On July 21, 2025 Cycle Pharmaceuticals (Cycle Pharma) reported it has entered into an exclusive U.S. commercialization agreement with Handa Therapeutics, LLC (Handa), for PHYRAGO, an FDA approved drug for treating two types of leukemia, Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) (Press release, Handa Oncology, JUL 21, 2025, View Source [SID1234654463]). PHYRAGO will be Cycle Pharma’s first oncology product (its ninth commercial product) and will see the company extend its expertise in caring for patients living with chronic conditions into oncology.

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PHYRAGO is a novel formulation of Sprycel (dasatinib) that allows concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs),1 which can directly benefit patients on dasatinib therapy who are prescribed both medications.2

With Sprycel, the drug exposure of dasatinib can be significantly reduced by more than 40% and 60% when administered with PPIs and H2RAs, respectively.3 In contrast, with PHYRAGO, no clinically significant reduction in the bioavailability of dasatinib was observed following concomitant use with PPIs or H2RAs.1

Handa will be working closely with Cycle Pharma to launch PHYRAGO in September 2025. PHYRAGO will be launched with best-in-class patient support from Cycle Vita, providing individualized product, educational, and financial assistance* to adult patients with Ph+ CML and Ph+ ALL.

"We are excited about our second partnership with Handa, and the expansion of our patient support offerings to oncology. With PHYRAGO, Cycle Vita’s expertise in providing individualized care to patients will soon be available to patients with leukemia," says Chikai Lai – SVP & Chief Commercial Officer, Cycle Pharmaceuticals. Bill Liu, President and CEO of Handa Therapeutics, LLC, added "Handa is proud to continue its partnership with Cycle Pharmaceuticals in the commercialization of PHYRAGO, the first and only dasatinib product that can be taken concomitantly with PPIs and H2RAs. Handa is committed to bringing high quality oncology treatments such as PHYRAGO to patients."

Indications

PHYRAGO is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance / intolerance to prior therapy including imatinib.
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
Important Safety Information

Warnings and Precautions:

Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor blood counts. Transfuse and interrupt PHYRAGO when indicated.

Fluid Retention: Fluid retention, including pleural effusions. Manage with supportive care and/or dose modification.

Cardiovascular Toxicity: Monitor for signs or symptoms and treat appropriately.

Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed.

QT Prolongation: Use PHYRAGO with caution in patients who have / may develop prolongation of the QT interval.

Severe Dermatologic Reactions: Cases of severe mucocutaneous dermatologic reactions have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain hydration and correct uric acid levels prior to initiating treatment.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.

Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients.

Hepatotoxicity: Assess liver function before initiation of treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.

Adverse Reactions:

Common adverse reactions (≥15%) include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

Postmarketing Experience:

Post approval adverse reactions:

Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.

Drug Interactions:

Strong CYP3A4 Inhibitors: Dose reduction may be necessary.

Strong CYP3A4 Inducers: Dose increase may be necessary.

Antacids: Avoid concomitant use.

Use in Specific Populations:

Pregnancy: PHYRAGO can cause fetal harm. Advise a pregnant woman of the potential risk to a fetus.

Contraception: Should be used during treatment and for 30 days after the last dose.

Lactation: Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.

Pediatric Use: Monitor bone growth and development in pediatric patients.

Due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with pediatric information.

Geriatric Use: Patients over 65 and older are more likely to experience: fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, appetite disturbance, abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease. Monitor closely.

For more detailed information, please refer to the full Prescribing Information at www.phyrago.com/PI/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at

1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-DAS-2500002 (June 2025)

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 18, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading provider of oncology-focused CRO services specializing in preclinical and clinical specialty testing, reported that its Board of Directors has appointed Rob Brainin as Chief Executive Officer and member of the Board of Directors, effective August 25, 2025 (Press release, Champions Oncology, JUL 18, 2025, View Source [SID1234654450]).

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Rob, who has served on Champions’ Board since 2021, will succeed Dr. Ronnie Morris, who has led the company as CEO since 2017. Dr. Morris will transition to the role of Executive Chair on August 25, supporting the leadership transition while remaining actively involved in the company’s strategic initiatives.

"I want to thank Ronnie for his outstanding leadership and vision since 2017, and I am thrilled he will continue to play an integral role as Executive Chair," said Joel Ackerman, Chairman of the Board, who will transition to a Director role. "As we expand beyond our core CRO services into a robust data offering, Rob’s expertise and track record of driving growth in innovative life sciences businesses make him the ideal leader to guide Champions through its next chapter."

Rob Brainin brings more than 25 years of experience in life sciences and technology, with a proven ability to scale and grow businesses built on cutting-edge science and data capabilities. He most recently served as Chief Business Officer at Veracyte, an oncology diagnostics company, and previously as CEO of Genuity Science, a company focused on genomics, data, and therapeutic discovery.

"I am honored and excited to join Champions at such a pivotal time," said Brainin. "The strength of Champions’ core CRO services provides a tremendous foundation to expand our emerging data platform and advance the pipeline of our discovery therapeutics subsidiary, Corellia AI. I look forward to working alongside this talented team to build on the company’s momentum and create value for our customers, employees, and shareholders."

Dr. Morris added, "I am incredibly proud of what we have accomplished together and the outstanding team we have assembled. I have complete confidence that Rob is the right leader to take Champions into its next phase of growth, and I look forward to supporting him and the team in realizing the company’s full potential."

On July 18, 2025 MEI Pharma, Inc. (Nasdaq: MEIP) (the "Company" or "MEI") reported that it has entered into securities purchase agreements for a private investment in public equity (PIPE) for the purchase and sale of 29,239,767 shares of common stock (or pre-funded warrants in lieu thereof) at a price of $3.42 per share, for expected aggregate gross proceeds of approximately $100 million, before deducting placement agent fees and other estimated offering expenses (Press release, MEI Pharma, JUL 18, 2025, View Source [SID1234654468]). In connection with the closing of the transaction, MEI will appoint Charlie Lee to its Board of Directors (at which time current member Taheer Datoo will resign) and GSR as its digital asset and treasury management advisor to oversee the implementation of its Litecoin Treasury Strategy.

Charlie Lee and GSR acted as lead investors, alongside participation from the Litecoin Foundation as well as prominent crypto venture capital firms and infrastructure providers including MOZAYYX, ParaFi, Hivemind, Primitive, RLH Capital, Delta Blockchain & CoinFund, among others.

This transaction marks a significant milestone in MEI’s long-term strategic plan and establishes MEI as the first and only publicly traded company to adopt Litecoin as a treasury reserve asset. Litecoin (LTC) is a leading peer-to-peer cryptocurrency that was created by Charlie Lee in October 2011. It is often referred to as the "silver to Bitcoin’s gold" due to its similarities to Bitcoin. As one of the longest-running blockchains with 100% uptime since its inception, Litecoin has demonstrated a proven track record of growth and reliability with significant enterprise-grade use cases. By integrating Litecoin into its treasury operations, MEI gains access to a decentralized monetary asset that complements its cash management framework.

"Litecoin was designed to be fast, secure, and decentralized – and it’s exciting to see those principles now being embraced by a public company like MEI," said Charlie Lee, Creator of Litecoin. "This milestone not only reflects growing institutional confidence in LTC but also sets the stage for broader adoption in traditional capital markets."

"We’re thrilled to partner with MEI in building a thoughtful LTC-focused treasury strategy," said Josh Riezman, US Chief Strategy Officer of GSR. "Our goal is to help institutions unlock the long-term potential of digital assets while managing risk and maintaining flexibility. This treasury strategy is centered around a completely fair and fully decentralized digital asset with a nearly unparalleled track record as a store of value and means of payment.

"MEI is pleased to pioneer this innovative public company treasury strategy with GSR and Charlie Lee, the first to our knowledge in the biotech sector," said Frederick W. Driscoll, Chairman of the Board of MEI.

The closing of the PIPE is expected to occur on or about July 22, 2025, subject to the satisfaction of customary closing conditions. The Company intends to use the funds to acquire the native cryptocurrency of the Litecoin blockchain commonly referred to as "LTC", which will serve as the Company’s primary treasury reserve asset.

Titan Partners Group, a division of American Capital Partners, is acting as the sole placement agent in connection with the PIPE.

The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from the registration requirement of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder, and applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirement of the Securities Act and such applicable state securities laws. Concurrently with the execution of the securities purchase agreements, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock. Any offering of the Company’s Common Stock under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

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