Janux Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

On May 7, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended March 31, 2026, and provided a business update.

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"Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic," said David Campbell, Ph.D., President and CEO of Janux. "Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress


JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.

An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.

JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation.

Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities.

JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers.

The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Strategic Collaborations


Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform.

Recently announced development candidate nomination, triggering a $35 million milestone payment.

Corporate & Leadership


Janux announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, supporting the Company’s continued clinical advancement as additional programs enter the clinic in 2026.

Upcoming Milestones


Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027.

Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026.

Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS:


Cash and cash equivalents and short-term investments: As of March 31, 2026, Janux reported cash and cash equivalents and short-term investments of $956.4 million, compared to $966.6 million on December 31, 2025.

Research and development expenses: Research and development expenses were $26.8 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. The change was primarily driven by manufacturing.

General and administrative expenses: General and administrative expenses were $11.1 million for the quarter ended March 31, 2026, compared to $9.8 million for the comparable period in 2025.

Net loss: Net loss was $24.4 million for the quarter ended March 31, 2026, compared to $23.5 million for the comparable period in 2025.

(Press release, Janux Therapeutics, MAY 7, 2026, View Source [SID1234665332])

Verastem Oncology Reports First Quarter 2026 Financial Results and Highlights Recent Business Updates

On May 7, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported financial results for the first quarter ended March 31, 2026, and highlighted recent business progress.

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"As we mark the one-year anniversary of the FDA-approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, I am incredibly proud of the progress we have made to deliver a meaningful impact for people living with this rare cancer," said Dan Paterson, president and chief executive officer at Verastem Oncology. "As we build on the foundation we have established with the commercial launch, we also look to continue accelerating VS-7375, our potential best-in-class oral, KRAS G12D (ON/OFF) inhibitor, and are pleased to announce the initiation of three Phase 2 registration-directed trials in pancreatic, non-small cell lung, and colorectal cancers. In an evolving competitive landscape, we remain encouraged by the efficacy data generated by our partner and emerging in the U.S., along with the safety and tolerability profile we are seeing across multiple solid tumor cancers and look forward to sharing data updates throughout this year. Altogether, we believe we are well-positioned to drive strong execution across our commercial launch and expedite VS-7375 development while maintaining disciplined capital management."

First Quarter 2026 and Recent Updates

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Commercial Performance

AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $18.7 million for the first quarter of 2026.
In April, the Company announced the launch of a new healthcare professional and patient marketing campaign, Reimagine Recurrent Low-Grade Serous Ovarian Cancer (LGSOC), to drive awareness of AVMAPKI FAKZYNJA CO-PACK.
In April, the Company announced new two-year median follow up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS mutant and KRAS wild-type recurrent LGSOC patients, with discontinuation rates consistent with the primary analysis, presented at the Society of Gynecologic Oncology 2026 Annual Meeting on Women’s Cancers. A new exposure-response analysis further demonstrated that the approved dose and schedule of avutometinib plus defactinib achieve the optimal therapeutic effect.
In February, the Company announced updated data for RAMP 201J in Japan evaluating the combination in patients with LGSOC with or without a KRAS mutation. As of a data cutoff of January 30, 2026, a confirmed overall response rate (ORR) of 38% (6/16) was achieved. Patients with a KRAS mutation achieved a confirmed ORR of 57% (4/7) and KRAS wild-type patients achieved a confirmed ORR of 22% (2/9). The safety profile was consistent with previously reported data outside of Japan.
Expected Key Milestones:

Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
Continue to pursue regulatory paths for potential expansion into Europe and Japan.
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors

Today, the Company provided an update on its ongoing VS-7375 clinical trials, including branding the trials as the VS-7375 TARGET-D Clinical Trial Program. In the ongoing TARGET-D 101 (VS-7375-101) Phase 1/2 dose escalation, dose expansion and combination-evaluation trial, the Company is now evaluating the 1200 mg daily dose (QD). The Company is also evaluating VS-7375 900 mg QD in combination with cetuximab. The Company expects to finish enrollment across the various expansion cohorts and combination cohorts with chemotherapies in the near term.
In addition, the Company shared updated pharmacokinetic (PK) data that showed the 900 mg QD dose achieves target plasma levels of VS-7375 and provides clear separation from the 600 mg QD dose.
The Company has initiated three Phase 2 registration-directed trials, including:
TARGET-D 201 to evaluate VS-7375 at 900 mg QD both as monotherapy and in combination with cetuximab in patients with second-line pancreatic ductal carcinoma (PDAC). The study is also evaluating VS-7375 and cetuximab in the first-line PDAC setting.
TARGET-D 202 to evaluate VS-7375 at 900 mg QD in patients with advanced non-small cell lung cancer (NSCLC) who have received one to two prior lines of therapy. The study is also evaluating VS-7375 in NSCLC patients with asymptomatic untreated brain metastases.
TARGET-D 203 to evaluate VS-7375 at 900 mg QD as both monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab, in previously treated colorectal cancer (CRC). The study will also evaluate VS-7375 in combination with chemotherapy in the first-line setting in patients with metastatic CRC.
In March, the Company announced that several late-breaking and regular abstracts were selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The abstracts included preclinical data demonstrating sustained tumor regressions with VS-7375 in combination with PRMT5 inhibitors in MTAP-deleted KRAS G12D mutant pancreatic cancer and improved efficacy in comparison to ON-only KRAS G12D or pan-RAS inhibitors.
In March, the Company reported an update on its progress with VS-7375, highlighting progress with its dose-escalation and dose-expansion trial, TARGET-D 101, a PK analysis, and a safety update, which demonstrated VS-7375 was generally well-tolerated across all monotherapy dose levels evaluated to date. Patients (n=23) receiving VS-7375 at either 400 mg QD, 600 mg QD or 900 mg QD with a mean duration of therapy of 1.6 months (0.7-5.6), reported no drug related liver function test abnormalities. As of the January 30, 2026 data cutoff, there was no drug-related neutropenia greater than Grade 2 and rates of nausea, vomiting and diarrhea remained lower than those reported by the Company’s partner in China. The Company also reported that the U.S. Food and Drug Administration (FDA) requested the Company develop separate Phase 2 trial protocols for their trials in PDAC, NSCLC and CRC.
In January, the Company reported progress from its ongoing TARGET-D 101 trial, with multiple dose levels cleared without dose-limiting toxicities or major toxicities. At that time, monotherapy cohorts and dose escalation combination cohorts were initiated across various KRAS G12D-mutated solid tumors.
The Company shared multiple updates from GenFleet Therapeutics, its partner developing VS-7375, known as GFH375 in China.

In April, GenFleet announced that GFH375 was granted Breakthrough Therapy Designation (BTD) in China for patients with KRAS G12D-mutated metastatic pancreatic cancer who have received at least one prior systemic therapy.
In March, GenFleet announced that GFH375 was granted BTD in China for patients with KRAS G12D-mutated NSCLC who have received prior systemic therapy.
Expected Key Milestones:

Report early data from the TARGET-D 101 trial in 1H 2026.
Report an update on the TARGET-D 101 trial in 2H 2026.
Announce first patient initiated in the TARGET-D 201, TARGET-D 202, and TARGET-D 203 clinical trials in mid-2026.
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in 1L Metastatic Pancreatic Cancer

Expected Key Milestone:

Report an update on the safety and efficacy of the RAMP 205 expansion cohort with at least six months of follow-up on all patients in Q2 2026.
Corporate Updates

The Company announced today the appointment of Daniel Lyons as chief commercial officer. Prior to joining, Mr. Lyons served as the Senior Vice President, Head of Rare Tumors International and Global Head of Market Access at SpringWorks Therapeutics.
First Quarter 2026 Financial Results

Verastem Oncology ended the first quarter of 2026 with cash, cash equivalents, and investments of $181.7 million.

Net product revenue for the three months ended March 31, 2026 (the "2026 Quarter") was $18.7 million, compared to no revenue recognized for the three months ended March 31, 2025 (the "2025 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.

Total operating expenses for the 2026 Quarter were $63.6 million, compared to $44.2 million for the 2025 Quarter. Cost of sales was $3.1 million for the 2026 Quarter, compared to no cost of sales recognized for the 2025 Quarter.

Research & development expenses for the 2026 Quarter were $38.2 million, compared to $29.2 million for the 2025 Quarter. The increase of $9.0 million, or 31%, was primarily due to higher costs for investigator fees, drug substance manufacturing, drug product manufacturing, clinical supply, and contract research organizations partially offset by the VS-7375 program option exercise fee paid to GenFleet in the 2025 Quarter.

Selling, general & administrative expenses for the 2026 Quarter were $22.3 million, compared to $15.0 million for the 2025 Quarter. The increase of $7.3 million, or 48%, was primarily due to higher costs for personnel and commercial operations.

Net loss (GAAP basis) for the 2026 Quarter was $36.6 million, or $0.37 per share (basic), compared to $52.1 million, or $0.96 per share (basic and diluted) for the 2025 Quarter.

Non-GAAP adjusted net loss for the 2026 Quarter was $42.7 million, or $0.43 per share (basic) compared to non-GAAP adjusted net loss of $42.9 million, or $0.79 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.

Conference Call and Webcast

Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the first quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

(Press release, Verastem, MAY 7, 2026, View Source [SID1234665350])

BriaCell Adds NYU Langone Health’s Perlmutter Cancer Center as Clinical Site in Pivotal Phase 3 Breast Cancer Study

On May 7, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported the addition of NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center, a renowned cancer center in New York City, as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC).

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BriaCell has enjoyed a marked uptick in interest from premier cancer centers and patient enrollment numbers following the prominent independent feature of its Phase 3 clinical trial in Nature Medicine’s publication, "Eleven clinical trials that will shape medicine in 2026", linked here.

BriaCell’s pivotal Phase 3 clinical study in Advanced Breast Cancer (Bria-ABC) is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus treatment of physician’s choice in advanced metastatic breast cancer.

"At NYU Langone Health’s Perlmutter Cancer Center, we are dedicated to offering state-of-the-art treatments to patients with difficult-to-treat cancers," stated Nancy Chan MD, Director, Breast Cancer Clinical Research, NYU Langone Health’s Perlmutter Cancer Center. "We look forward to helping accelerate the development of Bria-IMT, a novel immunotherapy with the potential to improve outcomes for patients with advanced metastatic breast cancer."

"We are thrilled to partner with clinical experts at the renowned NYU Langone Health’s Perlmutter Cancer Center, a patient-focused, NCI-designated Comprehensive Cancer Center, to further expand patient access to our novel immunotherapy treatment," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We continue to advance the study and look forward to sharing interim data in the coming months."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer. Importantly, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, MAY 7, 2026, View Source [SID1234665366])

Crinetics Pharmaceuticals Reports First Quarter 2026 Financial Results
and Provides Business Update

On May 7, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2026.

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"We are extremely pleased with the significant impact that Palsonify is making across the community. This is illustrated by the strong adoption of Palsonify by healthcare providers and the positive patient response to treatment," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The significant growth in our unique prescriber base reflects a growing confidence among endocrinologists in the compelling clinical data and proven efficacy of Palsonify. Expanding clinical adoption is fueling sustained demand, evidenced by the steady growth trend in new patient start forms. We are seeing an increasingly efficient path to treatment for patients as the reimbursement environment matures. These results reinforce our confidence in the long-term commercial trajectory of Palsonify and our ability to deliver transformative therapies at scale."

First Quarter 2026 and Recent Highlights:
•Reported $10.3 million in net product revenue, reflecting the rapid adoption of PALSONIFY as the preferred choice for the acromegaly community.
•Received 232 enrollment forms1 during the first quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to grow, with 263 unique healthcare providers (HCPs) having prescribed PALSONIFY within the first two quarters of launch. Approximately 70% of patients treated with PALSONIFY at the end of the first quarter of 2026 were on reimbursed therapy, as payers have increasingly provided coverage.
•In January 2026, we initiated the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients.
•In February 2026, the CHMP of the EMA adopted a positive opinion, recommending the marketing authorization of PALSONIFY for the medical treatment of adult patients with acromegaly. In April 2026, the European Commission approved PALSONIFY, the first once-daily oral, selectively targeted somatostatin receptor type 2 nonpeptide agonist, for the medical treatment of adults with acromegaly.
•In March 2026, Crinetics submitted a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY for the treatment of acromegaly in adults. In April 2026, SKK submitted a New Drug Application (NDA) in Japan for paltusotine for the treatment of acromegaly.
•In May 2026, Crinetics entered into an exclusive license agreement with Ohio University to develop an early preclinical growth hormone receptor antagonist for the treatment of acromegaly.
•We remain on schedule to initiate, in the second quarter of 2026, the pivotal, seamless Phase 2/3 trial evaluating atumelnant for the treatment of ACTH-dependent Cushing’s syndrome. The study will assess the efficacy and safety of our once-daily, oral ACTH antagonist, atumelnant, in a broad population including patients with both Cushing’s disease and ectopic ACTH syndrome.

First Quarter 2026 Financial Results:
•Revenue was $10.7 million for the quarter ended March 31, 2026, compared to $0.4 million for the same period in 2025. Revenue for the quarter ended March 31, 2026 includes $10.3 million in net product revenue from the U.S. commercial launch of PALSONIFY, up from $5.4 million in net product revenue reported in the fourth quarter of 2025.
•Cost of product revenue was $0.2 million for the quarter ended March 31, 2026, primarily related to distribution, packaging, and fulfillment of PALSONIFY.
•Research and development expenses were $100.1 million for the quarter ended March 31, 2026, compared to $76.2 million for the same period in 2025, and compared to $85.1 million in the quarter ended December 31, 2025. The increase compared to the prior year period reflects the advancement of our clinical and preclinical programs. The sequential increase compared to the prior quarter was primarily due to the ramp-up of ongoing Phase 3 trials, as well as the initiation of the Phase 2/3 pediatric study of atumelnant in CAH.
•Selling, general and administrative expenses were $50.8 million for the quarter ended March 31, 2026, compared to $35.5 million for the same period in 2025, and compared to $53.7 million in the quarter ended December 31, 2025. The increase compared to the prior year period is related to investments in our corporate infrastructure as we transition into a commercial-stage company. The fluctuation compared to the prior quarter reflects timing of commercial investment.
•Net loss was $127.8 million for the quarter ended March 31, 2026, compared to net loss of $96.8 million for the same period in 2025.
•Cash, cash equivalents, and investment securities totaled $1.3 billion as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The March 31, 2026 total includes net proceeds of $380 million from our January 2026 public equity offering.

Guidance and Outlook:
•Crinetics continues to expect 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles ("GAAP") to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million.
•Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures".

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 7, 2026 at 4:30 p.m. ET. To participate, please dial 1-833-461-5787 (domestic) or 1-585-542-9983 (international) and refer to Meeting ID 173777518. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

(Press release, Crinetics Pharmaceuticals, MAY 7, 2026, View Source [SID1234665317])

Lantheus Reports First Quarter 2026 Financial Results and Provides Business Update

On May 7, 2026 Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported financial results for its first quarter ended March 31, 2026.

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"Our first quarter results demonstrate disciplined execution across the business, with strong performance from PYLARIFY, Neuraceq, and DEFINITY, and continued progress against the priorities that underpin our long-term strategy," said Mary Anne Heino, Chief Executive Officer of Lantheus. "During the quarter, we secured FDA approval for PYLARIFY TruVu and achieved tentative approval for PNT2003. For the remainder of 2026, we are focused on sustaining our leadership in PSMA PET as we prepare for the PYLARIFY TruVu conversion later this year, expanding our Alzheimer’s imaging portfolio, and advancing our prioritized pipeline. At the same time, we will remain disciplined in our capital deployment, prioritizing radiodiagnostics while evaluating the best path to maximize value from our radiotherapeutic assets – all as we lay the groundwork for growth acceleration beginning in 2027."

Summary Financial Results

Three Months Ended
March 31,
(in millions, except per share data – unaudited) 2026 2025 % Change
Worldwide revenue $ 377.3 $ 372.8 1.2 %
GAAP net income $ 118.4 $ 72.9 62.3 %
GAAP fully diluted earnings per share $ 1.80 $ 1.02 76.5 %
Adjusted net income (non-GAAP) $ 95.8 $ 109.5 (12.5 %)
Adjusted fully diluted earnings per share (non-GAAP) $ 1.46 $ 1.53 (4.6 %)

First Quarter 2026

Worldwide revenue increased 1.2% to $377.3 million compared to the same period in 2025.
Sales of PYLARIFY were $240.9 million, a decrease of 6.5%.
Sales of Neuraceq were $35.4 million.
Sales of DEFINITY were $84.6 million, an increase of 6.8%.
Operating income decreased 20.3% to $81.3 million. Adjusted operating income (non-GAAP) decreased 10.5% to $129.1 million.
Fully diluted earnings per share increased 76.5% to $1.80, compared to fully diluted earnings per share of $1.02 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 4.6% to $1.46, compared to $1.53 in the prior year period.
Net cash provided by operating activities and free cash flow were $125.1 million and $121.9 million, respectively.
Balance Sheet

At March 31, 2026, the Company’s cash and cash equivalents were $498.6 million, including proceeds of $31.4 million from the sale of the Company’s single-photon emission computerized tomography ("SPECT") business to SHINE Technologies, LLC ("SHINE") on January 1, 2026, compared to $359.1 million at December 31, 2025.
The Company currently has access to up to $750.0 million from a revolving line of credit.
Recent Business Highlights

Received FDA approval for PYLARIFY TruVuTM (piflufolastat F18), a new formulation of PYLARIFY, the Company’s market-leading PSMA PET imaging agent, designed to enhance manufacturing efficiency and supply flexibility; a phased geographic commercial launch is planned to begin in the fourth quarter of 2026 to align with coding, coverage, payment, and customer and PMF readiness.
Completed the divestiture of the legacy SPECT business to SHINE (effective January 1, 2026), a decisive action taken to focus on PET radiodiagnostics and simplify the Company’s operating model. 
Achieved FDA tentative approval for PNT2003, which upon full approval would be the first radioequivalent to Lutetium Lu 177 Dotatate for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs); launch timing will consider the following factors: the timing of FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success.
The FDA extended the PDUFA date for LNTH-2501(Ga 68 edotreotide), the Company’s PET diagnostic imaging kit for somatostatin receptor-positive neuroendocrine tumors (NETs), by three months to June 29, 2026, to allow additional time to review manufacturing-related information. This standard review extension is not related to the efficacy or safety data of LNTH-2501.
Full Year 2026 Financial Guidance

Guidance Issued May 7, 2026 Guidance Issued February 26, 2026
FY 2026 Revenue $1.4 billion – $1.45 billion $1.4 billion – $1.45 billion
FY 2026 Adjusted fully diluted EPS $5.00 – $5.25 $5.00 – $5.25

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, May 7, 2026, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at View Source

A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

(Press release, Lantheus, MAY 7, 2026, View Source [SID1234665333])