On December 30, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 1,939,114 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate of 1,939,114 shares of common stock, in a registered direct offering priced at-the-market under Nasdaq rules. Each share of common stock (or pre-funded warrant in-lieu thereof) is being sold together with one warrant to purchase one share of common stock at a combined purchase price of $3.61 (or $3.6099 per pre-funded warrant and warrant). The warrants will have an exercise price of $3.482 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The pre-funded warrants will have an exercise price of $0.0001 per share, will be exercisable immediately upon issuance, and will not expire.

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Maxim Group LLC is acting as the lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-placement agent for the offering.

The gross proceeds to IMUNON from the offering are expected to be approximately $7.0 million, before deducting placement agents’ fees and other estimated offering expenses. The offering is expected to close on or about December 31, 2025, subject to satisfaction of customary closing conditions.

The securities described above in the registered direct offering, including the shares of common stock underlying the pre-funded warrants and warrants, are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279425) which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 22, 2024. The offering of the securities are being made only by means of a prospectus. A prospectus supplement and an accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

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

(Press release, IMUNON, DEC 30, 2025, View Source [SID1234661656])

On December 30, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that the New Drug Application ("NDA") for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

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This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study of savolitinib in gastric cancer patients with MET amplification in China. The study has met its primary endpoint of objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1). Additional details may be found at clinicaltrials.gov using identifier NCT04923932.

Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis.[1] It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.[2],[3] The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.

The NMPA has granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023. The NMPA granted this designation to this new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.

About Savolitinib
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.[5] Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS by our partner, AstraZeneca, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

(Press release, Hutchison China MediTech, DEC 30, 2025, View Source [SID1234661655])

On December 30, 2025 Alkermes plc (Nasdaq: ALKS) reported that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 44th Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, Jan. 13, 2026 at 10:30 a.m. PST (1:30 p.m. EST/6:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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(Press release, Alkermes, DEC 30, 2025, View Source [SID1234661654])

On December 29, 2025, PTC Therapeutics, Inc. (the "Company"), Royalty Pharma Investments 2019 ICAV ("RPI"), and, for the limited purposes set forth in the Purchase Agreement (as defined below), Royalty Pharma plc, entered into an Amendment No. 2 to Amended and Restated Royalty Purchase Agreement (the "Amendment"), which amends that certain Amended and Restated Royalty Purchase Agreement, dated as of October 18, 2023, as amended by Amendment No. 1 dated June 17, 2024 (the "Purchase Agreement").

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Under the Purchase Agreement, the Company sold to RPI a certain portion of the Company’s right to receive sales-based royalty payments on worldwide net sales of Roche’s Evrysdi (risdiplam) product and any other product developed pursuant to the License and Collaboration Agreement, dated as of November 23, 2011, by and among the Company, F. Hoffman-La Roche Ltd, Hoffman-La Roche Inc. (together with F. Hoffman-La Roche Ltd, "Roche"), and, for the limited purposes set forth therein, the Spinal Muscular Atrophy Foundation (such payments, the "Royalty").

Pursuant to the Amendment, on December 29, 2025, the Company sold to RPI its retained interest in the Royalty in exchange for $240.0 million in upfront cash consideration, and three potential additional cash purchase price payments of $20.0 million each conditioned upon receipt by RPI of more than $347.0 million of Assigned Royalty Payments (as defined in the Purchase Agreement) in respect of Calendar Year Net Sales (as defined in the Purchase Agreement) arising in 2027, $363.0 million of Assigned Royalty Payments in respect of Calendar Year Net Sales arising in 2028, and $379.0 million of Assigned Royalty Payments in respect of Calendar Year Net Sales arising in 2029, respectively. The retained interest sold by the Company to RPI pursuant to the Amendment is equal to 9.5111% of the Royalty before the 2020 Assigned Royalty Cap (as defined in the Purchase Agreement) has been met, and 16.6666% of the Royalty from and after such time as the 2020 Assigned Royalty Cap has been met. As a result of the sale, RPI owns 100% of the Royalty and the Company owns 0% of the Royalty.

The foregoing description of the material terms of the Amendment is qualified in its entirety by reference to the full text of the Amendment, which will be filed as an exhibit to the Company’s annual report on Form 10-K for the fiscal year ending December 31, 2025.

(Filing, 8-K, PTC Therapeutics, DEC 29, 2025, View Source [SID1234661658])

On December 29, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2025, as well as key clinical and corporate developments.

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"During fiscal 2025, our regulatory advancements accelerated driven by new opportunities for Multikine in Saudi Arabia and the green light we have received for our Confirmatory Registration trial in the U.S.," stated CEL-SCI CEO, Geert Kersten. "The Confirmatory Registration study required by the FDA is designed to confirm data from our prior Phase 3 study by evaluating Multikine in only those patients who showed the best type of tumor responses and survival in that study in a highly statistically significant manner. The long-term survival with our drug of 73% vs. only 45% without our drug, a huge improvement demonstrated in our prior Phase 3 study, significantly decreases risk associated with the development of Multikine as a cancer therapy. Preparations for this final registration study are ongoing, and we expect to commence enrollment in Spring 2026."

Clinical and Corporate Developments:

CEL-SCI is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028.
An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. CEL-SCI believes it has addressed all of the scientific questions posed by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia’s ambitious Vision 2030 goals to further advance the Kingdom’s global leadership in biotechnology.
CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts.
CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study.
A new study supports CEL-SCI’s strategy to seek early approval in the U.S. The third-party study recently published in Cancer Cell titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The data give further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June 2025, the FDA approved Merck’s KEYTRUDA (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine. Importantly, while Keytruda confers benefit in patients with a high levels of PD-L1, Multikine has been shown to significantly extend life in patients with low to zero levels of PD-L1. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.
Financial Results

During the fiscal year ended September 30, 2025, research and development expenses were $15.9 million, which decreased by approximately $2.3 million, or 13%, compared to the year ended September 30, 2024. General and administrative expenses in fiscal 2025 were $8.9 million, which increased by approximately $0.7 million, or 9%, compared to the year ended September 30, 2024. Net loss available to common shareholders decreased by $2.2 million to approximately $25.4 million for the twelve months ended September 30, 2025 from $27.6 million in fiscal 2024. The operating cash expenditures for the year were approximately $17.1 million. CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern. CEL-SCI raised gross proceeds of approximately $28.3 million in fiscal 2025 through the sale of common stock.

(Press release, Cel-Sci, DEC 29, 2025, View Source [SID1234661650])