Prime Medicine Reports First Quarter 2026 Financial Results and Provides Business Updates

On May 7, 2026 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported financial results for the quarter ended March 31, 2026 and provided a business update.

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"Prime Medicine continues to execute with clear momentum and a focused strategy designed to deliver on the transformative potential of Prime Editing," said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. "We remain on track to file regulatory applications for PM577 in Wilson Disease in the first half of this year, and for PM647 in AATD mid-year, bringing two of our most advanced programs to the brink of clinical entry, with initial data from both expected in 2027. In parallel, we continue to progress toward a potential BLA filing for PM359, which, if successful, would bring a one-time, potentially curative therapy to people living with CGD, who today face a lifetime of debilitating infections and limited treatment options. With a strengthened leadership team and a continued commitment to disciplined capital allocation, we believe Prime Medicine is well positioned to execute across our pipeline and unlock the broad promise of Prime Editing for patients."

Prime Medicine’s Pipeline:

Prime Medicine is currently advancing in vivo programs to cure two of the largest genetic liver diseases, Wilson Disease (WD) and Alpha-1 Antitrypsin Deficiency (AATD). Prime Medicine expects to file an Investigational New Drug application (IND) and/or Clinical Trial Application (CTA) for PM577 in WD in the first half of 2026 and for PM647 in AATD in mid-2026; initial clinical data from both programs are expected in 2027.

Prime Medicine is also advancing an in vivo Cystic Fibrosis (CF) program with support from the Cystic Fibrosis Foundation, and efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol Myers Squibb. Additionally, following positive proof-of-concept data from the first two patients treated in its Phase 1/2 study of PM359 for the treatment of Chronic Granulomatous Disease (CGD), Prime Medicine continues to engage in regulatory dialogue with the U.S. Food and Drug Administration (FDA) toward a potential Biologics License Application (BLA) filing for PM359.

Recent Corporate Updates:

In April 2026, Prime Medicine announced the appointment of Svetlana Makhni as Chief Financial Officer (CFO). Ms. Makhni brings over 20 years of experience across biotechnology and healthcare CFO and investment banking roles, and will oversee Prime Medicine’s financial operations and strategy, including investor relations, and financial planning and analysis.
Upcoming Presentation:
Today, Prime Medicine announced that it will present new preclinical data for its Wilson Disease program at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting (May 11-15 in Boston, MA). Details of the oral presentation are as follows:
•Session: Translational Gene Therapy and Editing in Storage Disorders

(Press release, Prime Medicine, MAY 7, 2026, View Source [SID1234665342])

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])

Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel

On May 7, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported an update following the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals, Inc. (PFP).

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PFP, with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to resubmitting the tab-cel BLA. The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a future marketing application of tab-cel for the proposed indication. PFP has indicated they intend to submit an updated dataset with additional patients and longer follow up from the pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data, as a part of the resubmission plan being defined with the FDA.

"We are grateful to the agency for engaging in a collaborative conversation with our partners, Pierre Fabre, and us. We appreciate the FDA’s continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We will continue to support Pierre Fabre as it prepares the resubmission and anticipate providing a further regulatory update in the third quarter."

(Press release, Atara Biotherapeutics, MAY 7, 2026, View Source [SID1234665311])

ImmunityBio Reports Record Q1 2026 Results: Net Product Revenue Increased Nearly 2.7x Year-Over-Year to $44 Million in Q1 2026 Expanding on the 2025 Full Year 700% Year-Over-Year Revenue Growth; Cash and Marketable Securities Total $381 Million

On May 7, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology company, reported financial and operational highlights for the fiscal quarter ended March 31, 2026. The Company reported net product revenue of approximately $44.2 million during the three months ended March 31, 2026, with net product revenue growth in every quarter since ANKTIVA’s commercial launch, including a 168% increase over Q1 2025. This builds on full-year 2025 net product revenue of $113.0 million, a 700% increase over full-year 2024. Q1 2026 net product revenue also represents a 15% sequential increase over the $38.3 million earned during Q4 2025, and the revenue growth expansion of 700% full year growth year-over-year in 2025 continues.

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The Company ended the quarter with $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026.

"We continue to see strong demand for ANKTIVA from both new prescribers and physicians expanding use across multiple eligible patients, including in the maintenance setting," said Richard Adcock, President and CEO of ImmunityBio. "We have also made meaningful progress expanding market access beyond the U.S., with ANKTIVA now commercially available in Saudi Arabia and additional markets anticipated this year. We are entering Q2 with a strong cash position, growing revenues, and a more experienced commercial organization positioned to support continued growth."

"We’re encouraged by the steady progress of our clinical programs and regulatory submissions across NMIBC and non-small cell lung cancer (NSCLC)," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "The full enrollment of our pivotal BCG-naïve NMIBC trial, with independent confirmation that no additional patients are required, supports our planned sBLA submission in 2026. In parallel, recent NCCN guideline updates now include ANKTIVA plus BCG for patients with BCG-unresponsive papillary-only disease, reinforcing the growing clinical evidence supporting our approach across a broader spectrum of bladder cancer patients. We are also advancing our NSCLC program in a randomized trial in patients who have progressed following prior checkpoint inhibitor therapy, an area of significant unmet need, alongside continued development of our cell therapy platforms, including CD19-targeted therapies in non-Hodgkin lymphoma and Waldenström’s macroglobulinemia, and PD-L1 t-haNK in glioblastoma."

Quarterly Financial Highlights

Cash and Marketable Securities Position

As of March 31, 2026, the Company had consolidated cash, cash equivalents, and marketable securities of $380.9 million.

First-Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $27.7 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to increased net trade sales of ANKTIVA as a result of ongoing commercial activities.

Research and Development Expense

Research and development (R&D) expense increased $19.8 million to $68.0 million during the three months ended March 31, 2026, as compared to $48.2 million during the three months ended March 31, 2025, mainly due to increased clinical trials costs, headcount-related costs, consulting fees, and external manufacturing costs.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $13.1 million to $45.8 million during the three months ended March 31, 2026, as compared to $32.7 million during the three months ended March 31, 2025, mainly due to increased professional services expenses, headcount-related costs, commercial-related expenses, other expense, and equipment expense.

Other Expense, Net

Other expense, net increased $497.5 million to $563.0 million during the three months ended March 31, 2026, as compared to $65.5 million during the three months ended March 31, 2025, primarily due to non-cash changes in the fair value of liabilities mainly driven by the significant increase in our common stock price. These fair value changes impacted our warrant and derivative liabilities, and a related-party convertible note. We also recorded a one-time write off of a convertible note receivable. These changes were partially offset by an increase in interest and investment income and a decrease in interest expense due to lower interest rates.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $632.8 million during the three months ended March 31, 2026, as compared to $129.6 million during the three months ended March 31, 2025. The increase in net loss was mainly driven by changes in fair value of warrant and derivative liabilities, and a related-party convertible note due to an increase in our common stock price during the quarter, and the write off of a convertible note receivable, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $3.6 million to $86.2 million during the three months ended March 31, 2026, as compared to $82.7 million during the three months ended March 31, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

(Press release, ImmunityBio, MAY 7, 2026, View Source [SID1234665327])

PTC Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

On May 7, 2026 PTC Therapeutics, Inc., (NASDAQ: PTCT) reported a corporate update and financial results for the first quarter ended March 31, 2026.

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"We are off to a strong start to 2026 with outstanding revenue performance this quarter that supports raising our full-year product revenue guidance," said Matthew B. Klein, M.D., Chief Executive Officer. "The Sephience launch continues to be strong, with sustained momentum in the US and growing momentum internationally as more countries contribute to the global launch."

Key Corporate Updates

Q1 2026 total revenue of $273 million, with $226 million of product revenue
Sephience global launch continues strong momentum
Q1 2026 revenue of $125 million, including $112 million revenue in the US and $13 million revenue ex-US, up 36% from Q4 2025
1,244 total patients on commercial therapy worldwide as of March 31, 2026
Continued strong cadence of patient start forms in the US, with ~140 per month over past several months, surpassing 1,500 mark in the quarter
First commercial sales in Japan in Q1 2026, with revenue expected from up to 30 countries by year-end 2026
Reported positive topline results in April 2026 from 24-month interim analysis of PIVOT-HD long-term extension study of votoplam, an oral small molecule splicing agent
Dose-dependent benefit on cUHDRS in Stage 2 participants relative to natural history cohort, with 52% slowing of disease progression at 10 mg dose
Continued favorable safety and tolerability with no treatment-related NfL spikes
PTC and Novartis will complete data review and align on potential regulatory interactions
Findings support ongoing global Phase 3 INVEST‑HD study of votoplam led by Novartis
First patient dosed in Phase 3 INVEST-HD study, triggering $50 million milestone payment from Novartis to PTC in Q2 2026
Type C meeting with FDA held in April 2026 to discuss vatiquinone study to support NDA resubmission for Friedreich’s ataxia program
Based on meeting discussion and written feedback, PTC expects to initiate an open-label study using matched natural history control in Q3 2026
Primary endpoint will be change in mFARS from baseline to 24 months
First Quarter 2026 Financial Highlights

Total net product revenue and royalty revenue was $272.4 million for the first quarter of 2026, compared to $189.9 million for the first quarter of 2025.
Total net product revenue across the commercial portfolio was $225.6 million for the first quarter of 2026, compared to $153.4 million for the first quarter of 2025, representing a 47% increase.
Sephience net product revenues were $124.6 million for the first quarter of 2026, representing 36% growth compared to fourth quarter of 2025.
Translarna (ataluren) net product revenues were $59.0 million for the first quarter of 2026, compared to $86.2 million for the first quarter of 2025. Translarna first quarter of 2026 revenue includes a large government purchase order from Brazil.
Emflaza (deflazacort) net product revenues were $21.5 million for the first quarter of 2026, compared to $47.8 million for the first quarter of 2025, due to continued generic erosion.
Roche reported Evrysdi (risdiplam) sales of approximately 464 CHF million, resulting in royalty revenue of $46.8 million to PTC for the first quarter of 2026, compared to $36.4 million to PTC for the first quarter of 2025.
Based on US GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were $100.9 million for the first quarter of 2026, compared to $109.0 million for the first quarter of 2025.
Non-GAAP R&D expenses were $89.7 million for the first quarter of 2026, excluding $11.1 million in non-cash, stock-based compensation expense, compared to $100.3 million for the first quarter of 2025, excluding $8.7 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $86.2 million for the first quarter of 2026, compared to $81.0 million for the first quarter of 2025.
Non-GAAP SG&A expenses were $73.9 million for the first quarter of 2026, excluding $12.3 million in non-cash, stock-based compensation expense, compared to $71.6 million for the first quarter of 2025, excluding $9.4 million in non-cash, stock-based compensation expense.
Net loss was $2.8 million for the first quarter of 2026, compared to net income of $866.6 million for the first quarter of 2025.
Cash, cash equivalents, and marketable securities were $1,892.5 million on March 31, 2026, compared to $1,945.4 million on December 31, 2025.
Shares issued and outstanding as of March 31, 2026, were 82,882,024.
PTC Updates Full-Year 2026 Financial Guidance

Total product revenue guidance raised to $750 to $850 million, with expected total revenue of $1.08 to $1.18 billion
GAAP R&D and SG&A expense guidance remains $775 to $815 million
Non-GAAP R&D and SG&A expense guidance remains $680 to $720 million, excluding estimated non-cash, stock-based compensation expense of $95 million

(Press release, PTC Therapeutics, MAY 7, 2026, View Source [SID1234665343])