On January 8, 2026 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported a strategic collaboration with Ottimo Pharma Limited ("Ottimo"), an innovative, clinical-stage biotech company developing one-of-a-kind PD-1/VEGFR2 dual paratopic antibodies to extend the lives of patients living with cancer. The partnership will utilize BostonGene’s advanced artificial intelligence (AI) platform to apply multiomic analytics and expedite the clinical development of Ottimo’s novel therapeutic candidate, OTP-01. OTP-01 is a first-in-class, bifunctional, dual paratopic antibody therapeutic that maintains a conventional IgG architecture while being engineered to simultaneously inhibit two critical signaling pathways, PD-1 and VEGFR2, with the goal of enhancing anti-tumor immunity and overcoming both primary and acquired resistance that limit the effectiveness of current immuno-oncology approaches.

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"The challenge of immune resistance in cancer treatment requires clinically precise solutions that address not only immune suppression, but also immune exclusion," said Robert Tighe, SVP Preclinical and Translational Sciences at Ottimo Pharma. "OTP-01’s novel dual mechanism is designed to address both by combining immune checkpoint blockade with VEGFR2-targeted vascular normalizing activity to improve immune cell access and enable more effective antitumor immune responses. Our collaboration with BostonGene provides a promising opportunity to establish a robust, data-driven development blueprint by helping us identify the patients most likely to benefit from this differentiated therapy."

Under the collaboration, BostonGene will synthesize preclinical datasets, early clinical signals, multiomic analyses, and tumor microenvironment insights to generate foundational biological hypotheses, define optimal first-in-man strategies, refine translational and correlative elements, and develop patient selection approaches that directly support Phase I/IIA progress. This analysis is intended to support early clinical decision-making and significantly de-risk and accelerate the path to market.

"Ottimo is at the forefront of engineering next-generation I-O molecules, and OTP-01 represents a significant advancement," said Ferran Prat, PhD, JD, Chief Commercial Officer at BostonGene. "Our powerful analytical engine is ideally suited to process the complexity of multiomic data generated by a dual-mechanism drug like OTP-01. By leveraging our AI foundation model, we will deliver the precision insights necessary for optimal patient stratification and clinical execution, ensuring this highly promising therapy reaches patients as efficiently as possible."

The agreement reflects a strong alignment of interests, featuring a shared-upside structure tied to clinical, regulatory, and commercial milestones.

(Press release, BostonGene, JAN 8, 2026, View Source [SID1234661878])

On January 7, 2026 Exelixis, Inc. (Nasdaq: EXEL) and Natera (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, reported their collaboration on the planned Exelixis-sponsored STELLAR-316 trial. This randomized phase 3 pivotal trial will evaluate zanzalintinib, Exelixis’ novel oral kinase inhibitor, with and without an immune checkpoint inhibitor, in patients with resected stage II/III colorectal cancer (CRC).

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This press release features multimedia. View the full release here: View Source

Using Natera’s Signatera test following completion of definitive therapy*, patients with CRC who test positive for molecular residual disease (MRD) and have no radiographic evidence of disease will be eligible for enrollment in the STELLAR-316 trial. Working with patients and their providers, this trial will be fully enrolled with patients who are receiving commercial Signatera testing as part of their routine standard of care.

The primary endpoint of STELLAR-316 is disease-free survival. Signatera will also be used for longitudinal monitoring of circulating tumor DNA clearance, one of the secondary endpoints of the trial. Exelixis expects to initiate STELLAR-316 in mid-2026.

CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Of the approximately 89,000 stage II/III colorectal cancer cases projected for 2035,2 about 20% of these patients are expected to remain MRD-positive following definitive therapy.3 Patients with stage II/III CRC who are MRD-positive have been shown to experience worse outcomes in multiple clinical studies3,4,5 and there are no established or approved therapies for this specific patient population in the U.S.

"Patients with colorectal cancer who are MRD-positive following definitive therapy face a high risk of recurrence, underscoring the urgent need for new treatment options that can help prevent clinical metastatic progression," said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. "STELLAR-316 is our second pivotal trial of zanzalintinib in patients with CRC and represents our continued commitment to addressing unmet needs in this patient population by conducting rigorous trials with the potential to improve standards of care. We are excited to collaborate with Natera on STELLAR-316, which, if successful, could make zanzalintinib the first MRD-guided treatment for these patients."

"Exelixis and Natera’s collaboration on STELLAR-316 underscores both companies’ commitment to advancing new approaches to treat CRC," said John Simmons, Ph.D., Global Vice President, Biopharma, Natera. "Leveraging Signatera to inform trial enrollment will help to identify high-risk patients earlier, enabling intervention when disease burden is lower – and importantly, with the potential to improve clinical outcomes."

About Zanzalintinib

Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.

Exelixis recently confirmed it has submitted a New Drug Application to the U.S. Food & Drug Administration for zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer, when used in combination with atezolizumab (Tecentriq). The regulatory filing was based on positive results from the phase 3 STELLAR-303 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy. Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination. The trial will proceed to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC

CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.6 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.6 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, JAN 7, 2026, View Source [SID1234661800])

On January 7, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference. The presentation is scheduled to take place on Tuesday, January 13, 2026, at 1:30 PM PST.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

(Press release, TG Therapeutics, JAN 7, 2026, View Source [SID1234661815])

On January 7, 2026 FibroGen, Inc. (Nasdaq: FGEN), reported it is rebranding the company to Kyntra Bio, representing the next step of the transformation of the Company and its focus on oncology and rare disease assets. The Company’s common stock will begin trading under the new Nasdaq symbol "KYNB" at stock market open on January 8, 2026.

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"2025 was a transformational year, highlighted by the sale of FibroGen China, the payoff of our senior secured term loan, and the extension of our cash runway into 2028. We begin this year as Kyntra Bio, a name that captures our company journey and evolution and reflects our purposeful move to a company obsessed with creating outsized impact for patients and shareholders," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "Today, with a sharpened direction, Kyntra Bio is laser-focused on our mid- and late-stage assets – specifically, FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, currently in a Phase 2 monotherapy trial in prostate cancer, and roxadustat, our Phase 3 ready asset, for which we recently received Orphan Drug Designation in myelodysplastic syndromes. We are thrilled to move forward with renewed purpose into this bold era for our company and are excited for what is in front of us."

Recent Highlights and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

•
Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC are expected to be presented at ASCO (Free ASCO Whitepaper) GU in the first quarter of 2026.
•
Interim results from the recently commenced Phase 2 monotherapy trial are expected in the second half of 2026. The trial will also assess the diagnostic performance of FG-3180 to determine the potential correlation between CD46 expression and response to FG-3246.

Roxadustat

•
Granted Orphan Drug Designation from the FDA for the treatment of myelodysplastic syndromes (MDS).
•
Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden to the U.S. Food and Drug Administration.

In addition to the new name, the Company is refreshing its corporate website to better reflect the Company’s strategy moving forward. The CUSIP number for the Company’s common stock is not affected by the name change.

(Press release, FibroGen, JAN 7, 2026, View Source [SID1234661801])

On January 7, 2026 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 10:30 AM PT.

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 30 days.

(Press release, Ultragenyx Pharmaceutical, JAN 7, 2026, View Source [SID1234661816])