Tozorakimab COPD Phase III Data Supports Best-in-Disease Profile; PDUFA Q1:27

Research evidence excerpt

Pharmaceuticals/Major

AstraZeneca PLC

TD SECURITIES (USA) LLC

QUICK TAKE: COMPANY UPDATE

September 8, 2026

Price: $162.70 | 12,042.00p (09/07/2026)

Price Target: $240.00 | 17,775.00p

Tozorakimab COPD Phase III Data Supports

Best-in-Disease Profile; PDUFA Q1:27

BUY (1)

Steve Scala, R.Ph., CFA

Michael Nedelcovych, Ph.D.

Chris LoBianco

Paul Kuhn, Ph.D.

Key Data

Symbol

NYSE: AZN | LSE: AZN.L

Market Cap

$252.4B | p18,677.7B

Click here for the full company update from

our latest quarterly report.

THE TD COWEN INSIGHT

Full Phase III data reinforce our view that tozorakimab could emerge as the leading biologic in

COPD. Exacerbation reductions exceeded efficacy bar set by KOLs, with ~30% benefit in the

overall population and meaningful efficacy across BEC levels. Potential for broad label and

competitive efficacy vs. Dupixent/Nucala in BEC > 300 cells/uL subgroup support positive view

ahead of Q1:27 PDUFA.

The News:

At ERS 2026, AZN presented full data from the replicate Phase III OBERON and TITANIA trials

which evaluated tozorakimab Q4W or placebo in a broad population of moderate-to-severe

COPD patients irrespective of smoking status and blood-eosinophil count (BEC). Positive

top-line was previously disclosed in March '26 (Link). The primary endpoint of both trials

was annualized rate of moderate or severe COPD exacerbations through 52 weeks in former

smokers; key secondary endpoint was annualized exacerbation rate in the overall population

(current + former smokers). Full numerical results at ERS showed a statistically significant

29-34% placebo-adjusted exacerbation reduction in former smokers and a statistically

significant 29-30% placebo-adjusted exacerbation reduction in the overall population.

Absolute rate of annualized exacerbations in the overall population placebo groups were

2.00-2.03 events/year, higher than recent COPD Phase III trials such as Dupixent BOREAS/

NOTUS (1.10-1.30) and itepekimab AERIFY-1/-2 (0.879-0.891). A pooled analysis of OBERON/

TITANIA (see below) also demonstrated clinically meaningful efficacy across BEC levels,

including a 43% placebo-adjusted exacerbation reduction (rate ratio 0.57; 95% CI: 0.44 - 0.74)

…