On June 26, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).

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The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. "The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program."

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

(Press release, Lantheus, JUN 26, 2026, View Source [SID1234668965])

On June 26, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported that eleven clinical sites have been initiated and are now open for patient enrollment in its Phase 2 TakeAim CLL study evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia. The Company also reaffirmed its guidance for the dosing of the initial five patients in the TakeAim CLL study by the end of July 2026, with data expected in December 2026. In addition, the Company reported that its stockholders approved a reverse stock split proposal at the special meeting of stockholders held on June 25, 2026.

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TakeAim CLL Update

Eleven clinical sites are now open for enrollment in the TakeAim CLL study, reflecting strong investigator interest in the combination of emavusertib and zanubrutinib as a strategy to enable dual blockade of NF-kB, a key driver of CLL disease. The Company reaffirmed its expectations to announce the dosing of the initial five patients in the TakeAim CLL combination study with zanubrutinib by the end of July 2026, with data expected in December 2026.

"We are pleased with both our operational progress in the CLL study and the strong support from our shareholders as we work to regain compliance with the NASDAQ bid price listing requirement," said James Dentzer, President and CEO of Curis, "and we look forward to building on those successes in the weeks and months to come."

Special Meeting Vote Results

At the Company’s special meeting of stockholders held on June 25, 2026, stockholders approved a proposal to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding shares of common stock at a ratio ranging from 1-for-5 to 1-for-25, in furtherance of the Company’s regaining compliance with Nasdaq’s $1.00 bid price rule, with the final ratio to be determined at the discretion of the Company’s Board of Directors. The Company intends to announce the specific ratio and effective date in advance of the reverse stock split becoming effective. Curis’s shares of common stock will continue to trade on the Nasdaq Capital Market under the ticker symbol "CRIS."

Additional information regarding the reverse stock split proposal can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on June 5, 2026, available at www.sec.gov and www.curis.com.

About the TakeAim CLL Study

The TakeAim CLL is an open label phase 2 study of emavusertib in combination with zanabrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), measurable residual disease positive (MRD+) as determined by the ClonoSEQ assay and actively taking zanubrutinib for at least 12 months.

(Press release, Curis, JUN 26, 2026, View Source,-Reaffirms-Patient-Dosing-Guidance,-and-Reports-Stockholder-Approval-of-Reverse-Stock-Split [SID1234668964])

On June 25, 2026 Sonnet BioTherapeutics reported on March 31, 2026, the company entered into an asset purchase agreement (the "APA") with Guidant Biotherapeutics, Inc. ("Guidant"), a newly-formed company. In connection with the consummation of the transactions contemplated by the APA on that date (the "Sonnet Disposition"), the company transferred $1.325 million in cash, various developmental assets and patents related to Sonnet’s tumor delivery platforms, certain employees and Sonnet’s Australian subsidiary to Guidant, and provided a deferred purchase price of $1.0 million subsequent to the execution of the APA, which is included with "other current liabilities" as of March 31, 2026 on its condensed consolidated balance sheets. In exchange, the company received a 40% common stock interest in Guidant. In connection with the APA, the ompany engaged Guidant under a transaction services agreement (the "TSA") to provide services to the company for fees of $0.175 million, paid at the closing of the APA.

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(Press release, Sonnet BioTherapeutics, JUN 25, 2026, View Source [SID1234670427])

On June 25, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported that it has agreed the pivotal trial design for faridoxorubicin (AVA6000, pre|CISION-enabled doxorubicin) with the U.S. Food and Drug Administration (FDA) for a potential full regulatory approval.

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This would comprise a single pivotal study with faridoxorubicin in patients with salivary gland cancer (SGC), with progression-free survival (PFS) as the sole primary endpoint for full approval. Furthermore, the proposed study population includes both first- and second-line patients, in the most prevalent subsets of SGC, while more rare subsets (e.g. undifferentiated histology and mucinous tumor types) are excluded due to differing natural histories.

Christina Coughlin, CEO of Avacta, commented:

"Our recent constructive discussions with the FDA have resulted in a clear path forward for our Gen One product faridoxorubicin towards full approval, based on one pivotal trial with a single primary endpoint of PFS.

"This would allow the company to move directly to the pivotal trial when the Phase 1b data are mature, enabling time savings with the clear focus on PFS data to secure approval. It provides further clarity in our continuing conversations with potential partners, with a defined route through clinical development towards potential approval and commercialization.

"The FDA had previously agreed to lifting the lifetime maximum dosing with faridoxorubicin at US sites, based on its excellent safety profile and absence of severe cardiac toxicity. The Company remains committed to progressing faridoxorubicin into further clinical development only with the support of a partner."

(Press release, Avacta Life Sciences, JUN 25, 2026, View Source [SID1234670224])

On June 25, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported that the Company will participate in the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference.

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Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Tuesday, June 30, 2026 at 9:00am EDT / 14:00pm BST.

A webcast of the fireside chat will be available on the "Events" page in the "Investor Relations & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

(Press release, Autolus, JUN 25, 2026, View Source [SID1234668961])