MIST Achieves Target Enrollment; Major APO1 Catalyst On Track for 2H27

Research evidence excerpt

MIST Achieves Target Enrollment; Major APO1 Catalyst On Track for 2H27

Update

June 17, 2026 01:43 PM GMT

Morgan Stanley & Co. LLCMAvalyn Pharma Inc | North America Judah C. Frommer, CFA

Equity Analyst

MIST Achieves Target Judah.Frommer@morganstanley.comNicholas D Japhet +1 212 761-1270

Research Associate

Nick.Japhet@morganstanley.com +1 212 761-2721

Enrollment; Major AP01 Parth Patel

Parth.Patel@morganstanley.com +1 212 761-5065

Catalyst On Track for 2H27

Avalyn Pharma Inc (AVLN.O, AVLN US)

Biotechnology | United States of America

Key Takeaways Stock Rating Overweight

Industry View Attractive

AVLN announced that the Ph2b MIST study of AP01 in PPF has achieved its Price target $53.00

target enrollment of 375 patients Shr price, close (Jun 16, 2026) $28.07

Mkt cap, curr (mm) $1,244

Additional patients in screening may be enrolled in the coming weeks 52-Week Range $32.23-24.15

Topline results in 2H27 could de-risk a multi-blockbuster opportunity

AVLN announced this morning that target enrollment (n=375) has been achieved

in the Ph2b MIST study of AP01 in PPF. Additional patients currently in screening

remain eligible for randomization and may be enrolled over the next several weeks.

Topline results are expected in 2H27. Recall from our recent initiation (see here),

AP01 is Avalyn's inhaled formulation of pirfenidone, a standard-of-care oral anti-

fibrotic that has achieved blockbuster revenue in pulmonary fibrosis despite

significant safety/tolerability limitations. Early clinical data for AP01 from the Ph1b

ATLAS study point to significantly improved safety/tolerability. Though we see the

potential for enhanced efficacy with AP01 in MIST, replication of AP01's Ph1b safety

profile along with 52 week FVC changes comparable to oral pirfenidone would be