Biolinerx Stock Price, News & Analysis

Hemispherian (NASDAQ: BLRX) announced a USPTO Notice of Allowance for U.S. Patent Application No. 18/602,969 titled “Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies.” The patent covers GLIX1 use in cancers where cytidine deaminase (CDA) is not over-expressed, a characteristic stated to represent over 90% of cancers. The allowance strengthens GLIX1 intellectual property through at least 2040 with eligibility for up to 5 additional years. Corresponding international applications are pending, and GLIX1 already holds issued patents for CNS cancers, including glioblastoma, in the U.S., Europe, and 13 other countries. A joint venture with BioLineRx is preparing a Phase 1/2a glioblastoma trial in Q1 2026 while advancing preclinical work in additional solid tumors.

BioLineRx (NASDAQ: BLRX) will release unaudited third quarter results for the period ended September 30, 2025 on Monday, November 24, 2025 before U.S. markets open.

Management will host a conference call on November 24, 2025 at 8:30 a.m. EST with remarks by Philip Serlin, CEO. U.S. dial-in is +1-888-281-1167; international dial-in is +972-3-918-0685. A live webcast and replay will be available on the company website; the replay will be posted about two hours after the call and a dial-in replay runs until November 26, 2025 (+1-888-295-2634 U.S., +972-3-925-5904 international).

BioLineRx (NASDAQ: BLRX) announced a U.S. Patent and Trademark Office Notice of Allowance for a patent titled Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies (Appl. Ser. No. 18/602,969) covering use of GLIX1 in cancers where cytidine deaminase (CDA) is not over-expressed.

The patent broadens GLIX1's intellectual property, extending protection for the treatment of cancer until 2040 with a possible patent-term extension up to five years. The company estimates >90% of cancers fall within the patent's CDA expression threshold. Corresponding international applications are pending, and GLIX1 combination claims with PARP inhibitors are at the international patent stage with potential protection to 2044 if granted. BioLineRx plans a first-in-human glioblastoma study in Q1 2026.

BioLineRx (NASDAQ:BLRX) and Hemispherian AS have formed a joint venture to develop GLIX1, a first-in-class oral drug targeting DNA damage response in glioblastoma and other cancers. The FDA has cleared the IND application for GLIX1, with a Phase 1/2a study set to begin in Q1 2026.

Under the agreement, Hemispherian contributes GLIX1's global rights and will initially hold 60% of the JV, while BioLineRx will manage and fund development activities with a 40% initial stake, potentially increasing to 70%. The glioblastoma market opportunity is projected to reach $3.8 billion annually across the US and EU5 by 2030.

GLIX1 has shown promising results in preclinical studies, including potent anti-tumor activity, blood-brain barrier penetration, and a favorable safety profile. The drug has received Orphan Drug Designation from both FDA and EMA.

BioLineRx (NASDAQ: BLRX) has reported its Q2 2025 financial results and provided corporate updates. The company recorded $0.3 million in revenues from APHEXDA royalties and reported a net loss of $3.9 million. The company's cash position stands at $28.2 million, extending their runway into H1 2027.

Clinical progress includes continued enrollment in the CheMo4METPANC Phase 2b trial for pancreatic cancer, with promising interim data showing 4 out of 11 patients remaining progression-free after one year. Two Phase 1 trials evaluating motixafortide for stem cell mobilization in sickle cell disease are progressing, with results expected in H2 2025.

The company is actively pursuing pipeline expansion opportunities in oncology and rare diseases, targeting a potential transaction in 2025.

BioLineRx (NASDAQ: BLRX), a development stage biopharmaceutical company focused on oncology and rare diseases, will release its Q2 2025 financial results on August 14, 2025, before U.S. markets open.

The company will host a conference call at 8:30 a.m. EDT featuring CEO Philip Serlin. Investors can access the call through U.S. dial-in (+1-888-281-1167) or international dial-in (+972-3-918-0685). A live webcast and replay will be available on the company's website, with the call replay accessible until August 16, 2025.

BioLineRx (NASDAQ/TASE: BLRX) reported promising new data from the pilot phase of its CheMo4METPANC Phase 2 trial for pancreatic cancer treatment. The trial combines motixafortide, cemiplimab, and standard chemotherapies. Key findings show 4 of 11 PDAC patients remained progression-free after one year, with two patients receiving definitive treatment. The combination therapy achieved a 64% overall response rate and 91% disease control rate, significantly higher than historical rates of 23% and 48% respectively. The study demonstrated increased CD8+ T-cell tumor infiltration across all patients. Based on these results, the trial has been expanded to a randomized study with enrollment increasing from 30 to 108 patients, with full enrollment expected by 2027. The data will be presented at ASCO 2025.

BioLineRx (NASDAQ: BLRX) reported Q1 2025 financial results with net income of $5.1 million, up from $0.7 million in Q1 2024. The company generated $0.3 million in revenues from APHEXDA royalties, down from $6.9 million in Q1 2024. Key highlights include: completed a $10 million financing in January 2025, reduced operating expenses by over 70%, and maintains cash runway through H2 2026. The company's APHEXDA drug, now licensed to Ayrmid, generated $1.4 million in sales in Q1. Clinical progress continues with the CheMo4METPANC Phase 2b trial for pancreatic cancer, with new data to be presented at ASCO 2025. The company held $26.4 million in cash and equivalents as of March 31, 2025, and is actively evaluating new assets in oncology and rare diseases.

BioLineRx (NASDAQ: BLRX), a development stage biopharmaceutical company focused on oncology and rare diseases, has scheduled the release of its Q1 2025 unaudited financial results for May 27, 2025, before U.S. markets open. The company will host a conference call at 8:30 a.m. EDT featuring CEO Philip Serlin.

Investors can access the call via U.S. dial-in (+1-888-281-1167) or international dial-in (+972-3-918-0685). A live webcast and replay will be available through the company's website, with a dial-in replay accessible until May 29, 2024.