On October 7, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported the completion of the final patient visit in its breast cancer vaccine clinical trial (Press release, Anixa Biosciences, OCT 7, 2025, View Source [SID1234656489]). This novel vaccine, invented at Cleveland Clinic, is being developed in partnership with Cleveland Clinic, and the Phase 1 trial is fully funded by a grant from the U.S. Department of Defense.

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The vaccine is designed to stimulate the immune system to recognize and target breast cancer before it can recur or develop. A total of 35 women received the vaccine in the study, spanning three distinct patient cohorts:

TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.
Prevention Group: Women who are cancer-free but carry genetic mutations associated with elevated breast cancer risk, and who elected to undergo preventive mastectomy.
Pembrolizumab (Keytruda ) Group: Women receiving pembrolizumab in a post-operative setting who were administered the vaccine concurrently with the checkpoint inhibitor.
The trial enrolled 26 patients in the TNBC group, four in the Prevention group, and five in the Pembrolizumab group.

With the completion of all patient visits and sample collection, comprehensive data analysis can now proceed. Following analysis, a final study report will be submitted to the Department of Defense, and a Clinical Study Report (CSR) will be filed with the U.S. Food and Drug Administration (FDA).

Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025.

Dr. G. Thomas Budd, of Cleveland Clinic Cancer Institute and Prinicipal Investigator of the study, commented, "We are pleased by the data we are seeing from this trial. Preliminary results indicate that our breast cancer vaccine is well tolerated, with more than 70% of participants demonstrating protocol-defined immune responses. We look forward to presenting the final trial data at the San Antonio Breast Cancer Symposium later this year."

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "While cancer vaccines have historically faced considerable challenges, our approach targets a novel antigen that has not been explored in this setting. We believe this strategy could represent a new paradigm in immuno-oncology, with potential utility in both the prevention and treatment of breast cancer."

On October 7, 2025 Circulogene reported the national launch of OncoGenDx, an innovative tissue-based comprehensive genomic profiling (CGP) assay that delivers expanded insights into all solid tumors (Press release, Circulogene, OCT 7, 2025, View Source [SID1234656488]). Designed to complement Circulogene’s existing portfolio—including OncoGenLDx, the industry’s only plasma-based test reporting PD-L1 expression, and LungLifeAI, a targeted solution for risk stratifying incidental lung nodules—the new assay reflects Circulogene’s ongoing commitment to advancing precision oncology with fast, modular, and clinically actionable testing options.

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"OncoGenDx reflects Circulogene’s commitment to innovation that simplifies the diagnostic landscape," said Mike Mullen, CEO of Circulogene. "By integrating tissue and liquid capabilities into a unified solution, we’re enabling clinicians to make faster, more confident treatment decisions—whether they’re evaluating initial diagnoses or monitoring disease progression."

About OncoGenDx

OncoGenDx is a next-generation sequencing (NGS) assay designed to deliver a comprehensive molecular analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue across all solid tumor types. Built on Roche’s AVENIO NGS platform and leveraging FoundationOne’s bioinformatics pipeline, the assay interrogates 335 DNA genes and 72 RNA genes to identify single nucleotide variants (SNVs), insertions/deletions (Indels), copy number variations (CNVs), and structural variants (SVs), including actionable fusions. It also reports three complex genomic signatures—Tumor Mutational Burden (TMB), Microsatellite Instability (MSI), and Homologous Recombination Deficiency (HRD)—to support both targeted therapy and immunotherapy decision-making. PD-L1 IHC (22C3 clone) is also available as an add-on service using CPS scoring.

Ordering is streamlined through direct submission to Circulogene, with the option to have the pathology retrieval coordinated by the Circulogene Client Services team. Results are delivered as a unified report typically within 10–14 days. The OncoGenDx platform is performed in Circulogene’s CLIA-certified laboratory and supports clinical decision-making, trial enrollment, and longitudinal profiling.

On October 7, 2025, Thermo Fisher Scientific Inc. (the "Company") reported to have issued $500,000,000 aggregate principal amount of 4.200% Senior Notes due 2031 (the "2031 Notes"), $750,000,000 aggregate principal amount of 4.473% Senior Notes due 2032 (the "2032 Notes"), $750,000,000 aggregate principal amount of 4.794% Senior Notes due 2035 (the "2035 Notes") and $500,000,000 aggregate principal amount of 4.894% Senior Notes due 2037 (the "2037 Notes" and, collectively with the 2031 Notes, the 2032 Notes and the 2035 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3ASR (File No. 333-285159) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (Filing, 8-K, Thermo Fisher Scientific, OCT 7, 2025, View Source [SID1234656486]).

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The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture") and the Twenty-Ninth Supplemental Indenture, dated as of October 7, 2025 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee.

The 2031 Notes will mature on March 1, 2031, the 2032 Notes will mature on October 7, 2032, the 2035 Notes will mature on October 7, 2035 and the 2037 Notes will mature on October 7, 2037. Interest on the 2031 Notes will be paid semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2026. Interest on the 2032 Notes, the 2035 Notes and the 2037 Notes will be paid semi-annually in arrears on April 7 and October 7 of each year, beginning on April 7, 2026.

Prior to February 1, 2031, in the case of the 2031 Notes, August 7, 2032, in the case of the 2032 Notes, July 7, 2035, in the case of the 2035 Notes and July 7, 2037, in the case of the 2037 Notes (each, a "Par Call Date"), the Company may redeem each series of the Notes, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes of such series to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Notes of such series being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such Notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus 10 basis points, in the case of the 2031 Notes, 10 basis points, in the case of the 2032 Notes, 10 basis points, in the case of the 2035 Notes and 15 basis points, in the case of the 2037 Notes, plus, in each case, accrued and unpaid interest on the Notes of such series being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem some or all of each series of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings, Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest to, but excluding, the date of repurchase.

On October 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need,reported that its first Data Monitoring Committee (DMC) meeting for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies (Press release, Soligenix, OCT 7, 2025, View Source [SID1234656485]). The confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (protocol # HPN-CTCL-04) and an ongoing investigator-initiated study (protocol # RW-HPN-MF-01), each further supporting the design of the FLASH2 clinical trial. With enrollment proceeding well, Soligenix anticipates providing an enrollment update in 4Q2025 and supporting the DMC in undertaking a pre-specified blinded interim efficacy analysis in 1H2026.

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"We are pleased to have reached this important milestone, confirming the expected safety to date in the confirmatory FLASH2 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "As patient enrollment continues to track with our initial estimates, we anticipate providing an update, including enrollment progress and the blinded aggregate response rate, before year-end. We look forward to completing this study on schedule with topline results in the second half of 2026."

"In the Phase 3 FLASH study, HyBryte was shown to be efficacious in early-stage CTCL with a promising safety profile," stated Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, Professor of Dermatology at the Hospital of the University of Pennsylvania, and Lead Investigator of the FLASH2 study. "CTCL patients are often searching for alternative treatments, with limited options especially for early-stage disease. HyBryte offers a distinct treatment option, including both a benign side effect profile and potentially rapid response rates, which patients found extremely useful and continue to specifically request. We look forward to continuing to enroll patients into FLASH2 to further elucidate the positive impact of HyBryte in a more "real world" setting with 18-weeks of continuous treatment in this 80-patient pivotal study."

FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that is enrolling approximately 80 subjects with early-stage CTCL. The study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte over a more prolonged, "real world" treatment course.

About HyBryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the Composite Assessment of Index Lesion Severity [CAILS] score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is ongoing. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte’s increased effect over a more prolonged, "real world" treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study is being initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback.

Additional supportive studies have demonstrated the utility of longer treatment times with a 75% response rate after 18 weeks treatment (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor (Study HPN-CTCL-04).

In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually).

On October 7, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the completion of the Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma") acquisition (Press release, Merck & Co, OCT 7, 2025, View Source [SID1234656484]). Verona Pharma is now a wholly-owned subsidiary of Merck and the American Depositary Shares (ADS) of Verona Pharma will no longer be listed or traded on the Nasdaq Global Market.

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"The Verona Pharma acquisition strengthens and complements our portfolio of treatments for patients with cardio-pulmonary diseases to include Ohtuvayre, while delivering near and long-term growth as well as value for shareholders," said Robert M. Davis, chairman and chief executive officer, Merck. "The addition of Ohtuvayre is another strong example of our business development strategy, which focuses on opportunities where compelling science and value align. Ohtuvayre is a novel, first-in-class maintenance treatment targeting an important unmet need for adult patients with COPD. We look forward to applying our commercial capabilities and working with our talented new colleagues from Verona Pharma to build on the strong uptake and performance to date to reach even more patients with this important medicine."

Through this acquisition Merck has added Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio. The U.S. Food and Drug Administration approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of non-cystic fibrosis bronchiectasis.

Additional Transaction Details
Under the terms of the acquisition agreement, Merck, through a subsidiary, has acquired all outstanding shares of Verona Pharma for $107 per ADS, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion.

As previously disclosed, the acquisition will result in the capitalization of most of the purchase price as an intangible asset for Ohtuvayre (which will be amortized as a GAAP-only charge over the life of the product). The transaction is expected to negatively impact non-GAAP EPS by approximately $0.16 in the first 12 months, representing costs associated with financing the transaction partially offset by Ohtuvayre performance.

Ohtuvayre Indication and Important Safety Information

INDICATION

Ohtuvayre is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

IMPORTANT SAFETY INFORMATION
Contraindication: Ohtuvayre is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

Warnings and Precautions:
Acute Episodes of Bronchospasm Ohtuvayre should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

Paradoxical Bronchospasm As with other inhaled medicines, Ohtuvayre may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Ohtuvayre, it should be treated immediately with an inhaled, short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative therapy should be instituted.

Psychiatric Events Including Suicidality Before initiating treatment with Ohtuvayre, healthcare providers should carefully weigh the risk and benefits of treatment with Ohtuvayre in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with Ohtuvayre if such events occur.

Treatment with Ohtuvayre is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received Ohtuvayre (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] Ohtuvayre 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] Ohtuvayre 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients [0.4%] receiving Ohtuvayre and no patients receiving placebo.

Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.

These are not all of the possible risks associated with Ohtuvayre.

Please see Prescribing Information for Ohtuvayre (ensifentrine) at: View Source, Patient Information for Ohtuvayre at: View Source

About Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition that causes restricted airflow and breathing problems. Emphysema and chronic bronchitis are the two most common types of COPD. Common symptoms of COPD include shortness of breath, an ongoing cough or a cough that produces a lot of mucus, wheezing, chest tightness or heaviness and fatigue. Smoking and air pollution are the most common causes of COPD. More than 390 million people were estimated to be suffering from COPD worldwide as of 2019 and COPD is the fourth leading cause of death worldwide. There is no cure for COPD.

About Ohtuvayre (ensifentrine)
Ohtuvayre is the first inhaled therapy for the maintenance treatment of adults with COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.