FDA Monthly Preview: Key August Decisions to Watch

Moderna set an Aug 5, 2026 PDUFA target action date for mRNA-1010, its seasonal influenza vaccine, after unanimous FDA advisory support.

Bias toward upside into the Aug 5 decision, with volatility around FDA communications and any label or review delays.

The text provides a concrete PDUFA target date and unanimous advisory committee vote, which typically supports sentiment, but it is still a pre-decision calendar item rather than an approval.

Gilead received Priority Review acceptance for bictegravir 75 mg/lenacapavir 50 mg, with an Aug 27, 2026 PDUFA target action date.

Potential positive drift into late August, with risk of sharp repricing if FDA requests additional data or narrows indications.

The article discloses a fresh regulatory milestone (Priority Review acceptance plus PDUFA date) tied to phase 3 ARTISTRY-1/2 support.

Lantheus got an Aug 13, 2026 PDUFA target action date for MK-6240, a fluorine-18 tau PET imaging agent for Alzheimer evaluation.

Moderately bullish into the Aug 13 date, with event-driven volatility typical for imaging agent reviews.

The text includes a specific PDUFA date and claims of meeting predefined phase 3 diagnostic endpoints, but it does not confirm approval.

Capricor announced an Aug 22, 2026 PDUFA target action date for deramiocel in Duchenne muscular dystrophy, with CTTGTAC review on July 29.

Upward bias into Aug 22, with downside risk if FDA signals concerns about efficacy durability or manufacturing/CMC.

While the article provides a PDUFA date and committee review timing, it lacks detailed committee vote/outcome and does not quantify results.

Bristol Myers Squibb received an Aug 17, 2026 PDUFA target action date for iberdomide plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma.

Potential positive repricing into mid-August, with volatility if FDA narrows the label or requests additional analyses.

The article discloses multiple regulatory accelerants (Priority PDUFA timing and Breakthrough Therapy) but remains a calendar preview rather than a decision.

Jazz Pharmaceuticals’ Ziihera supplemental BLA was accepted for Priority Review, with an Aug 25, 2026 PDUFA target action date for HER2-positive gastric/GEJ cancers.

Bullish bias into Aug 25, with event risk around FDA’s assessment of combination benefit and safety.

The text provides fresh regulatory acceptance and Priority Review plus a concrete PDUFA date, which is typically market-relevant for biotech.

Savara said FDA continues reviewing MOLBREEVI for autoimmune pulmonary alveolar proteinosis, with an Aug 22, 2026 PDUFA target action date and no advisory committee planned.

Range-bound to mildly positive into Aug 22, with volatility driven by any FDA Day 74 follow-ups or review-extension signals.

The article provides a PDUFA date and a procedural detail (no advisory committee planned) but no efficacy/safety update or FDA stance beyond the Day 74 letter.

Ultragenyx received FDA acceptance for Priority Review of DTX401 (pariglasgene brecaparvovec) for glycogen storage disease type Ia, with an Aug 23, 2026 PDUFA target action date.

Potential upside into Aug 23, with downside risk if FDA raises concerns about durability, endpoints, or gene therapy safety.

The article discloses a fresh regulatory milestone and cites long follow-up (up to 6 years) in 52 treated patients, supporting information content.