Avenzo Therapeutics to Present Initial Results from the Phase 1 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2025 San Antonio Breast Cancer Symposium

On October 30, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the acceptance of two abstracts for poster presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas from December 9-12, 2025.

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Avenzo will present preliminary safety and efficacy results from the Phase 1 portion of its ongoing Phase 1/2 clinical study of AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor. The company will also highlight the Phase 1/2 study design evaluating AVZO-023, its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, as a single agent and in combination with AVZO-021 and/or endocrine therapy.

Details of the presentations are as follows:

Abstract: 2206

Title: A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as a monotherapy and in combination for patients with advanced solid tumors, including hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and cyclin E1 (CCNE1)-amplified solid tumors: preliminary safety and efficacy results

Presentation Number: PS4-06-08

Date and Time: Thursday, Dec. 11, 2025, 5:00 to 6:30 p.m. CT

Abstract: 2267

Title: A phase 1/2 study of AVZO-023, a next-generation selective cyclin-dependent kinase 4 inhibitor (CDK4i), as a single agent and in combination with AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), and/or endocrine therapy in patients with advanced solid tumors

Presentation Number: PS5-12-17

Date and Time: Friday, Dec. 12, 2025, 12:30 to 2:00 p.m. CT

(Press release, Avenzo Therapeutics, OCT 30, 2025, View Source [SID1234657139])

ALX Oncology to Report Third Quarter 2025 Financial Results and Pipeline Progress Including Evorpacept CD47 Biomarker Data to be Presented at Upcoming SITC Annual Meeting

On October 30, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported plans to report its third quarter 2025 financial results and provide a business update on Friday, November 7th, 2025, before market open. The company will be hosting a teleconference in conjunction with this press release which will include review of the upcoming data presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting the full data set demonstrating CD47 overexpression as a key potential predictive biomarker for response with evorpacept in HER2+ gastric cancer.

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Third Quarter 2025 Webcast Information:
Date & Time: Friday, November 7, 2025 at 5:30 a.m. PT / 8:30 a.m. ET
Webcast Access: View Source;tp_key=b49359356f
Participant Listening Options by Phone: To access the conference call, please dial 1-877- 407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Third Quarter 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me link: View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

The poster presentation titled, CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial, abstract number 496, will be presented at SITC (Free SITC Whitepaper) on Saturday, November 8th and available to SITC (Free SITC Whitepaper) attendees as an eposter on November 7th. The poster will be presented by Dr. Zev A. Wainberg, Professor of Medicine and Co-Director of GI Oncology Program, University of California, Los Angeles.

(Press release, ALX Oncology, OCT 30, 2025, View Source [SID1234657126])

Agios Reports Third Quarter 2025 Financial Results and Provides Business Update

On October 30, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the third quarter ended September 30, 2025.

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"As we approach year-end, we remain focused on our two key PYRUKYND milestones – the potential U.S. approval in thalassemia and the topline results from the RISE UP Phase 3 trial in sickle cell disease. Our recent engagements with these communities have underscored the urgent need for innovation and PYRUKYND’s potential to address critical gaps in care for these serious and life-threatening diseases," said Brian Goff, Chief Executive Officer, Agios. "We continued strong execution across our rare disease portfolio in the third quarter, including the completion of enrollment in our Phase 2b tebapivat trial for lower-risk MDS. We look forward to building on this strong momentum and remain steadfast in our commitment to delivering meaningful progress for the patients we serve."

Third Quarter 2025 and Recent Corporate Highlights
Commercial Performance – PYRUKYND (mitapivat)

Generated $12.9 million in net revenue for the third quarter of 2025, representing an increase of 44 percent from $9.0 million in the third quarter of 2024 and a 3 percent increase from $12.5 million in the second quarter of 2025.
262 unique patients completed prescription enrollment forms, representing an increase of 6 percent over the second quarter of 2025.
149 patients are on therapy in the U.S., inclusive of new starts and continued therapy, representing an increase of 5 percent over the second quarter of 2025.
R&D Highlights
PYRUKYND (mitapivat)

Thalassemia –
United States –
U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia by three months, to December 7, 2025.
Extension was triggered by FDA request for a Risk Evaluation and Mitigation Strategy (REMS) to address the potential risk of hepatocellular injury described in the original application.
Extension was not the result of new or additional efficacy or safety data requested by the FDA or submitted by Agios.
U.S. commercial launch preparations remain underway, and the application remains under active FDA review.
Europe –
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PYRUKYND in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.
A final decision from the European Commission is expected by early 2026.
Gulf Cooperation Council (GCC) –
PYRUKYND received approval in Saudi Arabia for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
Commercial launch activities are underway in Saudi Arabia in partnership with NewBridge Pharmaceuticals.
In the United Arab Emirates, PYRUKYND thalassemia regulatory application remains under active review.
Sickle Cell Disease –
Topline results from the RISE UP Phase 3 trial of mitapivat in sickle cell disease are expected by year-end, potentially supporting a U.S. commercial launch in 2026.
Tebapivat

Lower-risk Myelodysplastic Syndromes (LR-MDS) –
Completed patient enrollment in the Phase 2b trial of tebapivat in LR-MDS. Following findings from the Phase 2a trial, the Phase 2b trial is evaluating three higher daily doses (10 mg, 15 mg, and 20 mg) versus placebo over 24 weeks. Topline results from this trial are expected in early 2026.
Third Quarter 2025 Financial Results
For the quarter ended September 30, 2025, net loss was $103.4 million dollars, compared to net income of $947.9 million dollars for the quarter ended September 30, 2024. The net income in the third quarter of 2024 was due to the milestone payment from Servier and the sale of royalty rights to Royalty Pharma, both of which were recorded in that quarter.

Net product revenue from sales of PYRUKYND for the third quarter of 2025 was $12.9 million, compared to $9.0 million for the third quarter of 2024.

Cost of sales for the third quarter of 2025 was $1.7 million.

Research and Development (R&D) Expenses were $86.8 million for the third quarter of 2025, an increase of $14.3 million compared to the third quarter of 2024. The year-over-year increase was primarily driven by increased clinical trial costs associated with the PK activation franchise.

Selling, General and Administrative (SG&A) Expenses were $41.3 million for the third quarter of 2025, representing an increase of $2.7 million compared to the third quarter of 2024, primarily driven by disciplined investment in preparation for the potential U.S. commercial launch of PYRUKYND in thalassemia.

Cash, cash equivalents and marketable securities as of September 30, 2025, were $1.3 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND commercial launches in thalassemia and sickle cell disease, advance existing clinical programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information
Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s third quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, OCT 30, 2025, View Source [SID1234657125])

Kyowa kirin reported its quarterly results

On October 30, 2025 Kyowa Hakko Kirin reported its quarterly results.

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(Press release, Kyowa Hakko Kirin, OCT 30, 2025, View Source [SID1234657124])

Sandoz delivers a further acceleration in sales growth; full-year margin guidance upgraded

On October 30, 2025 Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in affordable medicines, reported its net-sales performance for the nine months and third quarter ended September 30, 2025.

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9M net sales of USD 8,057 million
up by 5% at constant currencies (CC1) and in USD; up by 6% at comparable growth rates (CGR2). Volume growth of 8%
ten largest-selling medicines grew by combined 9% at CC and represented 34% of net sales
Q3 net sales of USD 2,825 million
up by 6% at CC and by 9% in USD, respectively; up by 7% at CGR. Volume growth of 8%
biosimilars represented more than 30% of net sales for first time
All regions in growth at CC in both periods. Europe 9M net sales grew by 6% at CC, while International was up by 4% at CC (by 6% when adjusted2 for 2024 China divestment). North America grew by 1% at CC (by 7% when adjusted2 for Cimerli acquisition)
Successful launches so far this year, in line with roadmap: primarily in US, including Wyost & Jubbonti(denosumab) and Pyzchiva (ustekinumab)
Anticipated biosimilar launches in fourth quarter include European rollouts of Wyost & Jubbontiand Afqlir (aflibercept), as well as Tyruko (natalizumab) in US
Full-year 2025 guidance: mid-single-digit net-sales growth at CC (unchanged); a core EBITDA margin of 21-22% (prior guidance: around 21%)
Doctor and patient with child
Richard Saynor, Chief Executive Officer of Sandoz, commented: "The third quarter once again demonstrated the ability of Sandoz to deliver on its commitments and execute against the strategic roadmap. Our comprehensive launch program is helping us expand access to affordable medicines for more patients.

Looking ahead, Sandoz is well-positioned to capitalize on significant growth opportunities, and we control our ability to seize them. We are making strong progress in building our biosimilar infrastructure, advancing our pipeline, and strengthening our capabilities, all supported by consistent financial performance. These are the reasons I am so confident in a Sandoz future reflected in compelling growth that underpins our Purpose to pioneer access for patients."

FULL-YEAR 2025 GUIDANCE

The Company has updated its 2025 financial guidance today:

FY 2025 net sales to grow by a mid-single-digit percentage at CC (unchanged)
a core EBITDA margin in FY 2025 of 21-22% (prior guidance: around 21%)
This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government.

Remco Steenbergen, Chief Financial Officer of Sandoz, commented: "The upgrade in our guidance for the year particularly reflects the success of our biosimilars and the excellence in execution by colleagues around the world. Our ambition is unrelenting; we aim to fully exploit the many opportunities ahead which we believe will deliver sustained strong results over the long term."

US SETTLEMENT: AFLIBERCEPT

Sandoz recently announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent disputes between the two companies relating to the US FDA-approved Sandoz aflibercept biosimilar. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea in the fourth quarter of 2026, or earlier in certain circumstances.

PENICILLINS: TRADE DISTORTION

As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. Recently, the imposition of tariffs by the US government has led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower prices for key penicillin APIs, including 6-APA, the foundational compound for all penicillins. This price drop has coincided with an increase in market supply.

As the last remaining fully vertically integrated penicillins producer in Europe, Sandoz is pleased to see growing recognition by policymakers of the need for sustainable European supply, but more action is required. The Company calls on the European Union and national governments to implement measures that reduce geopolitical exposure and safeguard long-term sustainability of European-produced penicillins.

KEY LINKS

A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here.

CALENDAR

The Company intends to publish its full-year results on February 25, 2026.

9M AND Q3 2025 NET SALES

By business

9M

9M 2025 %
net sales 9M 2024 change
USD m USD m USD % CC % CGR %

Net sales 8,057 7,642 5% 5% 6%
Generics 5,699 71% 5,558 3% 2% 2%
Biosimilars 2,358 29% 2,084 13% 12% 17%
9M net sales were USD 8,057 million, up by 5% at CC and by 6% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%; this decline was in line with a full-year assumption of low to mid-single-digit erosion. Net-sales growth was primarily driven by the performance of biosimilars, which continue to benefit from an extensive pipeline and launch program.

Generics overview

Net sales of generics in the first nine months were USD 5,699 million, reflecting growth of 2% at CC and CGR. Generics represented 71% of net sales (9M 2024: 73%, Q3 2025: 69%).

The increase in 9M net sales of generics in Europe was driven by the impact of launches in 2024 and 2025. International net sales of generics grew, after adjusting for the 2024 divestment of the Sandoz business in China. In North America, generics net-sales growth benefited from the successful Q4 2024 launch of paclitaxel.

Biosimilars overview

Net sales of biosimilars of USD 2,358 million in the first nine months reflected growth of 12% at CC and 17% at CGR. Biosimilars represented 29% of total net sales (9M 2024: 27%, Q3 2025: 31%).

Strong Europe biosimilars 9M net-sales growth at CC benefited from several good performances, including Pyzchiva and Tyruko, while excellent International biosimilar net-sales growth reflected the strong contribution from Omnitrope (somatropin) and Hyrimoz (adalimumab). Wyost and Jubbonti were launched in Q3 2025 in the International region.

North America biosimilar net sales declined at CC, reflecting the withdrawal of Cimerli in Q1 2025 and the impact of private-label adalimumab pricing dynamics; excluding the effect of the withdrawal, North America biosimilar net sales grew by a double-digit percentage at CC, partly a result of the strong launch of Wyost and Jubbonti.

Q3

Q3 2025 %
net sales Q3 2024 change
USD m USD m USD % CC % CGR %

Net sales 2,825 2,595 9% 6% 7%
Generics 1,963 69% 1,854 6% 3% 3%
Biosimilars 862 31% 741 16% 13% 17%
Net sales for the third quarter were USD 2,825 million, up by 6% at CC and by 7% at CGR. Volumes grew by 8%, partly offset by price erosion of 2%.

By region

9M

9M 2025 %
net sales 9M 2024 change
USD m USD m USD % CC % CGR %

Net sales 8,057 7,642 5% 5% 6%
Europe 4,362 54% 3,996 9% 6% 6%
International 1,943 24% 1,904 2% 4% 6%
North America 1,752 22% 1,742 1% 1% 7%

Europe overview

9M net sales in Europe were USD 4,362 million, reflecting growth of 6% at CC and CGR. Europe 9M net sales of generics grew at CC, strongly surpassed by the performance of biosimilars. Notable growth included that from Pyzchiva and Tyruko.

International overview

9M net sales in International amounted to USD 1,943 million, with good growth of 4% at CC and 6% at CGR. International net sales of generics declined at CC but grew at CGR, with an exceptional biosimilars result driven by the strong performances of Omnitrope and Hyrimoz.

North America overview

9M net sales in North America were USD 1,752 million, reflecting an increase of 1% at CC. Growth at CGR however, namely excluding the impact of the acquisition of Cimerli, amounted to 7%. The increase in North America net sales of generics was driven by the successful Q4 2024 launch of paclitaxel, as well as continued strong growth in Canada, while the region delivered strong biosimilar net-sales growth at CGR.

Q3

Q3 2025 %
net sales Q3 2024 change
USD m USD m USD % CC % CGR %

Net sales 2,825 2,595 9% 6% 7%
Europe 1,530 54% 1,362 12% 6% 6%
International 659 23% 635 4% 4% 4%
North America 636 23% 598 6% 7% 12%

APPENDIX

HISTORIC NET SALES

The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results.

2025

By business

Q1 2025 change Q2 2025 change H1 2025 change
USD m USD % CC % USD m USD % CC % USD m USD % CC %
Net sales 2,480 0% 3% 2,752 8% 5% 5,232 4% 4%
Generics 1,809 -3% 0% 1,927 5% 2% 3,736 1% 1%
Biosimilars 671 8% 11% 825 15% 12% 1,496 11% 12%
Q3 2025 change 9M 2025 change
USD m USD % CC % USD m USD % CC %
Net sales 2,825 9% 6% 8,057 5% 5%
Generics 1,963 6% 3% 5,699 3% 2%
Biosimilars 862 16% 13% 2,358 13% 12%

By region

Q1 2025 change Q2 2025 change H1 2025 change
USD m USD % CC % USD m USD % CC % USD m USD % CC %
Net sales 2,480 0% 3% 2,752 8% 5% 5,232 4% 4%
Europe 1,372 3% 7% 1,460 12% 6% 2,832 8% 6%
International 590 -8% -2% 694 11% 11% 1,284 1% 5%
North America 518 -1% 1% 598 -4% -3% 1,116 -2% -1%

Q3 2025 change 9M 2025 change
USD m USD % CC % USD m USD % CC %
Net sales 2,825 9% 6% 8,057 5% 5%
Europe 1,530 12% 6% 4,362 9% 6%
International 659 4% 4% 1,943 2% 4%
North America 636 6% 7% 1,752 1% 1%

2024


Q1 2024 % change Q2 2024 % change Q3 2024 % change Q4 2024 % change
USD m USD CC USD m USD CC USD m USD CC USD m USD CC
Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9%
Generics 1,869 0% 1% 1,835 -1% 1% 1,854 3% 4% 1,946 1% 4%
Biosimilars 623 21% 21% 720 35% 37% 741 36% 37% 769 23% 25%


Q1 2024 % change Q2 2024 % change Q3 2024 % change Q4 2024 % change
USD m USD CC USD m USD CC USD m USD CC USD m USD CC
Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9%
Europe 1,326 4% 2% 1,308 2% 3% 1,362 13% 12% 1,367 7% 8%
International 642 4% 12% 627 5% 9% 635 2% 8% 653 0% 6%
North America 524 6% 6% 620 22% 23% 598 17% 18% 695 13% 14%

(Press release, Sandoz, OCT 30, 2025, View Source [SID1234657117])