Notes

A news scan found the headline that GameStop will release its complete Q2 results on September 8, but it has already announced that it expects net sales of $780-800M, operating income of $150-170M, net income of $290-310M, cash and securities of $5.05-5.07B, and investment gains or losses. https://investor.gamestop.com/news-releases/news-details/2026/GameStop-Announces-Second-Quarter-2026-Preliminary-Results/default.aspx

A news scan found the headline that on September 2, 2026, a company filed an 8-K report, which is a financial report required by the government, stating that the GTX-102 Phase 3 Aspire trial missed the Bayley-4 cognitive primary endpoint, which measures cognitive development, and the MDRI key secondary endpoint; the company said there were no differences that supported the efficacy, or effectiveness, of the treatment and planned expense reductions. https://www.sec.gov/Archives/edgar/data/1515673/000119312526380165/rare-20260902.htm

A snapshot from the IEX exchange on September 3, 2026, showed that the stock closed at 58.075, which is lower than the previous close of 61.32, even though the company, IONS, received positive approval from the FDA, which is a government agency that reviews new medicines; this suggests that some investors may have sold their shares after the good news was announced, a phenomenon known as sell-the-news, and that some investors may have made decisions based on early information, which is called early-decision risk. https://data.alpaca.markets/v2/stocks/snapshots

The FDA approved Zanvastro on 2026-09-03, earlier than Ionis' target action date of 2026-09-22. This approval is for patients of all ages, including both pediatric and adult patients, and is based on a study of 49 patients, plus an additional 4 patients who were under the age of 2. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-alexander-disease

The company Mirum confirmed in their first quarter 2026 earnings report, which was filed on May 6, 2026, that the Food and Drug Administration, or FDA, will make a decision on September 26, 2026, regarding the drug zilurgisertib, which is used to treat a condition called fibrodysplasia ossificans progressiva, or FOP, and was licensed from another company called Incyte. The decision is based on positive results from a Phase 2 study called PROGRESS, which showed a 99.9% reduction in new bone lesions, and no major safety concerns were found. An adcom, which is a group of experts that advises the FDA, was not needed. The stock price of Mirum, which is represented by the ticker symbol MIRM, has been staying within a range of 95 to 104 over the last month, and on September 1, the stock closed at a price of 98.34. https://www.sec.gov/Archives/edgar/data/1759425/000175942526000036/mirm-20260506xexx991.htm

The company Ultragenyx confirmed in their quarterly earnings report, filed on August 4, 2026, that the Food and Drug Administration will make a decision on the UX111 treatment for Sanfilippo syndrome type A by September 19, 2026. This decision is called a PDUFA date, which stands for Prescription Drug User Fee Act date. The treatment was previously rejected in July 2025 due to manufacturing issues, not because it was ineffective or unsafe. Another treatment, DTX401, had its PDUFA date on August 23, 2026, which has already passed. The stock price of RARE has been stable between 24.7 and 28.5 dollars over the last month, and closed at 25.81 dollars on September 1. https://www.sec.gov/Archives/edgar/data/1515673/000119312526332802/rare-ex99_1.htm

The company Ionis confirmed in their second quarter 2026 earnings report, which was filed on July 29, 2026, that the Food and Drug Administration's target action date, also known as the PDUFA date, for zilganersen, a treatment for Alexander disease, is September 22, 2026. This means the FDA will make a decision on this date. The FDA is giving zilganersen a Priority Review, which is a special status given to drugs that may provide significant improvements over existing treatments. An adcom, which is a committee that advises the FDA on certain decisions, was not found to be necessary in this case. The stock price of Ionis increased from 55 to 64 between August 12 and August 25, and then decreased to 59.88 on September 1, with 1.9 million shares being traded on that day. The last closing price of the stock was 59.88. https://www.sec.gov/Archives/edgar/data/874015/000114036126029960/ef20078953_ex99-1.htm