On February 12, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium from Feb. 26-28. These data, including three studies that will be featured in the symposium’s press program, underscore Merck’s commitment to advancing research across its broad portfolio to improve patient outcomes.

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"We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "The results we’re presenting at ASCO (Free ASCO Whitepaper) GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients."

Data presentations will feature new findings from Merck’s broad portfolio of cancer medicines, including key data for KEYTRUDA (pembrolizumab), WELIREG (belzutifan) and LENVIMA (lenvatinib), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate (ADC) from Merck’s innovative pipeline: sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech.

Key data from Merck’s portfolio and pipeline to be presented at the 2026 ASCO (Free ASCO Whitepaper) GU Cancers Symposium:

First-time data from the Phase 3 KEYNOTE-B15/EV-304 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630, Oral abstract session B: Urothelial carcinoma), which will be featured in the official ASCO (Free ASCO Whitepaper) GU Press Program.1
Results from the first interim analysis of the Phase 3 LITESPARK-022 trial evaluating KEYTRUDA in combination with WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy (abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO (Free ASCO Whitepaper) GU Press Program.
First presentation of data from the Phase 3 LITESPARK-011 trial evaluating WELIREG plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy (abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO (Free ASCO Whitepaper) GU Press Program.2
First-time data presentation for the Phase 2 MK-2870-002 study evaluating sac-TMT plus KEYTRUDA for patients with advanced urothelial carcinoma (abstract #744, Poster session B: Prostate cancer and urothelial carcinoma).3
Details on abstracts listed above and additional key abstracts for Merck

Bladder cancer

Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, Phase 3 KEYNOTE-B15 study. M. D. Galsky.1

Abstract #LBA630, Oral abstract session B: Urothelial carcinoma

Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from the Phase 2 2870-002/SKB264-II-06 study. X. Bian.3

Abstract #744, Poster session B: Prostate cancer and urothelial carcinoma

Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible. To be determined.1

Abstract #638, Rapid oral abstract session B: Urothelial carcinoma

KEYMAKER-U04 substudy 04B: First-line (1L) enfortumab vedotin (EV) plus pembrolizumab (pembro)-based immune checkpoint inhibitor (ICI) combinations for advanced urothelial cancer (UC). A. Peer.1

Abstract #634, Rapid oral abstract session B: Urothelial carcinoma

SWOG 2427: Single arm Phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT). L. K. Ballas.4

Abstract #TPS913, Trials in progress poster session B: Urothelial carcinoma

Kidney cancer

Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized Phase 3 LITESPARK-022 study. T. K. Choueiri.

Abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer

Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy: Open-label Phase 3 LITESPARK-011 study. R. J. Motzer.2

Abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer

Ascending dose escalation of belzutifan plus palbociclib for previously treated advanced clear cell renal cell carcinoma (ccRCC): Phase 1/2 LITESPARK-024 study Part 1. D. F. McDermott.5

Abstract #423, Rapid oral abstract session C: Renal cell cancer and testicular cancer

KEYMAKER-U03 substudy 03B: Novel investigative regimens for previously treated advanced clear cell renal cell carcinoma (ccRCC). L. Albiges.

Abstract #505, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers

Phase 2 trial of belzutifan in participants from China and Japan with von Hippel-Lindau disease-associated tumors: Results from LITESPARK-015 cohort B1. G. Naik.

Abstract #494, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers

Prostate cancer

Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). H. Beltran.6

Abstract #182, Poster session A: Prostate cancer

(Press release, Merck & Co, FEB 12, 2026, View Source [SID1234662643])

On February 12, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that Thomas K. Equels, MS JD, Chief Executive Officer of AIM, will participate in a Virtual Investor Closing Bell Event on Thursday, February 19, 2026, at 4:00 PM ET.

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Equels will focus on AIM’s clinical and regulatory strategy for its lead drug Ampligen, with an emphasis on the ongoing DURIPANC clinical trial in collaboration with AstraZeneca combining Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer.

A live video webcast of the presentation will be available on the Events page of the Company’s website (aimimmuno.com). A webcast replay will become available two hours following the live presentation and will be accessible for 90 days.

(Press release, AIM ImmunoTech, FEB 12, 2026, View Source [SID1234662628])

On February 12, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported financial results and provided a business update for the three months ended December 31, 2025.

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Congenital Hyperinsulinism (HI)

· In December 2025, Rezolute reported topline results from sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI. The study did not meet its primary or key secondary endpoints.

· The study demonstrated reductions from baseline in hypoglycemia events by self-monitored blood glucose at both ersodetug dose levels, but reductions were not statistically significant compared to placebo, due to a pronounced study effect.

· A reduction in hypoglycemia time by continuous glucose monitoring (CGM) was also demonstrated with both dose levels of ersodetug, which was statistically significant compared to placebo at the Week 16 timepoint, but did not meet significance at the Week 24 end of pivotal timepoint.

· In sunRIZE, pharmacologic activity was observed, with target therapeutic drug concentrations achieved in both treatment groups, along with highly sensitive biomarker responses of decreased insulin cell signaling in the active treatment groups, indicating drug activity.

· Notably, all 59 participants who completed the study continued into the ongoing open-label extension portion, including the roll-over of placebo participants onto ersodetug, and the vast majority remain on therapy. Some of the children have been able to stop taking their standard congenital HI therapies and are now receiving ersodetug as monotherapy.

· Subsequent to the announcement of the topline results of the primary and key secondary endpoints, the Company is undertaking extensive analysis of the results and other endpoints, in preparation for its upcoming FDA meeting.

· The Company will be meeting with FDA prior to the end of the first quarter under Breakthrough Therapy Designation to determine next steps for the program.

Tumor HI

· upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.

§ Enrollment is underway and topline results are expected in the second half of 2026.

· In January 2026, the Company shared aggregate data from the initial 9 tumor HI patients treated under the historical Expanded Access Program (EAP).

§ The data show that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN, providing additional evidence of the activity and potential efficacy of ersodetug across various forms of HI.

§ This cohort was the basis for FDA to grant Breakthrough Designation and agree to a single-arm, open-label registrational study design.

§ The glucose infusion rate (GIR) assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants (out of approximately 16) who achieve at least a 50% reduction in GIR.

§ The full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange Commission, can be found here.

Corporate Updates

· In November 2025, the Company hosted a virtual Investor Event during which Rezolute Chief Commercial Officer, Sunil Karnawat, discussed the anticipated commercial opportunities for ersodetug as a potential treatment for congenital and tumor HI. The event also featured presentations from two leading physician experts who provided perspectives on disease background and the significant unmet clinical need in HI.

§ A replay of the virtual event is available on the Investor Relations section of the Company’s website here.

Second Quarter Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $132.9 million as of December 31, 2025, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.3 million for the second quarter of fiscal 2026, compared with $12.6 million for the same period a year ago. The increase from fiscal year 2025 to fiscal year 2026 was primarily due to (i) increased expenditures in clinical trial activities and (ii) higher employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force, partially offset by a decrease in manufacturing costs for ersodetug.

General and administrative (G&A) expenses were $9.9 million for the second quarter of fiscal 2026, compared with $4.5 million for the same period a year ago. The increase was primarily attributable to increased professional fees and employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force.

Net loss was $22.8 million for the second quarter of fiscal 2026 compared with a net loss of $15.7 million for the same period a year ago.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

(Press release, Rezolute, FEB 12, 2026, View Source [SID1234662644])

On February 12, 2026, in connection with the Acquisition (as defined below), Alkermes plc (the "Company") entered into a credit agreement (the "Credit Agreement"), by and among Alkermes plc, as the TopCo Borrower, Alkermes, Inc., as the U.S. Borrower, Alkermes Finance LLC, as the U.S. Co-Borrower, JPMorgan Chase Bank, N.A., as Administrative Agent, Joint Lead Arranger and Joint Bookrunner, BofA Securities, Inc., as Joint Lead Arranger and Joint Bookrunner, and the lenders party thereto. The Credit Agreement provides for (i) a senior secured term loan A facility in an aggregate principal amount of up to $750 million (the "TLA Facility") and (ii) a senior secured term loan B facility in an aggregate principal amount of up to $775 million (the "TLB Facility" and together with the TLA Facility, the "Facilities"). The TLA Facility matures on February 12, 2031, and the TLB Facility matures on August 12, 2031. On the closing date of the Facilities (the "Closing Date"), we borrowed the full $1.525 billion available under the Facilities.

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Borrowings under the TLA Facility will bear interest at an annual rate of, at our option, either (i) the Term SOFR Rate (as defined in the Credit Agreement) plus a Secured Net Leverage Ratio (as defined in the Credit Agreement)-based margin, which will initially be 2.75% per annum or (ii) the Alternate Base Rate (as defined in the Credit Agreement) plus a Secured Net Leverage Ratio-based margin, which will initially be 1.75% per annum. Borrowings under the TLB Facility will bear interest at an annual rate of, at our option, either (i) the Term SOFR Rate plus a margin of 2.75% per annum or (ii) the Alternate Base Rate plus a margin of 1.75% per annum. We have agreed to pay certain fees and expenses in connection with the Facilities, as set forth in the Credit Agreement and certain related fee letters.

The Credit Agreement (other than with respect to the TLB Facility) requires the maintenance of a maximum Secured Net Leverage Ratio and a minimum Consolidated Interest Coverage Ratio (as defined in the Credit Agreement), in each case, with the levels set forth in the Credit Agreement, as of the last day of any of our fiscal quarters ending after the Closing Date. In addition, the Credit Agreement contains customary affirmative and negative covenants, including limitations on indebtedness, liens, mergers, consolidations, sales of assets, investments, transactions with affiliates, restricted payments and sales and leasebacks. The Credit Agreement also contains certain customary events of default, including upon a change of control.

The Credit Agreement is guaranteed by subsidiary guarantors and secured by a lien on substantially all of the assets of the borrowers and the subsidiary guarantors, whether owned as of the Closing Date or thereafter acquired.

The foregoing description of the Credit Agreement does not purport to be complete, provides only a summary of the material terms of the Credit Agreement, and is subject to, and qualified in its entirety by reference to, the full text of the Credit Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01.

(Filing, Alkermes, FEB 12, 2026, View Source [SID1234662629])

On February 12, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.

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Dear Friends and Shareholders,

I would like to start by thanking you for your continued support, and by wishing you and your families a Happy New Year. With 2026 being an important year for us, we remain energized by the promise of our late-stage rare disease pipeline as we continue to evaluate potential strategic options, including, but not limited to, partnership and merger and acquisition opportunities. The previously publicly disclosed upcoming key clinical events and milestones are summarized below.

Top-line results from the actively enrolling 80 patient confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial for HyBryte (SGX301 or synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL) are expected in the second half of 2026, with an interim analysis fast approaching in 2Q. Patient enrollment continues to progress nicely with 66 patients enrolled in the study as of February 10th. Importantly, the overall blinded aggregate response rate remains consistent with what was reported in November and higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Just to remind you, this second Phase 3 trial (FLASH2) essentially replicates the first successful Phase 3 (FLASH) study, with the exception of shifting the primary endpoint assessment from 6 weeks in FLASH to 18 weeks in FLASH2, in keeping with findings in both the FLASH study and other recent supportive studies that have all shown that the longer we treat with HyBryte, the better it works.

A clinical update was provided for the ongoing open-label, investigator-initiated study (IIS) sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH study and is the Principal Investigator for the confirmatory Phase 3 FLASH2 study for the treatment of early-stage CTCL. The IIS evaluated extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage CTCL, with a similar design to that of the active HyBryte arm in FLASH2. Following 18 weeks of continuous "real world" treatment, 75% of patients achieved "Treatment Success," with three of the eight evaluable patients achieving a complete response over the course of the study. These results reinforce HyBryte’s potential as a safe and fast-acting therapy for this chronic and underserved cancer and may explain, in part, the higher aggregate blinded response rate seen in FLASH2.

We continue to work with our lead investigators in CTCL, including pursuing publications to enhance both medical and scientific awareness of HyBryte. We anticipate additional publications around HyBryte in the first half of the year.

Top-line results from the Phase 2a proof of concept clinical trial in Behçet’s Disease (BD) with SGX945 (dusquetide) were reported in July and achieved the study objective of demonstrating biological efficacy. The Phase 2a study was an open-label study designed to be highly comparable (e.g., study endpoints, inclusion-exclusion criteria) to the published Phase 3 study of apremilast (Otezla) used to support marketing approval for oral ulcers in BD. SGX945 outcomes were compared to both the apremilast and placebo arms in this Phase 3 study. Over 4 weeks of treatment, the area under the curve (AUC; a composite measurement of both peak number of oral ulcers and the time to resolution of the oral ulcers), average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study. Notably, outcomes in weeks 5 through 8 continued to show similar outcomes to the apremilast study, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. These results were published in Rheumatology (Oxford) in December. With these results, we intend to embark on a reformulation of SGX945 to enable home-based treatment and look forward to interacting with the health authorities in designing a follow-on placebo-controlled Phase 2b study in 2026.

Top-line results were reported in December for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. On average over the three evaluable patients (one patient discontinued for personal reasons), there were improvements in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. One patient achieved a disease status of "Almost Clear" using the IGA, which is considered a standard clinical measure for treatment success in psoriasis, with a substantial improvement in their PASI score, exceeding 50%. In totality, the initial exploratory phase of the study has confirmed that SGX302 improves psoriasis lesions, consistent with the general success of photodynamic therapies in psoriasis, and is well tolerated, potentially providing a non-carcinogenic, non-mutagenic treatment for the thicker lesions found in psoriasis. With the completion of this pilot study, the table has been set for a more detailed evaluation in this large underserved market.
Additionally, we continue to follow through on our financing strategies, and have sufficient capital and cash runway to meet our goals through 2026. We expect peak annual net sales of HyBryte in the U.S. to exceed $90 million, with the total addressable worldwide CTCL market estimated at greater than $250 million annually. Preliminary analysis of the total addressable worldwide psoriasis market opportunity with SGX302, which uses the same active ingredient as HyBryte, is significant and estimated to exceed $1 billion annually. SGX945 in BD is another meaningful worldwide market opportunity estimated at approximately $200 million annually. Overall, we are excited about our near-term and future upcoming catalytic milestones across our rare disease pipeline, with the potential for significant commercial returns of ~$2B in global annual sales.

With approximately $10.5 million in cash reported in our Form 10-Q for the quarter ended September 30, 2025, not including approximately $500 thousand in non-dilutive funding received through New Jersey’s net operating loss (NOL) sales program, we remain focused on advancing our development programs in our Specialized BioTherapeutics rare disease business segment, most notably, completion of our confirmatory Phase 3 HyBryte clinical trial, where we currently anticipate achieving multiple important and potentially transformational milestones through 2026. We also continue to evaluate strategic options before us to better position the company for growth and success.

We remain steadfast in our plans for partnership in the ex-U.S. markets and continue to pursue discussions with potential partners with similar reputation and expertise in this therapeutic area, as we advance towards successful completion of the FLASH2 confirmatory trial in order to aggressively pursue HyBryte marketing authorizations worldwide. Given HyBryte’s clinical success in CTCL, we also are evaluating other potential cutaneous indications that might similarly benefit from the use of our first-in-class synthetic hypericin.

In closing, thank you again for your interest and your ongoing support of Soligenix. Looking ahead, 2026 has the potential to be an exciting time for the Company, as we further advance our development programs towards commercialization.

(Press release, Soligenix, FEB 12, 2026, View Source [SID1234662645])