FDA

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.