This section highlights FDA-related milestones and regulatory updates for drugs developed by BioLineRx (BLRX).
Over the past two years, BioLineRx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
motixafortide and Soquelitinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
motixafortide - FDA Regulatory Timeline and Events
motixafortide is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- motixafortide
- Announced Date:
- May 30, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
BioLineRx Ltd. announced that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois.
AI Summary
BioLineRx Ltd. announced that a poster with new data from the pilot phase of its CheMo4METPANC Phase 2 clinical trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, from May 30 to June 3. The trial is testing a combination treatment for metastatic pancreatic cancer that includes the CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard chemotherapy agents gemcitabine and nab-paclitaxel. In the pilot study, four out of eleven patients stayed progression free for over one year. Two patients even underwent definitive treatment; one showed complete resolution of liver lesions and the other had a sustained partial response. The study also found increased CD8+ T-cell infiltration in tumors, suggesting that the treatment may boost the immune system’s ability to fight the cancer.
Read Announcement - Drug:
- motixafortide
- Announced Date:
- May 27, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
BioLineRx Ltd provided a corporate update.
AI Summary
BioLineRx Ltd provided a corporate update focused on its strategic efforts in oncology and rare diseases. CEO Philip Serlin explained that after out-licensing their FDA-approved stem cell mobilization agent, APHEXDA®, to Ayrmid Ltd., the company has been actively evaluating new assets in its core areas. Serlin expressed optimism about announcing a significant transaction later this year, highlighting that APHEXDA is performing well under Ayrmid’s management—a development that is expected to bring long-term value to BioLineRx.
The update also noted the company’s ongoing clinical development initiatives, including progress in the CheMo4METPANC Phase 2b trial sponsored by Columbia University, which aims to advance treatments for pancreatic cancer. Overall, BioLineRx is leveraging its drug development and regulatory expertise to explore innovative opportunities and bring new therapies to market.
Read Announcement- Drug:
- motixafortide
- Announced Date:
- April 17, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
BioLineRx Ltd announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma.
AI Summary
BioLineRx Ltd announced a poster presentation that focuses on improving apheresis center efficiency using CXCR4 antagonists, including APHEXDA (motixafortide), in patients with multiple myeloma. The poster, to be presented at the ASFA 2024 Annual Meeting in Las Vegas, examines how the use of APHEXDA in combination with filgrastim compares to daily filgrastim alone in mobilizing enough stem cells for autologous transplantation. The study is based on analyses from the Phase 3 GENESIS trial and other data, assessing the number of apheresis sessions needed to collect the target count of stem cells. By highlighting the benefits of combining a CXCR4 antagonist with standard care, the research suggests improvements in operational efficiency, which could enhance patient experience and reduce delays in treatment. This work offers valuable insights for clinicians and apheresis centers seeking more efficient mobilization strategies for multiple myeloma patients.
Read Announcement
Soquelitinib - FDA Regulatory Timeline and Events
Soquelitinib is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Soquelitinib
- Announced Date:
- June 25, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China.
AI Summary
Corvus Pharmaceuticals recently announced that the IND application submitted by its China partner, Angel Pharmaceuticals Ltd., has been approved by the Center for Drug Evaluation of the China National Medical Products Administration. This approval will allow Angel Pharma to begin a Phase 1b/2 clinical trial of soquelitinib, an investigational drug, for patients with moderate-to-severe atopic dermatitis in China.
The trial is designed to assess different dosing regimens over a 12‐week treatment period, with patient enrollment expected to start in the third quarter of 2025 and initial data available in 2026. This development builds on previous Phase 1 data, potentially offering a new treatment option for atopic dermatitis. The trial will help expand the clinical experience with soquelitinib and further explore its benefits for patients in China.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- June 11, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis will be presented today in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is taking place June 11-14, 2025 in Barcelona.
AI Summary
Corvus Pharmaceuticals, Inc. announced that new preclinical data demonstrating the potential of its lead ITK inhibitor, soquelitinib, to treat systemic sclerosis will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona from June 11-14, 2025. The data, which has already garnered attention from the Emerging EULAR Network by being selected as a top 10 abstract, highlights soquelitinib’s potential to prevent lung damage, inflammation, and pulmonary hypertension associated with systemic sclerosis. Dr. Gonçalo Boleto from Centro Académico de Medicina de Lisboa in Portugal will present the findings in a poster session. While Corvus Pharmaceuticals is primarily focused on its development programs for peripheral T cell lymphoma and atopic dermatitis, these preclinical findings may pave the way for future clinical trials or partnerships exploring ITK inhibition in systemic sclerosis treatment.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- June 4, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals, Inc. announced interim data from its Phase 1, randomized, double-blind, placebo-controlled clinical trial of soquelitinib for moderate to severe atopic dermatitis. The trial evaluated different dosing cohorts, with cohort 3 (200 mg twice daily) showing the most promising results. Patients in cohort 3 experienced earlier and deeper improvements, with a reduction in itch as early as day 8 and a 64.8% mean reduction in the Eczema Area and Severity Index (EASI) compared to 34.4% for placebo after 28 days. Overall, patients treated with soquelitinib showed statistically significant improvements compared to placebo, with meaningful reductions in itch and clear separation of effectiveness emerging by day 15. Building on these positive outcomes, enrollment has begun for an extension cohort using the same dose for an 8-week treatment period, looking to further enhance patient results.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- April 23, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting, which is taking place May 7-10, 2025 in San Diego, CA.
AI Summary
Corvus Pharmaceuticals, Inc. announced that new interim data from its Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented at the Society for Investigative Dermatology 2025 Annual Meeting in San Diego, CA. This trial is randomized, double-blind, and placebo-controlled, and the data will be shared through both an oral session and a poster presentation. The poster session is scheduled for May 8, 2025, while the oral presentation will take place on May 10, 2025.
The presentation will discuss the activity of soquelitinib, a selective ITK inhibitor, and its novel mechanism of action in treating atopic dermatitis. The company will also present details of these findings during its first quarter 2025 business update conference call and webcast, emphasizing promising developments in the treatment of this challenging skin condition.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- March 20, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
- Corvus Pharmaceuticals, Inc. announced that additional data from the Company's Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA.
AI Summary
Corvus Pharmaceuticals, Inc. announced that additional data from its Phase 1/1b clinical trial of soquelitinib for T cell lymphoma will be presented at the 16th Annual T-Cell Lymphoma Forum in San Diego, CA from March 20-22, 2025. The trial involved 25 patients treated with a 200 mg twice-daily dose, and the results showed promising signs of anti-tumor activity with a 39% overall response rate and a notable 26% complete response rate.
Dr. John Reneau from The Ohio State University Comprehensive Cancer Center will share the findings, including improvements in progression-free survival and reductions in T cell exhaustion. These encouraging outcomes support further clinical development of soquelitinib, reinforcing its potential as an effective treatment option for patients with T cell lymphoma.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- March 12, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.
AI Summary
Corvus Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID) has started a Phase 2 clinical trial of soquelitinib for treating Autoimmune Lymphoproliferative Syndrome (ALPS), a rare genetic disease. ALPS causes a harmful buildup of T cells that can lead to enlarged lymph nodes, spleen, and low blood counts, which make patients prone to serious complications. The study is led by Dr. V. Koneti Rao at the NIH Clinical Center and will evaluate the safety and effectiveness of soquelitinib in reducing these symptoms, using imaging and blood tests as primary measurements.
The trial will enroll up to 30 patients aged 16 and older, with two dosing groups being tested. Early preclinical results have shown that ITK inhibition with soquelitinib may rebalance the immune system by reducing dysfunctional T cells. This research offers hope for improved treatment options for ALPS patients.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- January 13, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals announced new interim results from its randomized, double-blind, placebo-controlled Phase 1 trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial included data from two cohorts. In cohort 1, patients received 100 mg twice a day, and in cohort 2, patients received 200 mg once daily. The results showed a favorable safety profile with no significant adverse effects or abnormal lab results.
Importantly, clinically meaningful endpoints were met using FDA-accepted measures. About 26% of patients taking soquelitinib achieved an Investigator Global Assessment (IGA) score of 0 or 1, and 37% reached a 75% reduction in the Eczema Area and Severity Index (EASI 75), while no patients in the placebo group reached these targets. These promising interim results suggest soquelitinib could offer a convenient and effective oral treatment for atopic dermatitis, and further results will be reported in the second quarter of 2025.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- December 18, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals announced interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals announced interim results from its randomized, double-blind, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. In the trial’s first cohort using the lowest dose (100 mg twice daily), the treatment showed a favorable safety profile with few mild adverse events and promising efficacy outcomes. Patients receiving soquelitinib experienced significant improvements in eczema severity, as demonstrated by notable reductions in Eczema Area and Severity Index (EASI) scores compared to placebo, with improvements evident as early as eight days into treatment. Additionally, analysis of cytokine levels revealed associations between clinical improvements and reductions in inflammatory markers such as IL-5, IL-17, IL-31, IL-33, and TSLP. These findings highlight the potential of soquelitinib as a new treatment option for atopic dermatitis and support the broader promise of ITK inhibition in managing immune-related diseases.
Read Announcement - Drug:
- Soquelitinib
- Announced Date:
- December 17, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals announce interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis tomorrow, December 18, 2024.
AI Summary
Corvus Pharmaceuticals announced that interim data from its randomized, double-blind, placebo-controlled Phase 1 clinical trial of soquelitinib will be shared on December 18, 2024. This trial is evaluating the drug in patients with moderate to severe atopic dermatitis. Soquelitinib, an investigational oral small molecule, is designed to selectively inhibit interleukin-2-inducible T cell kinase (ITK), which plays a role in immune cell function. The company plans to release the interim results through a press release and will present the data on a conference call and webcast. The event is scheduled for 8:00 a.m. ET / 5:00 a.m. PT, with access available via telephone or online through the Corvus Pharmaceuticals website. This announcement marks an important step in exploring new treatment options for patients suffering from atopic dermatitis.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- September 10, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
AI Summary
Corvus Pharmaceuticals, Inc. announced that it has started a registrational Phase 3 clinical trial for soquelitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This new study is a randomized, controlled trial that will test the safety and effectiveness of soquelitinib compared to the standard chemotherapy options such as belinostat or pralatrexate. Soquelitinib, a potential first-in-class ITK inhibitor, is designed to target T cell lymphomas using a unique mechanism that may boost the body’s natural tumor-fighting abilities. The trial plans to enroll about 150 patients who have already undergone one to three previous treatments. It will take place at around 40 sites in the United States, Canada, Australia, and South Korea. The main goal is to improve progression-free survival, with other important outcomes including overall survival and the duration of tumor response.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- August 1, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 - 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3 2024
AI Summary
Corvus Pharmaceuticals announced that its registrational Phase 3 clinical trial of soquelitinib in patients with relapsed or refractory peripheral T cell lymphoma (PTCL) is moving forward, with initial patient enrollment expected to begin in the third quarter of 2024. The trial targets adults who have undergone at least two previous lines of systemic therapy, addressing the unmet need for treatments in a patient group with limited effective options. The investigational oral drug, soquelitinib, has attracted strong interest from experienced investigators who specialize in T cell lymphomas. This Phase 3 study aims to further evaluate the safety and effectiveness of soquelitinib, offering a potential new treatment approach for PTCL patients. The advancement of this trial highlights Corvus Pharmaceuticals’ commitment to improving outcomes in a challenging disease area, where few approved therapies exist.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- August 1, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy.
AI Summary
Corvus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug, soquelitinib, for treating adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) who have received at least two lines of systemic therapy. This designation highlights the urgent need for new treatment options in PTCL, a condition where available therapies often fall short, providing limited benefit and carrying significant toxicity.
Fast Track Designation aims to speed up drug development and review by improving communication with the FDA and allowing parts of the application to be reviewed on a rolling basis. The decision underscores both the severe unmet medical need in this patient population and the potential of soquelitinib to address these critical challenges. The company is on track to begin patient enrollment in its Phase 3 registrational trial in Q3 2024.
Read Announcement
