FDA Decision Calendar
Before a new medicine can be sold in the US, the FDA has to approve it, and it promises an answer by a set day. For a small biotech company that one day can double the share price or halve it. Here are the decisions coming up, and what the shares did on recent ones.
The target day is here. The answer can come any time today, often after the market closes.
Lung cancer (EGFR-mutated, after targeted pills stop working). The FDA can also answer early, as it often does.Upcoming decisions
The target date the company announced. Priority review means the FDA promised an answer in 6 months instead of 10. A date that was moved means the FDA asked for more time, usually after the company sent extra data.
November 2026
- 14NovIvonescimabfor Lung cancer (EGFR-mutated, after targeted pills stop working)Summit TherapeuticsSMMT$16.33−10% in a year
First drug to block PD-1 and VEGF with one antibody. Its trial met the main goal (time without the cancer growing) but the survival result was not clear-cut.
5days left - 22NovDeramiocelfor Duchenne muscular dystrophy (arm and hand function)
A cell therapy the FDA rejected in July 2025. Capricor came back with new data and a narrower use, and the FDA added three months to review it.
13days left - 22NovMolbreevi (molgramostim)for Autoimmune pulmonary alveolar proteinosis, a rare lung disease
An inhaled medicine for a disease with no approved drug. The FDA added three months after Savara sent extra information.
13days left - 27NovBBP-418for Limb-girdle muscular dystrophy type 2I/R9BridgeBio PharmaBBIO$74.29+20% in a year
Would be the first treatment for this muscle disease. The trial met all its goals at the 12-month check, and the FDA does not plan an expert panel.
18days left - 27NovNeladalkibfor Lung cancer (ALK-positive, after earlier pills)
GSK bought Nuvalent for $10.6 billion in July 2026, largely for this drug and its sister drug zidesamtinib, which the FDA approved the same month.
18days left - 30NovPovetaciceptfor IgA nephropathy, a kidney disease
Fast-track (“accelerated”) approval based on almost 50% less protein in the urine than on placebo. An injection at home once every four weeks.
21days left - 30NovBezuclastinibfor GIST, a stomach and gut tumour (with sunitinib)Cogent BiosciencesCOGT$31.65+114% in a year
The first of two decisions for the same pill within a month. The second, for a blood disorder, follows on 30 December.
21days left
December 2026
- 12DecImsidolimabfor Generalized pustular psoriasis, a rare skin diseaseVanda PharmaceuticalsVNDA$3.82−13% in a year
53% of patients had clear or almost clear skin after four weeks, vs 13% on placebo. It would compete with Boehringer’s Spevigo.
33days left - 17DecRelacorilantfor Hypercortisolism (Cushing’s syndrome)
Second try: the FDA rejected it on 30 December 2025 and the shares halved. The same drug was approved for ovarian cancer in 2026.
38days left - 22DecLorundrostatfor High blood pressure that other pills do not controlMineralys TherapeuticsMLYS$15.33−60% in a year
Blocks aldosterone, a hormone behind hard-to-treat high blood pressure. Five positive trials. A big market for a small company.
43days left - 23DecAnito-celfor Multiple myeloma, a blood cancer (after 3 earlier treatments)Gilead (from Arcellx)GILD$166.89+40% in a year
A CAR-T cell therapy. Gilead agreed to buy Arcellx for $7.8 billion to own it fully. It would compete with J&J’s Carvykti.
44days left - 27DecRelutriginefor Severe childhood epilepsy (SCN2A and SCN8A)
Pushed back three months after Praxis sent extra analyses. The FDA found no major safety or efficacy concerns at its mid-review check.
48days left - 30DecBezuclastinibfor Non-advanced systemic mastocytosis, a blood disorderCogent BiosciencesCOGT$31.65+114% in a year
The FDA said it has found no review issues so far and plans no expert panel.
51days left
Q4 2026 (no exact date)
- Q42026CagriSemafor Obesity
A weekly shot that combines semaglutide (Wegovy) with cagrilintide. Novo expects the decision by the end of 2026 but has not given an exact date.
February 2027
- 1FebMitapivatfor Sickle cell disease
Already sold for another blood disorder. The FDA asked whether it needs a safety programme and added three months to review Agios’s answer.
84days left
March 2027
- 3MarZanzalintinibfor Colorectal cancer that has spread (with atezolizumab)
Patients lived a median 10.9 months vs 9.4 on the older pill, but with more serious side effects. Moved after Exelixis sent updated data.
114days left
What the shares did on recent decisions
Share price from the close before the news to the close of the next trading day, so news that came out after the market closed is included. Next to it, the biotech index (XBI) over the same days: the difference is the decision itself.
| News day | Company | Drug | Decision | Shares (2 days) | XBI (same days) |
|---|---|---|---|---|---|
| 29 Oct 2026 | Agios Pharmaceuticals AGIO | MitapivatSickle cell diseaseDecision moved from 1 November 2026 to 1 February 2027, days before it was due. Source | Delayed | −19.9% | −1.0% |
| 11 Sept 2026 | Exelixis EXEL | ZanzalintinibColorectal cancerDecision moved from 3 December 2026 to 3 March 2027 after updated data. Source | Delayed | −2.1% | +0.5% |
| 26 Aug 2026 | Revolution Medicines RVMD | DaraxonrasibPancreatic cancer (after chemotherapy)The first drug aimed at RAS, the gene behind most pancreatic cancers, approved weeks after filing through a priority voucher. Source | Approved | +4.6% | −0.5% |
| 24 Aug 2026 | Capricor Therapeutics CAPR | DeramiocelDuchenne muscular dystrophyDecision moved to 22 November. Investors read the extra time as a sign the FDA is still working towards a yes. Source | Delayed | +31.8% | +2.0% |
| 5 Aug 2026 | Moderna MRNA | mFLUSIVA (mRNA-1010)Flu vaccine, adults 50 and olderThe first mRNA flu vaccine in the US, after an expert panel voted 9–0 in favour. Widely expected. Source | Approved | −5.5% | +1.7% |
| 22 Jul 2026 | GSK (from Nuvalent) GSK | Jideytro (zidesamtinib)Lung cancer (ROS1-positive)Approved two months early, a week after GSK closed its $10.6 billion purchase of Nuvalent. Small news for a company as big as GSK. Source | Approved | −0.1% | −1.5% |
| 30 Jun 2026 | Unicycive Therapeutics UNCY | Oxylanthanum carbonateHigh phosphate in kidney diseaseThe second rejection in a row, both times over problems at an outside manufacturer, not the drug itself. Source | Rejected | −31.4% | −1.1% |
| 29 Jun 2026 | Praxis Precision Medicines PRAX | RelutrigineSevere childhood epilepsyDecision moved from 27 September to 27 December. No new trials requested. Source | Delayed | +2.1% | +1.8% |
| 26 Jun 2026 | Viridian Therapeutics VRDN | Lumvoa (veligrotug)Thyroid eye diseaseViridian’s first approved drug, four days early, for both active and long-lasting disease. Source | Approved | +8.1% | +4.4% |
| 15 Apr 2026 | Savara SVRA | Molbreevi (molgramostim)Autoimmune pulmonary alveolar proteinosisDecision moved from 22 August to 22 November. Source | Delayed | −7.1% | −0.2% |
| 1 Apr 2026 | Eli Lilly LLY | Foundayo (orforglipron)Obesity (a daily pill)Approved in about 50 days with a priority voucher, 294 days before its official target date. Source | Approved | +1.7% | +1.0% |
| 30 Dec 2025 | Corcept Therapeutics CORT | RelacorilantHypercortisolism (Cushing’s syndrome)The rejection came out after the market closed; the next day the shares lost half their value. Corcept resubmitted in June. Source | Rejected | −56.4% | −1.2% |
Biggest move here: Corcept Therapeutics, −56% in two days after the FDA rejected Relacorilant. Big companies barely move on one decision (Eli Lilly sells dozens of medicines); small ones with a single drug can lose most of their value in a day.
How an FDA decision works
A company that finishes its trials sends the FDA an application: an NDA for a classic drug, a BLA for a biological one (antibodies, vaccines, cell and gene therapies). If the FDA accepts it, it sets a target date under a 1992 law called PDUFA, so traders call it the “PDUFA date”.
- Approval: the drug can be sold. Often the FDA answers on the day, sometimes weeks early.
- Rejection (a “complete response letter”): the FDA explains what is missing: more data, a new trial, or fixes at a factory.
- Delay: if the company sends important new information during the review, the FDA can add three months.
- Expert panel (“AdCom”): for hard cases the FDA asks outside experts to vote first. It usually follows the vote, but not always.
How to read this page
Approvals that everyone expects often move the shares very little, or even down, because the good news was already in the price (“buy the rumour, sell the news”). The big moves come from surprises: a rejection, an early approval, a narrower label than hoped, or a delay that markets read as a good or a bad sign.
This is a short list of recent cases, not a statistic. Dates come from the companies and can change. Not financial advice. See the companies we review in the Biotech section, and how the whole sector moves in Biotech (XBI) vs Bitcoin.
Frequently asked questions
What is a PDUFA date?
It is the target date the FDA sets for its answer on a new medicine, under a 1992 law called PDUFA. The FDA sets it after accepting a company's application.
What can happen on an FDA decision date?
The FDA can approve the drug or reject it with a complete response letter explaining what is missing. It can also add three months if the company sends important new information.
What is priority review?
Priority review means the FDA promised an answer in 6 months instead of 10.
Why do biotech shares sometimes fall on approval?
Approvals everyone expects can move shares very little, or even down, because the good news was already in the price. The big moves come from surprises.
What is an FDA AdCom?
An AdCom is an expert panel. For hard cases the FDA asks outside experts to vote first, and it usually follows the vote, but not always.
Dates and decisions: company press releases and SEC filings, and trade press (linked on each entry). Share prices:Yahoo Finance (daily close, USD), updated every time the site is rebuilt. We add new dates as companies announce them.
