On May 20, 2025 The Management Board of 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) reported by representatives of the European Medicines Agency (EMA) that a negative recommendation from the Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorisation Application (MAA) for resminostat (Kinselby) for the treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) is expected on May 22, 2025 (Press release, 4SC, MAY 20, 2025, View Source [SID1234653253]).

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The information that a negative recommendation is to be expected comes despite 4SC’s extensive efforts to resolve the EMA’s last remaining significant objection regarding the demonstration of a positive benefit-risk balance for patients with advanced cutaneous T-cell lymphoma, most recently in an oral discussion today.

Therefore, 4SC is now discontinuing further development and commercialization of resminostat (Kinselby). 4SC’s Management Board will discuss the company’s future direction with the Supervisory Board in a timely manner and will inform shareholders as soon as possible. 4SC has sufficient financial resources to finance the company’s currently planned expenditures for at least 12 months.

On May 20, 2025 Veracyte, Inc. (Nasdaq: VCYT) a leading cancer diagnostics company, reported it will participate in the following investor conferences (Press release, Veracyte, MAY 20, 2025, View Source [SID1234653252]).

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William Blair 45th Annual Growth Stock Conference – Chicago, IL
Presentation on June 3rd at 5:40 p.m. Eastern Time
Jefferies Global Healthcare Conference – New York, NY
Presentation on June 4th at 2:00 p.m. Eastern Time

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days after each live presentation broadcast.

On May 20, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in a fireside chat at the A.G.P. Virtual Healthcare Company Showcase on Wednesday, May 21, 2025 at 8:20 am ET (Press release, Sellas Life Sciences, MAY 20, 2025, View Source;Virtual-Healthcare-Company-Showcase/default.aspx [SID1234653251]).

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A.G.P. Virtual Healthcare Company Showcase Details:

Format: Fireside chat
Date: Wednesday, May 21, 2025
Time: 8:20 a.m. ET
Webcast Link: Click Here

On May 20, 2025 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule oncology approaches with immunotherapeutic effects, reported a successful in-person End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA), allowing the company to prepare and submit a registrational Phase 3 study of PT-112 monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Promontory Therapeutics, MAY 20, 2025, View Source [SID1234653250]).

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Consistent with FDA Project Optimus, the FDA agreed with the proposed dosing regimen for use in a prospective, randomized controlled Phase 3 registrational study, on the basis of the completed Phase 2 clinical trial. The study design and endpoints, along with the proposed comparator and statistical framework, were agreed in principle, as were Promontory’s proposed patient population within mCRPC, and proposal for an interim analysis. The latter would allow a potential pathway for drug approval prior to the full completion of the Phase 3 study.

Promontory will now prepare its full Phase 3 study submission for final review on the basis of FDA’s guidance, and conduct similar meetings with international regulatory authorities.

The proof of concept and dose optimization Phase 2 study of PT-112 monotherapy in advanced mCRPC was conducted in the U.S. and France and included three randomized dosing arms of PT-112. Immune response biomarker data were recently presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, and preliminary clinical outcomes will be presented on June 2nd at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting.

For more information about Promontory Therapeutics and PT-112 visit www.PromontoryTx.com.

On May 20, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will participate in the following upcoming investor events (Press release, Mersana Therapeutics, MAY 20, 2025, View Source [SID1234653248]):

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TD Cowen 6th Annual Oncology Innovation Summit
Format: Fireside chat
Date/Time: Tuesday, May 27, 2025, at 2:00 p.m. Eastern Time

Goldman Sachs 46th Annual Global Healthcare Conference
Format: Presentation
Date/Time: Monday, June 9, 2025, at 2:00 p.m. Eastern Time

Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.