FDA

Kezar Life Sciences secured an FDA meeting to discuss zetomipzomib for autoimmune hepatitis. The meeting will focus on designing a Phase 2b clinical study for relapsed and refractory AIH patients. Kezar provided pharmacokinetic and safety data, seeking to amend monitoring requirements and align on trial conduct. This move aims to advance zetomipzomib, a potential treatment for a serious condition with unmet needs.

Aldeyra Therapeutics’ New Drug Application for dry eye treatment reproxalap has a new FDA target date of March 16, 2026, a three-month extension. This follows the FDA’s request for the Clinical Study Report of a recent field trial, which, while supportive, did not meet its primary endpoint. The FDA has indicated potential labeling requests and postmarketing requirements by February 16, 2026.

Investors are pivoting from AI stocks to traditional sectors as crucial economic data looms. The Federal Reserve’s leadership is under speculation, with potential Trump appointees emphasizing presidential input on rates. Meanwhile, FDA staff travel during a shutdown and the U.S. shipbuilding deficit requiring foreign partnerships are under scrutiny. On the entertainment front, “Stranger Things” concludes its successful run, leaving a significant cultural and commercial legacy. The week ahead features key labor and inflation data, plus earnings from Micron, Darden, FedEx, and Nike.

words.The FDA has lifted the partial clinical hold on Vanda Pharmaceuticals’ tradipitant study, reclassifying the NK‑1 antagonist as an event‑driven therapy for motion sickness and dropping the six‑month canine toxicity requirement. Vanda can now expand dosing and keep its NDA on track for a PDUFA decision by Dec. 30, 2025, potentially delivering the first new pharmacologic motion‑sickness treatment in over 40 years. Analysts estimate a $1.5 billion annual market, and the drug’s favorable safety profile could also enable combination strategies with GLP‑1 agonists.

Alvotech (ALVO) received a Complete Response Letter from the FDA for its AVT05 biosimilar application, citing deficiencies from a July 2025 facility inspection in Reykjavik. No other application deficiencies were noted, and the facility retains FDA approval for existing product manufacturing. Alvotech submitted a CAPA plan. The company revised its 2025 financial outlook to $570-600 million in revenue and $130-150 million adjusted EBITDA, reflecting facility investments and a temporary production slowdown. US sales of reference product Simponi were <$300M in 1H 2025; no Simponi biosimilar is approved in the US.

Philip Morris International (PMI) presented evidence to the FDA’s advisory committee (TPSAC) supporting the continued marketing of IQOS as a modified risk tobacco product (MRTP). PMI seeks to communicate that switching completely to IQOS significantly reduces exposure to harmful chemicals. The FDA previously authorized IQOS as an MRTP, and PMI is seeking approval for IQOS ILUMA. PMI has invested heavily in smoke-free products, aiming to transition smokers away from traditional cigarettes. The FDA’s decision will impact the regulation of next-generation nicotine products.

Sarepta Therapeutics is voluntarily pausing ELEVIDYS shipments in the U.S. to facilitate information exchange with the FDA and finalize safety labeling. This gene therapy treats Duchenne muscular dystrophy by delivering a micro-dystrophin gene. The pause will take effect July 22, 2025. The company emphasizes patient safety and maintaining a productive relationship with the FDA. ELEVIDYS is approved for Duchenne patients aged 4+ with confirmed DMD gene mutations.

Achieve Life Sciences priced a public offering of common stock and warrants at $3.00 per share to fund its cytisinicline program, targeting nicotine dependence. The offering, expected to close around June 30, 2025, aims to raise approximately $45 million, which will be used to advance cytisinicline through the FDA approval process. Cytisinicline, with Breakthrough Therapy designation, is designed to interact with nicotine receptors, potentially aiding smoking cessation.