On July 28, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported that the European Commission (EC) has granted orphan medicinal product designation for [²¹²Pb]VMT-α-NET for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

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Orphan medicinal product designation by the EC may provide certain development and commercial incentives, including protocol assistance, fee reductions, and, if approved, up to 10 years of market exclusivity. Criteria for designation include the potential to provide significant benefit to patients affected by the condition.

"Patients with unresectable or metastatic GEP-NETs often face a complex treatment journey, with limitations in currently available treatment options," said Thijs Spoor, Perspective’s CEO. "The European orphan designation for [²¹²Pb]VMT-α-NET provides important incentives to support its development in Europe, reflects the need for additional therapeutic options for European patients living with GEP-NETs, and advances our broader goal of developing next-generation targeted radiopharmaceuticals."

GEP-NETs are a heterogeneous group of tumors that arise from neuroendocrine cells throughout the gastrointestinal tract and pancreas. Although uncommon, their incidence and prevalence have increased substantially over the past several decades, driven in part by improved diagnostic techniques and greater disease awareness. Patients with GEP-NETs continue to face important treatment gaps, including delayed diagnosis due to nonspecific symptoms and limited durable disease control with available therapies, particularly in advanced or metastatic disease.

About [²¹²Pb]VMT-α-NET

Perspective designed [212Pb]VMT-α-NET to target somatostatin receptor subtype 2 (SSTR2), and to deliver the alpha-emitting radioisotope lead-212, or ²¹²Pb, to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation and dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive tumors who have not received prior radiopharmaceutical therapies (RPT).

Interim clinical data from the study, with a data cut-off date of April 17, 2026, were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026. These data included efficacy results for half of the patients in Cohort 2 and both patients in Cohort 1. Initial efficacy data for the remaining patients in Cohort 2 and patients in Cohorts 3 and 4 are pending. The Company plans to submit additional data for presentation at future medical conferences in 2026-7.

(Press release, Perspective Therapeutics, JUL 28, 2026, View Source [SID1234669476])

On July 28, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 (EOP1) meeting for CLN-049, a FLT3xCD3 T cell engager being evaluated in patients with acute myeloid leukemia (AML).

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The EOP1 meeting focused on the planned Phase 2 development strategy for CLN-049. Based on discussions with the FDA, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026. The study design agreed with the FDA incorporates a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose.

"Patients with AML continue to face poor outcomes and have limited treatment options, underscoring the need for new therapeutic approaches," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "The FDA’s feedback reinforces our confidence in the development strategy for CLN-049 and provides a clear path forward for potential regulatory approval. We look forward to continuing to advance the CLN-049 program and exploring its potential across AML patient populations."

As presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, CLN-049 demonstrated promising clinical activity and a favorable safety profile in patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of this study in Q4 2026.

Following the positive feedback from the FDA, the Company plans to initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 2026. The Company will also initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML (NCT07722767).

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 bispecific T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.2 Each year in the U.S., approximately 23,000 people are diagnosed with AML, and about half as many lives are lost to the disease.3 Globally, AML affects an estimated 145,000 people annually, with approximately 130,000 deaths.4

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.5 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.6,7 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.7 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, JUL 28, 2026, View Source [SID1234669475])

On July 28, 2026 PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, reported that management will participate in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference on Tuesday, August 11, 2026, at 9:00 AM ET in Boston, Massachusetts.

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A live webcast of the event can be accessed at the company’s investors page at investor.pacificbiosciences.com. A replay of the webcast will be available for at least 30 days following the event.

(Press release, Pacific Biosciences, JUL 28, 2026, View Source [SID1234669474])

On July 28, 2026 Vergent Bioscience, a clinical-stage biotechnology company developing a tumor-targeted imaging platform, reported that data published in The Annals of Surgical Oncology (ASO) demonstrated clinical utility of abenacianine, the company’s investigational intraoperative molecular imaging (IMI) agent. The results showed the intraoperative molecular imaging agent’s ability to visualize tumors during lung cancer surgery, and the potential to optimize resection by localizing primary and metastatic tumors and minimizing removal of normal tissue. These data support findings from earlier clinical trials suggesting abenacianine helped surgeons see tumors in real time during minimally invasive and robotic-assisted surgical procedures.

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"As lung cancer surgery continues to advance, the need for technologies that help surgeons see cancer in real time to inform their intraoperative decision-making is critical," said Adam Gridley, president and chief executive officer at Vergent Bioscience. "We believe abenacianine has the potential to fundamentally improve how surgeons approach tumor visualization in the lung, facilitating complete and confident resections, with the opportunity to extend this approach across a broad range of solid tumors. We are excited to progress our ongoing Phase 3 trial to further evaluate the potential of abenacianine for cancer in the lung including additional infusion timing flexibility out to four days before surgery."

The Phase 2B, multicenter, open-label VISUALIZE trial enrolled 89 individuals undergoing surgery for suspected or known cancer in the lung at six clinical investigative sites in the United States and Australia. Each patient in the trial received abenacianine preoperatively by intravenous infusion. Following an attempt to localize the patient’s target lung lesion using standard surgical techniques, investigators used commercially available surgical near infrared (NIR) imaging systems with abenacianine to visualize the lesion, which was then assessed by pathology.

The primary efficacy endpoint was the proportion of patients with at least one clinically significant event (CSE) defined as localization of lesions not found by standard surgical techniques, identification of additional cancers, identification of inadequate surgical margins confirmed by pathology, and detection of cancerous lymph nodes.

Of the 89 patients included in the trial, 40 (45%) of the patients had at least one CSE; meaning that, in 45 percent of surgical cases, the addition of abenacianine provided actionable information to surgeons resulting in improved surgical outcomes.

Tumors visualized by IMI with abenacianine included primary lung cancers (adenocarcinoma, squamous cell carcinoma, neuroendocrine tumor) and cancers that metastasized to the lung (breast, colorectal, prostate, thymoma, renal cell, sarcoma). Abenacianine appeared safe and well tolerated with no drug-related serious adverse events observed.

"While surgery remains the foundation of treatment of lung cancer, surgeons continue to face challenges in identifying small lesions and ensuring complete tumor removal," said clinical trial investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at the University of Pennsylvania. "These results further strengthen the growing body of evidence supporting intraoperative molecular imaging with abenacianine as a means to enhance tumor visualization during surgery, enabling more precise resection and helping to reduce the risk of leaving cancer behind."

To further evaluate the efficacy of abenacianine, Vergent is currently conducting the Phase 3 multicenter VISUALIZE-2 clinical trial (NCT07499674). Enrollment in this trial is advancing rapidly with a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) planned in 2027.

About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE trial (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the trial received 0.32 mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques alone, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection
Invented in Dr. Matt Bogyo’s lab at Stanford University School of Medicine, abenacianine is a tumor-activated intraoperative imaging platform designed to deliver molecular insight during surgery by revealing malignant tissue undetectable under white light. Administered via a short intravenous infusion several hours to several days before surgery, abenacianine binds covalently to cathepsins, a family of proteases overexpressed across a broad range of solid tumors. The agent incorporates the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with commercially available NIR imaging systems widely used in minimally invasive and robotic surgery. This compatibility and dosing flexibility enable seamless integration into existing surgical workflows.

(Press release, Vergent Bioscience, JUL 28, 2026, View Source [SID1234669473])

On July 28, 2026 NeoGenomics, Inc. (NASDAQ: NEO) (the "Company"), a leading provider of oncology diagnostic solutions that enable precision medicine, reported its second-quarter results for the period ended June 30, 2026.

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Financial Highlights

For the three-month period ended June 30, 2026, as compared to the same period in 2025:

Increased total revenue by 11% to $202 million
Increased clinical revenue by 14% to $187 million driven by robust NGS growth of 26%
Recorded GAAP net income of $2 million, including a gain on extinguishment of debt of $11 million
Delivered adjusted EBITDA(1) of $14 million, an increase of 36%
Generated $20 million from cash from operations to end the quarter with $146 million of cash, cash equivalents, and short-term investments
Business Highlights

Sharpened commercial strategy and go-to-market execution by launching a dedicated pathology and oncology commercial team
Submitted new RaDaR ST evidence to MolDx supporting Medicare reimbursement for a new indication. This marks the third RaDaR ST submission to MolDx pending approval
Strengthened capital structure through the completion of a $316 million private offering of 0.75% convertible senior notes due 2032
Finalized a civil settlement with the Department of Justice resolving a self-disclosed matter and investigation concerning consulting services provided by the Company
"Our second quarter results reflect the consistent operating and financial performance investors expect from this team," said Tony Zook, Chief Executive Officer of NeoGenomics. "Revenue growth of 11% year-over-year exceeded our outlook, with NGS revenue growth of 26% reflecting a continued mix shift to more advanced testing modalities. This revenue growth is being coupled with our focus on disciplined margin expansion, as evidenced by adjusted EBITDA increasing by 36%. Looking ahead, I remain confident that we are well positioned to deliver long-term profitable growth, while investing in our business and expanding our suite of on-market testing solutions for patients and providers."

Second-Quarter Results

Consolidated revenue for the second quarter of 2026 was $202 million, an increase of 11% over the same period in 2025. Clinical volume increased by 2%, while average revenue per clinical test increased by 12% to $515.

Consolidated gross profit for the second quarter of 2026 was $92 million, an increase of 19% compared to the second quarter of 2025. Consolidated gross profit margin, including amortization of acquired intangible assets and stock-based compensation expense, was 46%. Adjusted Gross Profit Margin(1), excluding amortization of acquired intangible assets and stock-based compensation expense, was 48%, an increase of 260 bps versus the same period in 2025.

Operating expenses for the second quarter of 2026 were $102 million, a decrease of $23 million, or 19%, compared to the second quarter of 2025. The decrease in operating expenses was primarily due to $20 million of impairment charges taken in the second quarter of 2025.

Net income for the quarter was $2 million compared to net loss of $45 million for the second quarter of 2025. Net income for the quarter includes a gain on extinguishment of debt of $11 million.

Adjusted EBITDA(1) for the second quarter of 2026 increased by 36% to $14 million, compared to $11 million in the second quarter of 2025. Adjusted Net Income(1) was $7 million compared to Adjusted Net Income(1) of $4 million in the second quarter of 2025.

Cash and cash equivalents totaled $146 million at quarter end. This reflects the net effects from the completion of the company’s $316 million private offering of 0.75% convertible senior notes due 2032. As part of the transaction, the Company repurchased approximately $276 million aggregate principal amount of the Company’s existing 0.25% convertible senior notes due 2028 and entry into capped call transactions intended to reduce potential dilution upon conversion. Company also repurchased shares of its common stock for an aggregate purchase price of $25 million.

(1)

The Company has provided adjusted financial information that has not been prepared in accordance with GAAP, including Adjusted EBITDA, Adjusted Gross Profit Margin, Adjusted Net (Loss) Income, and Adjusted Diluted EPS. Each of these measures is defined in the section of this press release entitled "Use of Non-GAAP Financial Measures." See also the tables reconciling such measures to their closest GAAP equivalent.

2026 Financial Guidance

The Company is revising its full-year 2026 guidance, as shown below (in millions).

FY 2025

Previous
FY 2026 Guidance

Updated
FY 2026 Guidance

YOY % Change from
FY 2025

(in millions)

Actual

Low

High

Low

High

Low

High

Consolidated revenue

$727

$797

$803

$802

$806

10%

11%

Net loss

$(108)

$(63)

$(50)

$(42)

$(34)

61%

69%

Adjusted EBITDA

$43

$55

$57

$56

$58

29%

34%

Conference Call

The Company has scheduled a webcast and conference call to discuss its second quarter 2026 results on Tuesday, July 28, 2026 at 4:30 p.m. Eastern Time. To access the live call via telephone, interested investors should dial (888) 506-0062 (domestic) or (973) 528-0011 (international) at least five minutes prior to the call. The participant access code provided for this call is 968605. The live webcast may be accessed by visiting the Investor Relations section of our website at ir.neogenomics.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

(Press release, NeoGenomics Laboratories, JUL 28, 2026, View Source [SID1234669472])