The back half of this week brings a dense cluster of scheduled company catalysts: an FDA advisory panel on a first-of-its-kind cancer blood test, quarterly results from some of the largest names in consumer staples and retail, and two FDA action dates for rare-disease and cancer drugs. This Catalyst Watch lays out the stock catalysts this week: what is on the calendar for September 23–26, 2026, what each event is, and where to find the primary information. It does not predict outcomes.
How to read this article: Verified items come from company releases, investor-relations calendars or FDA notices. Reported items come from news coverage linked in each section. Analysis is Vanderbiltreport context, not fact. Dates and times can change; always check the company’s own investor-relations page.
Catalyst Watch Calendar: Stock Catalysts This Week (September 23–26, 2026)
| Date | Company | Event | Type |
|---|---|---|---|
| Wed., Sept. 23 | GRAIL (NASDAQ: GRAL) | FDA advisory panel reviews Galleri multi-cancer test, 9 a.m.–6 p.m. ET | Regulatory |
| Wed., Sept. 23 | General Mills (NYSE: GIS) | Fiscal Q1 2027 results; Q&A webcast 8 a.m. CT | Earnings |
| Wed., Sept. 23 | Paychex (NASDAQ: PAYX) | Fiscal Q1 2027 results; call 9:30 a.m. ET | Earnings |
| Wed., Sept. 23 | Cintas (NASDAQ: CTAS) | Fiscal Q1 2027 results; webcast 10 a.m. ET | Earnings |
| Thu., Sept. 24 | Darden Restaurants (NYSE: DRI) | Fiscal Q1 2027 results before the open; call 8:30 a.m. ET | Earnings |
| Thu., Sept. 24 | Costco Wholesale (NASDAQ: COST) | Fiscal Q4 2026 results; call 2 p.m. PT | Earnings |
| Fri., Sept. 25 | HLB / Elevar Therapeutics | FDA target action date for lirafugratinib (bile duct cancer) | Regulatory (PDUFA) |
| Sat., Sept. 26 | Mirum Pharmaceuticals (NASDAQ: MIRM) | FDA target action date for zilurgisertib (FOP) | Regulatory (PDUFA) |
Regulatory Catalysts
GRAIL: FDA advisory panel on the Galleri test (Wednesday)
Verified. The FDA’s Molecular and Clinical Genetics Panel meets today, September 23, from 9 a.m. to 6 p.m. ET at FDA’s White Oak campus and online. The panel will review GRAIL’s premarket approval (PMA) application for Galleri, a blood test that looks for cancer-specific DNA methylation patterns to screen for multiple cancer types in adults 50 and older.
Verified. GRAIL said it filed the PMA on January 29, 2026, supported by the PATHFINDER 2 study (25,490 participants) and the first-year screening round of the NHS-Galleri randomized trial (more than 70,000 participants). The company describes Galleri as a complement to, not a replacement for, guideline-recommended screenings.
Reported. STAT reported that GRAIL shares rose about 33% after the FDA posted its briefing documents ahead of the meeting.
Analysis. Advisory panel votes are recommendations; the FDA makes the final decision and is not bound by the vote. Industry coverage, including AllSci, has described Galleri as the first multi-cancer early detection test to go before an FDA advisory panel (Reported).
HLB / Elevar: lirafugratinib decision (Friday)
Verified. Elevar Therapeutics, a Fort Lee, New Jersey-based subsidiary of South Korea’s HLB Co., Ltd., has a PDUFA target action date of September 25, 2026 for lirafugratinib under Priority Review. The proposed use is advanced or metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 fusions or rearrangements. On September 22, the company said the FDA had conditionally accepted the brand name LYRFIGTU.
Verified. In the Phase 1/2 ReFocus trial, lirafugratinib showed a 46% objective response rate and a median duration of response of 11.8 months in this patient group, according to Elevar. Elevar licenses worldwide rights from Relay Therapeutics (NASDAQ: RLAY).
Reported. Korea Biomedical Review reported that HLB held a late-cycle meeting with the FDA on July 23, 2026, and said no major issues were raised. That is the company’s characterization.
Mirum Pharmaceuticals: zilurgisertib decision (Saturday)
Verified. Mirum and Incyte (NASDAQ: INCY) reported that the FDA accepted the application for zilurgisertib under Priority Review with a PDUFA date of September 26, 2026. Mirum licensed worldwide rights to the drug from Incyte in April 2026.
Verified. The drug is an oral treatment for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disease in which bone forms in muscle and soft tissue. The companies estimate about 300 patients in the U.S. and 900 worldwide. In the PROGRESS study (63 patients aged 12 and older), zilurgisertib showed an 81% reduction in the share of patients developing new bone lesions at Week 24 versus placebo, but that primary endpoint was not statistically significant (p=0.0986). A secondary endpoint, total volume of new lesions, showed a greater than 99% reduction (p<0.0001).
Analysis. The PDUFA date falls on a Saturday. The FDA can act on or before a target date, and a decision may not be announced until the company discloses it.
Earnings Catalysts
Consensus figures below are analyst estimates compiled by Kiplinger’s earnings calendar (Reported). They are not company guidance.
| Company | Quarter | Timing | Consensus EPS (Reported) |
|---|---|---|---|
| General Mills (GIS) | Fiscal Q1 2027 | Wed., before open | $0.72 |
| Paychex (PAYX) | Fiscal Q1 2027 | Wed., before open | $1.32 |
| Cintas (CTAS) | Fiscal Q1 2027 | Wed., before open | $1.35 |
| Darden (DRI) | Fiscal Q1 2027 | Thu., before open | $2.05 |
| Costco (COST) | Fiscal Q4 2026 | Thu., after close | $6.53 |
General Mills (Wednesday)
Verified. General Mills will release its press release, prerecorded management remarks and slides on the morning of September 23, followed by a live Q&A webcast at 8 a.m. CT. The company reported fiscal 2026 net sales of $18 billion. Earlier this month it reaffirmed its annual guidance at the Barclays Global Consumer Staples Conference.
Paychex and Cintas (Wednesday)
Verified. Paychex hosts its fiscal first-quarter call at 9:30 a.m. ET. Cintas, the uniform and facility-services company, releases results the same day with a 10 a.m. ET webcast.
Analysis. Payroll processors and business-services companies are often watched for signals on small-business hiring and employment trends.
Darden Restaurants (Thursday)
Verified. The parent of Olive Garden and LongHorn Steakhouse reports before the market opens on September 24, with a conference call at 8:30 a.m. ET led by CEO Rick Cardenas and CFO Raj Vennam.
Costco Wholesale (Thursday)
Verified. Costco’s fiscal fourth-quarter 2026 earnings call is scheduled for September 24 at 2 p.m. PT, after the market close.
Analysis. Costco results are closely followed as a read on U.S. consumer spending, particularly membership renewal trends and traffic.
What We Are Not Doing Here
This article lists scheduled events. It does not forecast results, votes or FDA decisions, and it is not a recommendation to buy or sell any security. Company-reported data, especially topline clinical data, may change after full review.
Sources
- FDA: September 23, 2026 Molecular and Clinical Genetics Panel meeting
- GRAIL: FDA advisory committee meeting announced
- STAT: What a vote on Grail’s cancer detection test could mean
- Elevar Therapeutics: LYRFIGTU brand name conditionally accepted (Sept. 22, 2026)
- Korea Biomedical Review: HLB says lirafugratinib review enters final stage
- Mirum and Incyte: PROGRESS study results for zilurgisertib
- General Mills: Fiscal 2027 Q1 webcast notice
- Paychex: Q1 fiscal 2027 conference call
- Cintas: Q1 fiscal 2027 webcast notice
- Darden: Fiscal 2027 Q1 release date
- Costco: Q4 2026 earnings call
- Kiplinger: Earnings calendar for the week
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