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PharmaMar’s treatment for small cell lung cancer approved as first-line maintenance therapy in Taiwan

On March 23, 2026 PharmaMar (MSE:PHM) a Spanish biopharmaceutical company with 40 years of experience, reported that its treatment Zepzelca (lurbinectedin), in combination with atezolizumab (Tecentriq), has been approved by the Taiwan Food and Drug Administration (TFDA) as a first-line maintenance treatment for adult patients with advanced small cell lung cancer (SCLC).

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This approval as a first-line maintenance therapy means that the drug is administered after the initial induction treatment for those patients who achieve stable disease or better, in order to maintain the response achieved. In addition to Taiwan, this first-line maintenance combination has recently been approved for the same indication in the United Arab Emirates, Oman, Israel, Uruguay, Ecuador, Paraguay and Peru joining the United States and Switzerland, the first countries to have approved it for this indication. The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA), as well as in other countries worldwide.

PharmaMar commercializes its products outside Europe through agreements with strategic partners, with the aim of facilitating patient access worldwide to its innovative oncology therapies. Specifically, the Company collaborates with Lotus Pharmaceutical in Taiwan; Immedica in Oman and the United Arab Emirates; in Israel with Megapharm and Adium Pharma in Uruguay, Paraguay, Peru and Ecuador.

Furthermore, lurbinectedin as a monotherapy is approved as a second-line treatment, that is, after disease progression during or following platinum-based chemotherapy, in 22 countries.

Small cell lung cancer accounts for about 15% of lung cancer cases and is characterized by its aggressive behavior, and an early tendency to spread.

(Press release, PharmaMar, MAR 23, 2026, View Source [SID1234663827])

Outlook Therapeutics Announces Proposed Public Offering

On March 23, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has commenced a best-efforts public offering of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Outlook Therapeutics intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.

The securities described above are being offered by Outlook Therapeutics pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278340) that was originally filed with the Securities and Exchange Commission (the "SEC") on March 28, 2024, and became effective on April 5, 2024. This proposed public offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the effective registration statement. A preliminary prospectus supplement and an accompanying prospectus related to the proposed public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed public offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Outlook Therapeutics, MAR 23, 2026, View Source [SID1234663826])

Nurix Therapeutics Announces Multiple Presentations Showcasing Depth of Research Pipeline and Scientific Leadership at the American Association for Cancer Research (AACR) 2026 Annual Meeting

On March 23, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that two oral presentations and three poster presentations highlighting the breadth of its research pipeline and scientific leadership will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, to be held April 17-22, 2026, in San Diego, California.

The presentations will provide additional mechanistic validation of CBL-B, Aurora kinase A (AURKA) and mutant BRAF as therapeutic targets across multiple cancer indications and will highlight the potential of Nurix’s orally bioavailable degraders to effectively suppress the oncogenic activity of these proteins in preclinical models.

Additionally, Gwenn Hansen, Ph.D., chief scientific officer of Nurix Therapeutics, has been selected to speak in an AACR (Free AACR Whitepaper) Advances session on induced proximity pharmacology, including targeted protein degradation. AACR (Free AACR Whitepaper) Advances sessions bring together leading scientific perspectives to provide a comprehensive view of recent developments, the current state of research, and emerging challenges in the field.

Oral Presentation Details:

Title: Designing Effective Degrader Therapeutics: What Early Clinical Experience Has Taught Us
Speaker: Gwenn Hansen, Ph.D., chief scientific officer, Nurix Therapeutics
Session type: Advances in Diagnostics and Therapeutics
Session title: Induced Proximity Pharmacology: Degraders and Beyond
Session date and time: Wednesday, April 22, 2026, 10:15 a.m. – 11:45 a.m. PT

Title: Discovery and characterization of CBL-B intramolecular glue inhibitors that increase T cell activation and suppress tumor growth
Presenter: Fred Cohen, Ph.D.
Session type: Minisymposium
Session category: Chemistry
Session title: Targeted Therapies
Session date and time: Tuesday, April 21, 2026, 4:30 p.m. PT
Abstract presentation #: 6733

Poster Presentation Details:

Title: NRX-4972, a selective, oral, Aurora kinase A degrader, demonstrates increased efficacy in an SCLC tumor model, and greater in vitro synergy than an AURKA inhibitor
Presenting author: Ryan Rountree, Ph.D.
Session category: Targeted Protein Degradation and Induced Proximity
Session title: Targeted Protein Degradation and Induced Proximity
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 5166

Title: NRX-0305, an orally bioavailable, CNS penetrant pan-mutant BRAF degrader demonstrates robust efficacy in intracranial models of melanoma brain metastasis and primary glioma
Presenting author: Sasha Borodovsky, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 1
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 4617

Title: NRX-0305 is an orally bioavailable, pan-mutant BRAF degrader that exhibits single-agent and combination efficacy with MEKi or anti-EGFR across Class 1/2/3 BRAF-mutant cancers
Presenting author: Ya-Wen Lu, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 2
Session date and time: Tuesday, April 21, 2026, 2:00 p.m. – 5:00 p.m. PT
Poster #: 5801

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

About NRX-0305
NRX-0305 is a potent, selective, and orally bioavailable CNS-penetrant pan-mutant BRAF degrader that Nurix is exploring for use in oncology. Nurix has reported preclinical data demonstrating potent anti-tumor activity in multiple cell line-derived and patient-derived xenograft disease models representing Class I, Class II, and Class III B-RAF mutations. Anti-tumor activity was also observed in the setting of CNS disease and treatment-resistance, suggesting the potential for utility across a broad range of solid tumor types.

About NRX-4972
NRX-4972 is a CNS-penetrant, orally bioavailable and highly selective degrader of Aurora A kinase (AURKA). AURKA is an oncogene frequently overexpressed in adult solid tumors, hematologic malignancies, and pediatric cancers. Several AURKA inhibitors are effective in preclinical tumor models, but this activity has failed to translate into clinical efficacy. To address the limitations of inhibitors, Nurix has designed bifunctional targeted protein degraders of AURKA that enable removal of both enzymatic and scaffolding functions.

(Press release, Nurix Therapeutics, MAR 23, 2026, View Source [SID1234663825])

Moleculin Hits 45 Subject Enrollment Milestone, Triggering Final Countdown to Mid-2026 MIRACLE Trial Data Readout

On March 23, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the final phase of preparation for the trial’s interim 45 subject data unblinding, which remains on track for mid-2026 and represents a potentially defining inflection point for the Company.

"We believe this upcoming data readout represents the most important milestone in our history to date," said Walter Klemp, Chairman and CEO of Moleculin. "This is a critical achievement for Moleculin and, more importantly, for patients facing relapsed or refractory AML. Reaching the 45 subject mark brings us to the threshold of our first meaningful look at MIRACLE data. Based on what we believe to be encouraging blinded results announced in February, we believe we are building real momentum toward what could be a transformative outcome. Our Phase 2 AML MB-106 clinical trial generated greater efficacy than any drug ever approved for relapsed or refractory AML, and it contributed to the more than 100 patients treated to date without any associated cardiotoxicity. What remains now is to demonstrate that a larger Phase 3 trial can produce results that will support new drug approval. The upcoming unblinding of the first 45 subjects should be a strong indicator of that potential. A true next-generation anthracycline has long been sought by medical science and would rightly be considered a gamechanger, not just for AML but for a wide range of cancers. We now appear to be on the threshold of finding out whether this can become a reality."

Moleculin Biotech continues to advance toward a defining milestone with its ongoing MIRACLE trial, a global, adaptive Phase 2B/3 study designed to evaluate AnnAraC across eight countries to date. The trial protocol provides for early unblinding of data after the first 45 subjects complete treatment, which is expected to yield an initial dataset of approximately 30 patients treated with AnnAraC (at two different dose levels) and 15 patients in the control arm receiving cytarabine plus placebo. This upcoming interim readout is anticipated to provide critical insights into efficacy, safety, and dose optimization as the study progresses toward its Phase 3 portion. Enrollment continues in parallel with the 45th subject unblinding as the Company advances to 90 total subjects thereby concluding Part A of MIRACLE, expected in Q3 2026, with the complete unblinding of Part A thereafter.

Encouraging early signals have already emerged from this difficult-to-treat patient population. In February 2026, Moleculin reported a preliminary blinded composite complete remission rate of 40% among the first 30 patients enrolled in the MIRACLE trial, consisting of 30% complete remission and 10% complete remission with partial hematologic recovery. These findings are particularly notable given that approximately 35% of subjects had previously failed venetoclax-based therapies, and many exhibited adverse genetic markers typically associated with poor outcomes. Additionally, the multinational nature of the trial underscores consistent activity across diverse clinical settings. Even with the inclusion of the control arm, these preliminary blinded aggregate outcomes compare favorably to historical remission rates associated with cytarabine alone in relapsed or refractory acute myeloid leukemia.

The MIRACLE trial’s adaptive design is intended to support a streamlined global registration pathway by integrating data from its Phase 2B portion into the planned Phase 3 portion, in alignment with regulatory guidance, including FDA Project Optimus principles. Following the interim readout, enrollment is expected to continue toward 90 patients to enable a second unblinding, with the Phase 3 portion of the study commencing once the optimum dose is determined. The program remains on track toward a potential accelerated approval pathway based solely on the Complete Remission primary endpoint.

Progress in the MIRACLE trial also reflects broader momentum across Moleculin’s oncology pipeline, which includes ongoing and planned studies targeting pancreatic cancer, brain tumors, and soft tissue sarcoma. With dosing of the 45th subject now complete, the Company is entering a catalyst-rich period leading up to the anticipated mid-2026 interim data readout, a milestone that could significantly influence the future development of Annamycin in the treatment of acute myeloid leukemia.

For additional information on the MIRACLE trial, please visit ClinicalTrials.gov and reference Identifier: NCT06788756.

(Press release, Moleculin, MAR 23, 2026, View Source [SID1234663824])

GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan, granted Orphan Drug Designation for small-cell lung cancer in Japan

On March 23, 2026 GSK plc (LSE/NYSE: GSK) reported that risvutatug rezetecan (or Ris-Rez, for short), a B7-H3-targeted antibody-drug conjugate (ADC), has received Orphan Drug Designation (ODD) from Japan’s Ministry of Health, Labour and Welfare for the treatment of small-cell lung cancer (SCLC). The ODD was supported by preliminary clinical data showing durable responses in patients with extensive-stage SCLC (ES-SCLC) who were treated with Ris-Rez in the phase I ARTEMIS-001 clinical trial.1 This is the sixth regulatory designation for Ris-Rez, which is being developed in a range of solid tumours, including lung, prostate and colorectal cancers.

Lung cancer is the second most common cancer in Japan, and SCLC makes up 10-15% of cases.2,3 Of patients with SCLC, 70% have ES-SCLC, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.4 ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options and poor long-term survival. Most patients with ES-SCLC relapse after initial treatment and the median overall survival with standard-of-care for these patients is approximately 8 months.5

About Ris-Rez
Ris-Rez is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez. GSK’s global phase III trial (NCT07099898) for Ris-Rez in relapsed ES-SCLC began in August 2025.

Regulatory designations received for Ris-Rez to date include ODDs from the US Food and Drug Administration (FDA) in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.

(Press release, GlaxoSmithKline, MAR 23, 2026, View Source [SID1234663823])