Mid-cap biotech catalysts: FDA dates, earnings, and pipeline data to watch

Five US-listed biotechs in the roughly $3.7B–$7.7B market-cap range came out of the screen. Only two have a hard date in the sources found. The other three have news-driven or undated catalysts. Prices are as of Nov 9, 2026, 3:04 PM EST. Market caps come from screener snapshots and may lag live prices.

The Dated One: Cytokinetics

Analysts flag a Nov 14 PDUFA date (the FDA’s decision deadline) for label expansion based on the MAPLE-HCM study, per UBS commentary (Oct 14, 2026). A supplemental application for non-obstructive HCM is planned for Q4 2026, and an EDG-7500 Phase 3 start is also on the list, per coverage ahead of Q3 results (Nov 4, 2026).

Q3 revenue was $47.6M versus $40.6M expected, yet the stock fell 10.85% on the print. That shows how much good news was already priced in. A move in Cytokinetics (CYTK) above $60 ahead of the decision would signal the market is leaning toward approval.

Two Names in Free Fall

Arrowhead reports Nov 12 after hours, with consensus at EPS -1.55 and revenue of $59.19M. Its pipeline story is the tau-targeting ARO-MAPT, which showed up to 73% cerebrospinal fluid tau reduction in healthy volunteers, per H.C. Wainwright’s note (Oct 15, 2026). Management is eyeing primary-tauopathy studies from 2027. No article explaining today’s 15.84% slide was found. One earlier article listed a Nov 30 report date, but the earnings tool shows Nov 12 as official, so that date was used.

Ionis posted Q3 EPS of $0.66 versus a -$1.21 estimate and revenue of $243M versus $183M expected. The stock is still down 23.21% today, and no explanation for it was found in the sources. No dated upcoming catalyst was found, so the setup is "event just happened, reaction unresolved".

The Slower Burners

• Crispr: Phase 1b CTX310 data showed triglyceride lowering in severe hypertriglyceridemia, with FDA RMAT designations for two indications, per today’s release. The next earnings date is tentatively Feb 16, 2027.
• Viking: Q3 EPS was -1.55 versus -1.06 expected, yet the stock rose 7.91% on the print. Today’s +8.08% move has no cause in the sources pulled. Its next earnings date is tentatively Feb 10, 2027. No dated clinical readout was found. An obesity-race factbox (Oct 16, 2026) shows big pharma competition crowding the field.

Risk Check

Binary events cut both ways. A rejection or delay can hit hard, and positive news can already be in the price. These companies are also mostly unprofitable, so dilution and cash runway matter. Analyst-target upside is large across the screen, but targets tend to lag sharp moves like today’s.