Haverhill Financial Research · Watchlist · Updated October 12, 2026
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Why these dates matter
For a drug company, one FDA decision or trial result can move the stock more than a year of earnings reports. Between now and early January, ten companies we follow face exactly that kind of date: nine FDA target action dates set when the agency accepted the application, and one trial readout with no fixed date.
A target date is the day the FDA aims to act by, not a guarantee. Decisions can arrive early, and reviews can be extended, as happened this year to Capricor and Praxis. When a target date falls on a weekend, the FDA often acts on the business day before. Each line below says what is being decided and why it matters.
The calendar
Biotech dates to know10 names · Nov 1 to Jan 6
| Company | Date | What is being decided |
|---|
AGIO Agios Pharmaceuticals | Sun, Nov 1 PDUFA date (a Sunday) | FDA decision: mitapivat in sickle cell Would extend Agios's approved drug to a much larger patient group, under accelerated approval. |
SMMT Summit Therapeutics | Sat, Nov 14 PDUFA date (a Saturday) | FDA decision: ivonescimab in lung cancer First US approval for the drug; how the FDA weighs survival data will shape the label. |
CAPR Capricor Therapeutics | Sun, Nov 22 PDUFA date, extended from Aug 22 | FDA decision: deramiocel in Duchenne Capricor narrowed its request to upper-limb function, so label wording sets who is treated. |
VRTX Vertex Pharmaceuticals | Mon, Nov 30 PDUFA date | FDA decision: povetacicept in IgA nephropathy Would be Vertex's first kidney approval; full approval still rests on later kidney data. |
CORT Corcept Therapeutics | Thu, Dec 17 PDUFA date | FDA decision: relacorilant in Cushing's A resubmitted application; approval would give Corcept a second Cushing's syndrome drug. |
MLYS Mineralys Therapeutics | Tue, Dec 22 PDUFA date | FDA decision: lorundrostat in hypertension Mineralys's lead drug; label breadth matters in a market full of low-cost generics. |
PRAX Praxis Precision Medicines | Sun, Dec 27 PDUFA date, extended from Sept 27 | FDA decision: relutrigine in rare epilepsies Review extended for extra analyses; the FDA cited no safety or manufacturing concerns. |
COGT Cogent Biosciences | Wed, Dec 30 PDUFA date | FDA decision: bezuclastinib in NonAdvSM Cogent's second FDA decision in a month; its GIST application is due Nov 30. |
IBRX ImmunityBio | Wed, Jan 6, 2027 PDUFA date | FDA decision: Anktiva papillary label The first of the new bladder cancer labels our base case for the stock depends on. |
SLS SELLAS Life Sciences | No set date After the trial's 80th event | REGAL Phase 3 final analysis One result decides whether SELLAS files for approval; the price already assumes success. |
Source: company releases and SEC filings. FDA target dates can change.
The two names we cover
SELLAS (SLS). REGAL has no fixed date: the final analysis starts once 80 patients in the trial have died, and SELLAS said in August that the trial is approaching that count. We think the trial has a fair chance of working, but the share price already assumes a near-certain win. The full case, including what each outcome is worth, is in our SELLAS report and our REGAL news piece.
ImmunityBio (IBRX). The January 6 papillary decision is the first of the new labels the stock depends on. Approval on time keeps our base case intact; a delay or a second refusal would push peak sales toward our $1 billion bear case. The details are in our ImmunityBio report.
Sources and disclosures
Disclosures. Haverhill Financial Research is a publisher of general financial commentary. This watchlist is not personalized investment advice and does not consider any reader's financial situation; readers should do their own research. Inclusion on a watchlist is not a recommendation to buy or sell. FDA target dates and company guidance can change. Clinical-stage biotech stocks can lose most of their value on a single result. The author of this post does not hold positions in the companies named. Data as of October 12, 2026.
