On July 21, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") reported certain unaudited preliminary financial results for the second quarter ended June 30, 2025 (Press release, Amneal Pharmaceuticals, JUL 21, 2025, View Source [SID1234654447]). The Company plans to report actual second quarter 2025 financial results on August 5, 2025.

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Unaudited Preliminary Financial Results for the Second Quarter Ended June 30, 2025

Net revenue of $720 million to $730 million, an increase of approximately 3% versus the same period in 2024
Income before income taxes of $45 million to $56 million, versus $20 million in the same period in 2024
Adjusted EBITDA of $180 million to $185 million, an increase of approximately 13% versus the same period in 2024
Gross leverage decreased to 3.8x as of June 30, 2025, compared to 4.1x as of December 31, 2024, and net leverage decreased to 3.7x as of June 30, 2025, compared to 3.9x as of December 31, 2024, due to higher profitability and continued debt reduction
"Amneal continued to deliver robust growth and further deleveraging underscoring the power of our diversified pharmaceutical business. Based on our performance year-to-date and multiple growth drivers, we expect to meet or exceed our full year 2025 guidance. This quarter also marked the U.S. FDA approval of Brekiya autoinjector for the acute treatment of migraine and cluster headache in adults, as well as strong commercial uptake of CREXONT. Finally, we look forward to an expected BLA submission for a proposed biosimilar to XOLAIR in the fourth quarter of 2025. With a strong foundation, a relentless execution focus, and a deep pipeline, Amneal is well-positioned to deliver long-term growth," said Chirag and Chintu Patel, Co-Chief Executive Officers and Co-Founders.

Amneal’s preliminary financial results are based on the most recent information available to the Company’s management. Such preliminary financial results are forward-looking statements. Actual results may differ from these preliminary financial results due to the completion of the Company’s financial close procedures, final accounting adjustments and other developments that may arise between the date of this Current Report on Form 8-K and the time that financial results for the second quarter of 2025 are finalized, and such differences may be material. The preliminary financial results for the second quarter of 2025 are not necessarily indicative of the results to be achieved in any future period. The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the "Non-GAAP Financial Measures" section and the accompanying GAAP to non-GAAP reconciliation tables for more information.

On July 21, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage oncology company leveraging its proprietary RADR artificial intelligence (AI) platform to accelerate drug discovery, reported that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284 (Press release, Lantern Pharma, JUL 21, 2025, View Source [SID1234654464]). This patent, expected to be granted in the coming months with exclusivity through early 2039, strengthens Lantern’s global intellectual property (IP) portfolio and supports the development and commercialization path for LP-284, a novel therapy in development for relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL).

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LP-284, a next-generation acylfulvene, was optimized using Lantern’s RADR platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair deficiencies. Currently in a Phase 1 clinical trial (NCT06132503), LP-284 has demonstrated preclinical potential in addressing aggressive NHL subtypes, including MCL and double-hit lymphoma (DHL). The drug candidate has earned Orphan Drug Designations from the U.S. FDA for both MCL and HGBL, highlighting its role in tackling rare cancers with significant unmet needs.

Expanding Global Patent Protection

The EU patent complements a composition of matter patent granted in Japan (June 2024) and the U.S. (April 2023), with additional patent allowances grants in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships.

"The EU patent allowance for LP-284 is a critical milestone that enhances our ability to deliver this AI-advanced therapy to patients globally," said Panna Sharma, President and CEO of Lantern Pharma. "Our RADR platform enabled us to rapidly advance LP-284’s unique mechanism, achieving clinical trial readiness in under three years at a cost of approximately $1.5 to $2.0 million. This patent reinforces our commitment to precision oncology and creates opportunities for strategic collaborations with biotech partners."

Addressing Significant Market Need

LP-284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of NHL globally. Nearly all patients diagnosed with aggressive NHL subtypes like MCL will relapse after treatment, creating an urgent need for novel therapeutic approaches.

Lantern’s RADR platform, powered by over 200 billion oncology-focused data points and 200+ machine learning algorithms, has streamlined LP-284’s development, reducing timelines and costs compared to traditional drug discovery. This efficiency and capability positions Lantern to attract investment and partnerships with biotech and pharma companies seeking innovative oncology solutions.

About LP-284

LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed with guidance from Lantern’s AI platform RADR, LP-284 represents a novel therapeutic approach for treating relapsed or refractory non-Hodgkin’s lymphoma and other hematologic malignancies. The compound is currently being evaluated in a Phase 1 clinical trial (NCT06132503) to determine its safety profile, optimal dosing, and preliminary efficacy in patients with aggressive NHL subtypes who have failed standard therapies.

LP-284 has received multiple Orphan Drug Designations from the U.S. FDA, including designations for mantle cell lymphoma and high-grade B-cell lymphomas, recognizing its potential to address significant unmet medical needs in rare cancer populations.

On July 21, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that topline firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study in first-line EGFR exon20 insertion mutant non-small cell lung cancer (NSCLC) is projected to be in early 2026 (Press release, ArriVent Biopharma, JUL 21, 2025, View Source [SID1234654448]). The primary endpoint will assess progression free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In the first quarter of 2025, the study completed enrollment across global sites.

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About FURVENT

FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Seconday endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China.

About Firmonertinib

Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd.

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.

On July 21, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers, reported the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI (Press release, UroGen Pharma, JUL 21, 2025, View Source [SID1234654465]). The publication, titled "Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study", is now available online at View Source

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"Low-grade intermediate-risk bladder cancer is a chronic, recurring disease that often requires repeated surgical intervention," said Neal D. Shore, MD, FACS Medical Director for the START Carolinas/Carolina Urologic Research Center and lead author of the study. "The long-term data from the extension study of OPTIMA II highlight ZUSDURI’s ability to deliver sustained responses in an outpatient setting, which may be especially valuable for recurrent patients and thus for physicians who prefer a different, non-surgical treatment option."

Among the 41 patients who achieved CR at three months post-treatment with ZUSDURI in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response (DOR) was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months. These results build upon previously published 12-month DOR data, showing ZUSDURI’s potential to deliver meaningful, lasting event-free periods.

"These results reflect our continued commitment to bringing forward innovative treatments that give patients and physicians more options," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences."

Safety data were not collected during the long-term follow-up trial. The most commonly reported treatment emergent adverse events (>10% of patients) from the parent OPTIMA II study were dysuria in 26 (41% of patients); pollakiuria in 13 (21%); hematuria in 10 (16%); urgency to urinate or urinary tract infection, both occurring in 9 (14%); and fatigue in 7 (11%).

The OPTIMA II trial included both newly diagnosed and recurrent adult patients with LG-IR-NMIBC. Of the 17 patients that entered long-term follow up, 16 (94%) were recurrent and 1 (6%) was newly diagnosed. This cohort of patients had a median DOR of 3.5 years by Kaplan-Meier estimate. ZUSDURI is indicated only for the treatment of adults with recurrent LG-IR-NMIBC.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Visit ZUSDURI.com for more information.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About OPTIMA II

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) was an open-label, single-arm, multi-center Phase 2b clinical trial of ZUSDURI to evaluate its safety and efficacy in patients with LG-IR-NMIBC.

Learn more about the Phase 2b OPTIMA II trial at www.clintrials.gov (NCT03558503).

On July 21, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that the first patient was dosed in the global randomized sub-trial 1 of adaptive platform trial, MAIA-ovarian (which stands for MAintenance Immunotherapy with an Anti-PVRIG antibody), evaluating maintenance therapy with single agent COM701, a potential first-in-class anti-PVRIG antibody in patients with relapsed platinum sensitive ovarian cancer (Press release, Compugen, JUL 21, 2025, View Source [SID1234654451]).

"We are delighted to advance the development of COM701 as a maintenance therapy for patients with relapsed platinum sensitive ovarian cancer, potentially addressing a significant unmet medical need," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "This global trial is underpinned by a strong biological rationale, with high PVRIG pathway expression levels observed in ovarian cancer. In addition, clinical data showed that COM701 in triple combination with PD-1 and TIGIT blockade achieved durable responses and was well tolerated in patients with heavily pre-treated platinum resistant ovarian cancer typically not responding to immunotherapy. A response of greater than 18 months was also achieved in a patient treated with COM701 as a single agent."

Dr. Cohen-Dayag continued, "Based on historical data, we anticipate the benchmark for progression-free survival to be around six months and consider a three-month improvement over placebo to be clinically meaningful for these patients. An interim analysis of sub-trial 1 of MAIA-ovarian is planned to take place in the second half of 2026. We believe positive data could inform a registration path for COM701 monotherapy and an opportunity to combine COM701 with other agents, broadening COM701’s opportunities within the ovarian cancer population."

Ruth Peres, M.D., Ph.D., Medical Oncologist in the Division of Oncology, Head of Women’s Cancers Research Lab and Head of Phase 1 Clinical Trials in the Clinical Research Institute at Rambam Healthcare Campus, Haifa, Israel, added, "There is a need for drugs that provide durable responses and a favorable safety profile as maintenance therapy in patients with platinum sensitive ovarian cancer who respond to chemotherapy, but who are not candidates for bevacizumab or PARP inhibitors. We are delighted to be the first site to dose a patient in this sub-trial designed to evaluate if COM701 as a single agent can delay disease progression in these patients."

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About MAIA-ovarian

(MAintenance Immunotherapy with an Anti-PVRIG antibody: COM701, as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer.)

MAIA-ovarian is a global adaptive platform trial to evaluate the safety and efficacy of COM701 as maintenance monotherapy or combination therapy in patients with relapsed platinum sensitive ovarian cancer. The purpose of sub-trial 1 is to assess if COM701 delays the progression of ovarian cancer in patients with relapsed platinum sensitive ovarian cancer and further assess its safety profile in this disease setting. The adaptive-platform design enables additional sub-trials. Sub-trial 1 is a double-blind, randomized placebo-controlled trial in which 60 patients will be randomized in a 2:1 ratio to COM701 or placebo. Subsequent sub-trials may evaluate COM701 in combination with other anticancer drugs. For more information about this trial, visit clinicaltrials.gov, NCT06888921.