On June 24, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that the first patient has been dosed in the Company’s clinical trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer ("CRC") (Press release, CytoDyn, JUN 24, 2025, View Source [SID1234654085]).

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In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway. The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance.

According to the World Health Organization’s International Agency for Research on Cancer ("IARC"), colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year. The IARC also noted that the incidence rates of colorectal cancer in people younger than 50 years old have been increasing for at least 20 years, with some sources dating the increase trend back 30 years or more.

"Dosing the first patient in our Phase II CRC trial is a significant step forward in our mission to bring innovative treatment options to patients facing this challenging disease. This milestone reflects the dedication of our team and clinical partners, and we look forward to advancing this study to better understand the potential impact of our therapy across solid tumor oncology," said Dr. Jacob Lalezari, CEO of CytoDyn.

The study builds on the Company’s prior research demonstrating the potential clinical benefit of leronlimab in patients with relapsed CRC, and will also further the evaluation of the potential for the Company’s recently announced mechanism of action for leronlimab in solid tumor oncology. Given the promising survival rates observed in the Company’s prior studies in patients with metastatic triple-negative breast cancer and the Company’s ongoing clinical investigation efforts in CRC, CytoDyn views its current line of scientific evaluation as the most expeditious path to determining how broadly applicable this mechanism may prove to be across various solid tumors.

On June 24, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported the pricing of an underwritten public offering of 7,954,546 shares of its common stock at a price to the public of $44.00 per share. All of the shares are to be sold by Cidara (Press release, Cidara Therapeutics, JUN 24, 2025, View Source [SID1234654084]).

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The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $350.0 million. In addition, Cidara has granted the underwriters a 30-day option to purchase up to an additional 1,193,181 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 26, 2025, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

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

On June 24, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported a distribution agreement with the U.S. Pharmacopeia (USP) that enables the Company to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards with its analytical solutions, including the Maurice system, to support monoclonal antibody and gene therapy development around the world (Press release, Bio-Techne, JUN 24, 2025, View Source [SID1234654083]).

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More than 160 antibody therapies against nearly 100 targets and range of diseases have been approved worldwide. Maintaining consistent mAb quality is vital for their efficacy. The need for consistency is becoming increasingly more important as mAb patent protections expire, and biosimilar versions of these therapies become available. This leads to a greater need for manufacturers to rigorously test critical quality attributes throughout mAb development and manufacturing processes to demonstrate product safety and effectiveness.

Separately, gene therapy, which relies on recombinant AAV to deliver gene edits into cells, is one of the fastest-growing sectors in the biopharmaceutical industry. The exceptional growth of these groundbreaking treatments offers cures to previously incurable genetic diseases; however, challenges persist in the development and commercialization processes, including low yields, scalability hurdles, high costs, and analytical complexities. USP reference standards help solve these challenges by providing well-characterized benchmarks for analytical testing, ensuring accuracy, reliability, and regulatory compliance in product development and quality control.

Importantly, both USP mAbs and AAV reference standards provide stringent materials that can be used with Bio-Techne’s leading analytical instruments, such as the MauriceFlex system. By combining these standards with the Company’s rapid, easy-to-use, and multi-functional analytics, therapy manufacturers can achieve reliable, efficient, and integrated characterization for purity, charge, size, and identity applications for complex biologics, from development through product release.

"We are excited about our work with USP. This marks a significant milestone in advancing our commitment to providing cutting-edge tools and solutions to the scientific community," said Will Geist, President of Bio-Techne’s Protein Sciences Segment. "This relationship underscores our dedication to supporting advancements in biotherapeutic development and ensuring the highest standards of quality and safety for patient care."

"We are thrilled to engage Bio-Techne as an authorized distributor, which enables USP to expand access of our solutions within the scientific community and beyond, ensuring that safe and quality therapeutic products reach the market for the benefit of patients worldwide," said Fouad Atouf, Ph.D., Senior Vice President, Global Biologics for USP. "Through working with Bio-Techne, USP is reinforcing its commitment to addressing the most prevalent quality issues with innovative solutions, leveraging our robust framework of science-based quality standards for pharmaceutical manufacturers."

Addressing quality challenges is essential to ensure the safety and quality of biotherapeutics. Both USP and Bio-Techne have a long history of developing solutions to support mAbs and are applying their know-how to solving analytical challenges in AAV-based gene therapies. The ability to purchase USP reference standards from Bio-Techne further simplifies the method development process, enabling customers to assess system suitability and other critical criteria for charge and size based analytical assays on the Maurice system.

On June 23, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trial (formerly GaLuCi) (NCT05706129) evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous.

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ITM-91/ITM-94 is a first-in-class, peptide-based theranostic pair combining the radiotherapeutic compound ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), with the diagnostic agent ITM-94 (Debio 0328) ([68Ga]Ga-DPI-4452) to target Carbonic Anhydrase IX (CAIX). CAIX is a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. In September 2024, ITM gained the exclusive worldwide license from Debiopharm for the development and commercial rights of ITM-91/ITM-94. The initiation of this study arm represents a significant advancement for ITM and Debiopharm following their licensing agreement.

In the now initiated Part D of the trial, ITM-94 is being evaluated for its effectiveness to accurately classify an indeterminate renal mass as ccRCC or non-cancerous, when compared to CT/MRI imaging and histopathology. Secondary endpoints include sensitivity, specificity, and the positive and predictive value of ITM-94 PET/CT imaging compared to histopathology. This study arm is expected to enroll approximately 36 patients at around 15 clinical sites across the EU, US and Australia.

"The early results from the Gallium-68 CAIX PET/CT diagnostic are remarkable to date. I believe ITM-94 has the potential to change the way urologists and oncologists diagnose and stage patients with clear cell renal cell carcinoma, improving accuracy and reducing the need for biopsies. I have not seen a tracer with a similar profile since the PSMA PET/CT was established," added Prof. Michael Hofman, Director, Prostate Cancer Theranostics and Imaging Centre of Excellence (ProSTIC), Peter MacCallum Cancer Centre, Melbourne, Australia.

"Clear cell renal cell carcinoma is the most common form of kidney cancer, with more than 90% of cases overexpressing the CAIX encoding gene. As survival rates are highly dependent on the stage of progression, rapid and precise diagnosis is essential to provide patients with the best possible treatment options and therapeutic outcomes. ITM-94 has already demonstrated potential exceptional imaging qualities, including high tumor-to-background ratios and detecting lesions not visible by CT scan with a potential favorable safety profile. We look forward to exploring the full potential of the theranostic pair ITM-91/ITM-94 across this trial to characterize and treat CAIX expressing cancer cells, advancing the efficacy of targeted radiopharmaceutical therapies," said Dr. Celine Wilke, Chief Medical Officer of ITM.

"With high-quality imaging and high tumor uptake, ITM-94 has already demonstrated potentially significant diagnostic capabilities in solid tumors. The data gathered in Part D of the trial will be instrumental to the further validation of this theranostic pair. We highly value our partnership with ITM, which will continue to advance the rapid progression of these novel radio-diagnostics and -therapeutics through the clinic," said Angela Zubel, Chief Development Officer, Research & Development at Debiopharm.

About the Phase 1/2 ITM-91/ITM-94 Trial
The five-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In Part A of the trial, ITM-94 demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC, with results published in the Journal of Nuclear Medicine. Part B, which is ongoing, is assessing escalating doses of the therapeutic agent, ITM-91, in patients whose tumors show high uptake of the imaging tracer. Based on the recommended dose from Part B, Part C of the trial will assess the safety and preliminary efficacy of ITM-91 in patients with ccRCC, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma and potentially other tumor types. In addition to the newly initiated Part D, Part E will assess ITM-94 uptake in other tumors. ITM will assume full sponsorship of the program from Debiopharm once the transfer is completed.

AboutITM-91/ITM-94 (Debio 0228/ 0328)
ITM-91/ITM-94 is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94 ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CAIX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 ([177Lu]Lu-DPI-4452), which delivers targeted radiation to the tumor with the aim to destroy it from the inside.

(Press release, ITM Isotopen Technologien Munchen, JUN 23, 2025, View Source [SID1234661161])

On June 23, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported the appointment of Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025 (Press release, Galapagos, JUN 23, 2025, View Source [SID1234654108]). Mr. Cox succeeds Mr. Thad Huston, who will remain with the company through July 31, 2025, to ensure a smooth transition of responsibilities.

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Aaron brings more than two decades of leadership experience across biotechnology, capital markets, and M&A/corporate development. Most recently, he served as Executive Vice President and Chief Financial Officer at Horizon Therapeutics plc, where he played a pivotal role in the company’s $28 billion acquisition by Amgen. Prior to that, Aaron served as Horizon’s Head of Corporate Development and Chief of Staff to the CEO, supporting capital markets strategy, M&A execution, and the company’s transformation into a fully integrated biotech. His earlier career spans senior roles in investment banking.

"We are delighted to welcome Aaron to Galapagos," said Henry Gosebruch, CEO of Galapagos. "Aaron will be a key partner in accelerating pipeline growth through business development and focusing our resources through disciplined financial management. His dealmaking background and experience managing a global financial organization will be invaluable as we continue transforming Galapagos with the goal of making a meaningful impact on the lives of patients worldwide."

Aaron will lead the Finance, Accounting, Tax, Procurement, Communications and Investor Relations functions and will join the Executive Committee of Galapagos. As CFO, he will also work closely with leadership and the Board of Directors to execute transactions to build a new pipeline of innovative medicines and find a value-maximizing alternative for the cell therapy business.

"I am excited to join Galapagos at this pivotal moment," said Aaron Cox, incoming CFO of Galapagos. "I look forward to working with Henry and the talented team to help shape the company’s next chapter, create value for our shareholders, and advance meaningful innovations for patients."

Aaron holds a Bachelor’s degree in Finance from the University of Notre Dame and earned his MBA from the University of Chicago Booth School of Business.

In connection with this appointment, the Company will issue new restricted stock units (RSUs) and subscription rights.