BioMarin Announces Closing of Private Offering of Senior Notes

On February 12, 2026 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) ("BioMarin") reported that it closed its previously announced offering of $850 million of 5.500% senior unsecured notes due 2034 (the "Notes"). The issue price of the Notes is 100.000%.

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BioMarin intends to use the net proceeds from the offering of the Notes, together with borrowings under a new $2 billion senior secured term loan "B" facility (the "Term Loan B Facility") and $800 million senior secured term loan "A" facility (the "Term Loan A Facility" and, together with the Term Loan B Facility, the "Term Facilities") and cash on hand, to fund the consideration payable in connection with the pending acquisition (the "Acquisition") of Amicus Therapeutics, Inc. ("Amicus") and related fees and expenses in connection with the Acquisition and borrowings under the Term Facilities and the offering of the Notes. In addition to the Term Facilities, BioMarin expects to enter into a $600 million senior secured revolving credit facility connection with the Acquisition (the "New Revolving Facility" and, together with the Term Facilities, the "New Senior Secured Credit Facilities"). BioMarin may borrow up to $150 million under the New Revolving Facility to pay such fees and expenses.

Gross proceeds from the offering of the Notes were deposited into an escrow account at the closing of the offering, pending consummation of the Acquisition. In the event that the Acquisition is not completed on or prior to December 19, 2026, or upon the occurrence of certain other events, BioMarin will be required to redeem all of the Notes at a redemption price equal to 100% of the initial issue price of the Notes plus accrued and unpaid interest from the date of issuance, or the most recent date to which interest has been paid or provided for, to but excluding the special mandatory redemption date.

The Notes are jointly and severally guaranteed by certain of BioMarin’s subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities, including, after the closing of the Acquisition, Amicus and certain of its subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities.

The indenture governing the Notes contains customary covenants that, among other things, restrict, with certain exceptions, the ability of each of BioMarin and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the Notes were offered and sold only to a limited number of persons who were either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes are subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This press release is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

(Press release, BioMarin, FEB 12, 2026, View Source [SID1234662634])

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer

On February 12, 2026 Innovent Biologics, Inc. ("Innovent",HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first participant has been successfully dosed in the pivotal Phase 3 clinical study (HeriCare-Breast01). The trial is evaluating the company’s developed IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. IBI354 has two pivotal Phase 3 trials ongoing (HeriCare-Ovarian01, HeriCare-Breast01), which holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity".

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HeriCare-Breast01 (NCT07377643) is a multicenter, randomized, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival (PFS).

Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 88 participants with HER2-positive breast cancer were enrolled(the median prior treatment lines was 4) and were treated with 6-15 mg/kg doses of IBI354.

As of March 24, 2025, the overall confirmed objective response rate (cORR) was 59.1% and the disease control rate (DCR) was 90.9%.
Among them, ORR reached 72.4% and DCR reached 89.7% in 29 breast cancer participants treated with 9mg/kg Q3W.
The median follow-up time of 9mg/kg Q3W dose group was 13.6 months as of the cut-off date, and progression-free survival (PFS) was 14.1 month (95%CI: 8.3, NC). The data were presented at the ASCO (Free ASCO Whitepaper) 2025[Link].
IBI354 also demonstrated an excellent safety profile in this Phase 1/2 clinical study (n=368).

No DLT was occurred up to 18mg/kg dose group.
The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) in 9mg/kg Q3W dose group was 21.0%, the incidence of TRAEs leading to dose interruption was 9.9%, the incidence of TRAEs leading to dose reduction was 1.2%, the overall incidence of TRAEs leading to discontinuation was 1.2%, and no TRAE leading to death reported.
The most common TRAEs are white blood cell count decreased, nausea and anemia. The incidence of interstitial lung disease was only 1.2%, all were grade 1.
The Principal Investigator of the HeriCare-Breast01 study, Binghe Xu, academician of the Chinese Academy of Engineering from Cancer Hospital Chinese Academy of Medical Sciences, stated, "We are pleased to complete the first patient enrollment for the HeriCare-Breast01 study at our center. Although first-line treatment for HER2-positive advanced breast cancer has improved substantially—with the THP regimen delivering durable responses for many patients—important clinical challenges remain. These include treatment discontinuation driven by toxicity and limited tolerability of currently available ADCs, particularly among older patients and those with comorbid conditions. As a next-generation HER2-targeted ADC, IBI354 has shown compelling antitumor activity in Phase 1/1b studies, achieving class-leading ORR and DCR, alongside a notably favorable safety profile. In particular, IBI354 has demonstrated reduced incidence of key adverse events such as interstitial lung disease (ILD), peripheral neuropathy, and neutropenia. This "high-efficacy, low-toxicity" therapeutic window may allow a broader range of patients to achieve sustained, high-quality treatment outcomes. We look forward to the Phase 3 HeriCare-Breast01 study to further validate this potential and advancing IBI354 toward becoming a new standard of care in the first-line treatment for HER2-positive advanced breast cancer. "

Dr. Zhou Hui, Chief R&D Officer (Oncology) of Innovent, stated, "The initiation of the pivotal Phase 3 HeriCare-Breast01 trial in China marks a significant milestone in the clinical translation of Innovent’s ADC pipeline. Leveraging the world’s leading antibody engineering and differentiated linker-payload technologies, Innovent has established a highly competitive and innovative TOPO1i ADC technology platform SoloTx. IBI354 has demonstrated a compelling safety and efficacy profile in early-stage studies, strongly validating the strengths of our SoloTx ADC platform. IBI354 holds strong potential to offer a new first-line treatment option for patients with HER2-positive advanced breast cancer—one that combines durable antitumor activity with favorable long-term tolerability. Looking ahead, Innovent will continue to advance innovation of next-generation IO+ADC, with a steadfast commitment to delivering improved therapeutic outcomes for cancer patients."

About Breast Cancer

Breast cancer is one of the most common cancers among women worldwide. Approximately 1.3 million women are diagnosed with breast cancer each year, and about 30% of them develop locally advanced or metastatic breast cancer. The clinical proportion of HER2-positive breast cancer is approximately 20%[1]. Previous studies have demonstrated that overexpression of this HER2 gene plays a significant role in the occurrence and development of invasive breast cancer and is associated with an increased recurrence rate and poor prognosis [2]. At present, no ADC targeting HER2 has been fully approved for first-line treatment of advanced breast cancer in China. There is an urgent need for new drugs to improve the prognosis of patients.

About IBI354

IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent’s proprietary SoloTx ADC platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals.

With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors.

Starting from the urgent clinical needs, in addition to the Phase 3 studies (HeriCare-Breast01 and HeriCare-Ovarian01) already initiated in BC and PROC, Innovent will explore IBI354 in multiple solid tumor indications.

(Press release, Innovent Biologics, FEB 12, 2026, View Source [SID1234662651])

Orion Full-Year 2025 Result Presentation

On February 12, 2026 Orion reported Full-Year 2025 Results.

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(Presentation, Orion, FEB 12, 2026, View Source [SID1234663023])

AdvanCell and GlycoNet-supported startup 48Hour Discovery announce collaboration and exclusive licensing agreement

On February 12, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, and 48Hour Discovery, a peptide discovery platform company and GlycoNet-supported startup, reported a collaboration and exclusive licensing agreement to develop a novel peptide-based Lead-212 (²¹²Pb) radioligand therapy program for oncology.

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The collaboration is focused on the development of a purpose-built ²¹²Pb-targeted radioligand therapy, including a peptide ligand optimized for delivery of AdvanCell’s lead-212 (²¹²Pb) alpha-emitting payload. While centered on a 212Pb targeted RLT, the work also serves as a proof point for the broader applicability of 48Hour Discovery’s peptide discovery engine in radioligand therapy (RLT) development, demonstrating its ability to generate ligands compatible with targeted alpha delivery.

Precision Alpha Therapy, Enabled by Rapid Peptide Discovery
Lead-212 is a potent alpha-emitting radionuclide that enables localized, high-energy radiation delivery while minimizing damage to surrounding healthy tissue. AdvanCell has built an integrated platform around ²¹²Pb spanning isotope supply, manufacturing, and clinical development.

48Hour Discovery’s platform—combining large phage display libraries, high-throughput screening, and AI and chemical optimization—has been designed to rapidly generate peptides with high affinity and specificity. This program highlights the platform’s capacity to meet the stringent requirements of RLT development, including selectivity, PK and biodistribution properties, stability and payload compatibility.

"This collaboration reflects the strength of our ²¹²Pb platform and our ambition to translate scientific innovation into novel targeted alpha therapies that can meaningfully change outcomes for patients," said Philina Lee, PhD, CEO of AdvanCell. "It also demonstrates how innovative discovery technologies can be applied to accelerate the development of highly targeted alpha therapies."

Rick Finnegan, CEO of 48Hour Discovery, added:
"We see this program as an important validation of our discovery engine in the radioligand therapy space. It underscores the broader utility of our platform for generating ligands suited to demanding oncology applications. Importantly, this agreement is one of several partnerships we have entered into recently with companies developing radioligand therapies, and together they highlight the versatility of our platform across this rapidly growing modality."

(Press release, GlycoNet, FEB 12, 2026, View Source;utm_medium=rss&utm_campaign=advancell-and-glyconet-supported-startup-48hour-discovery-announce-collaboration-and-exclusive-licensing-agreement [SID1234662635])

CORMEDIX TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES

On February 12, 2026 CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be presenting and participating in investor meetings at upcoming investor conferences taking place in March.

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Leerink Partners Global Healthcare Conference
Date: March 10, 2026
Time: 1:00pm Eastern
Format: Fireside Chat
Webcast: Link to webcast

Citizens Life Sciences Conference
Date: March 11, 2026
Time: 9:35am Eastern
Format: Fireside Chat
Webcast: Link to webcast

Barclays 28th Annual Global Healthcare Conference
Date: March 12, 2026
Format: One-on-one investor meetings

(Press release, CorMedix, FEB 12, 2026, View Source [SID1234662636])