On September 16, 2025 Cebiotex reported that CEB-01, its lead product for local post-surgical cancer treatment, has been granted Orphan Drug Designation (ODD) status by the EMA for the treatment of pancreatic cancer (PC), a disease with one of the lowest survival rates and few effective treatment options (Press release, Cebiotex, SEP 16, 2025, View Source [SID1234655995]). In this context, CEB-01 implant offers the possibility for localized drug delivery to improve postoperative local control. While CEB-01 is not intended to replace existing treatment methods, its development aims to serve as a complementary therapy within the current standard of care.

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"Our goal is to integrate CEB-01 alongside surgery and adjuvant chemotherapy, enhancing the local control of residual disease at the surgical site, where recurrence often begins, and ultimately improving survival outcomes.", explains Toni Pérez, Chief Medical Officer of Cebiotex.

Receiving ODD from the EMA is a critical milestone in Cebiotex mission to address an unmet medical need for this rare and life-threatening condition by offering new alternatives to patients facing PC.

Anna Huguet, Regulatory Manager at Cebiotex, commented: "The granted ODD acknowledges the therapeutic potential of CEB-01 to address an existing unmet medical need in PC. It will facilitate CEB-01 development through scientific and regulatory support from EMA including fee reductions and drug development incentives that will support the path towards CEB-01 authorization. Importantly, it also means that CEB-01 is eligible for up to 10 years of market exclusivity in the EU upon authorization, further enhancing its attractiveness for long-term investment and development."

On September 16, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Bernstein Insights: Healthcare Leaders and Disruptors – 2nd Annual Healthcare Forum on Tuesday, September 23, 2025 (Press release, Bristol-Myers Squibb, SEP 16, 2025, View Source;2nd-Annual-Healthcare-Forum/default.aspx [SID1234655994]).

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The company will take part in a fireside chat beginning at 9:40 a.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

On September 16, 2025 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, reported that it continues to expand its patent portfolio for iadademstat and vafidemstat, Oryzon’s clinical-stage LSD1 inhibitors for oncology and central nervous system (CNS) disorders, following new Decisions to Grant from the Australian and European patent offices (Press release, Oryzon, SEP 16, 2025, View Source;utm_medium=email&utm_campaign=NdP.27+2025-09-16+IP+additional+decision+grant+ENG778 [SID1234655986]).

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The Australian Patent Office has issued a Decision to Grant for Oryzon’s patent application AU2020249493, titled "Combinations of iadademstat for cancer therapy". The allowed claims cover combinations of iadademstat with PD1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). A Decision to Grant is an official communication from a national patent office indicating that a patent application has met all requirements for issuance as a patent. Once formally granted, this Australian patent will remain in force until at least 2040, not including any potential patent term extensions. A corresponding patent has also been granted in Russia, and applications are pending in Europe, the United States, Japan, China, and other countries.

Iadademstat is currently being evaluated in combination with PD-L1 inhibitors (atezolizumab or durvalumab) in first line SCLC patients with extensive disease in a Phase I/II trial conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon. More than 30 sites accross the U.S. participate in the trial, including leading institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins, City of Hope, Yale University and the University of Chicago, among others.

Oryzon has also received a Decision to Grant from the European Patent Office for its patent application EP24205125.8, titled "Vafidemstat for treating behavior alterations". The allowed claims cover the use of vafidemstat for the treatment of aggressiveness and social withdrawal associated with CNS diseases. Among the allowed claims, there are claims specifically aimed at the treatment of aggressiveness associated with Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD), Alzheimer’s disease and other conditions, as well as claims directed to treating social withdrawal associated with diseases such as schizophrenia or ASD. Once formally granted, this European patent will remain in force until at least 2038, not including any potential patent term extensions. Additional patents in this family have already been granted or allowed in Europe, Australia, Canada, Hong Kong, Israel, South Korea, Malaysia, the Philippines, and Russia, with applications pending in other countries.

Vafidemstat is in advanced clinical development for the treatment of aggression in psychiatric disorders, with an upcoming Phase III trial in aggression in BPD (protocol submitted), and a Phase II trial in aggression in ASD patients under preparation. In addition, a Phase II trial is ongoing in schizophrenia, with a focus on negative symptoms. One of the most prominent negative symptoms of schizophrenia is social withdrawal.

"These new patent grants strengthen Oryzon’s global IP position by protecting key therapeutic indications under clinical development for iadademstat and vafidemstat, thereby extending the commercial life for both compounds", said Neus Virgili, Oryzon’s Chief IP Officer.

On September 15, 2025 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, SEP 15, 2025, View Source [SID1234656002]).

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On September 15, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported the closing of its previously announced non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of $2,000,000 (the "Offering") (Press release, Defence Therapeutics, SEP 15, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-completes-fully-subscribed-debenture-units-financing-of-2000000 [SID1234655997]). Each Unit consisted of (i) one $1,000 principal amount 8.0% convertible debenture (a "Debenture"), and (ii) 1,666 common share purchase warrants (the "Warrants"). Further to the previous announcement on August 22, 2025, the Company has obtained the approval from the Canadian Securities Exchange to upsize the Offering from the aggregate proceeds of $1,200,000 to $2,000,000.

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The Debentures bear interest at a rate of 8.0% per annum and mature on September 15, 2027, subject to early redemption by the Company. The Debentures are unsecured and rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each Debenture is convertible at the option of the holder into common shares in the capital of the Company (each, a "Share") at the conversion price of $0.60 per Share (the "Conversion Price"). The accrued interest of the Debentures will be paid annually in Shares at the Conversion Price or in cash at the Company’s election.

Each Warrant is exercisable to acquire one Share (a "Warrant Share") at an exercise price of $0.75 per Warrant Share on or before September 15, 2027.

In connection with the Offering, the Company paid aggregate cash finder’s fees totalling $160,000 and issued 266,667 finder’s warrants (the "Finder’s Warrants") to qualified arm’s length finders. Each Finder’s Warrant is exercisable into one Share (a "Finder’s Warrant Share") at an exercise price of $0.75 per Finder’s Warrant Share on or before September 15, 2027.

The Company intends to use the net proceeds of the Offering to advance its science programs and for general working capital. All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day from their date of issue in accordance with applicable securities legislation.

The securities being referred to in this news release have not been, nor will they be, registered under the United States (U.S.) Securities Act of 1933, as amended, and may not be offered or sold in the U.S. or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This news release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.