress illustrate portfolio-sustaining strategies amid tight funding.

Legal and competitive pressure: Pfizer vs Novo underscores how metabolic therapeutics are becoming the sector’s next regulatory battleground.

BIO-Europe (Vienna): Partnering sessions Day 2.

Corporate Earnings: Diagnostics and AI-health companies.

FDA: AdComm scheduling notices possible for late Nov.

Macro: U.S. Treasury refunding announcement watch.