On February 12, 2026 Alkermes plc (Nasdaq: ALKS) ("Alkermes") and Avadel Pharmaceuticals plc (Nasdaq: AVDL) ("Avadel") reported Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep medicine market and enhances its ability to unlock the full potential of its late-stage development pipeline focused on central disorders of hypersomnolence.

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The transaction was completed pursuant to an Irish High Court sanctioned scheme of arrangement (the "Scheme") under Chapter 1 of Part 9 of the Companies Act 2014 of Ireland. LUMRYZ (sodium oxybate) for extended-release oral suspension is approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.

"With the close of this acquisition, Alkermes achieved an important milestone in the continued advancement of our strategy, accelerating our entry into the commercial sleep medicine market at a pivotal moment as we work to initiate the planned phase 3 program for alixorexton in narcolepsy this quarter. Avadel’s commercial and R&D portfolio, established commercial infrastructure, and talented team strengthen our organization and expand our capabilities in this important therapeutic area. Supported by our strong balance sheet, this all‑cash acquisition is expected to enhance our revenue growth profile and underscores our ongoing commitment to creating long‑term value for shareholders," said Richard Pops, Chief Executive Officer of Alkermes.

The transaction is expected to be accretive in 2026 and represents a compelling financial and strategic opportunity, leveraging Alkermes’ existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. Avadel is a recognized innovator in the sleep medicine space, committed to addressing significant unmet needs for patients.

Since launching LUMRYZ in 2023, Avadel has successfully built and scaled a commercial organization that has driven strong demand. With an estimated population of >50,000 oxybate-eligible narcolepsy patients in the United States, LUMRYZ has significant opportunity for growth ahead. The acquisition also includes valiloxybate, Avadel’s in-licensed salt-free, once-at-bedtime oxybate candidate in phase 1 clinical development.

To finance the acquisition, Alkermes will use approximately $775 million of cash from its balance sheet and borrowed a total of $1.525 billion in term loans that are due in 2031. The company expects to pay down the debt quickly with cash flows from the business.

Alkermes will provide its 2026 financial expectations for the combined organization on Feb. 25, 2026 as part of its financial results announcement for the quarter and year ended Dec. 31, 2025. Alkermes’ financial expectations for 2026 will include certain expenses related to the transaction, including:

In the first quarter of 2026, Alkermes will record transaction-related costs of $40 million.
Alkermes will record approximately $180 million of LUMRYZ inventory fair value step-up, which will be expensed as cost of goods sold as the inventory is sold in 2026.
Alkermes will record approximately $1.5 billion of intellectual property related to LUMRYZ, which will be amortized over an expected life of 13 years. Alkermes expects amortization of intangible assets to be in the range of $95 to $105 million in 2026.
Net interest expense is expected to be in the range of $75 to $85 million in 2026.
The acquisition was approved by Avadel shareholders at a scheme meeting of shareholders and at an extraordinary general meeting of shareholders, each held on Jan. 12, 2026. The Irish High Court sanctioned the Scheme on Feb. 10, 2026. On Feb. 12, 2026 (the "Effective Date"), the Scheme and the acquisition became effective upon delivery of the court order of the Irish High Court to the Irish Companies Registration Office. Prior to the opening of trading on Feb. 12, 2026, all of Avadel’s shares will cease trading on the Nasdaq Global Market ("Nasdaq"), and Avadel intends to promptly cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Payment of the Cash Consideration to the Scheme Shareholders pursuant to the Scheme is being commenced by Alkermes today, Feb. 12, 2026. The Rights Agent will record the Scheme Shareholders as the owners of the CVR Consideration in the CVR Register in accordance with the terms of the CVR Agreement dated as of today, Feb. 12, 2026.

Except as otherwise defined herein, capitalized terms used but not defined in this announcement have the same meanings as given to them in the definitive proxy statement filed by Avadel with the U.S. Securities and Exchange Commission ("SEC") on Dec. 3, 2025, which also constitutes a scheme circular under Irish law.

(Press release, Alkermes, FEB 12, 2026, View Source [SID1234662630])

On February 12, 2026 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter and year ended December 31, 2025.

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"The year ahead marks an important turning point for the company, as we approach two potential product launches and a pivotal data readout that, together, could significantly accelerate our commercial revenue trajectory," said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. "We are implementing a strategic restructuring plan to reduce our operating expenses and ensure our resources are squarely aligned with our highest-impact opportunities, while leading the future of rare disease with multiple first ever treatments."

Fourth Quarter 2025 Selected Financial Data Tables and Financial Results

Revenues (dollars in millions), (unaudited)

Three Months Ended December 31, Year Ended December 31,
2025 2024 2025 2024
Crysvita
Product sales – Latin America and Türkiye $ 40 $ 22 $ 177 $ 135
Royalty revenue – U.S. and Canada 97 87 275 249
Royalty revenue – Europe 8 7 29 26
Total Crysvita Revenue 145 116 481 410
Dojolvi 32 31 96 88
Evkeeza 17 10 59 32
Mepsevii 13 8 37 30
Total revenues $ 207 $ 165 $ 673 $ 560


Revenues
Ultragenyx reported $207 million in total revenue for the fourth quarter 2025, which represents 25% growth compared to the same period in 2024. Crysvita revenue in the fourth quarter 2025 was $145 million, which includes product sales of $40 million from Latin America and Türkiye. Dojolvi revenue in the fourth quarter 2025 was $32 million. Evkeeza revenue in the fourth quarter 2025 was $17 million.

Total revenue for the year ended December 31, 2025 was $673 million, which represents 20% growth compared to the prior year. Full year 2025 Crysvita revenue was $481 million, which represents 17% growth compared to the prior year. This includes product sales of $177 million from Latin America and Türkiye, which represents 31% growth compared to the prior year. Dojolvi revenue in 2025 was $96 million, which represents 9% growth compared to the prior year. Evkeeza revenue in 2025 was $59 million, which represents 84% growth compared to the prior year, as demand continues to build following launches in the company’s territories outside of the United States.

Selected Financial Data (dollars in millions, except per share amounts), (unaudited)

Three Months Ended December 31, Year Ended December 31,
2025 2024 2025 2024
Total revenues $ 207 $ 165 $ 673 $ 560
Operating expenses:
Cost of sales 29 17 109 77
Research and development 203 188 750 698
Selling, general and administrative 89 82 349 321
Total operating expenses 321 287 1,208 1,096
Net loss $ (129 ) $ (133 ) $ (575 ) $ (569 )
Net loss per share, basic and diluted $ (1.29 ) $ (1.39 ) $ (5.83 ) $ (6.29 )

Operating Expenses

Total operating expenses for the fourth quarter 2025 were $321 million. Total operating expenses for the year ended December 31, 2025 were $1.2 billion, including $153 million of non-cash stock-based compensation.

Net Loss

Net loss for the fourth quarter 2025 was $129 million, or $1.29 per share basic and diluted, compared with a net loss for the fourth quarter 2024 of $133 million, or $1.39 per share basic and diluted. Net loss for the year ended December 31, 2025 was $575 million, or $5.83 per share basic and diluted, compared with a net loss the prior year of $569 million, or $6.29 per share, basic and diluted.

Cash Balance and Net Cash Used in Operations

Cash, cash equivalents, and marketable securities were $737 million as of December 31, 2025. For the three months ended December 31, 2025, net cash used in operations was $100 million and for the year ended December 31, 2025 was $466 million.

Financial Guidance and Strategic Restructuring Plan

2026 revenue guidance

Total revenues, excluding potential revenue from new product launches, in the range of $730 million to $760 million, an increase of 8% to 13% compared to 2025
Crysvita revenue in the range of $500 million to $520 million, reflecting growing underlying global demand partially offset by expected timing of ordering patterns in Brazil
Dojolvi revenue in the range of $100 million to $110 million

Strategic restructuring plan and path to profitability in 2027

Ultragenyx has initiated a strategic restructuring plan designed to reduce its headcount and expenses and focus resources on its largest value drivers. The significant reduction and partial reinvestment of expenses, and the planned growth in revenue from current and new product launches, are designed to keep the company on its path to profitability in 2027.

Today, in connection with the restructuring plan, the company announced a 10% workforce reduction, impacting approximately 130 employees.

Based on the progression of the business and the reductions from the restructuring plan:

In 2026, combined R&D and SG&A expenses are expected to be flat to down low-single digits versus 2025. This includes the impact of spend reductions and approximately $50 million for severance, manufacturing, and other non-recurring restructuring charges.
In 2027, R&D expenses are expected to decrease from 2025 levels by 38%, or approximately $280 million, driven by the completion of multiple phase 3 studies and reduction of early-stage research efforts. SG&A expenses are expected to increase in support of new product launches and existing approved products. On a combined basis, 2027 R&D and SG&A expenses are expected to decrease at least 15% versus 2025.

2026 Clinical and Regulatory Catalysts

DTX401 (pariglasgene brecaparvovec) AAV8 gene therapy for glycogen storage disease type Ia (GSDIa): Biologics License Application (BLA) rolling submission completed in December 2025, with an anticipated Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2026.

UX111 (rebisufligene etisparvovec) AAV9 gene therapy for Sanfilippo syndrome type A (MPS IIIA): The BLA was resubmitted in January 2026 and included substantial longer-term data, that were recently presented at the 2026 WORLDSymposium, on multiple measures of neurologic benefit to support an intermediate clinical endpoint for accelerated approval supported further by CSF heparan sulfate and other biomarker data, as agreed with the FDA during the last clinical review.
Earlier today the company received an Incomplete Response Letter (IRL) regarding its resubmitted BLA. The IRL requests additional supportive documentation related to its CRL CMC responses, which the company will provide in a resubmission.
GTX-102 (apazunersen) antisense oligonucleotide (ASO) for the treatment of Angelman syndrome (AS): Data from the fully enrolled, pivotal, Phase 3 Aspire study in patients with a genetically confirmed diagnosis of UBE3A deletion is expected in the second half of 2026. Enrollment in the Phase 2/3 Aurora study is also underway in other genotypes and ages, with the first patient dosed in October 2025.

UX701 (rivunatpagene miziparvovec) AAV9 gene therapy for Wilson disease: Enrollment is complete for the fourth cohort in the ongoing, dose-finding stage of the pivotal Cyprus2+ study. Data from this stage are expected in 2026.

Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, February 12, 2026, at 2 p.m. PT/5 p.m. ET to discuss the fourth quarter and full year 2025 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source The replay of the call will be available for three months.

(Press release, Ultragenyx Pharmaceutical, FEB 12, 2026, View Source [SID1234662646])

On February 12, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported its interim results for the third quarter of 2025 and provided a business update.

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"The fourth quarter of 2025 was marked by continued execution on our strategy, focusing on advancing mitazalimab towards initiation of registrational trials, strengthening the scientific foundation of our pipeline, and increasing financial flexibility. While the external funding environment for biotech remains challenging, we have concentrated on areas within our control — generating high-quality data, maintaining operational discipline, and making focused investments that position the company to progress mitazalimab toward late-stage development."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Scientific validation: Biomarker analyses from OPTIMIZE-1 were published in Cell Reports Medicine, deepening the understanding of mitazalimab’s mechanism of action and links to clinical outcomes.
Additional clinical publication: Data from the Phase 1 REACtiVe-2 study were published in Nature Communications, supporting mitazalimab’s ability to activate systemic immune responses in metastatic pancreatic cancer.
External visibility: Mitazalimab data were presented at international scientific congresses during the quarter, further strengthening clinical relevance and scientific recognition.
ATOR-4066

Pipeline progress: Preclinical and mechanistic data for ATOR-4066 were presented at international scientific meetings, supporting its immune-modulating potential as a next-generation bispecific antibody program.
Strengthened intellectual property: A U.S. patent covering ATOR-4066 was granted, reinforcing long-term protection and supporting the program’s future value.
HLX22

Program expansion: Henlius received approval to initiate Phase 2/3 studies in breast cancer in China, broadening the clinical scope of HLX22 and potentially increasing the opportunity for future milestone payments and royalty revenues for Alligator.
Company / Financial position

Rights issue completed: Alligator finalized a rights issue of units (shares and warrants) to strengthen its financial position and support continued development of mitazalimab.
Outcome announced 22 December: The issue was subscribed to approximately 64.8%, providing around SEK 91 million (gross) before issue costs and repayments.
Additional capital potential in 2026: The rights issue included warrants that may provide further funding next year, supporting continued flexibility.
Bridge financing and loan repayment: The rights issue followed bridge financing to secure near-term liquidity and enabled repayment of bridge loans and part of the outstanding loan to Fenja Capital.
FINANCIAL SUMMARY FOR Q4 AND YEAR-END 2025
The financial summaries for the quarterly periods ending 31 December 2025 and 31 December 2024 are presented below.

All amounts in MSEK,
unless specified October – December 2025 October – December
2024
Net sales - 41.8
Operating profit/loss -22.5 -60.1
Profit/loss for the period -29.0 -55.4
Cash flow for the period 37.2 17.1
Cash and cash equivalents 62.2 64.3
Earnings per share before and after dilution*, SEK -0.66 -73.10
* Adjusted for reverse share split.
The financial summaries for the year-to-date periods ending 31 December 2025 and 31 December 2024 are presented below.

All amounts in MSEK,
unless specified January – December
2025 January – December
2024
Net sales 0.5 57.8
Operating profit/loss -105.8 -229.1
Profit/loss for the period -51.4 -233.9
Cash flow for the period -1.2 -1.2
Cash and cash equivalents 62.2 64.3
Earnings per share before and after dilution*, SEK -1.87 -318.53
* Adjusted for reverse share split.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, 12 February 2026, at 3 p.m. CEST/ 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

(Press release, Alligator Bioscience, FEB 12, 2026, View Source [SID1234662631])

On February 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it will present data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California, from February 18-21, 2026.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high‑level expression of therapeutic genetic payloads directly within the tumor. CLD‑401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist, a known T-cell activator, in the TME.

BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor‑localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE.

"RedTail is a major leap forward in the delivery of genetic medicine via an engineered virus," said Eric Poma, PhD, Chief Executive Officer of Calidi. "It is able to avoid immune clearance allowing for systemic delivery but can only replicate and express payload in tumor cells."

"Our work with RedTail continues to highlight the flexibility of the platform to deliver complex biologics directly within the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "We believe simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to enable for T-cell engagement precisely where it is needed."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug

(IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, FEB 12, 2026, View Source [SID1234662648])

On February 12, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported significant recent expansions of its global intellectual property estate supporting its DDR-focused oncology pipeline.

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Aprea’s patent strategy is designed to secure durable global protection around its proprietary molecules, formulations, and therapeutic applications, to de-risk clinical development and maximize long-term commercial value.

"Our intellectual property estate is a foundational asset for Aprea and a key component of our long-term strategy to create value and differentiate Aprea within the DDR therapeutics field," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are building a broad, defensible portfolio across both our WEE1 and ATR programs, strengthened by multiple new patents granted in 2025 in key global markets. This portfolio is designed to protect our core compounds, formulations, and methods of use. By securing broad protection globally into the 2040s, we are positioning our assets for further development, future commercialization and potential strategic transactions with the ultimate goal of bringing new treatment options to patients with difficult-to-treat cancers."

The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations. Aprea’s WEE1 kinase inhibitor program is backed by an expanding global patent portfolio. The intellectual property estate includes one provisional U.S. patent application, two pending U.S. patent applications, one issued patent in Australia (issued in 2025) and 13 pending applications outside the United States. If granted, the core patents in the WEE1 family are expected to provide protection through 2042, excluding any additional regulatory exclusivities that may be available. The WEE1 portfolio is expected to protect key program assets, including new chemical entities (e.g., APR-1051), new pharmaceutical compositions comprising those entities, and methods of treating a range of oncology indications.

The Company’s lead ATR inhibitor, ATRN-119, is currently being evaluated in the ABOYA-119 clinical trial as monotherapy in patients with advanced solid tumors. The Company’s ATR inhibitor program is protected by a robust patent estate. This includes four issued U.S. patents and one pending U.S. application, and one international application, as well as 21 granted patents, including one recently issued in Japan in 2025, and 15 pending applications in international jurisdictions. The ATR portfolios protects new chemical entities, new pharmaceutical compositions comprising those entities, and methods of treating a range of oncological indications. Existing issued patents are expected to remain in force through 2035–2037, excluding any additional regulatory exclusivity that may be available. The pending applications, if granted, could extend intellectual property protection into 2045.

Aprea filed provisional applications in the U.S. in 2025 covering macrocyclic undisclosed DDR target inhibitors and methods of their preparation and use.

(Press release, Aprea, FEB 12, 2026, View Source [SID1234662632])