On February 11, 2026 SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, reported that the first patient has been dosed in the second of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with Pancreatic Ductal Adenocarcinoma.

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"Dosing the first patient in our FAPI-PRO trial is a major step forward in the evaluation of FAPI as an oncological diagnostic tool," said Philipp Czernin, Chief Business Officer, SOFIE Biosciences. "We undergo this trial encouraged by the results of our Phase 2 and independent academic investigator-initiated studies supporting [18F]FAPI-74’s potential role in staging accuracy, which is especially needed for pancreatic cancer."

"The potential sensitivity of [18F]FAPI-74 PET makes its availability to stage patients with newly diagnosed pancreatic ductal adenocarcinoma attractive to patients and clinicians alike. The whole team, including surgeons and oncologists, are enthusiastic about using [18F]FAPI-74 PET to help select the best initial treatments," said Dr. Gary Ulaner, James & Pamela Muzzy Endowed Chair in Molecular Imaging and Therapy, Hoag Family Cancer Institute, and Professor of Radiology and Cancer Biology, University of Southern California.

The FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer) trial is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in adults with Pancreatic Ductal Adenocarcinoma. The study is planned for 18 sites with an estimated enrollment of 200 subjects over a 24-month period.

The primary study endpoints are sensitivity and specificity for detection of distant metastatic disease (M1). For additional trial details, visit the study page on ClinicalTrials.gov NCT07217717).

The partner Phase 3 study, FAPI-GO (FAPI in Gastroesophageal Oncology), which began November 2025, is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in adults with gastroesophageal cancers. The first patient in FAPI-GO was dosed on December 26, 2025. For additional trial details, visit the study page on ClinicalTrials.gov (NCT07217704).

ABOUT [18F]FAPI-74

[18F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer in the FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety, and a biodistribution profile amenable to detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners.

(Press release, Sofie Biosciences, FEB 11, 2026, View Source [SID1234662608])

On February 11, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Francesca Barone, M.D., Ph.D., Candel’s Chief Scientific Officer, will present data and participate in multiple sessions at the 7th Annual Glioblastoma Drug Development Summit, taking place February 17-19, 2026 in Boston, Massachusetts.

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Dr. Barone will share insights from Candel’s HSV-based platform and the linoserpaturev (CAN-3110) program in recurrent high-grade glioma (rHGG) through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma.

Details are as follows:

Workshop Panel

Title: Harnessing Omics Data & Molecular Subtyping to Inform Patient Stratification in Clinical & Translational Strategies in Glioblastoma Drug Development
Date/Time: Tuesday, Feb. 17, 2026, 8:00 a.m. ET

Conference Presentation

Title: Integration of Biomarkers & Imaging to Define Patient Response in a Phase I/II Clinical Trial
Date/Time: Wednesday, Feb. 18, 2026, 9:30 a.m. ET

Panel Discussion

Title: Driving the Use of Biomarker-Based Enrollment in GBM Trials to Accelerate Clinical Success & Improve Patient Outcomes
Date/Time: Wednesday, Feb. 18, 2026, 12:00 p.m. ET

About linoserpaturev (CAN-3110)

CAN-3110 is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of recurrent HGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, FEB 11, 2026, View Source [SID1234662607])

On February 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company with a diversified portfolio of cell therapy and small molecule product candidates, reported its post-transaction strategy to advance its newly acquired CAR-T assets while maintaining a capital-efficient operation model.

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Following the recent closing of its strategic transaction, Tempest plans to prioritize development of its clinical-stage dual-targeting CD19/BCMA CAR-T program, TPST-2003, while expanding the portfolio into next-generation modalities, including TPST-4003, a newly disclosed in vivo CAR-T program designed to deliver the same dual-targeting CD19/BCMA construct without the need for ex vivo cell manufacturing.

"Our strategy is to leverage partner-funded and externally supported development where possible to generate high-value clinical data before committing significant internal capital," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "This approach allows us to advance multiple programs in parallel, expand the long-term optionality of our CAR-T portfolio and preserve flexibility as we evaluate the most compelling path forward."

Strategic Priorities:

Advance TPST-2003 through upcoming clinical milestones
Tempest plans to continue development of TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, with near-term clinical data expected from an ongoing Phase 1 clinical trial in China. The company anticipates initiation of a registrational Phase 2b in China by the end of 2026, with interim data expected in 2027. Development activities in China are funded by a strategic partner, providing access to pivotal data while preserving internal capital.
Expand the portfolio with in vivo CAR-T development (TPST-4003)
TPST-4003 represents Tempest’s first in vivo CAR-T program and is designed to extend the TPST-2003 biology into a potentially more scalable and patient-friendly modality. The company expects to advance the program through preclinical development and evaluate potential clinical entry through a strategic partner-funded Investigator Initiated Trial in the near-term.
Position amezalpat for pivotal development through business development
Amezalpat remains Phase 3-ready in first-line hepatocellular carcinoma ("HCC"), supported by global regulatory alignment and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development.
Advance TPST-1495 through externally funded clinical development
Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP"), with first patient enrollment expected in Q1 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement with limited internal capital deployment.
Advance a diversified next-generation CAR-T pipeline
Tempest plans to progress additional dual-targeting CAR-T programs that broaden the platform across modalities and indications, including:
TPST-3003: an allogeneic dual-targeting CD19/BCMA CAR-T
TPST-2206: a dual-targeting CD70/CD70 CAR-T
TPST-3206: an allogeneic dual-targeting CD70/CD70 CAR-T

(Press release, Tempest Therapeutics, FEB 11, 2026, View Source [SID1234662606])

On February 11, 2026 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the fourth quarter and full year 2025 and introduced full year 2026 guidance for Portfolio Receipts.

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"We had one of the most remarkable years in Royalty Pharma’s history in 2025," said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. "We grew Portfolio Receipts by 16%, driven by the strength of our diversified portfolio, we returned a record amount of capital to shareholders and we deployed $2.6 billion on royalty transactions, including our highest year ever for announced synthetic royalty transactions. Further, we achieved an important milestone with the successful internalization of our external manager. Looking ahead, our deal pipeline remains robust and we anticipate multiple events for our development-stage pipeline in 2026 – including pivotal study results for daraxonrasib, pelacarsen and litifilimab – that could unlock additional value. I am confident 2026 will be another year of exciting progress towards strengthening our leadership position in the rapidly growing royalty market and pursuing our goal to be the premier capital allocator in life sciences with consistent, compounding growth."

Strong double-digit growth in Royalty Receipts and Portfolio Receipts

•Royalty Receipts grew 17% to $856 million in the fourth quarter and 13% to $3,127 million in 2025, primarily driven by Voranigo, Trelegy, Tremfya and the cystic fibrosis franchise.
•Portfolio Receipts increased by 18% to $874 million in the fourth quarter and 16% to $3,254 million in 2025.

Balanced capital allocation approach drives value creation

•Capital Deployment of $2.6 billion; added royalties on nine(8) therapies to portfolio in the year, including a ground-breaking partnership with Revolution Medicines for Phase 3 therapy daraxonrasib for pancreatic cancer.

•Repurchased 37 million Class A ordinary shares for $1.2 billion in 2025, including $75 million in the fourth quarter.•Increased quarterly dividend by 7% in the first quarter of 2026.

Positive clinical and regulatory updates across royalty portfolio in 2025

•FDA approvals of Cytokinetics’ Myqorzo (formerly aficamten) in obstructive hypertrophic cardiomyopathy and Johnson & Johnson’s Tremfya in Crohn’s disease and ulcerative colitis.

•Positive Phase 3 results for Teva’s TEV-‘749 in schizophrenia, Gilead’s Trodelvy in 1L metastatic triple negative breast cancer, Emalex’s ecopipam in Tourette’s syndrome and Pharvaris’ deucrictibant in hereditary angioedema.

Financial guidance for full year 2026 (excludes contribution from future transactions)

•Royalty Pharma expects 2026 Portfolio Receipts to be between $3,275 million and $3,425 million.

•2026 Portfolio Receipts guidance includes expected growth in Royalty Receipts of 3% to 8%.

Financial & Liquidity Summary
Three Months Ended December 31,
Twelve Months Ended December 31,
(unaudited)
($ and shares in millions)
2025
2024
Change
2025
2024
Change
Portfolio Receipts
874
742
18%
3,254
2,801
16%
Net cash provided by operating activities
827
743
11%
2,490
2,769
(10)%
Adjusted EBITDA (non-GAAP)*
816
669
22%
2,966
2,565
16%
Portfolio Cash Flow (non-GAAP)*
815
678
20%
2,724
2,452
11%
Weighted average Class A ordinary shares outstanding – diluted
556
589
(6)%
564
594
(5)%

2026 Financial Outlook

Royalty Pharma has provided guidance for full year 2026, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided February 11, 2026
Portfolio Receipts
$3,275 million to $3,425 million
Payments for operating and professional costs
5.5% to 6.5% of Portfolio Receipts
Interest paid
$350 million to $360 million

Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. The above Portfolio Receipts guidance includes expected Royalty Receipts growth of 3% to 8% in 2026.

Royalty Pharma’s full year 2026 guidance reflects an estimated foreign exchange impact of approximately +1% to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2026.

Payments for operating and professional costs in 2026 are expected to decrease as a percentage of Portfolio Receipts, compared to 8.9% in 2025, primarily due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025.

Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 million to $360 million(5), with approximately $175 million in each of the first and third quarters of 2026. De minimis amounts are anticipated in the second and fourth quarters of 2026. These projections assume no additional debt financing in 2026, including no drawdown on the revolving credit facility. In 2025, Royalty Pharma collected interest of $34 million on its cash and cash equivalents.

Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Portfolio Receipts Highlights
Three Months Ended December 31,
(unaudited)
($ in millions)
2025
2024
Change
Products:
Marketers:
Therapeutic Area:
Cystic fibrosis franchise
Vertex
Rare disease
251
237
6%
Trelegy
GSK
Respiratory
95
74
28%
Tysabri
Biogen
Neuroscience
65
61
7%
Evrysdi
Roche
Rare disease
64
56
15%
Tremfya
Johnson & Johnson
Immunology
56
39
44%
Xtandi
Pfizer, Astellas
Oncology
53
46
16%
Imbruvica
AbbVie, Johnson & Johnson
Oncology
40
46
(13)%
Voranigo
Servier
Oncology
39
5
*
Promacta
Novartis
Hematology
27
44
(38)%
Cabometyx/Cometriq
Exelixis, Ipsen, Takeda
Oncology
22
20
13%
Spinraza
Biogen
Rare disease
14
15
(4)%
Erleada
Johnson & Johnson
Oncology
13
11
18%
Trodelvy
Gilead
Oncology
12
11
8%
Imdelltra
Amgen
Oncology
10
—
n/a
Other products(6)
96
67
43%
Royalty Receipts
856
729
17%
Milestones and other contractual receipts
18
13
42%
Portfolio Receipts
874
742
18%

Royalty Receipts was $856 million in the fourth quarter of 2025, an increase of 17% compared to $729 million in the fourth quarter of 2024. The increase was primarily driven by Voranigo, Trelegy, Tremfya and the cystic fibrosis franchise, which was partially offset by a decline from Promacta due to U.S. generic competition which launched in May 2025.

Portfolio Receipts was $874 million in the fourth quarter of 2025, an increase of 18% compared to $742 million in the fourth quarter of 2024, primarily driven by the same Royalty Receipts increases noted above.

(Press release, Royalty Pharma , FEB 11, 2026, View Source [SID1234662604])

On February 11, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows:

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TD Cowen 46th Annual Health Care Conference at 9:10 a.m. ET on Wednesday,
March 4, 2026

Leerink Partners 2026 Global Healthcare Conference at 10:40 a.m. ET on Wednesday,
March 11, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, FEB 11, 2026, View Source [SID1234662603])