Six Readouts in Eight Days: What the Clinical Data Actually Said

Last week's report was the FDA calendar. This one is the data that arrived while that calendar was still open.

Two of these names are clinical-stage. AbbVie, Novartis and Roche are the large caps. Corcept already sells the drug it just combined with a third agent. I have not found a correction, a pulled release, or a later filing that reverses any of the results below. Figures are as of October 27, 2026.

Oct 19: Disc Medicine, the study the FDA asked for

Disc Medicine (Nasdaq: IRON) said the Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria, including X-linked protoporphyria, met both co-primary endpoints and every secondary endpoint it listed (Disc, Oct 19, 2026).

On February 13, 2026, the FDA issued a complete response letter. It agreed earlier studies showed bitopertin lowers whole-blood metal-free protoporphyrin IX, and it said that reduction was not, on those data, reasonably likely to predict clinical benefit. APOLLO was the study that could support a traditional approval (Disc, Feb 13, 2026). A June 9 Type A meeting confirmed the same route if the trial succeeded (Disc, June 9, 2026).

APOLLO randomized 183 patients, ages 12 and older, one to one, to bitopertin 60 mg or placebo once daily for six months.

Dizziness was the most common adverse event on bitopertin, at 50%. Disc said those events were mild or moderate and generally transient. No treatment-emergent adverse event rose above Grade 3. The secondary endpoints Disc listed, including phototoxic reactions and time in light, were statistically significant too.

Disc said it plans to resubmit the application by the end of 2026 and anticipates a decision by mid-2027. That timing is the company's expectation. The FDA has not reviewed this package yet.

Oct 19: EyePoint missed, then cut the study

EyePoint (Nasdaq: EYPT) announced that LUCIA, the second pivotal Phase 3 of DURAVYU (vorolanib intravitreal insert) in wet age-related macular degeneration, missed statistical non-inferiority versus on-label aflibercept 2 mg on the change in best corrected visual acuity. Patients on DURAVYU still gained vision. The primary endpoint is the one that failed (EyePoint, Oct 19, 2026).

The presentation filed the same day puts letters on it. At the blended Week 52 and Week 56 analysis, the least-squares mean change was +2.5 letters on DURAVYU 2.7 mg every 24 weeks and +6.1 letters on aflibercept every eight weeks, a difference of 3.7 letters against DURAVYU. The confidence interval fell outside the 4.5-letter non-inferiority margin (Exhibit 99.2).

LUCIA enrolled 475 patients. LUGANO, the first Phase 3, enrolled 432 and also missed in the full dataset. EyePoint reported a 38% reduction in treatment burden in LUCIA and 42% in LUGANO, each with a nominal p-value below 0.0001, plus 52% of LUCIA eyes free of supplemental injections and 71% receiving zero or one through Week 56. Nominal means those tests were not the one the trial was built to win.

The same morning, EyePoint said the board had approved a plan on October 17, after seeing the topline, to eliminate about 53% of positions and to stop the pivotal wet AMD trials early, short of the second year. The company estimated about $30 million of annualized savings and about $9 million of separation charges. It also estimated cash, cash equivalents and short-term investments of about $118 million at September 30, 2026. The 8-K says that cash number is preliminary and has not been reviewed by the auditors (Form 8-K, Oct 19, 2026).

What the company kept is diabetic macular edema. COMO and CAPRI have enrolled 551 patients. EyePoint said those topline data are expected in the fourth quarter of 2027.

Oct 22: AbbVie cleared a high bar by eight points

AbbVie (NYSE: ABBV) said the Phase 3 INTREPID study of lutikizumab, an investigational antibody against IL-1α and IL-1β, met its primary endpoint in adults and adolescents with moderate to severe hidradenitis suppurativa (AbbVie, Oct 22, 2026).

HiSCR75 at Week 16 was 31.4% on lutikizumab and 23.4% on placebo, p≤0.001. Eight points. The trial randomized 1,400 patients one to one. AbbVie said it is the first Phase 3 in adults and adolescents with this disease to use that Week 16 endpoint, and that eight ranked secondaries also hit.

At Week 8, a three-point drop in skin-pain score was 26.2% versus 15.0% (p<0.0001). AbbVie said the pain curves separated at Week 1. Flares over 16 weeks were 18.4% versus 28.1% (p<0.0001). Adverse events tracked placebo: any event 53.4% versus 53.7%, serious events 3.0% versus 2.9%. No deaths on lutikizumab, one on placebo. The drug is not approved.

AbbVie said data from the 36-week blinded extension are expected in 2027, and that those data will support submissions in the second half of that year.

Oct 23: Novartis, relapses first

Novartis presented REMODEL-1 and REMODEL-2 on October 23 at MSToronto2026 and published them the same day in The Lancet (Novartis). Remibrutinib is the oral BTK inhibitor sold as Rhapsido. The FDA approved 25 mg for chronic spontaneous urticaria, and on October 7 approved it for symptomatic dermographism. These trials used 100 mg against teriflunomide in relapsing multiple sclerosis. Different dose. Different disease.

The primary endpoint is the annualized relapse rate. It hit in both studies. Novartis translates the rates to about one relapse every 13 years. Roughly 2,000 patients were randomized.

The risk of six-month confirmed disability progression fell 29.2%, and Novartis marked that comparison nominal. More than 92% of remibrutinib patients stayed free of that measure over 24 months. The three-month figure was a 20.5% reduction, which the company called a positive trend.

No Hy's Law cases. ALT above three times the upper limit of normal was 2.0% on remibrutinib and 7.4% on teriflunomide. Discontinuations for adverse events were 3.1% versus 5.8%. Two deaths on remibrutinib were judged unrelated by investigators: one accidental carbon monoxide poisoning, and one suicide.

Novartis said it plans to seek approval for relapsing MS around the world. A plan is not a filed application.

Oct 25: Roche, survival moved with the primary endpoint

Genentech, part of Roche (SIX: RO, ROP; OTCQX: RHHBY), presented Phase 3 Krascendo 1 in a presidential symposium at ESMO on October 25 and published it the same day in the New England Journal of Medicine (Genentech).

Divarasib is an investigational KRAS G12C inhibitor. The trial compared it with sotorasib or adagrasib in 338 adults with previously treated KRAS G12C-mutated non-small cell lung cancer. The primary endpoint is progression-free survival by blinded independent review. Overall survival is secondary. Both improved.

Response rates come from 328 response-evaluable patients. Ten people had no measurable disease at baseline and were left out of that set. Patients stayed on divarasib longer, 11.3 months versus 5.0 months. Discontinuation for treatment-related adverse events was 4.8% versus 11.7%, and serious treatment-related events were 7.8% versus 15.2%. The FDA granted breakthrough therapy designation in 2022 and orphan designation in this mutation in 2026. Genentech said it is talking with health authorities. Divarasib is not approved.

Oct 26: Corcept, a single arm set beside a different trial

Corcept (Nasdaq: CORT) reported Part A of Phase 2 BELLA on October 26. Lifyorli (relacorilant) plus nab-paclitaxel and bevacizumab, in 95 patients with platinum-resistant ovarian cancer, showed a median investigator-assessed progression-free survival of 7.2 months and a response rate of 59%. Median overall survival was not reached. Eighty-eight percent were alive at six months (Corcept).

BELLA Part A is single-arm and open-label. The figures Corcept sets next to it, 5.4 months and a 37% response rate for Lifyorli plus nab-paclitaxel, and 3.9 months and 30% for nab-paclitaxel alone, come from the Phase 3 ROSELLA trial. That is a different study. About half the BELLA patients had never received bevacizumab. In that subgroup, median progression-free survival was 8.1 months, the response rate was 66%, and 91% were alive at six months.

Corcept said the adverse events fit the known profiles of the three drugs, with no new safety signals. The most common, in at least 25% of patients, were neutropenia, anemia, nausea, asthenia, nail disorder, peripheral neuropathy, fatigue and leukopenia. Lifyorli is approved with nab-paclitaxel in this cancer. It is not approved together with bevacizumab. Full Part A results are planned for a medical conference next year.

November is the next date with a company on it

Pharming (Euronext Amsterdam: PHARM; Nasdaq: PHAR) put out third-quarter figures today and, with them, a date. Phase II topline data for leniolisib in a broader common-variable immunodeficiency population are expected in November. On October 14 the company presented a separate Phase II in genetically identifiable primary immunodeficiencies: 13 participants, nine of whom also had a CVID diagnosis, a mean 26.4% reduction in spleen volume, and all 12 patients who finished the study moved into a three-year extension. Cash, restricted cash and marketable securities were $190.9 million at September 30, and Pharming labeled the quarter preliminary. The same release assigns a goal date of January 30, 2027 to a lower-dose pediatric Joenja application for children 4 to 11 who weigh 13 to 27 kg (Pharming, Oct 27, 2026).

How I'd read a week like this

The pattern is the endpoint, then the denominator, then whatever adjective the headline picked. Disc still needs an FDA review of a package the agency has not seen. EyePoint gained letters and missed the margin. AbbVie's gap is eight points. Novartis marked the disability comparison nominal. Corcept's 7.2 months has no control arm inside BELLA.

Start there when the next release lands.

Sources: company press releases and SEC filings linked above, plus the Lancet and New England Journal of Medicine papers Novartis and Genentech cited with these data. All information as of October 27, 2026, and subject to change.

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