On May 7, 2026 ParcelBio, a biotechnology company developing a new class of potent and durable mRNA medicines, reported it has raised $13 million in seed financing led by Breyer Capital, with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, ZAKA VC, and other investors.

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The financing will support development of ParcelBio’s proprietary APEXm (Amplified and Prolonged EXpression mRNA) platform and advance its pipeline, including its lead in vivo CAR-T program for autoimmune disease, as well as additional programs in oncology and encoded protein therapeutics.

Current mRNA technologies are limited in their ability to achieve both high protein expression and sustained durability, often requiring tradeoffs between potency, duration, and manufacturability. These constraints have restricted the broader application of mRNA beyond vaccines and short-acting therapeutics.

ParcelBio is developing a new category of mRNA medicines designed to overcome these limitations. Its proprietary APEXm platform engineers RNA molecules to actively recruit the cell’s native RNA-stabilizing machinery, enabling significantly higher and more durable protein expression. This approach leads to a step-change in biological performance, reaching therapeutic thresholds that have historically been out of reach for mRNA.

"mRNA has transformed medicine, but today’s technologies are fundamentally limited in how much protein they can produce and for how long," said David Weinberg, Ph.D., Chief Executive Officer and Co-Founder of ParcelBio. "We engineered RNA to work with the cell’s machinery rather than against it, enabling meaningful improvements in both expression and durability that we believe are essential for true disease modification."

Unlike circular RNA and other next-generation approaches that often introduce manufacturing complexity or reduce peak output, ParcelBio’s platform maintains a simple, linear mRNA architecture while delivering both high peak expression and sustained activity. The platform is modular and broadly applicable across proteins and cell types, enabling diverse therapeutic applications ranging from immune reprogramming to protein replacement.

ParcelBio’s lead program focuses on in vivo CAR-T therapies targeting pathogenic B cells across autoimmune diseases, with the goal of achieving deep B-cell depletion for durable, drug-free remission. By enabling sustained CAR expression without viral delivery or ex vivo manufacturing, the company aims to develop scalable, off-the-shelf therapies with curative potential. Additional programs are in development in oncology and encoded protein therapeutics.

Preclinical data demonstrate that ParcelBio’s APEXm RNA drives significantly higher and more durable protein expression compared to a leading clinical mRNA design, translating into deeper biological responses, including more complete target cell depletion in in vivo CAR-T models. The company will be debuting the APEXm platform and preclinical data in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 14, 2026.

"ParcelBio’s durable, tunable expression is designed to collapse the tradeoffs that have constrained mRNA in chronic, deep-tissue disease, bringing durable, controllable immune reset within reach in refractory autoimmunity and beyond," said Dr. Morgan Cheatham, Partner and Head of Healthcare and Life Sciences at Breyer Capital. "Breyer Capital’s life sciences thesis is organized around the technologies that redefine what medicine can reach: programmable biology, controllable expression, and durable therapeutic impact. ParcelBio is built to advance all three."

"Most RNA platforms force a tradeoff between potency, durability, and manufacturability," said Chris Carlson, Ph.D., Chief Scientific Officer and Co-Founder of ParcelBio. "Our approach eliminates that tradeoff, enabling both higher peak expression and longer duration within a manufacturable system, and opening the door to entirely new classes of medicines."

(Press release, ParcelBio, MAY 7, 2026, View Source [SID1234665362])

On May 7, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease, which enrolled 125 patients. These data, as of April 21, 2026, demonstrated that patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. The progression rate to muscle-invasive or advanced disease was low, at 3.2%. Detalimogene was generally well tolerated with 55% of patients having experienced a treatment-related adverse event, mostly mild (Grade 1 and 2).

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"These updated data continue to reinforce the favorable safety and tolerability profile of detalimogene and its clinical activity in a heavily pretreated, high-risk NMIBC patient population with limited therapeutic options. Importantly, the low rate of progression to muscle-invasive disease leaves patients eligible for other bladder-sparing therapies," said Ron Cooper, President and Chief Executive Officer, enGene. "While durability outcomes to date are not what we hoped, these data are preliminary. We are focused on evaluating the totality of the data as it evolves and plan to continue to engage with the FDA and the medical community."

LEGEND Pivotal Cohort Data Update

The interim analysis is based on the 125 patients enrolled in Cohort 1. Patients who discontinued without any disease evaluation or who discontinued after a CR were considered not evaluable for subsequent landmark CR analysis.

Efficacy overview:

54% (95% CI: 45%, 63%) CR at any time (67/124)
91% of responses occurred at first disease assessment
43% (95% CI: 34%, 52%) CR rate at 6 months (52/121) with 14% (6/43) of patients having successfully converted from non-CR to CR post re-induction
Two re-induced patients have not yet had a 6-month assessment
Of the 52 responders at 6 months:
37/44 patients who had a 9-month assessment were in CR; an additional 8 patients are pending evaluation
13/22 patients who had a 12-month assessment were in CR; an additional 11 patients are pending evaluation
A maximum of 21 patients, including the 2 currently undergoing re-induction, still have the potential to achieve a CR at 12 months
The Kaplan-Meier (KM) estimate of the 12-month duration of response (DoR) is 25% (95% CI: 11%, 41%)
The KM estimate for median DoR is 37.3 weeks (range: 31.6-43.9 weeks)
Low rate of progression to muscle invasive or more advanced disease (3.2%)
Safety overview:

55% of patients experienced a treatment-related adverse event (TRAE)
Among patients with any TRAE, 91% experienced Grade 1-2 TRAEs
Grade ≥3 TRAEs were reported in 6 patients (4.8%)
Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)
Among the 32 patients who had their first disease assessment after the last data analysis (October 24, 2025, reported November 11, 2025), CR rates were lower than previously reported results. The CR rate at any time was 39% and at 6 months was 32% for these patients. A preliminary subgroup analysis has not revealed any material differences in demographics or key disease characteristics. A more comprehensive analysis of these patients, including potential contributing factors, is ongoing.

As a beneficiary of FDA’s RMAT designation and a participant in the FDA’s CDRP program, enGene has completed the required FDA manufacturing validation batches and submitted a Statistical Analysis Plan (SAP) to the agency. The Company plans further engagement with the FDA as it approaches a potential Biologics License Application (BLA) filing and plans to provide an update in the second half of 2026.

The Company plans to share these data with the broader medical community at a Plenary Presentation at the upcoming American Urological Association meeting on May 15, 2026.

Safety Information

The overall tolerability profile associated with detalimogene is favorable. Of the 125 patients assessed for safety in Cohort 1, 69 patients (55%) experienced at least one TRAE, which were mainly Grade 1/2 in severity. The most common TRAEs were fatigue (22%), dysuria (14%), micturition urgency (12%), pollakiuria (12%), and bladder spasm (11%). Six patients experienced Grade ≥3 TRAEs, including one Grade 4 TRAE, which has resolved. There were no Grade 5 TRAEs reported. TRAEs leading to dose discontinuations (2.4%) and dose interruptions (2.4%) were rare.

Conference Call

enGene will host a conference call and live webcast at 8:00 a.m. ET today, May 7, 2026. Individuals interested in listening to the conference call may do so by clicking the following link, which is also available at the "Investors" section of the Company’s website at www.engene.com/investors. Following the live webcast, an archived version of the call will also be available on the Company’s website for 90 days.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs to serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3).

(Press release, enGene, MAY 7, 2026, View Source [SID1234665361])

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])

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.

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"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])

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.

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"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])