Medicus Pharma Ltd. Completes Acquisition of Antev Limited

On September 2, 2025 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, and Antev Limited ("Antev"), a UK-based clinical-stage drug development company, reported that Medicus has acquired 98.6% of the issued and outstanding shares of Antev for aggregate consideration consisting of approximately US$2.97 million in cash and 1,603,164 common shares of Medicus, pursuant to the previously announced securities exchange agreement among Medicus, Antev and certain securityholders of Antev, dated as of June 29, 2025, as amended.

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Antev is a clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate.

Antev’s former shareholders will be entitled to receive up to approximately US$65 million in additional contingent consideration tied to potential future FDA Phase 2 and New Drug Application approvals.

Following the completion of the acquisition, Patrick J. Mahaffy, a veteran pharma executive and the former chairman of Antev, was unanimously appointed to Medicus’s board of directors. Mr. Mahaffy is also the former CEO of both Clovis Oncology (NASDAQ: CLVS) and Pharmion Corporation (NASDAQ: PHRM).

Dr. Paul Marchetto, Chairman of Medicus’s Scientific Advisory Board, and Dr. Faisal Mehmud, Chief Medical Officer of Medicus, were appointed Co-Chairmen of Antev’s Board of Directors. Carolyn Bonner, President of Medicus, and Viktoria Slepeniuk, Senior Vice President, Public Relations of Medicus, were also appointed to Antev’s Board of Directors.

Amit Kohli, a seasoned pharma executive, with several years of big pharma drug development experience, will continue to serve as the Interim Chief Executive Officer and as a director of Antev.

"We are delighted to complete the acquisition of Antev, which not only adds strategic depth to our drug development pipeline but also strengthens our team, both at the board and management level," stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO "We believe, Teverelix, a next generation GnRH antagonist, is well positioned to become a first in class product to prevent acute urinary retention relapse due to enlarged prostate, and to treat advanced prostate cancer in patients with high cardiovascular risk profile, collectively representing approximately US$6 billion in potential market opportunity."

In addition to resale restrictions prescribed under applicable securities laws, the common shares of Medicus issued to former Antev shareholders will be subject to a staggered lock-up and an agreement granting certain voting rights in favor of Medicus management for a period of 36 months.

Antev Acute Urinary Retention (AURr) Indication:
Teverelix is aiming to be the first-in-class indication product for preventing recurrence of acute urinary retention (AURr) in males 45 years or older who suffer from prostate enlargement. Antev has a U.S. Food and Drug Administration ("FDA") approved phase 2b study designed to randomize 390 men after a successful trial without catheterization ("TWOC"). 85% of nearly one million annual AURr episodes in the United States occur in men 60+ who suffer from enlarged prostate that manifests with age. An AURr episode is followed by a recurrent episode within 6 months for approximately 30% of men. This presents a potential market opportunity of more than US$2 billion annually.

Antev planned Phase 2b Study Design in Acute Urinary Retention:

Randomized controlled double blinded study in 390 men after a successful TWOC in 60-70 sites in the United States and European Union (EU). The participants shall receive either single intramuscular (IM) or subcutaneous (SC) injection (90mg or 120mg) or placebo in addition to standard therapy. The primary endpoint is a composite of AURr, need for surgery or poor urinary flow metrics in the first 28 weeks plus 24 weeks follow up.

Antev High Cardiovascular (CV) Risk Advanced Prostate Cancer (APC) indication:
Teverelix is aiming to be the best-in-class indication product for hormone therapy for advanced prostate cancer (APC) patients with increased CV risk. Antev has an FDA approved phase 2b open label study designed to recruit 40 men with advanced prostate cancer. Antev is targeting a niche in patients with increased CV risk, aiming to provide an androgen deprivation therapy (ADT) option with potentially lower cardiac toxicity than conventional GnRH agonists. If approved, Teverelix could become the first hormone therapy labeled specifically for treating prostate cancer in patients with a history of cardiovascular disease. An estimated 300,000 to 500,000 men in the United States are living with advanced stage prostate cancer presenting a potential market opportunity of more than US$4 billion annually.

Antev planned Phase 2b Study Design in Advanced Prostate Cancer

Open label study in 40 men with advanced prostate cancer suitable for ADT. The participants will receive a loading dose of 180mg IM plus x2 180mg SC (total 540mg), followed by x2 180mg (360mg) SC day 29 and every 6 weeks. The total duration of the treatment is 22 weeks. The primary endpoint is to confirm castration rate by day 29, sustaining to day 155, with a probability greater than 90%.

(Press release, Medicus Pharma, SEP 2, 2025, View Source [SID1234671209])

CRISPR Therapeutics to Participate in Upcoming Investor Conferences

On September 2, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following investor conferences in September (Press release, CRISPR Therapeutics, SEP 2, 2025, View Source [SID1234655637]).

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H.C. Wainwright 27th Annual Global Investment Conference
Date: Monday, September 8, 2025
Time: 4:30 p.m. ET

Morgan Stanley 23rd Annual Global Healthcare Conference
Date: Tuesday, September 9, 2025
Time: 8:30 a.m. ET

A live webcast will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following the presentation.

Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide

On September 2, 2025 Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide (Press release, Servier, SEP 2, 2025, View Source [SID1234655670]). Under the agreement, Servier obtains the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA retains its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

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"At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide," said Arnaud Lallouette, Executive Vice-President Global Medical & Patient Affairs at Servier. "Today, there are limited treatment options and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network, and expertise in developing oncology targeted therapies, to make this groundbreaking treatment accessible to patients across the globe."

"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development for darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We believe Servier’s global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the U.S. will ensure that this potentially life-changing treatment reaches as many patients as possible," said Daniel Simon, Chief Business Officer, IDEAYA Biosciences.

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial evaluating darovasertib in combination with crizotinib in first line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomized trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumor, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million, and be eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.

Curis to Present at Upcoming Healthcare Conferences in September

On September 2, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that James Dentzer, President and Chief Executive Officer of Curis, will participate at the following conferences (Press release, Curis, SEP 2, 2025, View Source [SID1234655639]):

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The Cantor Global Healthcare Conference 2025 being held September 3 – 5, 2025. Presentation details are as follows:

Format: Fireside Chat
Date: Friday, September 5, 2025
Time: 9:45 am ET
Cantor webcast
The H.C. Wainwright 27th Annual Global Investment Conference being held September 8 – 10, 2025. Presentation details are as follows:

Format: Company Presentation
Date: Wednesday, September 10, 2025
Time: 10:00 am ET
H.C. Wainwright webcast
Webcasts will be also available on the Curis website at www.curis.com in the ‘Investors’ section.

Philogen to attend the European Society of Nuclear Medicine (EANM) annual meeting on October 4 – 8, 2025

On September 2, 2025 Philogen reported that Dr. Samuele Cazzamalli is presenting "From DNA-encoded chemistry to ACP3-targeted radioligand therapeutics against prostate cancer" (Press release, Philogen, SEP 2, 2025, View Source [SID1234655656]). In addition, Dr. Cristiano Pini will give an update on "Diagnostic Performance, Safety, and Pharmacokinetics of [68Ga]Ga-OncoACP3 in Prostate Cancer – Preliminary Results from a Prospective Phase I Clinical Trial" and Prof. Philippp Backhaus will give a presentation on "Theranostic targeting of the prostatic acid phosphatase (ACP3) with [68Ga]Ga-OncoACP3-DOTA and [177Lu]Lu-OncoACP3-DOTA in prostate cancer patients".

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Moreover, Dr. Fabrizia Gelardi will present "First-in-Human Phase I Study of [68Ga]Ga-OncoCAIX: Preliminary Results on Safety, Dosimetry, Pharmacokinetics, and Diagnostic Performance".