Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer

On February 5, 2026 Akeso, Inc. (9926.HK) reported that ivonescimab, its global first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This latest designation applies to ivonescimab in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC).

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This milestone represents the fifth BTD awarded to ivonescimab by the NMPA, following three prior designations in lung cancer indications and one for triple-negative breast cancer (TNBC). The repeated recognition highlights ivonescimab’s broad clinical potential across multiple high unmet need tumor types.

A randomized, controlled, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) is evaluating ivonescimab plus chemotherapy versus durvalumab (a PD-L1 inhibitor) plus chemotherapy for first-line treatment of advanced BTC. Patient enrollment has been completed, and the BTD status for this indication underscores the promising clinical profile of ivonescimab. The BTD status is expected to accelerate both the ongoing clinical development and the regulatory review process in China.

Encouraging results from a Phase 1b/II study, presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting, support the potential of the ivonescimab combination therapy as a superior first-line treatment for advanced BTC. In the study, ivonescimab plus chemotherapy achieved an Objective Response Rate (ORR) of 63.6% and a Disease Control Rate (DCR) of 100%. The ivonescimab regimen also demonstrated a median Progression-Free Survival (mPFS) of 8.5 months and a median Overall Survival (mOS) of 16.8 months.

These compelling Phase II results provide a robust foundation for the ongoing Phase III registrational trial and reinforce ivonescimab’s potential to address the significant unmet needs in advanced BTC, where current treatment options often yield limited durable responses.

(Press release, Akeso Biopharma, FEB 5, 2026, View Source [SID1234662516])

AbbVie Reports Full-Year and Fourth-Quarter 2025 Financial Results

On February 4, 2026 AbbVie (NYSE:ABBV) reported financial results for the fourth quarter and full year ended December 31, 2025.

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"2025 was another outstanding year for AbbVie. We delivered record net sales in just the second full year following the U.S. Humira loss of exclusivity, underscoring the strength of our diversified growth platform. We also advanced promising new treatments for patients while enhancing the breadth and depth of our pipeline with strategic investments," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our strong fundamentals, we expect another year of robust growth in 2026. This momentum combined with our investments in innovation position AbbVie for long-term success."

Fourth-Quarter Results
•Worldwide net revenues were $16.618 billion, an increase of 10.0 percent on a reported basis, or 9.5 percent on an operational basis.
•Global net revenues from the immunology portfolio were $8.626 billion, an increase of 18.3 percent on a reported basis, or 17.7 percent on an operational basis.
◦Global Skyrizi net revenues were $5.006 billion, an increase of 32.5 percent on a reported basis, or 31.9 percent on an operational basis.
◦Global Rinvoq net revenues were $2.374 billion, an increase of 29.5 percent on a reported basis, or 28.6 percent on an operational basis.
◦Global Humira net revenues were $1.246 billion, a decrease 25.9 percent on a reported basis, or 26.1 percent on an operational basis.
•Global net revenues from the neuroscience portfolio were $2.961 billion, an increase of 17.9 percent on a reported basis, or 17.3 percent on an operational basis.
◦Global Vraylar net revenues were $1.022 billion, an increase of 10.5 percent.
◦Global Botox Therapeutic net revenues were $990 million, an increase of 13.4 percent on a reported basis, or 13.0 percent on an operational basis.
◦Global Ubrelvy net revenues were $339 million, an increase of 12.0 percent.
◦Global Qulipta net revenues were $288 million, an increase of 42.6 percent on a reported basis, or 41.8 percent on an operational basis.
•Global net revenues from the oncology portfolio were $1.664 billion, a decrease of 1.5 percent on a reported basis, or 2.5 percent on an operational basis.
◦Global Imbruvica net revenues were $671 million, a decrease of 20.8 percent.
◦Global Venclexta net revenues were $710 million, an increase of 8.6 percent on a reported basis, or 6.4 percent on an operational basis.
◦Global Elahere net revenues were $182 million, an increase of 22.6 percent on a reported basis, or 21.3 percent on an operational basis.
•Global net revenues from the aesthetics portfolio were $1.286 billion, a decrease of 0.9 percent on a reported basis, or 1.2 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $717 million, an increase of 4.2 percent on a reported basis, or 3.8 percent on an operational basis.
◦Global Juvederm net revenues were $249 million, a decrease of 10.7 percent on a reported basis, or 10.8 percent on an operational basis.
•On a GAAP basis, the gross margin ratio in the fourth quarter was 72.6 percent. The adjusted gross margin ratio was 83.6 percent.
•On a GAAP basis, selling, general and administrative (SG&A) expense was 23.4 percent of net revenues. The adjusted SG&A expense was 22.3 percent of net revenues.
•On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues.
•Acquired IPR&D and milestones expense was 7.6 percent of net revenues.
•On a GAAP basis, the operating margin ratio in the fourth quarter was 27.3 percent. The adjusted operating margin ratio was 38.3 percent.
•Net interest expense was $655 million.
•On a GAAP basis, the tax rate in the quarter was 32.0 percent. The adjusted tax rate was 18.3 percent.
•Diluted EPS in the fourth quarter was $1.02 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.71. These results include an unfavorable impact of $0.71 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced a voluntary agreement with the Trump administration to further advance access and affordability for Americans while protecting and investing in U.S. pharmaceutical innovation. Under the agreement, AbbVie will provide low prices in Medicaid, and expand affordable, direct-to-patient offerings for treatments used by millions of Americans. The company will also commit $100 billion in U.S. R&D and capital investments, including manufacturing, over the next decade. This three-year agreement provides AbbVie with exemption from tariffs and future pricing mandates.

•AbbVie announced it submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients living with non-segmental vitiligo. The submissions are supported by data from the Phase 3 Viti-Up clinical trials, in which Rinvoq achieved the co-primary endpoints of 50 percent improvement in total body re-pigmentation (T-VASI 50) and 75 percent improvement in facial re-pigmentation (F-VASI 75) from baseline at week 48. If approved, Rinvoq will be the first systemic treatment for patients with vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease.

•AbbVie announced it submitted an application to the EMA for expanded use of Aquipta (atogepant) for the acute treatment of adults with migraine. The submission was supported by data from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of Aquipta versus placebo for the acute treatment of migraine in adults. The study met its primary and key secondary endpoints, with Aquipta demonstrating superiority in pain freedom and freedom from the most bothersome migraine symptom two hours after treatment of the first migraine attack. Study results were shared as a late-breaking presentation at the European Headache Congress.

•AbbVie announced the FDA approval of Epkinly (epcoritamab) in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the Phase 3 EPCORE FL-1 study in which Epkinly with R2 demonstrated significantly superior progression-free survival (PFS) and overall response (OR) rates compared to standard of care R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the third indication for Epkinly and first FDA approval for a bispecific combination therapy in lymphoma. Epkinly is being co-developed by AbbVie and Genmab.

•AbbVie announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating Epkinly compared to investigator’s choice of chemoimmunotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL). The study demonstrated an improvement in PFS and improvements were observed in CR rates, duration of response and time to next treatment among patients treated with Epkinly. The study did not demonstrate a statistically significant improvement in overall survival (OS). Based on the topline results from the trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps.

•AbbVie and RemeGen announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors including certain lung cancers. This transaction further strengthens AbbVie’s diverse oncology portfolio and may offer new opportunities to explore combination regimens with AbbVie’s antibody-drug conjugates (ADCs) such as investigational Temab-A (telisotuzumab adizutecan), across multiple solid tumors with high unmet need.

•AbbVie and West Pharmaceutical Services announced a definitive agreement for AbbVie to acquire a device manufacturing facility in Tempe, Arizona and associated intellectual property from West. The acquisition will support production of AbbVie’s current and next-generation immunology and neuroscience medicines.

Full-Year 2026 Outlook
AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2026 of $14.37 to $14.57. The company’s 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2026, as both cannot be reliably forecasted.

(Press release, AbbVie, FEB 4, 2026, View Source [SID1234662461])

Rakovina Therapeutics Reports Strong Industry Validation and Emerging Collaborations Following 9th Annual DDR Inhibitors Summit

On February 4, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0)("Rakovina" or the "Company"), a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported a corporate update following the participation of its President and Chief Scientific Officer, Prof. Mads Daugaard, at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit in Boston, MA.

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The summit, which gathered global academic and industry leaders from institutions including Dana-Farber, MD Anderson, Merck, and Roche, served as a critical forum for discussing the future of DDR therapeutics. Prof. Daugaard presented Rakovina’s AI-driven strategy to develop brain-penetrant inhibitors and participated in expert panels on translational strategy and investment alignment.

Validating the Strategy: Solving the "Brain Penetration" Gap

A focal point of the summit was the clinical landscape of ATR inhibitors, specifically considering recent Phase 3 data in non-small cell lung cancer (NSCLC)

Rakovina’s presentation highlighted a distinct competitive advantage: unlike current clinical-stage candidates, Rakovina’s lead kt-5000 series is designed to be dual-targeting (ATR + mTOR) and brain-penetrant.

"The consensus from the summit is that the field is hungry for a brain-penetrant ATR inhibitor," said Prof. Mads Daugaard, Chief Scientific Officer of Rakovina Therapeutics. "While other programs face challenges with patient stratification and blood-brain barrier penetration, our data supports a different path: positioning ATR inhibition in a PTEN-deficient context with added mTOR blockade to shut down resistance pathways. The feedback we received from clinical thought leaders was clear, we are addressing the exact limitations that have held this drug class back."

Interest in Novel ADC Payloads

In addition to its small-molecule pipeline, the Company received inbound interest regarding its kt-3000 series as potential payloads for Antibody-Drug Conjugates (ADCs). With major pharmaceutical companies actively seeking novel payloads to overcome resistance to current ADC therapies, Rakovina intends to prioritize proof-of-concept studies to further unlock this partnership value.

"Our participation in Boston transformed our standing from a quiet innovator to a recognized problem-solver in the DDR space," added Prof. Daugaard. "We have confirmed that our scientific rationale is sound, our targets are high-value, and our AI-designed molecules are doing what the competition cannot: reach the brain."

(Press release, Rakovina Therapeutics, FEB 4, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-reports-strong-industry-validation-and-emerging-collaborations-following-9th-annual-ddr-inhibitors-summit [SID1234662476])

Aclaris Therapeutics to Participate in Two February Healthcare Conferences

On February 4, 2026 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported that the Company will participate in two upcoming healthcare conferences in February 2026.

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On Thursday February 12, 2026, at 2:30 PM EST, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York, NY.

On Thursday February 26, 2026, at 8:40 AM EST, Aclaris’ President and Chief Operating Officer Hugh Davis, Ph.D. will provide a corporate presentation during the virtual Oppenheimer 36th Annual Healthcare Life Sciences Conference.

A live and archived webcast of both events will be accessible on the Events page of View Source The webcasts will be available on the Aclaris website for at least 30 days.

(Press release, Aclaris Therapeutics, FEB 4, 2026, View Source [SID1234662462])

Revolution Medicines to Participate in Guggenheim Securities Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will participate in a fireside chat as part of the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11 at 9:30 a.m. ET.

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To listen to a live webcast of this event, or access an archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, FEB 4, 2026, View Source [SID1234662477])