On May 7, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, reported financial results and business highlights for the first quarter ended March 31, 2026.

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"In the first quarter of 2026, we continued to advance our next-generation TCE platform and clinical programs," said William Ho, Chief Executive Officer and co-founder of IN8bio. "Our encouraging GBM data positions us to engage the FDA on potential regulatory pathways forward, and we expect to deliver meaningful preclinical, regulatory and clinical milestones across our pipeline this year. As industry interest in novel TCEs accelerates, our next-generation platform is designed to address the key challenges in TCE development. We believe IN8bio is well positioned to create meaningful value for patients and shareholders in 2026 and beyond. We look forward to sharing further updates across our programs at our upcoming R&D Day in New York City on May 21, 2026."

Key Highlights

Advancing Next-Generation Gamma-Delta T Cell Engager Platform (INB-619)

Continued to advance our internally developed INB-600 platform of novel γδ T cell engagers, designed to potently eliminate targets such as CD19, potentially reduce toxicities such as cytokine release syndrome (CRS) and widen the therapeutic window over traditional CD3-targeting engagers.
Presented encouraging preclinical data for INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases. The data showed complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release (IL-6, TNF-α), reinforcing the platform’s differentiation and therapeutic potential.
Progressing INB-619 into IND-enabling studies, with initial animal data expected in 2026.

Presented Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma

In January 2026, IN8bio reported updated data as of December 31, 2025, from its Phase 1 (INB-200) and Phase 2 (INB-400) clinical trials evaluating DeltEx drug resistant immunotherapy (DRI) γδ T cells in patients with newly diagnosed GBM. The data included a concurrent standard-of-care (SOC) control group enrolled at the same time and clinical sites as treated patients.

Median progression-free survival (mPFS) for repeat dose patients was 13.0 months versus 6.6 months for SOC patients (+97% improvement).
Median overall survival (mOS) in repeat dose patients is still climbing, currently at 17.2+ months as of December 31, 2025, surpassing the 13.2-months for the SOC control arm.
Several patients remained progression-free beyond two years, including one grade 4, IDH-mutant glioma patient who remains progression-free with no additional therapy for more than 4.5 years.
No dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), neurotoxicity (ICANS), tumor inflammation-associated neurotoxicity (TIAN) or other unexpected severe adverse events were reported.
Updated mOS results to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting (Abstract 2077, Poster 442) on June 1, from 1:30 – 4:30 p.m. CDT.

IN8bio Research & Development Day 2026

IN8bio will host its R&D Day on May 21, 2026 (9:00 – 11:30 a.m. EDT), in New York City.
The event will feature presentations on the Company’s γδ TCE platform targeting oncology and autoimmune diseases.
The Company will also provide updates on its clinical program in GBM, including a clinical perspective from renowned neuro-oncologist Dr. David Reardon, Director, Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School.
Register Online: View Source

Upcoming Conferences & Anticipated Milestones

International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting (Dublin, Ireland)

Title: Unraveling Complexity: The Impact, Interactions and Outcomes of a γδ T Cell Therapy in Glioblastoma
Poster Details: 1253
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 – 2:30 p.m. EDT)
Title: Lean Infrastructure for CGT Early-Stage Companies: Leveraging Integrated Digital Platforms to Achieve Sustainable Operation Efficiency and Scalable Compliance
Poster Details: 801
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 – 2:30 p.m. EDT)

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting (Boston, MA)

Title: Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance?
Abstract: 328
Date and Time: May 14, 2026, 11:00 – 11:15 a.m. EDT

Anticipated Milestones

Guidance from the FDA on potential accelerated regulatory pathways for GBM program in 2H26.
Publication of Phase 1 INB-200 clinical data in newly diagnosed GBM patients in a peer-reviewed journal.
Additional GBM clinical updates, including updated mOS data at ASCO (Free ASCO Whitepaper) 2026.
Initial TCE preclinical animal data and additional IND-enabling data for INB-619 in 2H26.
Completion of INB-100 patient dosing and presentation of long-term follow-up results at a medical meeting in late 2026.

First Quarter 2026 Financial Highlights

Cash position: As of March 31, 2026, the Company had cash of $21.9 million, compared with $11.9 million, for the comparable prior year period.
Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended March 31, 2026, compared with $3.0 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. The decrease primarily reflects lower clinical trial activity in the INB-400 program.
General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended March 31, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation.
Net loss: The Company reported a net loss of $5.1 million, or $0.26 per basic and diluted common share, for the three months ended March 31, 2026, compared with a net loss of $5.6 million, or $2.16 per basic and diluted common share, for the comparable prior year period.

(Press release, In8bio, MAY 7, 2026, View Source [SID1234665328])

On May 7, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2026. Unless otherwise stated, all comparisons are for the first quarter 2026 compared to the first quarter 2025.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2026 was $42.0 million, compared to product revenue, net of $43.1 million in the first quarter of 2025.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $3.8 million, or $0.07 per basic and diluted share, for the first quarter of 2026, compared to net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025.

Non-GAAP adjusted net loss was $1.9 million, or $0.04 per basic and diluted share, for the first quarter of 2026, compared to non-GAAP adjusted net income of $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2026 was $15.4 million, compared to net cash provided by operating activities in the first quarter of 2025 of $3.6 million. At March 31, 2026, Puma had cash, cash equivalents and marketable securities of $101.5 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025. Total debt at March 31, 2026 was $11.3 million, compared to total debt of $22.5 million at December 31, 2025. On May 4, 2026, Puma remitted the final payment of principal, interest and exit fees due under its 2021 Note Purchase Agreement, which reduced outstanding debt to zero and terminated all remaining obligations, other than customary continuing indemnification obligations.

"We are very pleased that the first quarter of 2026 marked another quarter of year-over-year demand increase resulting in our raising revenue guidance for 2026. According to our current forecasts, FY 2026 will mark our second consecutive year of NERLYNX demand increase year over year," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We are also pleased with the interim data from ALISCA-Breast1 and ALISCA-Lung1, which appear to demonstrate an increased clinical effect of alisertib in biomarker subgroups where aurora kinase A appears to be playing a role. We look forward to continuing the development of alisertib in ALISCA-Breast1 and ALISCA-Lung1 while carefully managing our resources to achieve positive net income for this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) expansion of enrollment in ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer to obtain more data in biomarker focused populations (H2 2026); (ii) expansion of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2026); and (iii) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the first quarter ended March 31, 2026, total revenue was $44.8 million, of which $42.0 million was net product revenue and $2.8 million was royalty revenue. This compares to total revenue of $46.0 million in the first quarter of 2025, of which $43.1 million was net product revenue and $2.9 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $48.6 million for the first quarter of 2026, compared to $42.0 million for the first quarter of 2025.

Cost of Sales

Cost of sales was $10.4 million for the first quarter of 2026, compared to $10.6 million for the first quarter of 2025. Cost of sales was relatively consistent year-over-year as our product bottle sales were relatively consistent.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $18.4 million for the first quarter of 2026, compared to $17.6 million for the first quarter of 2025. The $0.8 million increase resulted primarily from a $0.9 million increase in employee compensation and a $0.4 million increase in marketing and market access costs, partially offset by decreases in provision for credit losses, facility and equipment costs, and stock-based compensation expense totaling $0.4 million.

Research and Development Expenses

Research and development expenses were $19.8 million for the first quarter of 2026, compared to $13.8 million for the first quarter of 2025. The $6.0 million increase resulted primarily from an increase of approximately $5.2 million in clinical trial expense, primarily due to increased alisertib study activity, and an increase of approximately $0.7 million in employee compensation expense.

(Press release, Puma Biotechnology, MAY 7, 2026, View Source [SID1234665344])

On May 7, 2026 ParcelBio, a biotechnology company developing a new class of potent and durable mRNA medicines, reported it has raised $13 million in seed financing led by Breyer Capital, with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, ZAKA VC, and other investors.

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The financing will support development of ParcelBio’s proprietary APEXm (Amplified and Prolonged EXpression mRNA) platform and advance its pipeline, including its lead in vivo CAR-T program for autoimmune disease, as well as additional programs in oncology and encoded protein therapeutics.

Current mRNA technologies are limited in their ability to achieve both high protein expression and sustained durability, often requiring tradeoffs between potency, duration, and manufacturability. These constraints have restricted the broader application of mRNA beyond vaccines and short-acting therapeutics.

ParcelBio is developing a new category of mRNA medicines designed to overcome these limitations. Its proprietary APEXm platform engineers RNA molecules to actively recruit the cell’s native RNA-stabilizing machinery, enabling significantly higher and more durable protein expression. This approach leads to a step-change in biological performance, reaching therapeutic thresholds that have historically been out of reach for mRNA.

"mRNA has transformed medicine, but today’s technologies are fundamentally limited in how much protein they can produce and for how long," said David Weinberg, Ph.D., Chief Executive Officer and Co-Founder of ParcelBio. "We engineered RNA to work with the cell’s machinery rather than against it, enabling meaningful improvements in both expression and durability that we believe are essential for true disease modification."

Unlike circular RNA and other next-generation approaches that often introduce manufacturing complexity or reduce peak output, ParcelBio’s platform maintains a simple, linear mRNA architecture while delivering both high peak expression and sustained activity. The platform is modular and broadly applicable across proteins and cell types, enabling diverse therapeutic applications ranging from immune reprogramming to protein replacement.

ParcelBio’s lead program focuses on in vivo CAR-T therapies targeting pathogenic B cells across autoimmune diseases, with the goal of achieving deep B-cell depletion for durable, drug-free remission. By enabling sustained CAR expression without viral delivery or ex vivo manufacturing, the company aims to develop scalable, off-the-shelf therapies with curative potential. Additional programs are in development in oncology and encoded protein therapeutics.

Preclinical data demonstrate that ParcelBio’s APEXm RNA drives significantly higher and more durable protein expression compared to a leading clinical mRNA design, translating into deeper biological responses, including more complete target cell depletion in in vivo CAR-T models. The company will be debuting the APEXm platform and preclinical data in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 14, 2026.

"ParcelBio’s durable, tunable expression is designed to collapse the tradeoffs that have constrained mRNA in chronic, deep-tissue disease, bringing durable, controllable immune reset within reach in refractory autoimmunity and beyond," said Dr. Morgan Cheatham, Partner and Head of Healthcare and Life Sciences at Breyer Capital. "Breyer Capital’s life sciences thesis is organized around the technologies that redefine what medicine can reach: programmable biology, controllable expression, and durable therapeutic impact. ParcelBio is built to advance all three."

"Most RNA platforms force a tradeoff between potency, durability, and manufacturability," said Chris Carlson, Ph.D., Chief Scientific Officer and Co-Founder of ParcelBio. "Our approach eliminates that tradeoff, enabling both higher peak expression and longer duration within a manufacturable system, and opening the door to entirely new classes of medicines."

(Press release, ParcelBio, MAY 7, 2026, View Source [SID1234665362])

On May 7, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the first quarter of 2026 and provided a business update.

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"We are pleased to have aligned with the FDA on the pivotal ANTLER-3 trial design for vispa-cel," said Rachel Haurwitz, PhD, president and CEO of Caribou. "Vispa-cel continues to demonstrate a differentiated profile as an off-the-shelf CAR-T cell therapy with a well-tolerated safety profile and robust response rates resulting in long-term durable outcomes in high-risk patients. Our pivotal trial will compare vispa-cel to standard-of-care regimens that lack curative intent yet are often the only options available to the 75% of second-line large B cell lymphoma patients who do not receive autologous CAR-T cell therapy. We look forward to reporting longer follow up on the phase 1 data for vispa-cel at an upcoming medical conference this year as well as sharing longer follow up on dose escalation and initial dose expansion data for CB-011 in patients with relapsed or refractory multiple myeloma in 2026."

Clinical highlights

Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•Caribou reached alignment with the U.S. Food and Drug Administration (FDA) regarding the vispa-cel pivotal trial design following interactions to date with the agency enabled by the Regenerative Medicine Advanced Therapy (RMAT) designation for vispa-cel.
•ANTLER-3 is expected to be a randomized, controlled pivotal phase 3 clinical trial enrolling approximately 250 CD19-naïve second-line (2L) large B cell lymphoma (LBCL) patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy.
◦Patients in the investigational arm will receive a single dose of 80×106 vispa-cel CAR-T cells following lymphodepletion.
◦Patients in the comparator arm will be treated with an investigator’s choice of standard-of-care regimen, such as: polatuzumab vedotin (Pola), bendamustine, rituximab (R) (Pola-BR); R, gemcitabine, and oxaliplatin (R-GemOx); Pola-R-GemOx (Pola-RGO); or tafasitamab and lenalidomide. Crossover to the vispa-cel arm is permitted after progressive disease.
◦The primary endpoint is progression-free survival (PFS).
◦Clinical trial sites will include both academic and sophisticated community centers in the United States and globally.

•Clinical data disclosed in November 2025 and in a poster presented at the 2026 Tandem Meetings highlight vispa-cel’s potential — as an immediately available, off-the-shelf CAR-T cell therapy manufactured at scale — to help meet the needs of the 75% of 2L LBCL patients who do not receive autologous CAR-T cell therapy.
•Longer follow up ANTLER phase 1 clinical trial data will be presented at a medical conference in 2026.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•On March 31, 2026, Caribou announced the FDA granted RMAT designation to CB-011 for r/r MM.
•RMAT was granted based on promising initial clinical data, including previously disclosed data on the 12-patient, BCMA-naïve r/r MM patient cohort treated at the recommended dose for expansion: 92% overall response rate, 75% complete response (CR) or stringent CR rate, and 91% minimal residual disease negativity. These data highlight CB-011’s potential as the best-in-class allogeneic CAR-T cell therapy for patients with r/r MM.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial and expects to report longer follow up on dose escalation data and initial dose expansion data in 2026.

Upcoming events
•BofA Securities 2026 Health Care Conference, Las Vegas, NV
May 13, 2026, fireside chat at 8:40 am PT
Webcast
First quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $2.4 million for the three months ended March 31, 2026, unchanged from the same period in 2025.

R&D expenses: Research and development expenses were $20.6 million for the three months ended March 31, 2026, compared to $35.5 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities, expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025, facilities and allocated expenses, and expenses related to licenses, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $8.1 million for the three months ended March 31, 2026, compared to $9.7 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025 and lower legal expenses.

Cash, cash equivalents, and marketable securities: Caribou had $118.6 million in cash, cash equivalents, and marketable securities as of March 31, 2026, compared to $142.8 million as of December 31, 2025. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. The Company is exploring multiple options to fully fund its planned vispa-cel pivotal trial.

About vispacabtagene regedleucel

Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a September 2, 2025, data cutoff date, 84 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40×106, 80×106, and 120×106 CAR-T cell CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million (80×106) CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial

The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial is evaluating safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAY 7, 2026, View Source [SID1234665313])

On May 7, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"In the first quarter of 2026, momentum across Insmed’s commercial portfolio and pipeline continued to build," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The trajectory of the BRINSUPRI launch continues to exceed our expectations, and we are especially encouraged by the positive topline results from the ENCORE Phase 3b study, which could enable us to extend our reach to even more patients. We remain focused on improving bronchiectasis diagnosis, expanding the ARIKAYCE label, advancing our Phase 3 programs for TPIP, and progressing our early-stage pipeline, with the ambition of delivering meaningful innovation and improving the lives of patients with serious diseases."

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

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BRINSUPRI

•
BRINSUPRI global revenue grew 44% in the first quarter of 2026 compared to the fourth quarter of 2025, driven by strong growth in the U.S. market.

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In February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in the United Kingdom (U.K.) for BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months.

•
Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.

•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

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ARIKAYCE global revenue grew 6% in the first quarter of 2026 compared to the first quarter of 2025, driven by strong growth in international markets.

•
In March 2026, Insmed reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.

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Insmed plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

•
Insmed continues to enroll patients in the PALM-ILD trial, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH).

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In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.

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Insmed expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the third quarter of 2026.

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Insmed anticipates initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) by the end of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

INS1148

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Insmed plans to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and is exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.

Immunology & Inflammation

INS1033

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Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial investigational new drug (IND) filing expected in the second half of 2026.

Neuro & Other Rare

INS1201

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Insmed continues to enroll patients in the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

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Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

2
INS1203

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Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Corporate Updates

•
Insmed plans to present six abstracts from across its Respiratory Therapeutic Area (BRINSUPRI, ARIKAYCE, TPIP) at the American Thoracic Society (ATS) 2026 International Conference, taking place May 15-20, 2026.

(Press release, Insmed, MAY 7, 2026, View Source [SID1234665329])