On December 9, 2025 Zydus Lifesciences Limited (including its subsidiaries and affiliates), an innovation-led life-sciences company, with an international presence, reported that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda1 (Pembrolizumab) in the USA and Canada market.

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Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories. The BLA application is expected to be submitted to the USFDA in the near future and is aimed at making immunotherapy affordable and accessible to patients in need.

Commenting on this strategic partnership, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, stated, "We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda across US and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care."

Dr. Stefan Glombitza, CEO of Formycon, stated, "FYB206, a biosimilar of Keytruda, demonstrates Formycon’s advanced expertise in developing biosimilar medicines for highly regulated countries. Partnering with Zydus, an organization recognized for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients. This collaboration strengthens our collective commitment to expanding access to medicines."

(Press release, Zydus Cadila, DEC 9, 2025, View Source [SID1234661326])

On December 9, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it has entered into a definitive agreement for the purchase of an aggregate of 9,462,423 shares of its common stock, Series A warrants to purchase up to an aggregate of 9,462,423 shares of its common stock and Series B warrants to purchase up to an aggregate of 9,462,423 shares of its common stock, at a purchase price of $1.65 per share and accompanying warrants in a registered direct offering. The warrants will have an exercise price of $1.95 per share and will be exercisable beginning six months after the date of issuance.

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H.C. Wainwright & Co. is acting as the exclusive lead placement agent for the offering. Rodman & Renshaw LLC is acting as co-placement agent for the offering.

The closing of the offering is expected to occur in three tranches. The first closing of the offering is expected to occur on or about December 10, 2025, subject to satisfaction of customary closing conditions. At the first closing, the Company will issue an aggregate of 5,219,999 shares of its common stock, Series A warrants to purchase up to an aggregate of 5,219,999 shares of its common stock and Series B warrants to purchase up to an aggregate of 5,219,999 shares of its common stock. The second closing of the offering is expected to occur by no later than January 30, 2026. At the second closing, the Company will issue an aggregate of 3,030,303 shares of its common stock, Series A warrants to purchase up to an aggregate of 3,030,303 shares of its common stock and Series B warrants to purchase up to an aggregate of 3,030,303 shares of its common stock. The third closing of the offering is expected to occur by no later than February 27, 2026. At the third closing, the Company will issue an aggregate of 1,212,121 shares of its common stock, Series A warrants to purchase up to an aggregate of 1,212,121 shares of its common stock and Series B warrants to purchase up to an aggregate of 1,212,121 shares of its common stock. The Series A warrants will expire five and one-half years from the date of the first closing and the Series B warrants will expire twenty-four months from the date of the first closing.

The gross proceeds to the Company are expected to be approximately $8.6 million from the first closing of the offering, approximately $5 million from the second closing of the offering and approximately $2 million from the third closing of the offering, before deducting the placement agents’ fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital, satisfaction of the Company’s $3.4 million bridge note obligation to the Matthew Nachtrab Revocable Trust, and general corporate purposes. The bridge note obligation bears interest at a rate of 3% per month and requires repayment on the earlier of December 31, 2025 or on the date that is 30 days following the successful closing of an equity financing in which the Company receives gross cash proceeds in excess of $12,000,000.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-291239) filed with the Securities and Exchange Commission ("SEC") on November 3, 2025, which became effective automatically on November 22, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected] and Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 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, TuHURA Biosciences, DEC 9, 2025, View Source [SID1234661325])

On December 9, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that they will present their Phase 1/2 study results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium held on Jan 8-10, 2026 in San Francisco, CA. This marks the first public release of Phanes’ clinical trial data from their ongoing U.S. multi-center study with spevatamig. Details of the presentation are below:

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Title: Phase 1/2 study of spevatamig (PT886) in combination with gemcitabine plus nab-paclitaxel (GnP) in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

Abstract #: 709

Session: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract

Date/Time: January 9th, 2026, at 11:30am-1pm (PST)

First Author: Anwaar Saeed, MD, University of Pittsburgh Medical Center

ABOUT SPEVATAMIG
Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase 1/2 clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase 2 study of spevatamig has begun in China.

(Press release, Phanes Therapeutics, DEC 9, 2025, View Source [SID1234661324])

On December 9, 2025 D3 Bio, a global clinical-stage biotechnology company focused on the discovery and development of innovative oncology therapeutics, reported the completion of a $108 million Series B financing round.

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The funding round was backed by a distinguished group of investors, including IDG Capital and SongQing Capital. Existing investors — WuXi AppTec’s Corporate Venture Fund, Temasek, HSG, MPCi, and Medicxi — also contributed to the round. The robust involvement from both new and current investors highlights widespread confidence in D3 Bio’s innovative pipeline and its global development strategy.

Proceeds from this financing will primarily support the planned global Phase III pivotal program for the company’s lead asset, elisrasib (D3S-001). These pivotal trials will assess elisrasib as both a monotherapy and in combination therapies for KRAS G12C-mutant cancers across key countries and regions, including the United States, China, and the European Union, to facilitate global regulatory submissions.

Furthermore, the funding will facilitate ongoing development of D3 Bio’s comprehensive pipeline of targeted and immuno-oncology programs, which are centred on innovative mechanisms with first-in-class or best-in-class potential.

Dr. George Chen, Founder, Chairman, and CEO of D3 Bio, stated, "The completion of our Series B financing demonstrates the strong confidence our investors place in our vision, scientific approach, business operations, and global development capabilities. This funding enables us to advance our lead program into late-stage clinical trials and further expand our pipeline of innovative therapies designed to benefit patients globally."

Dr. Antoine Yver, Member of the Board of Directors and Scientific Committee of D3 Bio, stated, "This financing demonstrates that the swift and effective pursuit of the best- or first-in-class science is meaningful to society, and validates D3 Bio’s leading innovation, scientific vision and development strategy. It also highlights the unique potential of elisrasib for individuals affected by KRAS G12C-mutant cancers."

(Press release, D3 Bio, DEC 9, 2025, View Source [SID1234661323])

On December 9, 2025 Daiichi Sankyo reported first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab.

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DESTINY-Ovarian01 is being conducted in collaboration with the European Network of Gynecological Oncological Trial Groups (ENGOT), with the Spanish cooperative group (GEICO) as the lead ENGOT group, The GOG Foundation, Inc. (GOG-F) and Asia-Pacific Gynecologic Oncology Trials Group (APGOT).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The prognosis for patients with ovarian cancer is poor with an estimated five-year survival rate of 31.8% for those with advanced disease.1 Approximately 70% to 80% of patients with advanced ovarian cancer (Stage 3 or 4) will experience disease recurrence following standard treatment with surgery and platinum-based chemotherapy regimens.2 Maintenance therapy may be given to delay relapse and current recommended treatment strategies include bevacizumab or PARP inhibitor monotherapy or bevacizumab/PARP inhibitor combination treatment, depending on the biomarker status of the tumor. 3 There currently are no HER2 directed medicines approved as maintenance therapy despite HER2 expression being present in up to 55% of ovarian cancers.

"Results from the ovarian cancer cohort of DESTINY-PanTumor02 demonstrated clinically meaningful and durable responses in previously treated patients with HER2 expressing advanced ovarian cancer, supporting the development of ENHERTU in earlier lines of therapy," said Abderrahmane Laadem, MD, Head, Late- 2 Stage Oncology Clinical Development, Daiichi Sankyo. "Given the important role first-line maintenance therapy can play in disease control, we have initiated this first phase 3 trial in ovarian cancer to evaluate whether ENHERTU combined with bevacizumab could become a new maintenance strategy for patients with HER2 expressing advanced high-grade epithelial ovarian cancer."

About DESTINY-Ovarian01

DESTINY-Ovarian01 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab. The randomized period of the trial was preceded by a non-randomized safety run-in phase to evaluate the safety of ENHERTU in combination with bevacizumab

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the HER2 IHC 3+/2+ population. The key secondary endpoint is overall survival (OS) in the HER2 IHC 3+/2+ population. Additional secondary endpoints include PFS as assessed by BICR and OS in the HER2 IHC 3+/2+/1+ population as well as PFS as assessed by investigator in both the HER2 IHC 3+/2+ and HER2 IHC 3+/2+/1+ populations.

DESTINY-Ovarian01 will enroll approximately 580 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

(Press release, Daiichi Sankyo, DEC 9, 2025, View Source [SID1234661322])