On April 15, 2026 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OPN-6602, a dual EP300/CBP inhibitor, for the treatment of multiple myeloma (MM). The Fast Track designation applies to patients with relapsed/refractory MM who have received at least four prior lines of therapy.

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OPN-6602 is an oral, small molecule inhibitor of EP300 and CREB-binding protein (CBP) currently in a Phase 1 clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary clinical activity in patients with relapsed and/or refractory MM.

Multiple myeloma is a hematologic malignancy marked by the uncontrolled proliferation of plasma cells in the bone marrow, often leading to bone damage, kidney dysfunction and immune suppression. Despite therapeutic advances, most patients ultimately relapse or become refractory to available therapies, highlighting an unmet need for novel treatment options.

"Opna Bio has been a pioneer in the EP300/CBP inhibitor space and OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties. We are encouraged by the progress of the study to date and look forward to reporting emerging clinical data at an upcoming scientific congress," said Reinaldo Diaz, chief executive officer of Opna Bio.

The FDA’s Fast Track designation is designed to facilitate development and expedite review of therapies addressing serious conditions with unmet need. It offers benefits including more frequent FDA interactions, potential eligibility for accelerated approval and priority review, and rolling NDA submission. OPN-6602 was previously granted Orphan Drug Designation by the FDA in January 2025.

(Press release, Opna Bio, APR 15, 2026, View Source [SID1234664415])

On April 14, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO) reported the pricing of an underwritten public offering of 87,500,000 shares of its common stock at a price to the public of $2.00 per share. The gross proceeds from this offering are expected to be $175 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Allogene. The offering is expected to close on or about April 16, 2026, subject to customary closing conditions. In addition, Allogene has granted the underwriters for the offering a 30-day option to purchase up to 13,125,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Allogene expects to use the net proceeds from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, general and administrative expenses, and capital expenditures.

Goldman Sachs & Co. LLC, Jefferies and TD Cowen are acting as joint bookrunners for the offering. Piper Sandler and William Blair are also acting as joint bookrunners for the offering. Baird and Canaccord Genuity are acting as lead managers for the offering. TPG Capital BD, LLC is acting as co-manager for the offering.

The shares of common stock described above are being offered by Allogene pursuant to a shelf registration statement filed by Allogene with the Securities and Exchange Commission (SEC) that was declared effective on April 25, 2024. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, or by telephone at (877) 821-7388, or by emailing [email protected]; or from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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, Allogene, APR 15, 2026, View Source [SID1234664364])

On April 15, 2026 Quanterix Corporation (Nasdaq: QTRX) reported plans to debut its Content Innovation Engine at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Built on the integration of Akoya Biosciences’ spatial biology platform and Quanterix’s decades of ultra-sensitive, quantitative immunoassay development from the SIMOA technology, the Content Innovation Engine is organized around the hallmarks of cancer framework, giving researchers a systematic, biology-first approach to revealing more from every tissue section.

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It is supported by the end-to-end capabilities spatial biology needs to advance beyond discovery: world-class spatial instrumentation, and the assay design and reagent formulation expertise, quality systems, and manufacturing scale to support measurements that meet the requirements of translational and clinical applications.

"Spatial biology has fundamentally changed how we see cancer," said Everett Cunningham, President and CEO of Quanterix. "Akoya built a platform that gave researchers an entirely new way to study it. What Quanterix brings is the assay expertise, quality systems, and scale to carry that science further, into translational settings, into the clinic, into decisions that affect patients. The Content Innovation Engine is the first expression of what that combination makes possible."

IO60 Named Edison Award Finalist; Spike-In Module Deepens Immunotherapy Biology

The PhenoCode Discovery IO60 panel has been named a Finalist in the Edison Awards. At AACR (Free AACR Whitepaper), Quanterix will introduce a new IO60 Spike-In Module extending biological coverage into two high-priority areas: checkpoint therapy markers spanning PD-1/PD-L1, CTLA-4, and next-generation blockade; and tertiary lymphoid structure (TLS) markers, an emerging correlate of durable immunotherapy response.

ADC + IO: Combination Biology in a Single Tissue Section

New high-plex ADC content compatible with IO60 and PhenoCode Discovery panels on PhenoCycler-Fusion will enable co-measurement of ADC target expression and tumor immune contexture in a single tissue section. This addresses growing demand for combination biology readouts at the ADC-immunotherapy interface.

PhenoCode Molecular Barcoding Kit, Debuting at AACR (Free AACR Whitepaper), Early Access May 2026

Quanterix will introduce the PhenoCode Molecular Barcoding Kit at AACR (Free AACR Whitepaper), built on a new PhenoCode 2.0 chemistry. The kit enables researchers to barcode virtually any antibody of their choice with exceptional reliability and yield. Existing panels can be expanded into immuno-oncology, neuroscience, and beyond without adding complexity to the workflow. Early access begins May 2026. Attend the live in-booth presentation at Booth 2028 on April 20, 11:30 AM to 12:00 PM to learn more.

PhenoImager HT: Two New ADC Lung Cancer Panels, Available Now via Accelerator

The Accelerator Service Lab will present two new ADC lung cancer panels for PhenoImager HT at AACR (Free AACR Whitepaper). Building on the ADC breast cancer panel debut at AACR (Free AACR Whitepaper) 2025, both panels are available today as a fully managed service. Attend the live in-booth presentation at Booth 2028 on April 21, 11:30 AM to 11:45 AM for details.

Quanterix’s growing spatial biology community will also be represented at AACR (Free AACR Whitepaper) 2026, with 25+ posters from customers and collaborators presenting data generated on PhenoCycler-Fusion and PhenoImager HT across a range of cancer indications.

For more information visit: View Source

(Press release, Quanterix, APR 15, 2026, View Source [SID1234664416])

On April 15, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for eftilagimod alfa ("efti") for the treatment of Soft Tissue Sarcoma (STS), a rare cancer with significant unmet medical need.

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The FDA’s Orphan Drug Designation program is designed to encourage development of therapies for rare diseases affecting fewer than 200,000 people in the United States. Benefits of ODD may include regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.

This designation recognises the potential therapeutic relevance of efti in STS, supported by encouraging clinical data from the investigator-initiated Phase II EFTISARC-NEO trial which has been evaluating efti in combination with radiotherapy and KEYTRUDA (pembrolizumab) in the neoadjuvant setting in patients with resectable soft tissue sarcoma. In 38 evaluable patients, the study met its primary endpoint, demonstrating a median tumour hyalinization/fibrosis of 51.5%, significantly exceeding the pre-specified target of 35% and historical benchmarks of ~15% with radiotherapy alone.1

These results were observed across multiple sarcoma subtypes and were supported by translational data showing immune activation consistent with efti’s mechanism of action, with a favourable safety profile and no delays to planned surgery.2

CEO of Immutep, Marc Voigt said: "We are pleased that the FDA has recognised the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer. As previously communicated, the Company is currently undertaking a comprehensive review and analysis following the discontinuation of its Phase III TACTI-004 trial and the outcome will influence the decision regarding any potential future clinical trial with efti. The FDA’s designation, based on very encouraging data from the EFTISARC-NEO trial, provides us with a potential direct step forward into a late-stage study in the neoadjuvant setting for STS."

(Press release, Immutep, APR 15, 2026, View Source [SID1234664365])

On April 15, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, and Predicta Biosciences, a precision oncology company developing novel diagnostic solutions for deep molecular characterization of hematologic malignancies with a focus on circulating tumor cells, reported the commercial expansion of a co-branded whole-genome sequencing (WGS) assay, currently known as GenoPredicta, intended for the comprehensive genomic characterization of hematologic malignancies and measurable residual disease (MRD) monitoring.

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GenoPredicta is an ultrasensitive assay that extracts deep genetic insights from peripheral blood or bone marrow. By integrating flow cytometry for precise tumor cell detection and enumeration with WGS, the assay delivers a comprehensive analysis of a cancer genome. It identifies genetic alterations (SNVs/indels, CNVs, SVs)—from as few as 50 tumor cells, corresponding to a sensitivity as low as one in a million cells—to aid in diagnosis, risk classification, and the identification of therapy resistance mechanisms. This sensitivity expands testing eligibility to cases with low tumor burden.

The assay is currently available to Tempus’ Life Sciences partners to support exploratory research and clinical development programs. The assay has been clinically validated in Multiple Myeloma and other plasma cell dyscrasias and is available for research use only across other indications. The technology powering the assay stems from the foundational work of Predicta scientific co-founder Dr. Irene Ghobrial, whose research redefined early detection and intervention in blood cancers.

"By joining forces with Tempus, we are delivering unprecedented sensitivity and clarity to researchers – enabling the potential for earlier detection, smarter treatment decisions, and a deeper understanding of disease biology from a single assay," said Brian McKernan, CEO of Predicta Biosciences. "This partnership with Tempus will help accelerate market adoption and the utility of our tests in order to optimize clinical trials."

"GenoPredicta offers a novel, unified solution for our life science partners and a comprehensive replacement for traditional, siloed testing," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "By consolidating flow cytometry, cytogenetics, and WGS into one ultrasensitive workflow, we can identify high-risk biomarkers and track clonal evolution from as few as 50 tumor cells. Crucially, because the assay delivers 100% concordance between peripheral blood and bone marrow, it can provide these deep insights while sparing patients from biopsies."

(Press release, Tempus, APR 15, 2026, View Source [SID1234664417])