Tempest Lays Out Strategic Plan to Advance Recently Acquired Dual-Targeting CAR-T Assets

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])

ROYALTY PHARMA REPORTS Q4 AND FULL YEAR 2025 RESULTS

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])

Regeneron Announces Investor Conference Presentations

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])

Nuvectis Pharma, Inc. Reports 2025 Financial Results and Business Highlights

On February 11, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the year ended December 31, 2025 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "2025 was an eventful year for Nuvectis, with significant progress made in the NXP900 development program, laying the groundwork for multiple potential data readouts in 2026. Our Phase 1b monotherapy study evaluating NXP900’s clinical potential in several molecularly and histologically-defined target tumors, and the combination study of NXP900 with osimertinib in patients with EGFR-mutated non-small cell lung cancer ("NSCLC") are enrolling patients. In addition, a combination with lorlatinib in ALK-positive NSCLC, is pending commencement. With the potential embedded in the NXP900 Phase 1b program, we expect 2026 to be an exciting year for Nuvectis."

Mr. Bentsur concluded, "We remain focused on operational execution and financial responsibility, and believe that our current cash position can take us through multiple potential NXP900 Phase 1b milestones and well into the second half of 2027."

Full Year 2025 Financial Results

Cash and cash equivalents were $31.6 million as of December 31, 2025, compared to $18.5 million as of December 31, 2024. The increase of $13.1 million resulted from the Company’s February 2025 public offering and from access to our at-the-market facility, partially offset by operating expenses.

The Company’s net loss was $26.4 million for the year ended December 31, 2025, compared to $19.0 million for the year ended December 31, 2024, an increase in net loss of $7.4 million. Net loss for the 2025 fiscal year included $6.0 million in non-cash stock-based compensation and one-time license fees associated with milestone achievements of $2.4 million.

Research and development expenses, including non-cash and one-time non-recurring expenses, were $18.2 million for the year ended December 31, 2025, compared to $12.9 million for the year ended December 31, 2024, an increase of $5.3 million.

General and administrative expenses, including non-cash and one-time non-recurring expenses, were $9.4 million for the year ended December 31, 2025, compared to $6.9 million for the year ended December 31, 2024, an increase of $2.5 million.

Finance income was $1.1 million for the year ended December 31, 2025, compared to $0.8 million for the year ended December 31, 2024, an increase of $0.3 million.

(Press release, Nuvectis Pharma, FEB 11, 2026, View Source [SID1234662602])

Neurocrine Biosciences Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Financial Expectations for 2026

On February 11, 2026 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the fourth quarter ended December 31, 2025.

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"Our 2025 performance reflects the strength and durability of our commercial business and meaningful progress we are making transforming Neurocrine into a broader, more diversified biopharmaceutical company," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2026, we are focused on delivering strong, sustainable growth for INGREZZA and CRENESSITY (crinecerfont) while advancing our pipeline anchored by Phase 3 programs, including osavampator in major depressive disorder and direclidine in schizophrenia. We expect this building momentum will create value for all stakeholders as Neurocrine is well positioned to improve the lives of even more patients in the years ahead."

Net Product Sales Highlights

Total fourth-quarter and full-year 2025 net product sales were $798.3 million and $2.83 billion, reflecting 29% and 22% growth year-over-year, respectively.
INGREZZA fourth-quarter and full-year 2025 net product sales were $657.5 million and $2.51 billion, reflecting 7% and 9% growth year-over-year, respectively. Results reflected double-digit prescription volume growth in TRx and NRx driven by strong patient demand, partially offset by a lower net price due to new formulary access investments to support long-term growth.
CRENESSITY fourth-quarter and full-year 2025 net product sales were $135.3 million and $301.2 million, reflecting 431 and 2,048 total new patient enrollment start forms, respectively, driven by strong patient demand with over 80% reimbursement coverage for dispensed scripts in the fourth-quarter.
Recent Clinical and Corporate Developments

Published a landmark narrative review on FDA-approved vesicular monoamine transporter 2 (VMAT2) inhibitors demonstrating the unique profile of INGREZZA in CNS Spectrums. The review highlighted the distinct profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concluded that VMAT2 inhibitors are not clinically interchangeable.
Presented head-to-head INGREZZA capsules data at the American College of Neuropsychopharmacology 64th Annual Meeting showing a nearly two-fold higher VMAT2 mean target occupancy, consistent with greater potency when compared to AUSTEDO XR (deutetrabenazine) after a single dose. In addition, the lowest approved dose of INGREZZA (40 mg) exhibited higher estimated VMAT2 target occupancy at steady state versus the highest approved dose of AUSTEDO XR (48 mg) at steady state.
At Neurocrine’s R&D Day in December, provided an update on Neurocrine’s R&D engine, which remains on track to deliver multiple first- and best-in-class medicines across an industry-leading neuropsychiatry portfolio, including Phase 3 programs for osavampator in major depressive disorder and direclidine in schizophrenia. Neurocrine remains well-positioned for long-term value creation across core therapeutic areas and announced the strategic expansion and diversification of the corticotropin releasing factor (CRF) platform as a foundation for a new class of medicines targeting metabolic diseases, including obesity.
Announced the initiation of a Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of VMAT2. Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD.
Fourth-Quarter and Full-Year 2025 Financial Results

Three Months Ended

December 31,

Twelve Months Ended

December 31,

(unaudited, in millions, except per share data)

2025

2024

2025

2024

Revenues:

INGREZZA Net Product Sales

$ 657.5

$ 615.2

$ 2,513.7

$ 2,313.5

CRENESSITY Net Product Sales

135.3

1.7

301.2

1.7

Other Revenues

12.7

10.8

45.6

40.1

Total Revenues

$ 805.5

$ 627.7

$ 2,860.5

$ 2,355.3

GAAP Research and Development (R&D)

$ 258.2

$ 185.6

$ 1,015.7

$ 731.1

Non-GAAP R&D

$ 233.8

$ 164.4

$ 924.7

$ 662.3

GAAP Selling, General, and Administrative (SG&A)

$ 301.8

$ 287.8

$ 1,156.2

$ 1,007.2

Non-GAAP SG&A

$ 265.6

$ 241.6

$ 1,024.9

$ 862.5

GAAP Net Income

$ 153.7

$ 103.1

$ 478.6

$ 341.3

GAAP Earnings Per Share – Diluted

$ 1.48

$ 1.00

$ 4.67

$ 3.29

Non-GAAP Net Income

$ 194.6

$ 173.4

$ 654.5

$ 656.3

Non-GAAP Earnings Per Share – Diluted

$ 1.88

$ 1.69

$ 6.39

$ 6.33

(unaudited, in millions)

December 31,

2025

December 31,

2024

Total Cash, Cash Equivalents, and Marketable Securities

$ 2,543.4

$ 1,815.6

Differences in fourth-quarter 2025 GAAP and Non-GAAP operating expenses compared with fourth-quarter 2024 were driven by:
Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio including investments in osavampator Phase 3 program in major depressive disorder (MDD) and muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia.
Increased SG&A expense including incremental investment in CRENESSITY launch activities and continued investment in INGREZZA.
Increased acquired in-process research and development (IPR&D) expense associated with upfront payments for early-stage development candidates license agreements
Fourth-quarter 2025 GAAP net income and earnings per share were $153.7 million and $1.48, respectively, compared with $103.1 million and $1.00, respectively, for fourth-quarter 2024.
Fourth-quarter 2025 Non-GAAP net income and earnings per share were $194.6 million and $1.88, respectively, compared with $173.4 million and $1.69, respectively, for fourth-quarter 2024.
Differences in fourth-quarter 2025 GAAP and Non-GAAP net income compared with fourth-quarter 2024 were primarily driven by:
Higher net product sales of $177.1 million
Increased operating expenses in support of expanding and advancing R&D portfolio, incremental investment in CRENESSITY launch activities, and continued investment in INGREZZA
Increased IPR&D expense associated with upfront payments for early-stage development candidates license agreements
At December 31, 2025, the Company had cash, cash equivalents, and marketable securities totaling approximately $2.54 billion.
A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release.

Full-Year 2026 Financial Guidance

Range

(in millions)

Low

High

INGREZZA Net Product Sales 1

$ 2,700

$ 2,800

GAAP R&D Expense 2

$ 1,200

$ 1,250

Non-GAAP R&D Expense 2, 3

$ 1,110

$ 1,160

GAAP and Non-GAAP IPR&D 4

$ 20

$ 20

GAAP SG&A Expense 5

$ 1,375

$ 1,400

Non-GAAP SG&A Expense 3, 5

$ 1,240

$ 1,265

INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington’s disease.
R&D guidance reflects the continued advancement of the Company’s pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately $90 million in R&D and $125 million in SG&A, divestiture-related expenses and vacated legacy campus facility costs. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve.
IPR&D guidance represents completed collaboration and licensing arrangements.
SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth and the launch of CRENESSITY including expansion of sales teams expected to be completed by the end of the first quarter of 2026.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-579-2543 (US) or 785-424-1789 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

(Press release, Neurocrine Biosciences, FEB 11, 2026, View Source [SID1234662601])