Accessible version US Biopharmaceuticals 2026 Year Ahead: What to expect from our coverage universe in 2026 Price Objective Change Biopharma favorable despite lingering uncertainties Despite its challenges, Biopharma ended 2025 on a high note (NBI +32%, DRG +21% vs. SPX +17%)—with, in our view, reasons for optimism heading into 2026. Admittedly, the macro concerns weighing on 1H25 sentiment (inflation, tariffs) remain overhangs. That said, 1) sector-specific worries, mostly around drug pricing, eased; 2) lo ...

Core Insights - Insmed's shares have increased by 78% over the past six months, driven by strong momentum from its late-stage pipeline and robust sales from marketed drugs, enhancing investor confidence [1] Group 1: Product Approvals and Market Potential - The FDA approved brensocatib, branded as 'Brinsupri', in August 2025, making it the first approved therapy for non-cystic fibrosis bronchiectasis (NCFB) [2] - Brinsupri's approval positions Insmed to access a multi-billion-dollar market and marks the company's second marketed product, generating $28.1 million in revenues in Q3 2025 due to strong patient uptake [3] - Insmed's shares surged following the approval of Brinsupri, reflecting its strong revenue potential [7] Group 2: Financial Performance - Over the past year, Insmed's shares have surged by 149.2%, significantly outperforming the industry growth of 17.5% [4] - Arikayce, Insmed's established product, generated $314.5 million in sales in the first nine months of 2025, reflecting a 21% year-over-year increase, which alleviates near-term cash flow concerns [5] - Following the third-quarter release, Insmed raised its full-year guidance for Arikayce revenues to a range of $420 million to $430 million, up from $405 million to $425 million [8] Group 3: Pipeline Developments - Insmed faced a setback with the phase IIb BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps, which failed to meet key efficacy goals, leading to the discontinuation of this indication [9] - Despite this, Insmed is strengthening its pipeline with the addition of INS1148 for interstitial lung disease and asthma, and is evaluating brensocatib in the phase II CEDAR study for hidradenitis suppurativa, with data expected in the first half of 2026 [10] - Insmed is also progressing treprostinil palmitil inhalation powder into late-stage studies for pulmonary hypertension indications [12]

Industry Overview - The drug and biotech sector experienced a volatile performance in 2025, with a significant recovery in the last few months attributed to improved drug pricing policies and strong merger and acquisition activity [2] - The biotech sector has rallied 26% over the past six months, outperforming the S&P 500 index [2] Innovation and Regulatory Activity - Key growth areas in the industry include obesity, gene therapy, inflammation, and neuroscience, attracting investor interest [3] - The FDA approved 44 novel therapies as of December 22, 2025, indicating healthy regulatory activity [3] Company Highlights Mineralys Therapeutics - Mineralys is developing lorundrostat, an aldosterone synthase inhibitor for uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea [5] - The pivotal phase III Launch-HTN study and phase II Advance-HTN study met primary efficacy endpoints, showing favorable safety [6] - The company plans to submit a new drug application for lorundrostat in early 2026, with shares up 203.4% year-to-date [8][9] Lyell Immunopharma - Lyell focuses on next-generation CAR T-cell therapies, with its lead candidate ronde-cel for large B-cell lymphoma [11] - A pivotal phase III study for ronde-cel is expected to begin in early 2026, and the company has a strong cash position of approximately $320 million [14] - Shares have increased by 191.6% in 2025, with loss per share estimates narrowing from $12.68 to $9.70 [15] Insmed - Insmed markets Arikayce for refractory MAC lung disease, generating $314.5 million in sales in the first nine months of 2025, a 21% increase year-over-year [16] - The FDA approved Brinsupri for non-CF bronchiectasis, with sales of $28.1 million in Q3 2025 [17] - Despite a setback with the BiRCh study, the company is evaluating Brinsupri for hidradenitis suppurativa, with shares up 156% year-to-date [19][20] Nektar Therapeutics - Nektar is developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with positive data from phase IIb studies [21][22] - The company plans to advance rezpeg into phase III development in 2026, with shares soaring 218.8% year-to-date [24][25]

Key Takeaways MLYS' lorundrostat hit key endpoints, supporting plans for an NDA submission in early 2026.LYEL rose as ronde-cel advanced in pivotal studies and new CAR T assets strengthened its oncology pipeline.INSM climbs on Brinsupri's FDA approval, despite a setback in a mid-stage rhinosinusitis study.The drug and biotech sector witnessed a see-saw performance in 2025. After a weak show for most of the year, the sector picked up in the past couple of months. This can be attributed to improved policies f ...

Insmed Incorporated (NASDAQ:INSM) stock plunged on Thursday. • Insmed stock is showing notable weakness. What’s behind INSM decline?The company released data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).The trial did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.Brensocatib was well tolerated, with no new safety signals identified, including in the 40 mg arm, which is the highest dose Ins ...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Dive Brief: A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial. The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago ...

Core Insights - Stanley Druckenmiller, a renowned investor, has a significant focus on biotech stocks, which make up 30% of his portfolio despite the popularity of AI stocks in the market [2][3]. Biotech Sector Overview - The biotech sector is challenging for retail investors due to its speculative nature and the need for scientific knowledge [2]. - Druckenmiller's private investment firm, Duquesne Family Office, has three major biotech holdings: Natera, Insmed, and Teva Pharmaceutical [3]. Natera - Natera represents 13% of Duquesne's portfolio, with over 3.2 million shares valued at approximately $517 million [4]. - The company utilizes AI to enhance disease detection, focusing on women's health, oncology, and organ health [5]. - Natera's stock has increased by 48% in 2023, with a 35% revenue growth year-over-year for the first nine months of 2025 [6]. - The company raised its annual revenue guidance for 2025 by $160 million, although it faces increased losses due to R&D and administrative expenses [6]. Insmed - Insmed accounts for 8.6% of the portfolio, with over 2.4 million shares valued at around $349 million [7]. - The company is focused on developing drugs for chronic diseases, with two drugs currently commercialized [8]. - Insmed's stock has surged nearly 200% year-to-date, driven by a 21% revenue growth from its drug Arikayce and the FDA approval of Brinsupri [9]. Teva Pharmaceutical - Teva Pharmaceutical comprises 8.3% of the portfolio, with approximately 16.6 million shares valued at about $335.2 million [10]. - The company manufactures a variety of drugs and has seen its stock rise over 17% this year [11]. - Teva reported a 3% year-over-year revenue growth to nearly $4.5 billion in the third quarter and has a strong pipeline of drugs nearing commercialization [12]. - The stock is trading at 1.7 times forward revenue and 9.5 times forward earnings, indicating a reasonable valuation [13].

Core Viewpoint - Carillon Tower Advisers' "Carillon Eagle Mid Cap Growth Fund" reported a continued rally in equity markets during Q3 2025, driven by enthusiasm for AI, limited inflationary effects from tariffs, and expectations for interest rate cuts by the U.S. Federal Reserve [1] Market Performance - The Russell Midcap Growth Index increased by 2.78%, while the Russell Midcap® Value Index outperformed with a gain of 6.16% during the same quarter [1] Sector Insights - The investor letter provided detailed insights on various sectors including Cyclicals, Healthcare, Information Technology, Financials, and Consumer sectors [1] Company Spotlight: Insmed Incorporated - Insmed Incorporated (NASDAQ:INSM) is highlighted as a key stock, with a one-month return of 25.19% and a remarkable 173.43% increase over the last 52 weeks [2] - As of November 24, 2025, Insmed's stock closed at $206.93 per share, with a market capitalization of $44.133 billion [2] Product Approval and Impact - Insmed received approval for its Brinsupri product to treat non-cystic fibrosis bronchiectasis, marking a significant milestone for a condition affecting up to 500,000 people [3] - The positive trial results for another treatment for pulmonary fibrosis contributed to the strong performance of Insmed's stock [3] Hedge Fund Interest - Insmed was held by 82 hedge fund portfolios at the end of Q2 2025, an increase from 64 in the previous quarter, indicating growing interest among institutional investors [4]

Core Insights - Baron Health Care Fund reported a 5.39% increase in Q3 2025, slightly outperforming the Russell 3000 Health Care Index which gained 5.05% [1] - The fund's performance was impacted by stock selection and negative effects from active sub-industry allocations and cash holdings during a rising market [1] Fund Performance - The Baron Health Care Fund's Institutional Shares rose 5.39% in Q3 2025 [1] - The Russell 3000 Index had a higher gain of 8.18% during the same period [1] Key Holdings - Insmed Incorporated (NASDAQ:INSM) was highlighted as a significant stock, with a one-month return of 11.47% and a 52-week gain of 110.54% [2] - As of October 31, 2025, Insmed's stock closed at $161.38, with a market capitalization of $34.112 billion [2] Company Overview - Insmed is focused on developing therapies for serious pulmonary diseases, with potential peak sales exceeding $8 billion from three lead drug candidates [3] - The recent U.S. approval of Brinsupri for non-cystic fibrosis bronchiectasis presents a $5 billion market opportunity due to the lack of approved treatments [3] - The company is also developing treprostinil palmitil inhalation powder (TPIP), which aims to improve treatment for pulmonary arterial hypertension with a once-daily dosage [3] Market Position - Insmed was held by 82 hedge fund portfolios at the end of Q2 2025, an increase from 64 in the previous quarter [4] - Despite its potential, some analysts suggest that certain AI stocks may offer greater upside potential with less downside risk compared to Insmed [4]

Core Insights - Insmed reported a Q3 2025 loss of $1.75 per share, wider than the Zacks Consensus Estimate of a loss of $1.32, compared to a loss of $1.27 per share in the same quarter last year [1][9] - Quarterly revenues increased by 52% year over year to over $142.3 million, surpassing the Zacks Consensus Estimate of approximately $115 million, driven by sales of its two marketed products [1][9] Financial Performance - Sales of Arikayce rose 22% year over year to $114.3 million, with domestic sales increasing by 11% to $74 million and ex-U.S. sales surging by 52% to $40.3 million [3] - Brinsupri generated $28.1 million in its first quarter of sales, contributing to strong investor optimism following its commercial launch [4][9] - Research and development expenses increased by 24% year over year to $186.4 million, attributed to a rise in employee headcount and clinical expenses [7] - Selling, general and administrative expenses rose by 57% to $186.4 million, driven by higher professional service costs and increased compensation for a larger workforce [8] Market Position and Guidance - Insmed's stock has increased by 181% year to date, compared to the industry's 11% growth [6] - The company raised its sales guidance for Arikayce to between $420 million and $430 million for the full year, indicating nearly 17% year-over-year growth at the midpoint [11] Pipeline Developments - Insmed has completed patient enrollment in the phase III ENCORE study for Arikayce, with top-line data expected in the first half of 2026 [12] - The EMA recommended approval for Brinsupri to treat NCFB in patients aged 12 and older, with a final decision expected before year-end [13] - Insmed is evaluating Brinsupri in the phase IIb BiRCh study for chronic rhinosinusitis and in the phase II CEDAR study for hidradenitis suppurativa, with data readouts expected in early 2026 [14] - The company plans to initiate two late-stage studies on its investigational treprostinil palmitil inhalation powder (TPIP) next year for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease [15] - Insmed has completed dosing in the early-stage ASCEND study for its gene therapy INS2101 for Duchenne muscular dystrophy and received FDA clearance for clinical studies on INS1202 for ALS patients [16]