On October 27, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported posters at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) highlighting preclinical data that further illustrate the potential for ORIC-944, a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, to treat prostate cancer and various other solid tumors.

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"These preclinical data underscore the potential of ORIC-944 to overcome resistance not only in prostate cancer but in other solid tumors and highlight that the therapeutic potential of PRC2 inhibition may be maximized in combination with inhibitors of key tumor drivers, including AR inhibitors and KRAS inhibitors," said Lori Friedman, PhD, chief scientific officer. "Based on these data and clinical findings to date, we continue to believe ORIC-944 is a potential best-in-class PRC2 inhibitor with potential in both castration-resistant and castration-sensitive prostate cancer, as well as multiple other tumor types."

Key findings of posters presented at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper):

PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies

ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with androgen receptor (AR) inhibition, synergistically impaired tumor growth, significantly improved survival and extended the duration of response to AR inhibitors in vivo by restricting cellular plasticity and delaying prostate tumor adaptation in castration-sensitive prostate cancer (CSPC).
Transcriptional effects induced by combining ORIC-944 and AR inhibitors were comparable across all AR inhibitors tested (i.e., darolutamide, apalutamide or enzalutamide), and consistent with transcriptional effects of mevrometostat and AR inhibitor combination.
Mechanistically, ORIC-944 in combination with AR inhibition in CSPC was linked to increased luminal cell state, and the restriction of lineage adaptation through reduced chromatin accessibility at binding sites of transcription factors associated with lineage diversification and cell plasticity such as FOXA, HNF1A and ONECUT2. These results were reproduced with mevrometostat and AR inhibitor combination and are consistent with what was previously reported in preclinical studies of CRPC.
PRC2 inhibition enhances KRAS inhibitor response to delay treatment relapse in KRAS-mutant preclinical lung and colorectal cancer models

ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with KRAS inhibition, significantly improved efficacy and progression-free survival in KRAS G12C mutant non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models, demonstrating that PRC2 inhibition can deepen and extend responses by preventing or delaying resistance to KRAS inhibition.
PRC2 activity is increased in tumors from KRAS-mutant NSCLC and CRC patients, and transcriptional analysis from in vivo studies of CRC demonstrated that PRC2 inhibition drives tumor cell differentiation.
ORIC-944 combined with the KRAS inhibitor adagrasib, regressed 100% of tumors in KRAS-mutant adenocarcinoma and squamous NSCLC xenograft models in vivo. The combination also prevented adagrasib tumor relapse and extended progression-free survival in a KRAS G12C adenocarcinoma NSCLC xenograft model.

About ORIC-944
ORIC-944 is a potent and selective allosteric PRC2 inhibitor via EED subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement, and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA (apalutamide) and in combination with NUBEQA (darolutamide) for prostate cancer (NCT05413421).

(Press release, ORIC Pharmaceuticals, OCT 27, 2025, View Source [SID1234657035])

On October 27, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported the closing of its previously announced underwritten registered offering of 24,485,799 shares of its common stock at a purchase price of $10.21 per share. The gross proceeds to Nurix from the offering were $250.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix.

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"The successful completion of this offering not only allows Nurix to accelerate our implementation of pivotal trials in chronic lymphocytic leukemia (CLL), but it also enables us to move more decisively to explore the use of bexobrutideg in autoimmune disease, which could unlock a new dimension of therapeutic potential of the BTK degradation mechanism," said Arthur T. Sands, M.D., Ph.D., president and CEO of Nurix. "We are very fortunate to be strongly supported in our mission to advance novel medicines for patients with cancer and autoimmune disease by a fantastic group of both current and new investors."

The offering included participation from both new and existing investors, including General Atlantic, Redmile Group, Braidwell LP, Deep Track Capital, Perceptive Advisors, Trails Edge Capital Partners, and Vestal Point Capital, as well as other healthcare-dedicated funds.

J.P. Morgan Securities LLC, Jefferies LLC, and Stifel, Nicolaus & Company, Incorporated acted as joint book-running managers for the offering. Oppenheimer & Co. Inc. and Robert W. Baird & Co. Incorporated acted as lead managers.

Nurix currently intends to use the net proceeds from this offering primarily to fund the clinical development of its drug candidates, including the ongoing development of bexobrutideg (NX-5948) in chronic lymphocytic leukemia (CLL) and the exploration of potential autoimmune indications, as well as to support research and development activities to expand its pipeline and for working capital and general corporate purposes.

The securities were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-280117) previously filed with the Securities and Exchange Commission ("SEC") and declared effective on June 11, 2024. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov.

A copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388, or via email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or via email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities of Nurix, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nurix Therapeutics, OCT 27, 2025, View Source [SID1234657034])

On October 27, 2025 GSK plc (LSE/NYSE: GSK) and Syndivia, a private biotechnology company focused on next-generation ADCs, reported an agreement granting GSK exclusive worldwide rights to develop and commercialise a preclinical ADC for mCRPC.

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Approximately 1.4 million men worldwide are diagnosed with prostate cancer each year and approximately 10-20% develop advanced disease, castration resistance with metastases, within five years.1 For patients whose cancer has advanced to mCRPC, targeted treatment options are limited, and standard of care options may be difficult to access in community practice settings, and can be poorly tolerated with modest efficacy outcomes. Survival rates for these patients are low, with a 5-year survival rate of approximately 30% and a median survival of approximately two years.2,3,4

The novel ADC, which utilises Syndivia’s next-generation GeminiMab conjugation technology, has shown enhanced anti-tumour activity and an encouraging safety profile, demonstrating best-in-class potential. In preclinical studies, the ADC was effective at shrinking tumours without causing a proportional increase in significant side effects, even at higher doses. This ADC could provide a targeted treatment directly to the tumour, currently a gap in available therapies, along with a more easily accessible treatment in the community practice setting for mCRPC.

GSK is developing an innovative pipeline that spans ADCs with distinct antigens and payloads, next-generation small molecules, and T-cell engagers. These diverse approaches, such as GSK’227 and this novel ADC, enable GSK to advance potential therapeutic options across various stages and types of prostate cancer.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "Prostate cancer represents a significant health burden and an emerging area of growth for GSK, where targeted therapies are urgently needed in metastatic castration-resistant settings. The addition of this ADC builds on GSK’s growing portfolio and strengths in tumour-targeted technologies, including GSK’227, our B7-H3-targeting ADC."

Sasha Koniev, Chief Executive Officer, Syndivia, said: "We are proud that GSK will advance this programme on a global scale. This agreement underscores the value of our GeminiMab ADC platform and the opportunity to bring a promising new therapy to patients with pressing unmet medical needs."

Financial considerations
Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million. They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program.

(Press release, GlaxoSmithKline, OCT 27, 2025, View Source [SID1234657033])

On October 27, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it has appointed Dr Helen Tayton-Martin as new Chief Executive Officer (CEO). She will take up her new position on November 24, 2025, and simultaneously step down from Evaxion’s Board of Directors (Board).

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Holding a Ph.D. in molecular immunology, and an MBA from London Business School, Helen Tayton-Martin was a co-founder of cancer-focused biotech company Adaptimmune, where she served as Chief Operating Officer and later Chief Business & Strategy Officer during her 17 years with the company. Through this time, she oversaw transatlantic growth, multiple clinical, academic and commercial collaborations and private and public financing through to its Nasdaq IPO. Dr. Tayton-Martin was responsible for all Adaptimmune’s strategic partnerships including those with Astellas, Genentech, a member of the Roche Group, GlaxoSmithKline and Galapagos NV.

Prior to Adaptimmune, Dr. Tayton Martin spent 15 years working within the pharma, biotech and consulting environments for various companies. She also previously served as a non-executive director of Trillium Therapeutics Inc. from October 2017 through to the sale of the company in November 2021 to Pfizer Inc.

"I am delighted that Helen Tayton-Martin is taking over the CEO position. She is a skilled executive with exactly the right experience in leading an organization, making partnerships and monetizing assets in biotech. Helen knows Evaxion from her time on the Board and we have seen her leadership quality and have already established a working relationship. It is with great faith that we welcome her to a new role in the company" says Marianne Søgaard, Chairman of the Board at Evaxion.

"I also want to extend my thanks to Birgitte Rønø, who has done a fantastic job as interim CEO in a crucial time for Evaxion, on top of her duties as Chief Scientific Officer. Birgitte will now again focus on this role, and we look forward to continuing to benefit from her capabilities and experience as she leads our research and development work," says Marianne Søgaard.

"I am very excited to be joining Evaxion as CEO at an incredibly exciting time for the company. I have seen first-hand from my time on the Company’s Board the strength of its AI-Immunology platform to deliver real potential products, exemplified with the recent out-licensing of EVX-B3 to MSD and the presentation of unprecedented data for EVX-01 at ESMO (Free ESMO Whitepaper), demonstrating Evaxion is in a very strong position for further future value generation. I am looking forward to working with the highly skilled and committed team of employees to build from this extraordinary scientific, medical and commercial potential of Evaxion," says Helen Tayton-Martin.

Changes to the Board of Evaxion
Helen Tayton-Martin will step down from the Board of Evaxion when taking up the CEO position. Seasoned life science executive Jens Bitsch-Norhave will join the Board of Directors as adviser and observer with the intention of seeking election as board member at the Annual General Meeting in 2026.

"We are looking forward to welcoming Jens Bitsch-Norhave to Evaxion. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong addition to the Board", says Marianne Søgaard.

Jens Bitsch-Norhave is currently Corporate Vice President and Global Head of Corporate Development at Hengrui Pharmaceuticals, where he is responsible for strategy, business development, licensing, M&A, and alliance management, advancing the company’s globalization and growth. He holds an MSc and Ph.D. in neuropharmacology from the University of Copenhagen and an Executive MBA in Technology & Innovation from Copenhagen Business School.

(Press release, Evaxion Biotech, OCT 27, 2025, View Source [SID1234657032])

On October 27, 2025 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported financial results for the third quarter ended September 30, 2025.

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"We are pleased with the contributions from our Enzyme Therapies and Skeletal Conditions business units to date this year driven by more than 20% revenue growth from PALYNZIQ and VOXZOGO," said Alexander Hardy, President and Chief Executive Officer of BioMarin. Our strategic investments in these focused business units are generating strong results, and we anticipate sustained financial performance from each of them. Both Enzyme Therapies and Skeletal Conditions remain central to our growth strategy, in addition to new business development opportunities and our advancing internal pipeline. As we focus on the business units aligned with our strategic priorities, today we are announcing the decision to pursue options to divest ROCTAVIAN and remove it from our portfolio. We continue to believe ROCTAVIAN has an important role to play in the treatment of hemophilia A and are therefore evaluating out-licensing options for this innovative gene therapy. This decision is consistent with BioMarin’s portfolio strategy and offers the most promising opportunity for ensuring continued patient access to ROCTAVIAN.

Mr. Hardy concluded, "Looking ahead, we will rely on our disciplined strategic focus and proven capabilities to develop and commercialize innovative therapies that generate sustainable value for patients, employees, and shareholders."

Third Quarter 2025 Financial Highlights
•Total Revenues for the third quarter of 2025 were $776 million, an increase of 4% compared to the same period in 2024, driven by strong revenue growth in VOXZOGO and PALYNZIQ attributable to new patients initiating therapy across all regions. These increases were partially offset by lower sales volume for ALDURAZYME due to timing of order fulfillment to Sanofi and NAGLAZYME due to timing of large government orders in Latin America.

•GAAP Net Loss increased to $31 million for the third quarter of 2025 compared to GAAP Net Income of $106 million for the same period in 2024. The increase in GAAP Net Loss was primarily due to the In-Process Research & Development (IPR&D) charge of $221 million recorded in connection with the acquisition of Inozyme Pharma, Inc. (Inozyme). This increase in GAAP Net Loss was partially offset by improved gross profit as a result of revenue growth mentioned above, lower Cost of Sales from favorable product mix during the quarter, and lower provision for income taxes.

•Non-GAAP Income for the third quarter of 2025 decreased to $22 million compared to $178 million for the same period in 2024. The decrease in Non-GAAP Income was primarily due to the factors noted above.
Third Quarter 2025 Business Highlights
Innovation
•Skeletal Conditions: At the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, investigators shared new data demonstrating improved spinal morphology – one of the factors that contributes to spinal stenosis, a leading cause of morbidity in achondroplasia – following treatment with VOXZOGO in children ages 5 and under (see PR here). VOXZOGO is the only approved therapy with data showing a positive impact on spinal morphology, and these findings add to the extensive body of evidence supporting VOXZOGO’s health benefits beyond improving growth.

•As a follow-up to the encouraging PK data announced last quarter for BMN 333, BioMarin’s long-acting C-type natriuretic peptide, the company plans to initiate dosing of children with achondroplasia in its registration-enabling Phase 2/3 study in the first half of 2026.

•VOXZOGO pivotal data for the treatment of hypochondroplasia is expected in the first half of 2026, followed by potential launch in 2027, should data be supportive. Hypochondroplasia can be associated with significant co-morbidities, including respiratory, orthopedic, mental health, and ear nose and throat complications, representing high unmet medical need for this skeletal condition with no approved therapies.

•Four new VOXZOGO indications are under development as part of BioMarin’s CANOPY clinical program, with a focus on the most severely impacted sub-set of children. These conditions include idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency, and are currently enrolling patients, with potential registration-enabling studies in 2027.

•Enzyme Therapies: Based on new data from the PALYNZIQ Phase 3 PEGASUS study in 12- to 17-year-olds demonstrating statistically significant blood phenylalanine (Phe) lowering compared to diet alone, the company is pursuing approvals in this age group in the United States and Europe, with potential approval in 2026.

•With BMN 401, a potential first-in-disease treatment for ENPP1 deficiency, initial pivotal data readout for the ENERGY 3 study in children ages 1–12 years is anticipated in the first half of 2026, with potential launch in 2027.

•Other Clinical Updates: For BMN 351, BioMarin’s next generation oligonucleotide for Duchenne muscular dystrophy, the company expects to share a clinical update for the 6 mg/kg and 9 mg/kg cohorts by year-end.

Growth

•As of the end of the quarter, children with achondroplasia in 55 countries around the world were being treated with VOXZOGO, tracking to the company’s plan to open access in more than 60 countries by 2027. Year-to-date VOXZOGO revenue increased 24% Y/Y, with Q4’25 VOXZOGO revenue expected to reach its highest level of the year. BioMarin reaffirmed full-year 2025 VOXZOGO revenue outlook of between $900 million and $935 million.

•Representing approximately 75% of total VOXZOGO revenue, markets outside of the U.S. (OUS) benefited from BioMarin’s established global footprint to drive VOXZOGO uptake across key large markets during the quarter.

•Initiatives implemented to expand treatment with VOXZOGO in the U.S. resulted in new patient starts across all ages in the third quarter, with the majority from children under 2 years of age. Due to the geographical dispersion and management across a range of specialties for older children in the U.S, the company has implemented initiatives to address slowing uptake in that demographic.

•PALYNZIQ marked its third consecutive quarter of 20%+ Y/Y growth. PALYNZIQ strength continued to be driven by greater numbers of patients titrating to daily maintenance dose and strong adherence. Total Enzyme Therapies revenue grew 8% Y/Y, year-to-date, reflecting high penetration rates and strong adherence to these treatments.

•Today, the company announced its plan to pursue options to divest ROCTAVIAN, including exploring out-licensing opportunities. BioMarin plans to continue to make ROCTAVIAN commercially available in the U.S., Italy and Germany until next steps are finalized. The company will continue to provide support and monitoring for people treated with ROCTAVIAN.

Value Commitment

•Acquired IPR&D charges in Q3 from BioMarin’s acquisition of Inozyme resulted in Y/Y increases in GAAP and Non-GAAP R&D expenses. Q3 GAAP and Non-GAAP SG&A expenses increased Y/Y due to investment in business unit expansion initiatives. Year-to-date GAAP Diluted EPS and Non-GAAP Diluted EPS increased Y/Y, driven by underlying strong revenue performance and operational efficiencies.

•The company generated operating cash flows totaling $369 million in third quarter 2025 and generated $728 million in year-to-date operating cash flows. Total cash and investments at the end of the third quarter were approximately $2.0 billion, and increasing operating cash flow is expected to continue, supporting BioMarin’s priority of investment in innovation and future growth.

•Today, BioMarin increased total revenue guidance, at the midpoint, reflecting strong demand for its therapies through 2025. Revised Non-GAAP Operating Margin and Non-GAAP Diluted EPS guidance include the impact of Q3 acquired IPR&D expenses, partially offset by underlying strong topline performance and operational execution throughout the year.

Refer to the 2025 Full-Year Financial Guidance on page 4 of this press release.
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 % Change 2025 2024 % Change
Total Revenues $776 $746 4% $2,347 $2,107 11%
Net Product Revenues by Product:
VOXZOGO $218 $190 15% $654 $527 24%
Enzyme Therapies:
VIMIZIM $183 $178 3% $587 $549 7%
NAGLAZYME 122 132 (8)% 365 370 (1)%
PALYNZIQ 109 91 20% 308 255 21%
ALDURAZYME 54 71 (24)% 159 145 10%
BRINEURA 48 37 30% 137 121 13%
Total Enzyme Therapies Revenue $516 $509 1% $1,556 $1,440 8%
KUVAN $24 $28 (14)% $76 $93 (18)%
ROCTAVIAN
$3 $7 (57)% $23 $16 44%
GAAP Net Income (Loss)(1)
$(31) $106 (129)% $395 $302 31%
Non-GAAP Income (1)(2)
$22 $178 (88)% $525 $506 4%
GAAP Operating Margin % (1)(3)
(6.0)% 15.3% 19.4% 15.3%
Non-GAAP Operating Margin % (1)(2)
2.8% 27.7% 26.3% 27.7%
GAAP Diluted Earnings (Loss) per Share (EPS)(1)
$(0.16) $0.55 (129)% $2.04 $1.56 31%
Non-GAAP Diluted EPS (1)(2)
$0.12 $0.91 (87)% $2.69 $2.60 3%

September 30,
2025 December 31,
2024
Total cash, cash equivalents & investments $ 1,991 $ 1,659

(Press release, BioMarin, OCT 27, 2025, View Source [SID1234657031])