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Form 10-Q Avalyn Pharma Inc. For: Jun 30

Wed, 12 Aug 2026 08:15:00 -0400

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Form 10-Q Avalyn Pharma Inc. For: Jun 30

Wed, 12 Aug 2026 08:15:00 -0400

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Form 8-K Avalyn Pharma Inc. For: Aug 12

Wed, 12 Aug 2026 08:07:00 -0400

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Form 8-K Avalyn Pharma Inc. For: Aug 12

Wed, 12 Aug 2026 08:07:00 -0400

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Avalyn Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Wed, 12 Aug 2026 08:00:00 -0400

Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027

Two abstracts accepted for presentation at the European Respiratory Society (ERS) Congress, including data modeling AP01 lung tissue distribution

Ended the second quarter of 2026 with $413.5 million in cash, cash equivalents and marketable securities; cash runway projected into 2029

BOSTON, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today

Avalyn Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Wed, 12 Aug 2026 08:00:00 -0400

Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027

Two abstracts accepted for presentation at the European Respiratory Society (ERS) Congress, including data modeling AP01 lung tissue distribution

Ended the second quarter of 2026 with $413.5 million in cash, cash equivalents and marketable securities; cash runway projected into 2029

Form SCHEDULE 13G Avalyn Pharma Inc. Filed by: Norwest Venture Partners XV, LP

Tue, 11 Aug 2026 17:03:00 -0400

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Form SCHEDULE 13G Avalyn Pharma Inc. Filed by: Norwest Venture Partners XV, LP

Tue, 11 Aug 2026 17:03:00 -0400

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Form SCHEDULE 13G/A Avalyn Pharma Inc. Filed by: FMR LLC

Thu, 06 Aug 2026 11:00:00 -0400

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Form SCHEDULE 13G/A Avalyn Pharma Inc. Filed by: FMR LLC

Thu, 06 Aug 2026 11:00:00 -0400

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Form 8-K Avalyn Pharma Inc. For: Jun 29

Wed, 01 Jul 2026 17:21:00 -0400

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Form 8-K Avalyn Pharma Inc. For: Jun 17

Wed, 17 Jun 2026 08:03:00 -0400

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Avalyn completes enrollment in Phase 2b trial of inhaled pirfenidone

Wed, 17 Jun 2026 08:00:32 -0400

Avalyn Pharma Inc. (Nasdaq: AVLN) announced it has completed target enrollment of 375 patients in its Phase 2b MIST clinical trial evaluating AP01, an inhaled formulation of pirfenidone, for patients with progressive pulmonary fibrosis (PPF).

The company said additional patients currently in screening remain eligible for randomization and may be enrolled over the next several weeks. Avalyn expects to report topline 12-month clinical results in the second half of 2027.

MIST is a global, randomized, double-blinded, placebo-controlled trial evaluating two doses of AP01. Patients were randomized 2:1:2 into three cohorts: AP01 100 mg twice-daily, AP01 50 mg twice-daily, and placebo. The primary

Avalyn Completes Target Enrollment in Phase 2b MIST Trial of AP01 (Inhaled Pirfenidone) for Patients with Progressive Pulmonary Fibrosis

Wed, 17 Jun 2026 08:00:00 -0400

Company expects to report topline 12-month clinical results in the second half of 2027

BOSTON, June 17, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN) (Avalyn or the Company), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks.

“PPF

Avalyn Completes Target Enrollment in Phase 2b MIST Trial of AP01 (Inhaled Pirfenidone) for Patients with Progressive Pulmonary Fibrosis

Wed, 17 Jun 2026 08:00:00 -0400

Company expects to report topline 12-month clinical results in the second half of 2027

“PPF

Form 10-Q Avalyn Pharma Inc. For: Mar 31

Wed, 03 Jun 2026 08:01:00 -0400

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Form 8-K Avalyn Pharma Inc. For: Jun 03

Wed, 03 Jun 2026 07:25:00 -0400

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Avalyn Reports First Quarter 2026 Financial Results and Recent Business Highlights

Wed, 03 Jun 2026 07:00:00 -0400

On track to complete enrollment of MIST Phase 2b trial of AP01 in progressive pulmonary fibrosis (PPF) in mid-2026, with newly presented long term open-label extension clinical data that support favorable tolerability profile

Enrollment underway in AURA Phase 2 trial of AP02 in patients with idiopathic pulmonary fibrosis (IPF) with topline data anticipated by the end of 2027

Upsized initial public offering (IPO) gross proceeds of $345.0 million, together with approximately $123.1 million in cash, cash equivalents, and marketable securities as of March 31, 2026, projected to be sufficient to fund operations into 2029

Avalyn Reports First Quarter 2026 Financial Results and Recent Business Highlights

Wed, 03 Jun 2026 07:00:00 -0400

Enrollment underway in AURA Phase 2 trial of AP02 in patients with idiopathic pulmonary fibrosis (IPF) with topline data anticipated by the end of 2027

Avalyn to Participate in the Jefferies Global Healthcare Conference

Wed, 27 May 2026 08:00:00 -0400

BOSTON, May 27, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced Avalyn management will present a company overview at the Jefferies Global Healthcare Conference in New York City on June 4, 2026, at 9:55-10:25 a.m. ET.

Access to the live webcast of this event, and the archived recording, will be posted under the News & Events page of the Investor section of the company’s website at https://investors.avalynpharma.com/

About Avalyn Pharma
Avalyn aims to

Avalyn to Participate in the Jefferies Global Healthcare Conference

Wed, 27 May 2026 08:00:00 -0400

About Avalyn Pharma
Avalyn aims to

Evercore ISI Starts Avalyn Pharma (AVLN) at Outperform

Tue, 26 May 2026 07:41:03 -0400

Evercore ISI analyst Gavin Clark-Gartner initiates coverage on Avalyn Pharma (NASDAQ: AVLN) with a Outperform rating.

For an analyst ratings summary and ratings history on Avalyn Pharma click here. For more ratings news on Avalyn Pharma click here.

Shares of Avalyn Pharma closed at $28.84 yesterday.

Morgan Stanley Starts Avalyn Pharma (AVLN) at Overweight

Tue, 26 May 2026 00:54:55 -0400

Morgan Stanley analyst Judah Frommer initiates coverage on Avalyn Pharma (NASDAQ: AVLN) with a Overweight rating and a price target of $53.00.

The analyst comments: “AVLN is a clinical-stage biotech company developing AP01 and AP02, inhaled formulations of pirfenidone (branded as Esbriet) and nintedanib (branded as Ofev), respectively. Esbriet and Ofev were the first two anti-fibrotic therapies approved for pulmonary fibrosis (PF) and both have achieved blockbuster status. However, despite the poor prognosis facing PF patients (median survival of ~3 to 5 years), the uptake of these anti-fibrotics has been significantly limited by their challenging safety/tolerability profiles that likely stem from

Morgan Stanley Starts Avalyn Pharma (AVLN) at Overweight

Tue, 26 May 2026 00:54:55 -0400

Morgan Stanley analyst Judah Frommer initiates coverage on Avalyn Pharma (NASDAQ: AVLN) with a Overweight rating and a price target of $53.00.

Jefferies Starts Avalyn Pharma (AVLN) at Buy

Mon, 25 May 2026 10:31:59 -0400

Jefferies analyst Roger Song initiates coverage on Avalyn Pharma (NASDAQ: AVLN) with a Buy rating and a price target of $52.00.

The analyst comments: “The Investment Case in Three Arguments

1. The ATLAS efficacy signal is real and multi-stream. AP01 100mg BID showed -0.4%/yr FVC vs. -4.9%/yr at 50mg QD and ~-6 to -8%/yr natural history yielding a total 83% reduction (p=0.041). Three independent streams of efficacy: 1) FVC slope, 2) qHRCT structural improvement (3 super-responders: +380/+500/+850mL), and 3) KBILD PRO. DSMB unanimously switched all patients to 100mg BID on interim review. With 23/100 OLE pts still on drug for 4.5yrs+, PPF-naive