On May 7, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO will participate in a fireside chat at the 2026 Stifel Virtual Targeted Oncology Forum on May 19, 2026 at 4:00 PM ET, and members of management will be available for 1×1 meetings.

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A webcast can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, MAY 7, 2026, View Source [SID1234665308])

On May 7, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that it has entered into a definitive merger agreement to acquire PathAI, a US-based company in digital pathology and AI-powered technology for pathology laboratories and the biopharma industry. This acquisition builds on the successful partnership between Roche and PathAI, established in 2021 and scaled up in 2024 to include the development of AI-enabled companion diagnostic algorithms. Subject to the closing of the transaction, which is expected in the second half of the year, the acquired entity will become part of the Diagnostics division.

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This acquisition strengthens Roche’s position in Digital Pathology, which is transforming extensive manual workflows into fully automated, AI-driven processes and insights. Digital pathology enables the creation of high-resolution digital images from physical tissue on slides, allowing pathologists to use AI tools to facilitate diagnostic workflows and provide patients with faster results.

"Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens," said Matt Sause, CEO of Roche Diagnostics. "Bringing PathAI into Roche Diagnostics will allow us to combine their best-in-class digital pathology tools with our leading oncology diagnosis platforms to deliver better insights for physicians and potentially better outcomes for patients worldwide."

Andy Beck, CEO and Co-Founder of PathAI, adds: "Joining forces with Roche marks a new era for PathAI, enabling us to realise our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed. Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide."

PathAI’s AISight IMS software interface is efficient and user-friendly, seamlessly integrating advanced analysis and workflow capabilities within the digital pathology laboratory. In the rapidly growing pathology market, Roche intends to scale this solution globally.

In addition, the expanded capabilities strengthen Roche’s competitiveness in precision medicine by enhancing its biopharma services. PathAI’s strength in AI-driven solutions, including clinical trial support and translational research, will complement Roche’s deep expertise in companion diagnostics. Combining these capabilities will foster the discovery of new biomarkers, potential drug targets and novel diagnostic tools, increasing the value Roche can bring to biopharma companies.

Terms of the merger agreement
The closing of the transaction is subject to customary closing conditions, including antitrust and regulatory approvals and is currently expected in the second half of the year.

Under the terms of the agreement, Roche will pay a purchase price of USD 750 million upfront and additional milestone payments of up to USD 300 million.

(Press release, Hoffmann-La Roche, MAY 7, 2026, View Source [SID1234665324])

On May 7, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the first quarter ended March 31, 2026, highlighted recent business accomplishments, and reaffirmed financial guidance for the full year 2026.

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First Quarter and Recent Strategic and Operational Highlights

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Secured Milestone Medicare Coverage for Lung Cancer: Received Medicare coverage approval in the first quarter for the surveillance of cancer recurrence in lung cancer patients for Stage I to III non-small cell lung cancer (NSCLC). This marks the Company’s second major coverage decision in six months, alongside breast cancer.
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Announced Early Access Launch of Real-Time Variant Tracker: Launched a pioneering new feature for NeXT Personal that empowers clinicians to longitudinally track resistance and therapeutically targetable mutations during routine disease monitoring, and potentially optimize treatment.
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Published Neoadjuvant Treatment Monitoring Results in Breast Cancer: Featured data in the Journal of Clinical Oncology from the PREDICT-DNA prospective study for Triple-Negative (TNBC) and HER2+ breast cancer patients that showed NeXT Personal can outperform current standard approaches for predicting patient outcomes following neoadjuvant therapy (NAT).

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Presented Compelling Data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
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Colorectal Cancer (CRC) Podium Presentation: Highlighted the ultrasensitive ctDNA detection by NeXT Personal for predicting and tracking response to neoadjuvant immunotherapy in CRC patients, demonstrating a remarkable 100% negative predictive value and 100% specificity for disease relapse following surgery.
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Lung Cancer Poster Presentation: Demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal successfully predicts the early response of immunotherapy in recurrent metastatic NSCLC patients.
First Quarter 2026 Financial Results Compared with First Quarter 2025

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Quarterly Revenue: $15.5 million compared with $20.6 million; reflecting the planned decline in non-core revenue as the company focuses on growing revenue from its strategic MRD offering.
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Clinical Revenue: Clinical test revenue of $1.4 million, compared with $0.3 million; delivered 7,815 clinical tests compared with 2,184, representing a 258% increase.

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Core Revenue Streams: Pharma testing services and all other customers contributed $11.2 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $2.9 million.
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Strong Cash Position: Ended the quarter with approximately $233.2 million in cash, cash equivalents, and short-term investments. This includes approximately $21.0 million in net proceeds from the Company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $10.00 per share.
CEO Commentary

"Our accomplishments in the first quarter demonstrated that our ‘Win-in-MRD’ strategy is working to establish NeXT Personal as the new standard for how cancer is detected and monitored," said Chris Hall, Chief Executive Officer of Personalis. " Delivering 26% sequential and 258% year-over-year clinical volume growth—especially during what is traditionally the industry’s toughest seasonal quarter reflects the strong market demand for our ultrasensitive NeXT Personal test. With new Medicare coverage for lung cancer joining our existing breast cancer win, Personalis now has a reimbursement success in two of the largest oncology indications. We are transforming our ultrasensitive MRD technology from a clinical leader into a potential commercial powerhouse and we remain firmly on track to grow our clinical revenue five-fold this year."

Full Year 2026 Outlook

Personalis reaffirmed the following guidance for the full year of 2026:

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Total company revenue in the range of $78.0 to $80.0 million.
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Clinical test volume scaling rapidly to a range of 43,000 to 45,000 tests, reflecting 171% growth year-over-year at the midpoint.
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Clinical revenue of $10.0 to $11.0 million, representing roughly a five-fold growth year-over-year, driven by Medicare reimbursement from breast and lung cancer surveillance.
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Revenue from pharma testing services and all other customers in the range of $55.0 to $56.0 million.
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Revenue from population sequencing and enterprise sales of approximately $13.0 million.
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Gross margin in the range of 15% to 20%, reflecting the strategic decision to accelerate clinical volume adoption ahead of full reimbursement coverage to establish market share.
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Net loss of approximately $105.0 million.
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Cash usage of approximately $100.0 million, driven by commercial investments to support projected clinical test volume growth and expansion.

(Press release, Personalis, MAY 7, 2026, View Source [SID1234665340])

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])

On May 7, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"The FDA approval of YUVIWEL, our third consecutive TransCon product, and the robust patient uptake for YORVIPATH are cementing our position as a leading global biopharma," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "Our strong focus on science and making a meaningful difference for patients will continue to be the fundamental driver for our success."

Select Highlights & Anticipated 2026 Milestones

YORVIPATH
(palopegteriparatide, developed as TransCon PTH)
YORVIPATH revenue for the first quarter of 2026 totaled €197 million, which for the U.S. includes normal seasonality and the temporary impact of additional patients supported by free drug, as well as a one-time impact in Europe Direct related to expanded market access.
In the U.S., more than 1,000 new patient enrollments in the first quarter of 2026.
As of March 31, 2026, more than 6,300 unique patient enrollments by more than 2,700 prescribing healthcare providers since launch in the U.S.
Outside the U.S., continued expansion of commercial launches with full reimbursement. Now available commercially or through named patient programs in 35 countries.
Ongoing label expansion trials through PaTHway60 (adults) and PaTHway Adolescent.

YUVIWEL
(navepegritide, developed as TransCon CNP)
Received U.S. Food & Drug Administration (FDA) accelerated approval, indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses.
The FDA granted orphan drug exclusivity for YUVIWEL, which will run through February 27, 2033.
As of May 1, 2026, more than 60 unique patient enrollments by more than 35 prescribing healthcare providers since U.S. commercial availability in April 2026.
Marketing Authorisation Application remains under review by the European Medicines Agency, with a decision anticipated in the fourth quarter of 2026.
Label expansion trial in infants with achondroplasia, reACHin, is ongoing with enrollment completion anticipated in the third quarter of 2026.
Phase 3 trial planned to investigate TransCon CNP monotherapy for the treatment of hypochondroplasia in the second half of the year.

SKYTROFA
(lonapegsomatropin, developed as TransCon hGH)
SKYTROFA revenue for the first quarter of 2026 totaled €44 million.
Announced Week 52 data from the Phase 2 New InsiGHTS Trial in Turner syndrome that demonstrated comparable efficacy and safety to daily somatropin.
Ongoing Phase 3 HighLiGHts basket trial across a range of established growth disorders including idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA).

TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)
Announced Phase 2 COACH Trial Week 52 topline results demonstrating mean annualized growth velocity that exceeded the 97th percentile of average stature children, improvements in body proportionality, and a safety profile consistent with TransCon CNP and TransCon hGH monotherapies.
Announced additional Week 52 results from COACH demonstrating meaningful benefits beyond linear growth, including improvements in spinal canal dimensions and lower limb alignment, along with unprecedented improvements in arm span compared to monotherapy.
Interim Week 78 data from COACH expected in the second quarter of 2026 with Week 104 data expected around year end.

Oncology Program
(onvapegleukin alfa)
In the ongoing Phase 1/2 IL-BELIEVE Trial, TransCon IL-2 β/γ in combination with paclitaxel demonstrated improved median overall survival (OS) up to 10 months from 6-7 months for historical controls, with a generally well-tolerated safety profile in patients with late-stage platinum-resistant ovarian cancer, validating the science behind TransCon IL-2 β/γ.
As further internal oncology development does not align with our strategic focus, we have decided to discontinue internal development of TransCon IL-2 β/γ in Oncology and will explore other ways to maximize the value of this asset.

Key Financial Highlights

Total revenue for the first quarter of 2026 was €247 million, compared to €101 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to an increase in product revenue from YORVIPATH.
Operating profit for the first quarter of 2026 totaled €25 million, reflecting a margin of 10.1%. On a non-IFRS basis, operating profit was €55 million*, reflecting a margin of 22.4%*.
Net profit for the first quarter of 2026 totaled €629 million, or €9.75 per diluted share, including the recognition of previously unrecognized deferred tax assets of €679 million. On a non-IFRS basis, net profit was €18 million*, or €0.27 per diluted share*.
As of March 31, 2026, Ascendis Pharma had cash and cash equivalents totaling €573 million, which includes the impact of repurchases under the previously announced share repurchase program of €52 million and the net settlement of certain Restricted Stock Units for €8 million, compared to cash and cash equivalents totaling €616 million as of December 31, 2025.
Subsequent to March 31, 2026:
On April 20, 2026, the Company’s ordinary shares commenced trading on The Nasdaq Global Select Market, replacing the prior listing of American Depositary Shares (ADSs).
On May 6, 2026, Ascendis redeemed all $575 million aggregate principal amount of its outstanding 2.25% convertible notes due 2028. Within the redemption period, all holders of the convertible notes surrendered their notes for conversion, whereupon the Company delivered 3,635,813 ordinary shares, together with cash in lieu of any fractional shares. The conversion resulted in the settlement of the current liabilities of convertible notes, comprising borrowings and derivative liabilities totaling €733 million as of March 31, 2026. The carrying amount as of the settlement date will be reclassified to equity in the second quarter of 2026.
Entered into agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $187.5 million in cash, before transaction-related expenses. The PRV was awarded by the FDA upon approval of YUVIWEL in February 2026. The transaction is subject to customary closing conditions and is expected to close in the second quarter of 2026.

* See "Non-IFRS Financial Measures" below for definitions of these non-IFRS measures and a reconciliation to the most directly comparable IFRS measures.

First Quarter 2026 Financial Results
Total revenue for the first quarter of 2026 was €247 million, compared to €101 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to an increase in product revenue from YORVIPATH.

Total Revenue
(In EUR’000s) Three Months Ended
March 31,
2026 2025
Revenue
Commercial products 240,853 96,028
Services and clinical supply 5,110 3,524
Licenses 638 1,402
Total revenue 246,601 100,954

Revenue from Commercial Products
(In EUR’000s) Three Months Ended
March 31,
2026 2025
Revenue from commercial products
YORVIPATH 196,896 44,688
SKYTROFA 43,957 51,340
Total revenue from commercial products 240,853 96,028

Research and development expenses for the first quarter of 2026 were €59 million, compared to €87 million during the same period in 2025. The decrease was driven primarily by the completion of certain clinical trials and development activities within our Endocrinology Rare Disease and Oncology pipeline and the first quarter of 2026 being positively impacted by a reversal of prior period write-downs of pre-launch inventories related to YUVIWEL.

Selling, general, and administrative expenses for the first quarter of 2026 were €145 million, compared to €101 million during the same period in 2025. The increase was primarily due to the impact from commercial expansion, including global launch activities.

Total operating expenses for the first quarter of 2026 were €204 million compared to €188 million during the same period in 2025.

Operating profit for the first quarter of 2026 was €25 million, compared to an operating loss of €104 million during the same period in 2025. The increase was primarily driven by the increase in product revenue.

Net finance expenses for the first quarter of 2026 were €63 million, compared to €16 million during the same period in 2025. The increase was primarily driven by non-cash fair-value remeasurement of derivative liabilities associated with our convertible notes.

Income taxes for the first quarter of 2026 included the recognition of previously unrecognized deferred tax assets of €679 million.

For the first quarter of 2026, Ascendis Pharma reported net profit of €629 million, or €10.20 per share basic and €9.75 per share (diluted), compared to a net loss of €95 million, or €1.58 per share (basic and diluted), for the same period in 2025. Net profit for the first quarter of 2026 included the recognition of previously unrecognized deferred tax assets of €679 million.

Cash flows used in operating activities for the first quarter of 2026 were €8 million compared to €14 million used during the same period in 2025. The change primarily reflects the prior-year period benefiting from the $100 million upfront payment received under our exclusive license agreement with Novo Nordisk, which did not recur in the current period, while the current period reflects improved operating performance offset by working capital build.

As of March 31, 2026, Ascendis Pharma had cash and cash equivalents totaling €573 million, compared to €616 million as of December 31, 2025. As of March 31, 2026, Ascendis Pharma had 62,376,846 ordinary shares outstanding, including 265,251 held by the Company.

Beginning with the first quarter of 2026, Ascendis Pharma is introducing supplemental non-IFRS financial measures that management believes will help investors evaluate the Company’s underlying operating performance from period to period and enhance comparability against peer companies. The non-IFRS measures presented are not a substitute for, and should be considered together with, the comparable IFRS measures. See the table below on page 14 for specific reconciling items.

For the first quarter of 2026, non-IFRS operating profit was €55 million, compared to a non-IFRS operating loss of €79 million for the same period in 2025.

For the first quarter of 2026, non-IFRS net profit was €18 million, or €0.27 earnings per diluted share, compared to a non-IFRS net loss of €73 million, or €1.22 loss per diluted share, for the same period in 2025.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 8:00 am Eastern Time (ET) to discuss its first quarter 2026 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

(Press release, Ascendis Pharma, MAY 7, 2026, View Source [SID1234665309])