On November 12, 2025 BetaGlue Therapeutics ("BetaGlue" or the "Company") a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

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The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

"The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose and a meaningful step forward in our commitment to innovation in oncology," said Alexis Peyroles, CEO of BetaGlue Therapeutics. "This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities".

(Press release, BetaGlue Therapeutics, NOV 12, 2025, View Source [SID1234661240])

On November 11, 2025 The U.S. Food and Drug Administration (FDA) reported it has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.

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OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma.

"This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy," says Alok Sharma, Global Clinical Market Director at Promega. "We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes."

The approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.

OncoMate MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. This approval applies to the United States and its territories. Promega MSI technology has received additional regulatory approvals in China and the European Union.

Learn more about Promega MSI technology here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Promega, NOV 11, 2025, View Source [SID1234659767])

On November 11, 2025 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported the pricing of an underwritten public offering of 13,158,000 shares of its common stock at a public offering price of $1.90 per share. All of the shares of common stock in the offering are being sold by INOVIO. The offering is expected to close on or about November 12, 2025, subject to the satisfaction of customary closing conditions. INOVIO also granted the underwriters an option for a period of 30 days to purchase up to 1,973,700 additional shares of the Company’s common stock at the public offering price, less the underwriting discounts and commissions.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by INOVIO, excluding any exercise of the underwriters’ option to purchase additional shares of common stock, are expected to be approximately $25 million.

Piper Sandler & Co. is acting as sole manager for the offering.

A shelf registration statement relating to the shares of common stock offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, or by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.

(Press release, Inovio, NOV 11, 2025, View Source [SID1234659754])

On November 11, 2025 MannKind Corporation (Nasdaq: MNKD) reported that Michael Castagna, Chief Executive Officer, and Chris Prentiss, Chief Financial Officer, are scheduled to present and share updates during the Jefferies London Healthcare Conference on Wednesday, November 19, at 6:30 am ET/11:30 am GMT.

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The link to the live audio webcast of the session is available on MannKind Corporation’s website at: View Source Recorded versions will also be available on the website for approximately 90 days following the conference.

(Press release, Mannkind, NOV 11, 2025, View Source [SID1234659755])

On November 11, 2025  Prokarium, a clinical-stage biopharmaceutical company pioneering the field of microbial immunotherapy, reported the appointment of Ibs Mahmood as Chief Executive Officer (CEO). Ibs succeeds Kristen Albright, who will join the Board of Directors to continue shaping Prokarium’s strategic direction.

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Ibs brings 25 years as a biotechnology entrepreneur having founded and led multiple life science companies through clinical development, financing and strategic transactions, raising more than $300 million for his own ventures and over $2 billion for clients. He previously co-founded and led AMO Pharma, DrugDev and Induction Healthcare, and enjoyed senior roles at IQVIA, Abingworth, Shire Pharma and Investec. Ibs read medicine at the University of Oxford.

"Ibs’ appointment marks an important step in Prokarium’s evolution. His unique blend of medical insight, entrepreneurial drive and industry experience will help us accelerate our mission to change the treatment paradigm in bladder cancer," said Ted Fjällman, Chairman of Prokarium’s Board of Directors. "With strong clinical momentum and a clear vision for transforming bladder cancer treatment, Prokarium is well positioned for the future. We’re also deeply grateful to Kristen for her exceptional leadership and pleased she will continue to provide her guidance and expertise on the Board."

Ibs added "Bladder cancer is common and the tools for its management today mean that we are letting down patients. Prokarium is redefining how we treat bladder cancer, using microbial immunotherapy to activate the immune system in ways traditional approaches cannot. I am excited to join the team as we continue to advance through clinical milestones to shift the standard of care."

(Press release, Prokarium, NOV 11, 2025, View Source [SID1234659756])