On March 2, 2026 Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) and Eisai (Headquarters: Tokyo, CEO: Haruo Naito) reported the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG (belzutifan), Merck & Co., Inc., Rahway, NJ, USA’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/ programmed death-ligand 1 (PD-L1) therapy. These data are being presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA417) and are included in the official ASCO (Free ASCO Whitepaper) GU Press Program.

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At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol.

Based on data from the LITESPARK-011 trial, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review seeking approval for WELIREG plus LENVIMA for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PD-L1 inhibitor. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of October 4, 2026, for both the WELIREG and LENVIMA sNDAs. Merck & Co., Inc., Rahway, NJ, USA and Eisai will also discuss these data with regulatory authorities worldwide to support potential submissions outside the United States.

"Choosing the right treatment for patients with advanced renal cell carcinoma after immunotherapy has been an ongoing challenge, and treatment options in this setting had not previously been evaluated against a current standard of care tyrosine kinase inhibitor in a Phase 3 trial," said Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist, Memorial Sloan Kettering Cancer Center. "The LITESPARK-011 study demonstrated a 30% reduction in the risk of disease progression or death with belzutifan plus lenvatinib compared to cabozantinib, and 52.6% of patients experienced a response to treatment. These findings mark a critical step forward for these patients."

"The LITESPARK-011 trial highlights the potential of this first-of-its-kind combination regimen to deliver a meaningful benefit for patients with advanced renal cell carcinoma whose disease progresses after PD-1/L1 therapy," said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, MSD Research Laboratories. "These WELIREG plus LENVIMA data demonstrate important progress for patients with advanced renal cell carcinoma and reinforce our commitment to improving the lives of patients through innovative treatment strategies."

"The LITESPARK-011 results reinforce LENVIMA’s established role in renal cell carcinoma and highlight the potential of this novel combination to address an area of significant unmet need," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. "The acceptance of this regulatory filing is an important milestone, and we remain committed to working toward approval to bring this option to patients as soon as possible. We are grateful to the patients, their families, and the investigators, whose dedication made this research possible."

Additional findings

Data for objective response rate (ORR) and duration of response (DOR), two key secondary endpoints, were also reported. At the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib.

WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to treatment discontinuation in 11.1% of patients receiving WELIREG plus LENVIMA and in 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

LITESPARK-011 is part of a comprehensive late-stage clinical development program for WELIREG comprised of several Phase 2 and Phase 3 trials in pheochromocytoma and paraganglioma, von Hippel-Lindau disease-associated neoplasms and RCC. The Phase 3 LITESPARK-012 trial is evaluating the addition of WELIREG to KEYTRUDA (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, plus LENVIMA in the first-line advanced RCC disease setting.

WELIREG is approved(New Window) in the U.S., European Union (EU), Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

Dr. Motzer has provided consulting and advisory services for Merck & Co., Inc., Rahway, NJ, USA and Eisai.

About LITESPARK-011

LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231(New Window)) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include ORR per RECIST v1.1 as assessed by BICR, DOR per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC.1 In 2022, there were about 435,000 new cases of kidney cancer and approximately 156,000 deaths from the disease worldwide.2 RCC is about twice as common in men as in women.1 Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Eisai, MAR 2, 2026, View Source [SID1234663177])

On March 2, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), a publicly traded biotechnology company advancing next-generation therapeutics using its proprietary Accum platform, reported its participation in a series of major international industry events taking place in March 2026.

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These high-profile meetings will provide Defence with multiple opportunities to advance strategic partnerships, strengthen its global network, and further position Accum as a differentiated intracellular delivery technology for antibody-drug conjugates (ADCs), radiopharmaceutical conjugates (RDCs), and other complex biologics.

BIO-Europe Spring: Primary Focus on Strategic Partnerships

Defence will participate in BIO-Europe Spring (March 23–26, Lisbon, Portugal), the premier global partnering event for the life sciences industry. At BIO-Europe, the Company will prioritize discussions with biopharmaceutical partners seeking to collaborate on enhancing the intracellular delivery and efficacy of their ADC programs using Accum.

DCAT Week: Advancing Biomanufacturing Capabilities

Defence will also attend DCAT Week (March 23–26, New York), where the Company will focus on strengthening its manufacturing strategy. During DCAT, Defence plans to meet with contract research and manufacturing partners to advance the robust and high-quality biomanufacturing of Accum, a key operational objective for the Company. Defence has recently become a member of the Drug, Chemical & Associated Technologies Association ("DCAT"), reinforcing its commitment to ensuring the well-characterized, quality-controlled, and commercially ready production of Accum.

Expanding U.S. Presence and Investor Engagement

In parallel, Defence will participate in the South Florida Life Sciences Showcase (March 24, Miami) and FII PRIORITY Miami (March 25–27), supporting the Company’s ongoing investor outreach and business development efforts in the United States. Defence has also recently joined BioFlorida, further strengthening its footprint within the Florida life sciences ecosystem.

"As we engage with partners and industry stakeholders across these key events, our priority is to build meaningful collaborations that support the continued growth and adoption of Accum," said Sébastien Plouffe, CEO of Defence Therapeutics. "By enabling more efficient intracellular delivery of complex biologics, Accum has the potential to significantly enhance therapeutic performance and tolerability, positioning the platform as a game-changing solution in the ADC field.". To explore partnering opportunities or schedule a meeting, please contact Defence Therapeutics at [email protected].

(Press release, Defence Therapeutics, MAR 2, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-showcase-accum-platform-at-key-international-industry-events-in-march [SID1234663176])

On March 2, 2026 Day One Pharmaceuticals presented its corporate presentation.

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(Presentation, Day One, MAR 2, 2026, View Source [SID1234663175])

On March 2, 2026 Pulmatrix ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE technology, reported that on February 28, 2026, Cullgen Inc. notified Pulmatrix that Cullgen was terminating the Merger Agreement (as defined herein) and related transactions thereunder. This termination follows the December 2025 announcing that Pulmatrix and Cullgen had mutually agreed to waive the "No Solicitation" clause in the Merger Agreement in order to permit each party to explore alternate transactions in the period until closing. At this time, Pulmatrix continues to pursue alternative merger opportunities.

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Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Due to the significant delays at the Chinese Regulatory Authority (CSRC) in 2025, we initiated a process earlier this year to identify an alternative reverse merger opportunity for the Company, and we are encouraged by both the interest we’ve had to date as well as the recent increase in transaction activity within our industry."

Prior Proposed Merger with Cullgen

As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen, as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and the transactions contemplated thereunder, collectively, the "Merger").

Additional information about the Merger Agreement and the previously proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025.

On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which meeting the Company’s stockholders approved the Merger and related proposals. The closing of the Merger was subject to certain closing conditions, including approval from the China Security Regulatory Commission which had not been obtained at the time of Cullgen’s termination.

Pulmatrix Clinical Assets and Proprietary iSPERSE Technology

iSPERSE Technology

iSPERSE, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases.

As of December 31, 2025, Pulmatrix’s patent portfolio related to iSPERSE included approximately 149 granted patents, 18 of which are U.S.-granted patents, plus approximately 48 pending patent applications in the U.S. and other jurisdictions.
PUR3100

PUR3100, a Phase 2-ready asset, is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix’s iSPERSE dry powder inhalation technology for the treatment of acute migraine has a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.

The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed publication, Headache: The Journal of Head and Face Pain. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously ("IV") administered DHE dose group.
PUR1800

PUR1800 is a Narrow Spectrum Kinase Inhibitor ("NSKI"), engineered with our iSPERSE technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease ("AECOPD"). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was well-tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.

In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis".
PUR1900

PUR1900, approved to proceed to a Phase 3 in India conducted by our partner Cipla, is the Company’s inhaled iSPERSE formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States, and in 2025 completed their Phase 2 study in India and have been approved by India’s Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial.

Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla share the rights 50/50 and will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

(Press release, Cullgen, MAR 2, 2026, View Source [SID1234663174])

On March 2, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") and Congruence Therapeutics reported that they have expanded their existing multi-target research partnership through the execution of a new research collaboration for two additional programs.

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The expanded collaboration is focused on two clinically validated high-value targets in the areas of neurology and immunology for which Congruence will lead the effort to discover small molecule modulators and advance them to the development candidate stage. Ono will have the option to secure exclusive worldwide rights to further develop and commercialize development candidates generated under the new agreement.

An original collaboration between the companies, which began in December 2024, is focused on leveraging Congruence’s proprietary computational engine, Revenir, to discover novel small molecule correctors directed to mutants of a difficult-to-drug cancer target.

"We are excited to expand our partnership with Ono, a global pioneer of innovative medicines," said Sharath Hegde PhD, Chief Scientific Officer of Congruence. "The expansion is a testament to the significant contributions we have made in our existing collaboration as well as the trust and confidence we continue to build with Ono. We look forward to leveraging the complementary strengths of both organizations to advance important research for the benefit of patients."

The new collaboration continues to leverage Congruence’s computational drug discovery engine, Revenir, which systematically captures the biophysical features of proteins in different functional states to enable a highly differentiated approach to small-molecule discovery.

Congruence’s wholly owned program directed to MC4R-deficient genetic obesity is entering a Phase 1/1b clinical study this month. In the next few weeks, Congruence will also nominate development candidates for each of its programs directed to GBA1-driven Parkinson’s Disease and Alpha-1 Antitrypsin deficiency.

"Congruence’s advanced computational discovery engine is attracting growing global attention with its lead program entering clinical development. We are honored that our ongoing collaboration with Congruence is expanding beyond oncology to other priority areas including both neurology and immunology," said Seishi Katsumata, Corporate Officer / Executive Director, Discovery & Research of Ono. "Through this partnership, we will be committed to accelerating the drug development so that we can deliver innovative new medicines to patients with unmet medical needs as quickly as possible."

Under the terms of the new agreement announced today, Congruence will receive an upfront payment and is eligible to receive additional payments upon the achievement of certain milestones in discovery, development, approval and commercialization – in addition to tiered royalties based on annual net sales of related products. Moreover, Ono will reimburse Congruence for the internal and external research costs it incurs in connection with the activities undertaken in the expanded partnership.

About Revenir Drug Discovery Platform

Revenir, Congruence’s proprietary computational drug discovery platform, captures the dynamic biophysical changes of proteins in different functional states, offering unique insights into protein function and their modulation. By examining surface features and a spectrum of biophysical descriptors across an ensemble of protein conformers, Revenir predicts small molecule induced modulation of underlying physiologic protein states. This platform-driven strategy underpins Congruence’s growing pipeline of first-in-class and best-in-class programs directed to genetically validated targets implicated in conditions associated with significant unmet medical need, supporting a readily scalable and repeatable value creation paradigm.

(Press release, Congruence Therapeutics, MAR 2, 2026, View Source [SID1234663173])