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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

On May 7, 2026 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three months ended March 31, 2026, provided operating and partner program updates, and increased 2026 financial guidance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"OmniAb experienced strong momentum during the first quarter as multiple partnered programs advanced into later-stage clinical development, reinforcing the diversity and value of our portfolio. With a very strong start to the year, we are raising our 2026 revenue guidance," stated Matt Foehr, Chief Executive Officer of OmniAb. "Continued progression of partner programs highlights the value of our technology platform and positions our business well for the future. Our innovation efforts continue to differentiate our platform as demonstrated by the launch of OmniUltra and our xPloration partner access program."

First Quarter 2026 Financial Results

Revenue for the first quarter of 2026 was $14.4 million, compared with $4.2 million for the same period in 2025, with the increase primarily related to milestone revenue.

Research and development expense was $9.6 million for the first quarter of 2026, compared with $12.6 million for the same period in 2025, with the decrease due to lower personnel expense, share-based compensation expense, and external expenses associated with legacy small molecule ion channel programs. General and administrative expense was $6.6 million for the first quarter of 2026, compared with $7.9 million for the same period in 2025, with the decrease primarily due to lower personnel expense, share-based compensation expense, and legal fees.

Amortization of intangibles increased to $6.0 million for the first quarter of 2026, compared with $3.2 million for the same period in 2025, primarily due to a $2.9 million non-cash impairment related to the discontinuation of certain legacy small-molecule ion channel programs.

Total costs and operating expenses were $22.3 million for the first quarter of 2026, compared with $23.0 million for the same period in 2025. Cash costs and operating expenses were $12.3 million for the first quarter of 2026, compared with $14.7 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure).

Net loss for the first quarter of 2026 was $7.7 million, or $0.06 per share, compared with a net loss of $18.2 million, or $0.17 per share, for the same period in 2025.

2026 Financial Guidance

OmniAb revises 2026 financial guidance and now expects revenue to be in the range of $28 million to $33 million, versus $25 million to $30 million previously, and costs and operating expenses to be in the range of $83 million to $88 million, versus $80 million to $85 million previously. Cash costs and operating expenses remain unchanged and are expected to be in the range of $50 million to $55 million (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). The Company now expects to end the year with cash and cash equivalents in the range of $33 million to $38 million, versus $30 million to $35 million previously. The full-year 2026 effective tax rate is expected to be approximately 0%.

First Quarter 2026 and Recent Business Highlights

During the first quarter of 2026, OmniAb entered into a new license agreement with Florida State University. As of March 31, 2026, the Company had 107 active partners and 409 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

Business and partner highlights from the first quarter of 2026 and recent weeks included the following:

IMVT-1402 & batoclimab

The potentially registrational trial with IMVT-1402 in difficult-to-treat rheumatoid arthritis is fully enrolled, with topline data expected in the second half of this year. Topline data from the proof-of-concept trial with IMVT-1402 in cutaneous lupus erythematosus is also expected in the second half of this year.
Potentially registrational studies with IMVT-1402 in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease remain on track with topline data in GD and MG expected in 2027.
Immunovant announced topline data from its two Phase 3 studies evaluating batoclimab as a treatment for active, moderate-to-severe thyroid eye disease and intends to review future plans for the development of batoclimab with its partner HanAll Biopharma Co. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402.
TEV- ‘408

Teva Pharmaceuticals announced a funding agreement with Royalty Pharma of up to $500 million to accelerate the clinical development of Teva’s anti-IL-15 antibody TEV-‘408 for vitiligo.
Topline results of the Phase 1b trial evaluating TEV-‘408 for vitiligo are expected in the first half of this year. Topline results of the Phase 2a trial evaluating TEV-‘408 for celiac disease are expected in the second half of this year.
Precemtabart tocentecan (M9140)

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, pooled data on precemtabart tocentecan, a novel anti‑CEACAM5 antibody‑drug conjugate with a topoisomerase 1 inhibitor payload, from the PROCEADE-CRC-01 study in patients with metastatic colorectal cancer were presented that showed an objective response rate of 26.8% and median progression-free survival of 6.9 months. The overall safety profile was consistent with earlier data with no new or unexpected treatment-emergent adverse events.
Merck KGaA indicated that based on Phase 1 data, it plans to advance precemtabart tocentecan directly to Phase 3 trials in metastatic colorectal cancer, with study initiation anticipated in the second or third quarter of 2026.
OmniAb expects that multiple partner programs will be highlighted at the ASCO (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2, 2026.

Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 563758100. Slides, as well as the live and replay webcast, are available at View Source

(Press release, OmniAb, MAY 7, 2026, View Source [SID1234665351])

On May 7, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the first quarter 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Webcast scheduled for 7 May 2026 at 08:30 CET. Link to webcast here.

Operational Highlights Q1 2026:

First clinical site activated:
As announced yesterday, Zelluna has activated its first clinical site, The Christie NHS Foundation Trust in the United Kingdom. This marks the transition from clinical preparation to the execution phase of the ZIMA-101 study. Activation of the second clinical site, The Royal Marsden, is expected in the near term.
CTA approval:
On 20 February 2026, Zelluna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) had approved the Company’s Clinical Trial Application (CTA) for ZIMA-101, a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.
Collaboration with Etcembly Ltd:
On 9 March 2026, the Company announced a collaboration with Etcembly Ltd to leverage AI-enabled TCR engineering to develop KKLC1-targeting TCRs.
Medpace selected as CRO:
On 11 February 2026, Zelluna announced that it had entered into a clinical partnership with Medpace to support the Phase 1 trial of ZI-MA4-1 (ZIMA-101).
Financial Highlights Q1 2026

Total operating expenses: MNOK 20.4
Total loss: MNOK 20.4
Cash and cash equivalents: MNOK 49.3 as of 31 March 2026
Financial runway: into Q1 2027
"Q1 2026 marked a major step forward for Zelluna as we moved from regulatory submission into the clinic, following approval of our CTA for ZI-MA4-1 and activation of our first clinical site, announced earlier today. As we progress through 2026, our priorities are clear: dose the first patients in the ZIMA-101 study and execute with discipline as we begin generating clinical data in patients. In parallel, we will continue to selectively advance our pipeline to build on the long-term potential of the TCR-NK platform," says CEO Namir Hassan.

Outlook

Zelluna enters 2026 with its lead programme, ZI-MA4-1, progressing toward first clinical evaluation in patients following successful GMP manufacturing and CTA approval in the UK. As announced earlier today, the Phase 1 study ZIMA-101 is now underway following activation of the first clinical site. Initial clinical data are expected from mid-2026. The current cash position is expected to support operations into Q1 2027.

The quarterly report and presentation will be made publicly available on the Zelluna website. The Company will host a webcast on 7 May at 08:30 CET, and questions can be submitted throughout the event. The webcast will be archived for replay following the conference call. Link to webcast here.

(Press release, Zelluna Immunotherapy, MAY 7, 2026, View Source [SID1234665367])

On May 7, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center ("UPMC") Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme ("Merck") are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer-data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Read more about the study at ClinicalTrials.gov: NCT03734692.

Topline results included:

50% Objective Response Rate (ORR), including 21% complete responses
79% Clinical Benefit Rate
Median Overall Survival of 32.5 months
Durable responses exceeding 70+ months in select patients
No Grade 4 or 5 toxicities observed
Read the full UPMC Primary Endpoint Report here.

Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.

Robert P. Edwards, MD, McCall Chair of Obstetrics, Gynecology, and Reproductive Science at the University of Pittsburgh School of Medicine, stated: "This single-arm Phase 2 trial is the third in a series of consecutive studies evaluating IP chemotherapy or chemoimmunotherapy using this analytical approach. The addition of IP Ampligen and systemic PD-1 checkpoint inhibition to IP cisplatin chemotherapy resulted in a significant improvement in both clinical response rates and immune activation across highly comparable patient cohorts in the 3 trials."

AIM Chief Executive Officer Thomas K. Equels stated, "These results represent what we believe is a strong step forward in the potential to enhance treatment of recurrent ovarian cancer, if further studies support findings of relatively low toxicity, clinical benefit and durable response. Once again, data suggests that Ampligen may unlock the full potential of checkpoint immunotherapies. We are particularly encouraged by the durability of the observed responses. This supports our proposition that Ampligen has the potential to play a major role in solid tumor immuno-oncology – expanding the number of patients who benefit from checkpoint inhibitors across multiple cancer types, including ovarian cancer and pancreatic cancer. With strong intellectual property protection extending into 2039 and a growing body of positive clinical evidence, we believe we are well positioned to advance Ampligen into later-stage development and strategic partnerships."

(Press release, AIM ImmunoTech, MAY 7, 2026, View Source [SID1234665297])