Entry into a Material Definitive Agreement

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])

AIM ImmunoTech to Participate in Live Virtual Investor Closing Bell Event

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])

Agios Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On February 12, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the fourth quarter and year ended December 31, 2025.

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"2025 was another year of continued execution across our portfolio, highlighted by the historic U.S. approval of AQVESME – the only medicine approved to treat anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The U.S. launch is off to a strong start, with AQVESME now available and earning an enthusiastic response from the thalassemia community," said Brian Goff, Chief Executive Officer, Agios. "In 2026, we are focused on driving a high-impact U.S. launch of AQVESME, expanding our PK activation franchise into additional high-value indications such as sickle cell disease and lower-risk myelodysplastic syndromes, and advancing our promising early-stage pipeline to further diversify across hematologic and other rare diseases. With disciplined capital allocation and strong operational execution, we are very well positioned at this critical inflection point to deliver a transformative medicine for the thalassemia community and advance our clinical programs as we work toward our goal of becoming a sustainable rare disease company."

Fourth Quarter 2025 and Recent Corporate Highlights
Mitapivat Commercial Performance and Update

PYRUKYND (mitapivat 5 mg, 20 mg, 50 mg)
$16.0 million in U.S. net revenue in the fourth quarter of 2025, driven by continued commercial focus in pyruvate kinase (PK) deficiency ahead of the U.S. commercial launch of AQVESME (mitapivat) in thalassemia, an additional ordering week in the fourth quarter, and favorable gross-to-net adjustments. This represents an increase of 49 percent from $10.7 million in the fourth quarter of 2024 and a 24 percent increase from $12.9 million in the third quarter of 2025.
$4.0 million in ex-U.S. net revenue in the fourth quarter of 2025, driven by inventory stocking ahead of demand pull-through in Europe for PK deficiency, as patients transition onto commercial supply.

AQVESME (mitapivat 100 mg)
In December 2025, the U.S. Food and Drug Administration (FDA) approved AQVESME as the only medicine for the treatment of anemia in adults with alpha- or beta-thalassemia, regardless of transfusion burden.
AQVESME is now available in the U.S. following the implementation of its Risk Evaluation and Mitigation Strategy (REMS) program in late January 2026.
R&D Highlights

Mitapivat
Sickle Cell Disease –
Topline results from the RISE UP Phase 3 trial of mitapivat in sickle cell disease were reported in November 2025.
Agios will have a pre-supplemental New Drug Application (sNDA) meeting with the FDA in the first quarter of 2026 and intends to submit a U.S. marketing application for mitapivat in sickle cell disease following that engagement. The company will provide an update on its regulatory filing strategy following receipt of the meeting minutes.
Tebapivat
Sickle Cell Disease –
Agios has completed enrollment for the Phase 2 trial of tebapivat in sickle cell disease, and expects to report topline results in the second half of 2026. This double-blind, randomized, placebo-controlled trial is evaluating three tebapivat doses (2.5 mg, 5 mg, and 7.5 mg) versus matched placebo over a 12-week period. The primary endpoint is hemoglobin response, defined as a ≥1.0 g/dL increase in average hemoglobin concentration from Week 10 through Week 12 compared with baseline.
Fourth Quarter 2025 Financial Results
For the quarter ended December 31, 2025, net loss was $108.0 million dollars, compared to net loss of $96.5 million dollars for the quarter ended December 31, 2024.

Net product revenue from U.S. sales of PYRUKYND for the fourth quarter of 2025 was $16.0 million, compared to $10.7 million for the fourth quarter of 2024.
Net product revenue from ex-U.S. sales of PYRUKYND for the fourth quarter of 2025 was $4.0 million.
Cost of sales for the fourth quarter of 2025 was $1.9 million.
Research and Development (R&D) Expenses were $88.1 million for the fourth quarter of 2025, compared to $82.8 million for the fourth quarter of 2024, associated with the advancement of the company’s early-stage clinical programs.
Selling, General and Administrative (SG&A) Expenses were $51.6 million for the fourth quarter of 2025, which were flat compared to $51.7 million for the fourth quarter of 2024.
Cash, cash equivalents and marketable securities were $1.2 billion as of December 31, 2025, compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, advance the company’s existing clinical programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information
Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s fourth quarter and full year 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, FEB 12, 2026, View Source [SID1234662627])

AbCellera to Present at Upcoming Investor Conferences in March and April 2026

On February 11, 2026 AbCellera (Nasdaq: ABCL) reported that the Company will present at the following investor conferences:

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TD Cowen 46th Annual Health Care Conference, March 4, 2026
KeyBanc Capital Markets Healthcare Forum, March 17, 2026
Bloom Burton & Co. Healthcare Investor Conference, April 21-22, 2026

A live audio webcast of each presentation may be accessed through a link that will be posted on AbCellera’s Investor Relations website closer to date. A replay will be available through the same link following the presentation.

(Press release, AbCellera, FEB 11, 2026, View Source [SID1234662616])

Valar Labs Publishes Pivotal Study in Journal of Clinical Oncology Validating AI to Predict Chemotherapy Response for Pancreatic Cancer Patients

On February 11, 2026 Valar Labs, a leader in computational histology and precision oncology, reported the publication of a major study in the Journal of Clinical Oncology (JCO), a premier, peer-reviewed medical journal published by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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The report, appearing in the Journal of Clinical Oncology (JCO), uses Valar Labs’ proprietary AI algorithm that analyzes standard H&E-stained pathology slides—universally available for almost every cancer patient—to identify distinct histological signatures in pancreatic cancer that correlate with response to specific therapies.

"This study proves that there is a wealth of predictive information hidden within standard pathology images that the human eye cannot quantify, but AI can," said Viswesh Krishna, Co-founder and CTO of Valar Labs.

Pancreatic cancer remains a difficult-to-treat disease and currently, oncologists have limited tools to decide between the two standard-of-care, first-line chemotherapy options (FOLFIRINOX vs. Gemcitabine/Nab-Paclitaxel), often relying on patient performance status rather than tumor biology. This trial-and-error approach can cost patients valuable time and expose them to unnecessary toxicity.

The paper, titled "Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer," details the development and rigorous validation of Valar Labs’ Vitara Pancreas AI diagnostic test. The study demonstrates the AI’s ability to accurately predict patient response to specific first-line chemotherapy regimens, addressing a critical unmet need in one of the deadliest forms of cancer.

"Publication in the Journal of Clinical Oncology is a significant milestone that underscores the scientific rigor and clinical validity of our approach," said Anirudh Joshi, Co-founder and CEO of Valar Labs. "For too long, first-line treatment decisions in advanced pancreatic cancer have been a bit of a guessing game. By validating our technology with high-quality data from PanCAN and the COMPASS trial, we can provide oncologists with a tool to personalize care and potentially improve outcomes for thousands of patients."

The study utilized data from two prospective cohorts to validate the AI biomarker:

PanCAN’s Know Your Tumor initiative: A precision medicine service offered by the Pancreatic Cancer Action Network (PanCAN) that has pioneered molecular profiling for pancreatic cancer patients, accessed via PanCAN’s SPARK health data platform.
The COMPASS clinical trial: A renowned prospective trial focused on genomics-driven precision medicine for advanced pancreatic cancer.
"This work reflects how AI has the potential to move the field forward by helping guide treatment decisions," said Anna Berkenblit, MD, MMSc, PanCAN Chief Scientific and Medical Officer.

"By leveraging de-identified patient health data in the PanCAN SPARK health data platform, this initiative underscores how AI-driven data discoveries can not only accelerate research but can also lead to improved patient outcomes," said Kawther Abdilleh, PhD, PanCAN Director, Data Science and Informatics and co-author.

Following this biomarker validation, Valar Labs is pleased to make the Vitara Pancreas ChemoPredict test available under early access to oncologists for advanced pancreatic cancer patients. Participating providers can order the test to gain actionable insights into which first-line chemotherapy regimen is most likely to benefit each patient.

"Biomarkers to guide choice of first-line chemotherapy in advanced pancreatic cancer have been a decades-long goal for the pancreatic cancer community," said Dr. Andrew Hendifar, Pancreatic Cancer Medical Director at Cedars Sinai Samuel Oschin Cancer Center, and lead author of the study. "We are excited to share results validating a predictive AI biomarker for this important clinical decision and look forward to integrating the Vitara Pancreas test into our clinical decision making for patients."

Valar Labs is a recognized leader in AI-driven diagnostics for genitourinary cancers, with its flagship Vesta bladder cancer portfolio in use across dozens of leading health systems and cancer centers nationwide. The successful validation of Vitara Pancreas and its availability mark Valar Labs’ expansion into gastrointestinal cancers, further establishing the company as a multi-tumor oncology platform committed to transforming cancer care through artificial intelligence.

Article: Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer

(Press release, Valar Labs, FEB 11, 2026, View Source [SID1234662615])