On May 11, 2026 Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in a broad range of neurological diseases.

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The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions, fill unmet medical needs, and bring promising therapies to patients more quickly. Drugs granted this designation are eligible for more frequent interactions with the agency regarding development plans, a rolling NDA/BLA review, and potential priority review and accelerated approval.

"Fast Track designation for SIR2501 in CIPN is a meaningful recognition of the urgent unmet medical need and the potential of our entire SARM1 program," said Dr. Shefali Agarwal, Sironax President and CEO. "The FDA’s designation not only validates our approach in CIPN, but also the broader potential of SARM1 inhibition to address additional neurological diseases. We are inspired to advance this potential therapy for millions of patients around the world."

CIPN is a common nerve-damaging side effect of chemotherapy that affects the hands and feet. Symptoms include burning or shooting pain, loss of temperature and tactile sensation, muscle weakness, and impaired fine motor skills. A significant number of cancer patients receive high-risk chemotherapy (e.g., taxanes, platinum, vinca alkaloids), develop CIPN, and subsequently discontinue or reduce chemo regimen due to the disease.

"For too long, millions of cancer patients have found themselves in the difficult position of experiencing painful symptoms while receiving their cancer treatment," said Dr. Robert Coleman, Gynecologic Oncologist, Texas Oncology, and Chief Medical Officer of Vaniam Group; and one of the country’s preeminent gynecologic oncologists. "Unfortunately, the severity of these symptoms has led many patients to either curtail or completely stop their treatment regimens. I’m pleased that a potential treatment for CIPN is advancing that could at last address this condition."

About SIR2501
SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in diseases such as CIPN and amyotrophic lateral sclerosis (ALS). By binding SARM1 away from its active site and maintaining the enzyme in an inactive state, SIR2501 is designed to protect nerves and prevent degeneration, while avoiding potential adverse effects observed with orthosteric inhibitors. SIR2501 has demonstrated strong neuroprotective effects in multiple preclinical models, and global Phase 1b/2 clinical trials evaluating SIR2501 in patients with CIPN and ALS are ongoing.

(Press release, Sironax, MAY 11, 2026, View Source [SID1234665475])

On May 11, 2026 Daiichi Sankyo reported FY2025 Financial Results and 5-Year Business Plan Presentation & Discussion.

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(Presentation, Daiichi Sankyo, MAY 11, 2026, View Source [SID1234669155])

On May 11, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered into an exclusive strategic collaboration with Sino Biopharmaceutical, (SBP Group), through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), to accelerate bepirovirsen in mainland China at launch. Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B (CHB) under priority regulatory review in China. CTTQ is a market leader in hepatitis B in China with one of the country’s most comprehensive liver disease portfolios and a broad commercial footprint covering more than 5,000 medical centres across care settings. CTTQ has played a significant role in advancing the diagnosis and treatment of hepatitis B in China.

The collaboration combines GSK innovation with CTTQ’s local scale and in-market execution to reach more patients, more quickly. Under the agreement, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy. The agreement also grants GSK the ability to review certain early-stage pipeline assets of the SBP Group to evaluate the potential for collaboration opportunities outside China.

Mike Crichton, President International, GSK, said: "Chronic hepatitis B affects 75 million people in China1 and is a leading cause of liver cancer in the country.2 By combining GSK’s innovation with CTTQ’s extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China’s most pressing healthcare priorities."

Chronic hepatitis B is a national health priority in China. The latest National Action Plan for the Prevention and Treatment of Viral Hepatitis (2025-2030) has set out functional cure as a treatment goal for Hepatitis B. Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen (HBsAg) – are undetectable in the blood for at least 6 months after stopping all treatment. Functional cure is associated with a meaningful reduction in the risk of long-term complications, including liver cancer.3

Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 phase III trials, which demonstrated statistically significant and clinically meaningful functional cure rates.

Collaboration terms
Under the terms of the agreement, CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years. The term may be extended thereafter by mutual agreement. GSK will book sales of bepirovirsen supplied to CTTQ through the collaboration.

GSK also has the ability to review certain early-stage pipeline assets of the SBP Group to evaluate potential collaboration opportunities outside China.

About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic Hepatitis B (CHB) occurs when the immune system is unable to clear the virus, resulting in long-lasting infection. CHB affects more than 250 million people worldwide. Each year, the disease causes approximately 1.1 million deaths.1 Many patients often require lifelong antiviral therapy for viral suppression; making functional cure a critical goal in disease management.

CHB remains a significant public health challenge in China, affecting an estimated 75 million people and causing approximately 450,000 deaths annually.1 84.4% of patients with liver cancer in China are associated with CHB infection.2 Functional cures are associated with a significant reduction in the risk of long-term liver complications, including liver cancer.3

About bepirovirsen
Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), designed to inhibit the replication of viral DNA in the body, suppress the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulate the immune system to increase the chances of a durable and sustained response.

GSK licensed bepirovirsen from Ionis and collaborated with them on its development. Bepirovirsen has been recognised by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Priority Review, Fast Track and Breakthrough Designations from the US FDA, Priority Review and Breakthrough Therapy designation in China and SENKU designation in Japan.

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(Press release, GlaxoSmithKline, MAY 11, 2026, View Source [SID1234665436])

On May 11, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

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HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone. A clear signal of added benefit in this study design would support INBRX-106’s potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications.

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments. The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update.

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes.

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone. The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator.

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

"We are greatly encouraged by these early clinical results," said Mark Lappe, Chief Executive Officer of Inhibrx. "These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism."

Next Steps

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter. The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027. Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. To date, over 175 patients have been treated with INBRX-106.

(Press release, Inhibrx, MAY 11, 2026, View Source [SID1234665460])

On May 11, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the first quarter ended March 31, 2026 and provided a business update.

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"The first quarter of 2026 reflects strong progress as we work to position ficerafusp alfa as the cornerstone of treatment in HPV-negative head and neck cancer. In addition to advancing our FORTIFI-HN01 pivotal trial, we continued to enroll patients in additional Phase 1b signal-seeking studies as we aim to unlock the full blockbuster potential of ficerafusp alfa. Based on recent FDA discussions, we plan to initiate a randomized study to evaluate a loading and every-three-week maintenance dosing regimen – further differentiating ficerafusp alfa and expanding optionality for patients and providers. We also look forward to sharing an important data update at ASCO (Free ASCO Whitepaper) 2026, which will further characterize the role of TGF-β in driving depth and durability of response across three 1L R/M HNSCC expansion cohorts," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "Alongside our clinical progress, we are rapidly evolving toward becoming a commercial-stage company, and to support that evolution, today we announced several executive changes. David Raben has transitioned from Chief Medical Officer to a Senior Executive Advisor role after three years of instrumental contributions, and Bill Schelman, formerly Executive Vice President of Clinical Development, has stepped into the Chief Medical Officer role. We have also welcomed Chris Sarchi as our Chief Commercial Officer, who brings extensive oncology commercialization and leadership experience as we build toward launch."

First Quarter 2026 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Continued strong execution in FORTIFI-HN01, our pivotal trial in 1L HPV-negative R/M HNSCC; expect to be substantially enrolled by the end of the year to enable an interim analysis in mid-2027 to support potential accelerated approval.
Based on recent discussions with the U.S. Food and Drug Administration (FDA), the company plans to initiate a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W). The company expects to initiate the study in the third quarter of 2026 to have results in time for potential U.S. accelerated approval.
Phase 1b Studies of Ficerafusp Alfa Across HNSCC and Other Solid Tumor Types

Continued to enroll multiple Phase 1b expansion cohorts to identify early proof-of-concept signals and inform ficerafusp alfa development strategy beyond 1L R/M HPV-negative HNSCC.
Published a manuscript detailing results from a Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizumab in 1L R/M HNSCC in the Journal of Clinical Oncology. Read the manuscript here.
Corporate Highlights

Announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio.
Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data, which will further characterizing the role of TGF-β inhibition in driving depth and durability of response, from three Phase 1b expansion cohorts of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Other Solid Tumors, Including mCRC

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
First Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Bicara had cash, cash equivalents and marketable securities of $539.8 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. The company received approximately $161.8 million in net proceeds from an oversubscribed public offering in the first quarter of 2026. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $47.5 million for the first quarter of 2026 as compared to $34.3 million for the first quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, as well as the company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $12.7 million for the first quarter of 2026 as compared to $7.5 million for the first quarter of 2025. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials.
Net Loss: Net loss totaled $56.2 million for the first quarter of 2026 compared to $36.8 million for the first quarter of 2025.
Upcoming Investor Conferences

Bicara Therapeutics will participate in two upcoming investor conferences:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Wednesday, May 27, 2026 at 10:30 a.m. ET.
A live webcast of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2026 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, MAY 11, 2026, View Source [SID1234665476])