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])

On December 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will participate in the upcoming 44th Annual J.P. Morgan Healthcare Conference in San Francisco.

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Guardant Health’s management is scheduled to present and participate in a Q&A session on Monday, January 12, at 3:45 p.m. Pacific Time / 6:45 p.m. Eastern Time. Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

(Press release, Guardant Health, DEC 29, 2025, View Source [SID1234661649])

On December 29, 2025 Johnson & Johnson (NYSE: JNJ) (the "Company") reported the successful completion of its acquisition of Halda Therapeutics OpCo, Inc. ("Halda"), a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer, for $3.05 billion in cash.

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"This strategic milestone underscores our commitment to redefining cancer treatment with breakthrough science and transformative medicines," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. "We are excited to formally welcome the talented Halda team to Johnson & Johnson and look forward to working together to achieve our shared goal of eliminating cancer."

With this acquisition, Johnson & Johnson adds HLD-0915, a clinical-stage therapy for prostate cancer, building on the Company’s nearly two decades of innovation in this disease area. HLD-0915 is a once-daily oral therapy that uses a novel RIPTAC platform with a precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment. Additionally, the Company adds several earlier candidates for breast, lung and multiple other tumor types, based on RIPTAC technology, to its leading oncology portfolio. The novel technology may also enable the creation of transformative targeted therapies beyond oncology.

"Johnson & Johnson continuously seeks new ways to meet patient needs and deliver innovative therapies," said John C. Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, R&D, Johnson & Johnson. "Now that we have finalized this acquisition, we will focus on advancing the potential of this promising pipeline of novel product candidates and harnessing the powerful RIPTAC platform to discover more molecules in oncology and beyond."

The acquisition will be accounted for as a business combination. With the transaction now closing in 2025, Johnson & Johnson expects dilution in Q4 2025 and 2026 earnings. The total dilution to Adjusted Earnings Per Share (EPS) of approximately $0.20 is expected to split equally between 2025 and 2026 based on the latest estimates for the non-recurring charge related to Halda employee equity awards, financing and integration costs. Johnson & Johnson will provide commentary on full year 2026 guidance during the fourth quarter earnings call on Wednesday, January 21, 2026.

(Press release, Johnson & Johnson, DEC 29, 2025, View Source [SID1234661648])