Exploring Insmed's Key Growth Drivers...

(RTTNews) - It's been a banner year so far for Insmed Inc. (INSM), with its shares having more than doubled, thanks to Arikayce's surging sales, Brensocatib's ASPEN study success, and TPIP's promising phase II results.

Arikayce, the company's marketed drug, is an antibacterial drug, which secured accelerated approval from the FDA in Sep.2018, for the treatment of a serious lung disease caused by a group of bacteria, Mycobacterium avium complex, in adults who have limited or no alternative treatment options.

Launched in the U.S. in October 2018, the net sales of Arikayce have improved year-over-year. The drug's net sales were $305.2 million for full year 2023, compared to $245 million in the prior year, an increase of nearly 25%, reflecting continued strong growth in the U.S., Japan, and Europe.

For the first quarter ended March 31, 2024, global revenue of Arikayce jumped 16% to $75.5 million from $65.2 million in the year-earlier quarter. Looking ahead to full-year 2024, the company expects revenue of Arikayce to range between $340 million and $360 million, representing 15% year-over-year growth at the midpoint compared to 2023.

Now, turning to the second factor that boosted Insmed's stock price - the ASPEN study of Brensocatib.

The ASPEN study is a global, placebo-controlled phase III study evaluating the efficacy, safety, and tolerability of the company's lead drug candidate Brensocatib in patients with non-cystic fibrosis bronchiectasis. Brensocatib was licensed from AstraZeneca in October 2016.

The topline results from the ASPEN study were reported in May of this year.

According to the study findings, Brensocatib demonstrated statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) versus placebo. The trial also met several of its prespecified secondary endpoints with statistical significance.

A New Drug Application for Brensocatib in patients with bronchiectasis is expected to be filed with the FDA in the fourth quarter of 2024.

Brensocatib is also being explored in other indications.

-- A phase IIb trial of Brensocatib in patients with chronic rhinosinusitis without nasal polyps, dubbed BiRCh, is underway, with topline data anticipated in 2025. -- A phase II study of Brensocatib in patients with hidradenitis suppurativa is expected to be initiated in the second half of 2024.

Finally, the third element that drove Insmed's stock upward - phase II results of TPIP.

TPIP (Treprostinil palmitil inhalation powder) is being evaluated in the indications of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).

The company reported positive topline safety and tolerability data as well as certain exploratory efficacy endpoints from the phase II study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in May of this year.

Additionally, the company is making progress in its plans to engage with global regulatory authorities on the design of a phase III study of TPIP in PH-ILD, with initiation of the study expected in 2025.

A phase II trial of TPIP in patients with pulmonary arterial hypertension (PAH) is also underway.

Encouraging blinded data from the first 40 patients in the phase II PAH Study of TPIP were also reported in May of this year, with topline data on track for 2025.

Assuming everything proceeds according to plan, the company expects its three key programs - Arikayce, Brensocatib, and TPIP - to each generate annual sales exceeding $1 billion at their peak performance.

We featured INSM on our website initially on Sep.5, 2023, when it was trading around $24.05, then again on Mar.25, 2024, when it was trading around $26.52, and most recently on May 28, 2024, when it was trading around $51.

The stock, which touched a 52-week high of $78.87 during intraday trading on July 16, 2024, has since experienced a slight pullback, and it closed Friday's trading (July 19, 2024) at $75.97.

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