Drug Approval Leads to Forecasted Blockbuster Sales for Insmed's Pharmaceutical Product by Analysts

In a significant breakthrough for respiratory health, the Food and Drug Administration (FDA) has approved Insmed's Brinsupri as the first drug specifically designed for Non-Cystic Fibrosis Bronchiectasis (NCFB). This condition, affecting approximately 1 million adults worldwide, is increasingly recognized beyond the context of cystic fibrosis.

In the United States, approximately 500,000 Americans are estimated to have NCFB, according to a July 15 review article published in JAMA. The global presence of NCFB varies, with estimates suggesting it could be as high as 1,200 per 100,000 inhabitants in China in adults ages 40 and older.

Insmed, the pharmaceutical company behind Brinsupri, is gearing up for its market launch. They plan to provide early launch metrics such as new patient starts and the cumulative number of physicians who have prescribed Brinsupri. The company's shares surged 17% on news of the approval, with a 85% year-to-date increase, reflecting investor optimism.

Joseph P. Schwartz, senior managing director at Leerink Partners, raised his price target on Insmed shares by 6%, to $133 a share. Schwartz and his team project peak-year sales for Brinsupri to be over $5 billion. Other analysts share this optimism, with at least four projecting peak-year sales ranging from $3.7 billion by 2031 to more than $7 billion by 2033.

Brinsupri directly targets neutrophilic inflammation, a root cause of bronchiectasis exacerbations, according to Doreen Addrizzo-Harris, an investigator in the Phase III ASPEN trial. This targeted approach could make Brinsupri a valuable addition to the treatment of NCFB.

Insmed is not resting on its laurels. They plan to announce data from a futility analysis portion of the Phase II CEDAR trial evaluating brensocatid in adults with moderate to severe hidradenitis suppurativa (HS) during the first quarter of 2026. They also plan to release data from the Phase II BiRCh trial assessing brensocatib in adults with chronic rhinosinusitis without nasal polyps by the end of the year.

Insmed's pipeline is not limited to Brinsupri. They have three drugs expected to be on the market in the coming years: Arikayce for mycobacterium avium complex (MAC) lung disease, treprostinil palmitil inhalation powder for pulmonary hypertension associated with interstitial lung disease, and a Phase III trial for PAH planned for initiation in early 2026.

Meanwhile, another significant development came from Precigen, who received full FDA approval for the first-ever treatment indicated for adults with the rare disease of recurrent respiratory papillomatosis (RRP). Precigen's Papzimeos, a non-replicating adenoviral vector-based immunotherapy, has a "multibillion dollar global blockbuster potential."

The international launch of Brinsupri is anticipated by J.P. Morgan for 2026. With more than 90% of physicians surveyed by Insmed intending to prescribe Brinsupri to patients with two or more pulmonary exacerbations, the future looks promising for this groundbreaking treatment.

Schwartz finds the inclusion of potential disease-modifying FEV1 benefit in Brinsupri's label at the higher 25 mg dose encouraging. However, he and Fye of J.P. Morgan Securities project that 30% of "gross-to-net" patients in the United States treated with Brinsupri will be those whose potential revenue is lost to discounts, rebates, and other adjustments.

As Insmed moves forward with the commercialisation of Brinsupri, it is clear that this drug could make a significant impact on the lives of those suffering from NCFB. The approval of Brinsupri marks a crucial step forward in the treatment of this often underrecognized condition.

Drug Approval Leads to Forecasted Blockbuster Sales for Insmed's Pharmaceutical Product by Analysts