July 2026 Biotech Catalysts: 6 FDA Dates & Phase 3 Readouts

Phase 3 SKYSCRAPER-01 OS update for tiragolumab in NSCLC

Tiragolumab · First-line PD-L1 high NSCLC

Roche's TIGIT inhibitor tiragolumab gets a final overall survival readout in lung cancer after multiple prior misses across the TIGIT class. A positive OS result would be a major comeback for TIGIT as an immuno-oncology mechanism.

TIGIT class has had repeated setbacks (Merck's vibostolimab, Gilead's domvanalimab). Probability of OS hit is low (~25-30%). A positive result reopens TIGIT investment across the sector.

Sponsor record: 144 of 1040 late-stage studies registered by Roche were stopped early. Trials stop for many reasons — see the company profile for each one.

Program confirmed on ClinicalTrials.gov · 2026-09-05 · the date itself is unverified

[Superseded] UX111 in MPS IIIA (Sanfilippo A) — decision moved to September 19, 2026

UX111 (rebisufligene etisparvovec) · MPS IIIA / Sanfilippo syndrome type A

Correction to this archived entry: no July 2026 decision occurred. The original UX111 BLA received a Complete Response Letter in July 2025 over manufacturing (CMC) issues; Ultragenyx resubmitted, the FDA accepted the new BLA in April 2026, and the action date is now September 19, 2026. See the September 2026 catalyst calendar for the current entry.

This entry is retained for the archive but superseded — the live UX111 decision is tracked on /catalyst/2026-09 with a September 19, 2026 PDUFA date.

Tight against cash. Cash reaches roughly Q1 2027 on the disclosed figures, about 2 quarters past this Q3 2026 catalyst. A disappointing result would leave little room to fund what comes next.

Sponsor record: 10 of 40 late-stage studies registered by Ultragenyx Pharmaceutical were stopped early. Trials stop for many reasons — see the company profile for each one.

Unverified — date is AI-generated and has not been checked against a primary source.

Phase 3 ARISE topline data for KarXT in Alzheimer's psychosis

Cobenfy (KarXT) · Alzheimer's-related psychosis

BMY tests its Karuna acquisition Cobenfy in Alzheimer's psychosis. Acadia's Nuplazid failed the analogous trial; BMY's M1/M4 muscarinic mechanism is different. Approval would be a major new indication for the $14B Karuna acquisition.

Primary endpoint is psychosis symptom reduction at week 12. A clean win adds $2-4B in peak sales potential to Cobenfy and validates the Karuna deal. A miss puts pressure on BMY's neuro pipeline narrative.

Sponsor record: 113 of 689 late-stage studies registered by Bristol-Myers Squibb were stopped early. Trials stop for many reasons — see the company profile for each one.

Unverified — date is AI-generated and has not been checked against a primary source.

Phase 3 EVOLVE Phase 3 topline data for sepiapterin in PKU

Sepiapterin · Phenylketonuria (PKU)

PTC's oral BH4 precursor sepiapterin targets the BH4-responsive PKU population. Approval would establish a multi-hundred-million dollar franchise and validate PTC's strategic pivot after the Translarna setbacks.

Primary endpoint is phenylalanine reduction versus placebo. Phase 2 data was strong. A clean readout supports a 2026 NDA filing.

Sponsor record: 16 of 50 late-stage studies registered by PTC Therapeutics were stopped early. Trials stop for many reasons — see the company profile for each one.

Program confirmed on ClinicalTrials.gov · 2026-09-05 · the date itself is unverified

Phase 2 SOLSTICE topline data for tobevibart + elebsiran in chronic hepatitis B

Tobevibart + elebsiran combination · Chronic hepatitis B (functional cure)

Vir tests its combination siRNA + neutralizing antibody approach for functional cure of chronic hepatitis B. A meaningful functional cure rate would be transformative for a market with ~300M global patients and limited current options.

Functional cure rate (sustained HBsAg loss) versus standard of care. A cure rate above 25% would be a major positive signal. Most prior HBV cure programs have disappointed.

Sponsor record: 2 of 13 late-stage studies registered by Vir Biotechnology were stopped early. Trials stop for many reasons — see the company profile for each one.

Unverified — date is AI-generated and has not been checked against a primary source.

Phase 2 topline data for tegavivint in CTNNB1-mutant solid tumors

Tegavivint · Beta-catenin mutant solid tumors

Iterion's small molecule Wnt pathway inhibitor tegavivint reports its first meaningful efficacy readout in a precision-defined patient population. Beta-catenin mutations are a recognized resistance driver across multiple solid tumors with no approved targeted options.

Watch for objective response rate, disease control rate, and durability. Even modest activity in a defined biomarker population supports a Phase 3 pathway.

Unverified — date is AI-generated and has not been checked against a primary source.