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AbCellera to Present at Upcoming Investor Conferences in May and June 2026

On May 7, 2026 AbCellera (Nasdaq: ABCL) reported that the Company will present at the following investor conferences:

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Bank of America Health Care Conference, May 13, 2026
Jefferies Global Healthcare Conference in New York, June 4, 2026

A live audio webcast of each presentation may be accessed through a link that will be posted on AbCellera’s Investor Relations website closer to date. A replay will be available through the same link following the presentation.

(Press release, AbCellera, MAY 7, 2026, View Source [SID1234665360])

Repertoire Immune Medicines Announces FDA Fast Track Designation for its Investigational Immune Medicine, RPTR-1-201

On May 7, 2026 Repertoire Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to RPTR-1-201 for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) after progression on, or intolerance to, available standard therapies. RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine that is currently in a Phase 1/2 trial for the treatment of multiple advanced solid tumors.

"Patients with advanced TNBC often face limited options after progression on standard therapies," said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire Immune Medicines. "Fast Track Designation underscores the seriousness of this disease and the unmet needs for new treatment options. RPTR-1-201 is designed to redirect T cells by targeting a tumor-selective epitope on tumor cells in selected patients, and we appreciate the FDA’s engagement as we evaluate its potential in this population."

"RPTR-1-201 reflects our ability to discover tumor-selective epitopes and intentionally engineer TCR bispecifics designed to engage them with high affinity and specificity," said Anthony Coyle, PhD, President and Head of Research and Development at Repertoire Immune Medicines. "Derived from our DECODE platform, RPTR-1-201 couples an epitope-specific TCR with an anti-CD3 domain to engage and redirect T cells. Fast Track Designation supports closer dialogue with the FDA as we advance the program and continue its clinical evaluation."

The FDA’s Fast Track program is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and address unmet medical needs. The designation may enable more frequent interactions with the FDA and may allow rolling review of a future marketing application if relevant criteria are met.

RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. RPTR-1-201 is derived from Repertoire’s DECODE platform, which maps the immune synapse to identify TCR-epitope pairs and translate these insights into T cell-targeted immune medicines.

RPTR-1-201 is currently being evaluated in a Phase 1/2 clinical trial as monotherapy and in combination with an anti-PD-1 therapy in participants with advanced solid tumors (ClinicalTrials.gov Identifier: NCT07293754). Repertoire plans to discuss development options in the Fast Track indication with the FDA as the program advances.

(Press release, Repertoire, MAY 7, 2026, View Source [SID1234665359])

Photocure ASA: Results for the first quarter of 2026

On May 7, 2026 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 139.0 million in the first quarter of 2026 (Q1 2025: NOK 125.3 million), and an adjusted EBITDA of NOK 15.3 million (Q1 2025: NOK 9.7 million) for the company. In 2026, Photocure expects product revenue growth in the range of 7% to 11% on a constant currency basis and adjusted EBITDA margin expansion.

"Photocure delivered a solid start to 2026, with strong growth across all territories and continued execution across both our commercial and strategic priorities. Revenue growth was robust in North America and Europe, reflecting accelerating adoption of blue-light cystoscopy and increasing procedural penetration in key markets," says Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue-light cystoscopy (BLC) use in Q1 2026 with the installation of 11 new Saphira towers in the U.S. — 4 new accounts and 7 blue light tower upgrades. Photocure had 413 active accounts in the U.S. at the end of the quarter, an increase of 21% versus the first quarter of 2025. Across Europe, a total of 75 Olympus Visera Elite III BLC capable systems were installed since the launch in Q1 2025.

Total revenues ended at NOK 264.6 million in the first quarter of 2026, an increase from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026 includes recognized milestone payments of NOK 125.6 million for the approval of Cevira in China and the acceptance of the marketing authorization approval request in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million). EBIT ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents were NOK 192.7 million at the end of the period.

"As a very important regulatory and strategic update, the U.S. Food and Drug Administration has provided clarity on the reclassification pathway for OAY-related equipment (Diagnostic Endoscopic Light Source Systems) following its response to the Karl Storz Citizen Petition and has confirmed plans to initiate a proposed reclassification process in the second half of 2026. This marks an important step towards a more structured and predictable regulatory framework for BLC equipment in the U.S. market. For Photocure, reclassification has the potential to be a step-change driver for the business, unlocking a significantly larger commercial opportunity, as we move towards double-digit penetration across the expanded market relative to where we are today," Schneider adds.

Photocure’s partners Richard Wolf and Asieris achieved a significant milestone with the April approval of the System blue BLC platform in China, which will be commercialized alongside Hexvix following its prior approval by the National Medical Products Administration (NMPA) in November 2024, enabling a fully integrated drug–device offering. At the same time, the recent CE mark and early commercial traction of blue light–compatible systems in Europe from the leading global medtech company Stryker, reinforce the growing recognition of BLC as an important standard in bladder cancer management and supporting broader adoption over time.

"Cevira, originally developed by Photocure and out-licensed to Asieris, was approved in China by the NMPA in March as a first-in-class non-invasive therapy for cervical precancerous lesions. Shortly thereafter, Cevira was endorsed with Level 1A evidence in expert consensus guidelines in China, reinforcing its clinical adoption potential. In Europe, the European Medicines Agency accepted the Marketing Authorization Application for Cevira during the quarter as well. The approval of Cevira in China and the EMA acceptance serve as milestones with contractual payments owed to Photocure in the amounts of 11.0 million and 2.0 million dollars respectively. The NMPA approval milestone is in dispute, with Asieris having paid 6.6 million of the 11.0 million dollars owed. Photocure believes its legal position to collect the full amount is strong and intends to engage in discussions with Asieris to explore potential pathways forward," Schneider says, and continues:

"Furthermore, in addition to our Hexvix/Cysview base business and partnered developments mentioned above, Photocure also remains committed to advancing a strategy of building an integrated diagnostics platform and leveraging our existing strong commercial footprints in North America and Europe. The uro-oncology landscape is rapidly evolving toward more personalized and data-driven care pathways, increasing the importance of multi-modal precision diagnostics tools. During the quarter, we made a targeted 3.0 million dollar minority investment in Vesica Health, a company within precision diagnostics, developing and launching a multi-omic urine biomarker test for early detection of bladder cancer with best-in-class performance. Our initiatives in flexible cystoscopy with Richard Wolf, AI-enabled software with Claritas/ISC, biomarkers with Vesica Health, and other innovations are progressing as planned, with the goal of improving early detection, diagnostic confidence, surveillance and treatment decision-making."

Photocure sees multiple drivers supporting continued growth in its base business, including sustained procedural adoption, expansion of installed equipment, increased utilization across existing accounts, and continued upgrade cycles to next-generation imaging systems. In addition, several strategic catalysts will further enhance its trajectory, including FDA reclassification of BLC to bring additional rigid equipment manufacturers to the U.S. and the reintroduction of flexible BLC solutions.

"We remain confident in Photocure’s momentum and continued positive trajectory. We expect strong underlying revenue growth across all regions, with product revenue growth of 7% to 11% on a constant currency basis, supported by sustained commercial execution. As operating leverage improves, we anticipate further expansion in adjusted EBITDA margin, reflecting the scalability of our platform and disciplined execution across the base business alongside a strategic platform extension. Our focus remains on delivering consistent execution and building long-term shareholder value," Schneider concludes.

(Press release, PhotoCure, MAY 7, 2026, View Source [SID1234665358])

PHERGain and PHERGain-2 advance therapeutic de-escalation in early HER2-positive breast cancer in selected patients

On May 7, 2026 MEDSIR, an international company and a leader in oncology research, reported the results of the PHERGain and PHERGain-2 studies at the ESMO (Free ESMO Whitepaper) Breast 2026 scientific congress. Both studies evaluate de-escalation strategies based on targeted therapies in HER2-positive early breast cancer, with the aim of identifying which patients could safely avoid standard chemotherapy without compromising therapeutic benefit. Taken together, these studies reinforce a more personalized approach focused on reducing treatment-related toxicity while better preserving patients’ quality of life.

PHERGain is an international, multicenter, phase II clinical trial in which 356 patients were enrolled across 45 hospitals in seven European countries, including Spain. Following publication of the primary results in leading scientific journals such as The Lancet, MEDSIR has now presented the five-year survival outcomes at ESMO (Free ESMO Whitepaper) Breast 2026. The objective of the study was to further validate a therapeutic de-escalation strategy in patients with HER2-positive early breast cancer, based on PET imaging and adapted to pathological complete response (pCR), allowing chemotherapy to be omitted without compromising disease control or survival.

The study demonstrated the efficacy of the combination of trastuzumab and pertuzumab within this adaptive strategy, showing that approximately 30% of patients with localized HER2-positive early breast cancer could avoid chemotherapy. The results presented at the congress confirm the robustness of this approach, with close to 90% of patients remaining recurrence-free five years after surgery. These findings support the validity of this adaptive therapeutic strategy as a safe and durable alternative over time, prioritizing patient well-being by avoiding conventional chemotherapy and its associated toxicities.

In addition, the company presented a translational analysis of the PHERGain study showing that circulating tumor DNA detected through liquid biopsy represents a precise, rapid, and non-invasive tool with the potential to identify patients who will remain disease-free in the long term.

As highlighted during the congress by Dr. Javier Cortés, principal investigator of the study and Director of the International Breast Cancer Center in Madrid and Barcelona: "In addition to the clinical outcomes, with nearly 90% of patients free from relapse five years after surgery, we see that the analysis of circulating tumor DNA in blood is emerging as a key tool to enable early identification of patients with a better prognosis and those who may benefit from more intensive treatment."

PHERGain-2: De-escalation with a focus on quality of life

PHERGain-2, presented at ESMO (Free ESMO Whitepaper) Breast 2026 and published simultaneously in Annals of Oncology, is an international, multicenter, phase II trial that enrolled 396 patients across 47 centers in Spain, Italy, Denmark, Hungary, Poland, and Bulgaria. The study aims to demonstrate the efficacy of a de-escalation strategy in HER2-positive early breast cancer in selected low-risk patients. Specifically, it focuses on patients with tumors measuring between 5 and 30 mm, with no nodal involvement at diagnosis and high HER2 protein expression.

The trial explores a chemotherapy-free, pCR-guided strategy based on the targeted therapies trastuzumab and pertuzumab, incorporating T-DM1 within the treatment regimen. In addition, quality of life is established as the primary safety objective, placing patient-reported outcomes at the center of treatment evaluation. The results presented suggest that more than half of the patients maintain a satisfactory quality of life throughout the first year of treatment, reinforcing the notion that avoiding chemotherapy contributes to a reduction in long-term adverse effects.

With regard to efficacy, the primary endpoint is still pending. Nevertheless, the observed pCR rate of 60% is encouraging, particularly considering that treatment is initiated without chemotherapy. These findings support the clinical potential of this strategy in this patient population.

As stated by Dr. Antonio Llombart-Cussac, principal investigator of the study and Head of the Medical Oncology Department at Hospital Arnau de Vilanova in Valencia: "The results of PHERGain-2 reinforce the idea that it is possible to offer patients a therapeutic alternative that prioritizes quality of life by avoiding side effects that negatively impact physical and emotional well-being, such as fatigue, hair loss, or other health problems associated with chemotherapy."

(Press release, MedSIR, MAY 7, 2026, View Source [SID1234665357])

Generate Biomedicines, Inc. Reports First Quarter 2026 Financial Results and Provides Business Update

On May 7, 2026 Generate Biomedicines, Inc. (NASDAQ: GENB) ("Generate") reported financial results for the first quarter ended March 31, 2026, and highlighted progress across its clinical portfolio.

"We saw strong progress in the first quarter across our clinical pipeline, next generation of therapeutic programs, and advancing our platform," said Mike Nally, chief executive officer of Generate Biomedicines, Inc. "We are advancing GB-0895 in Phase 3 for severe asthma and Phase 1b for COPD. In oncology, we expect to progress two clinical trials this year with GB-4362, an MMAE neutralizer, and GB-5267, a MUC16 CAR T developed with Roswell Park. Together, these programs reflect the breadth of our clinical portfolio across therapeutic areas, modalities, and both wholly owned and partnered programs."

Recent Progress
Generate continues to advance its generative biology platform, applying its capabilities across therapeutic areas and modalities to advance programs into the clinic.

In inflammation and immunology, Generate’s GB-0895 (anti-TSLP) program continues to advance, with Phase 3 clinical trials underway in severe asthma with its global SOLAIRIA-1 and SOLAIRIA-2 replicate studies, and a Phase 1b trial is ongoing in COPD.

In oncology, Generate’s GB-4362 (MMAE neutralizer) program has activated clinical trial sites, and the first patient is expected to be dosed in mid-2026. This program has received FDA Fast Track designation.

Generate’s GB-5267 (MUC16 armored CAR T) program, developed in collaboration with Roswell Park Comprehensive Cancer Center, is expected to dose the first patient in the second half of 2026 in a Phase 1 clinical trial in solid tumors, initially targeting ovarian cancer.

Financial Results
Cash, cash equivalents, and marketable securities were $516.6 million as of March 31, 2026, compared with $221.5 million as of December 31, 2025. The cash, cash equivalents, and marketable securities as of March 31, 2026, reflects $369.3 million in net proceeds from Generate’s IPO, which was completed on March 2, 2026. Generate believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operations into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended March 31, 2026, was $7.2 million, compared with $8.8 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs.

Research and development expenses were $57.8 million for the quarter, compared with $46.8 million for the same period in 2025. The increase was primarily driven by continued investment in the GB-0895 Phase 3 program in severe asthma, as well as by an increase in personnel-related costs, offset by a decrease in external discovery and other program related costs.

General and administrative expenses were $13.5 million for the quarter, compared with $10.1 million for the same period in 2025. The increase was primarily driven by an increase in stock-based compensation and professional fees associated with operating as a public company following Generate’s initial public offering in February 2026.

Net loss was $61.7 million for the quarter ended March 31, 2026, compared with $44.3 million for the same period in 2025, which includes non-cash stock-based compensation expense of $6.4 million and $4.7 million, respectively.

Net cash used in operating activities was $80.4 million for the quarter ended March 31, 2026, compared with $53.2 million for the same period in 2025.

(Press release, Generate Biomedicines, MAY 7, 2026, View Source [SID1234665356])