Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply

On October 6, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and LOTTE Biologics, a contract development and manufacturing (CDMO) organization, reported a long-term strategic manufacturing partnership.

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Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse facility in New York for global supply, with the potential to further expand the collaboration over time. The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing, supported by on-site process development and quality control capabilities. The site has an established track record in commercial biologics manufacturing and recently completed an unannounced FDA inspection with zero observations, further demonstrating its strong quality and regulatory capabilities.

The agreement expands Alvotech’s US-based manufacturing footprint while strengthening its global supply network. The additional capacity complements Alvotech’s existing manufacturing partnerships and its in-house development and manufacturing capabilities, supporting its expanding portfolio and providing greater flexibility to meet demand across international markets.

"Alvotech has one of the most comprehensive, internally developed product portfolios in the industry," said Lisa Graver, CEO of Alvotech. "With the expansion of our global manufacturing network, we will have sufficient capacity to meet demand for our pipeline for the next ten years. Our collaboration with LOTTE Biologics will bring additional manufacturing capacity in New York to support patients worldwide, complementing our existing capabilities as we scale our portfolio and prepare for future launches."

"Alvotech’s expertise in biosimilar development, combined with LOTTE Biologics’ manufacturing capabilities, creates a strong foundation for this collaboration," said James Park, CEO of LOTTE Biologics. "We look forward to strategically supporting Alvotech’s growing portfolio and the reliable supply of high-quality, more affordable biologic medicines to patients worldwide. With our Syracuse operations and the completion of our Songdo Bio Campus, we are committed to providing flexible, dual-site manufacturing support as the partnership grows."

Commercial supply will be subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals.

(Press release, Alvotech, OCT 6, 2026, View Source [SID1234673249])

Nurix Therapeutics Announces First Patient Enrolled in Phase 1b/2 Combination Study of Bexobrutideg in Chronic Lymphocytic Leukemia

On October 6, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX) reported that the first patient has been enrolled in the Phase 1b/2 NX-5948-203 study evaluating bexobrutideg, an investigational oral Bruton’s tyrosine kinase (BTK) degrader, in combination with venetoclax, a standard-of-care therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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The study is being conducted under the global collaboration between Nurix and Roche and is designed to evaluate the safety, tolerability and clinical activity of bexobrutideg in combination with venetoclax, a BCL2 inhibitor. Data from the trial are expected to inform future registrational development strategies across lines of therapy in CLL, including evaluating bexobrutideg in combination with the anti-CD20 antibodies rituximab and obinutuzumab across multiple cohorts of patients with relapsed or refractory and previously untreated CLL, and potential expansion into other B-cell malignancies.

"The initiation of this study marks another important milestone in our effort to realize the full potential of bexobrutideg across B-cell malignancies," said Arthur T. Sands, M.D., Ph.D., chief executive officer of Nurix. "Combination therapies are becoming increasingly important in the treatment of CLL, especially in earlier lines of therapy, and we believe bexobrutideg’s differentiated mechanism of action, robust single-agent activity and favorable tolerability make it an attractive partner for combination approaches to deliver deep, durable responses with fixed-duration therapy."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in a broad clinical development program in patients with chronic lymphocytic leukemia (CLL), including the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL previously treated with covalent and noncovalent BTKi and a BCL2i; the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL previously treated with a covalent BTKi; the NX-5948-203 Phase 1b/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax in patients with relapsed/refractory CLL and potentially treatment-naïve CLL; and the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, OCT 6, 2026, View Source [SID1234673248])

Orion Pharma announces agreement with Qilu Pharma Europe for pembrolizumab biosimilar for European market

On October 6, 2026 Orion Corporation ("Orion Pharma") and Qilu Pharma Europe ("Qilu") reported to have entered into an agreement to commercialise intravenous (IV) pembrolizumab biosimilar in Europe. Pembrolizumab is an immune checkpoint inhibitor which is used to treat various cancers. Qilu is currently developing IV pembrolizumab.

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Under the terms of the agreement, Orion Pharma will gain exclusive right to distribute, market and sell Qilu’s IV pembrolizumab biosimilar in Europe. Qilu will supply the product to Orion Pharma, and is entitled to receive a share of profits from Orion Pharma as well as certain development, regulatory and sales milestone payments.

"We are pleased to expand our strategic partnership with Qilu," said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma. "With this agreement, we are one step closer to reaching our division’s long-term targets and strategic goals, and to creating broader access to affordable quality medicines."

(Press release, Orion, OCT 6, 2026, View Source [SID1234673247])

Regeneron Showcases Advances in Care Across Several Cancers and Cancer-associated Complications at ESMO 2026

On October 6, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the presentation of new clinical research at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place from October 23-27 in Madrid, Spain. Highlights from the company’s 10 abstracts will cover new data and analyses from trials in cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), ovarian cancer, melanoma and cancer-associated thrombosis.

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"At ESMO (Free ESMO Whitepaper), we look forward to sharing data across a range of conditions reflecting the breadth of our research," said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. "For the first time, we’re showcasing how our work extends beyond the treatment of cancer itself, and addresses some of the complex challenges patients face as a result of their disease. Together, these data reflect our broader commitment to advancing comprehensive cancer care for patients."

Highlights include:

Adjuvant treatment with Libtayo in adults with CSCC with high risk of recurrence after surgery and radiation: Late-breaking overall survival (OS) data at approximately 3.5 years follow-up from the C-POST Phase 3 trial will provide further evidence supporting Libtayo as the standard of care in this indication.
Neoadjuvant treatment with Libtayo in stage II-IV CSCC: Data include the final analysis of Phase 2 results, which represent the most mature data set in patients treated with Libtayo prior to surgery.
Factor XI antibodies (cenvacibart and amrecibart) as a potential approach to reducing thrombosis in patients with cancer: Data include a Phase 2 sub-analysis and modeling in catheter-related VTE, plus an update on the Phase 3 ROXI-CAT-II trial.

The full list of Regeneron presentations at ESMO (Free ESMO Whitepaper) are as follows: 

Abstract Title Abstract Presenter Session Date/Time (CET)
Skin Cancer
C-POST Phase 3 trial of adjuvant cemiplimab vs. placebo for high-risk CSCC: OS update at approximately 3.5 years’ median follow-up LBA: 59
Danny Rischin Sunday
October 25,
10:15-11:45
A Phase 2 study of neoadjuvant cemiplimab for Stage II–IV CSCC: final analysis Poster presentation: 2490P Neil D. Gross Saturday
October 24,
12:00-12:45
Long-term Overall Survival (OS) with Fianlimab (FIAN) plus Cemiplimab (Cemi) in Advanced Melanoma (aMel): Survival Follow-up of a Phase 1 Study Poster presentation: 2091P Omid Hamid Saturday
October 24,
12:00-12:45
Lung Cancer
Impact of objective response on PROs in patients receiving cemiplimab + chemotherapy vs. placebo + chemotherapy for aNSCLC: EMPOWER-Lung 3 Part 2 Poster presentation: 2714P Konstantin Penkov Monday
October 26,
12:00-12:45
CEMI-LUNG, a European-based observational study to assess cemiplimab real world effectiveness and safety in patients with advanced non-small cell lung cancer Poster presentation: 2580P Jesus Corral Jaime Monday
October 26,
12:00-12:45
Ovarian Cancer
Circulating tumor DNA (ctDNA), cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) associate with survival outcomes in patients with platinum-resistant ovarian cancer treated with ubamatamab Poster presentation: 1957P Jung-Yun Lee Saturday
October 24,
12:00-12:45
A Phase 1/2 study of REGN5668 (ubamatamab) (mucin 16 [MUC16] × cluster of differentiation [CD]28 costimulatory bispecific antibody), in combination with other targeted therapies, in patients with recurrent ovarian cancer or endometrial cancer: Trial in progress update ePoster presentation: 1445eTiP Roisin E. O’Cearbhaill N/A
Thrombosis (cenvacibart [REGN7508] and amrecibart [REGN9933])
Phase 3 trial-in-progress evaluating cenvacibart for the treatment and secondary prevention of venous thromboembolism (VTE) in participants with solid and hematologic cancers (ROXI-CAT-II) ePoster presentation: 1534eTiP Andrés J. Muñoz N/A
Sub-analysis of a Phase 2 study investigating amrecibart and cenvacibart for the prevention of contact-mediated VTE in participants with active cancer undergoing peripherally inserted central catheter (PICC) placement (ROXI-CATH) Poster presentation: 1468P Jeffrey I. Zwicker Monday
October 26,
12:00-12:45
Population pharmacokinetic/pharmacodynamic modeling of REGN7508Cat in patients with a PICC from ROXI-CATH who have active cancer supports maximal Factor XI pathway inhibition Poster presentation: 3968P Jeffrey I. Zwicker Saturday
October 24,
12:00-12:45

The potential uses of neoadjuvant Libtayo in CSCC, ubamatamab, cenvacibart and amrecibart described above are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

(Press release, Regeneron, OCT 6, 2026, View Source [SID1234673246])

Telomir Pharmaceuticals Secures $5.6 Million Financing as Billionaire Entrepreneur John Paul DeJoria Increases Investment in the Company

On October 6, 2026 Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, reported an approximately $5.6 million private investment in public equity (PIPE) financing through the issuance of common stock, without any accompanying investor warrants or convertible securities.

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The financing includes an additional $1.0 million investment from billionaire entrepreneur and existing significant shareholder John Paul DeJoria, co-founder of John Paul Mitchell Systems and Patrón Spirits. Other existing shareholders and new investors also participated in the financing.

DeJoria most recently reported beneficial ownership of approximately 3.55 million shares, representing approximately 5.0% of Telomir’s outstanding common stock. His additional $1.0 million investment further increases his investment in Telomir as the Company advances its lead program into clinical development.

"I have always looked for opportunities that can do the greatest good for the greatest number of people, and that is part of what attracted me to Telomir," said John Paul DeJoria. "Cancer continues to take an enormous toll on patients and families, and there remains a need for new approaches that can potentially improve the way we treat this disease. Telomir is pursuing a different scientific approach, and with the Company now moving into human clinical trials, I am pleased to increase my investment and support the team as they work to determine what Telomir-Zn may be able to do for patients."

Alexander Capital, L.P. acted as placement agent for the financing. The Company expects to receive aggregate gross proceeds of approximately $5.6 million, before deducting placement agent fees and other offering expenses.

Financing Terms

Under the terms of the financing, Telomir issued 4,843,300 shares of common stock at a purchase price of $1.16 per share, representing a 5% discount to the applicable 10-day volume-weighted average price (VWAP). The financing resulted in aggregate gross proceeds to the Company of approximately $5.6 million, before deducting placement agent fees and other offering expenses.

Investors in the financing purchased common stock at a fixed price, with no accompanying investor warrants, convertible securities, or variable-price or reset features.

The securities were issued in a private placement. Telomir has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares issued in the financing, subject to the terms of the Registration Rights Agreement.

The Company intends to use the net proceeds primarily to support the clinical development of Telomir-Zn, including its Phase 1/2 clinical program in advanced or metastatic triple-negative breast cancer (TNBC), as well as for working capital and general corporate purposes.

"We have been very deliberate about how and when we access the capital markets," said Erez Aminov, Chairman and CEO of Telomir. "Our strategy is to raise capital around meaningful milestones, deploy it toward value-driving objectives and progressively de-risk the program, while remaining mindful of our existing shareholders. As Telomir enters clinical development, our focus is on execution: deploying this capital efficiently to advance Telomir-Zn through its Phase 1/2 clinical program, generate meaningful human data and position the Company strongly for the milestones ahead."

Strengthening Telomir’s Position for Clinical Execution

The financing comes as Telomir advances Telomir-Zn, its lead investigational oral small molecule, into human clinical evaluation. The U.S. Food and Drug Administration has cleared Telomir’s Investigational New Drug (IND) application for Telomir-Zn, enabling the Company to proceed with its first-in-human Phase 1/2 clinical trial in patients with advanced or metastatic TNBC.

TNBC is an aggressive form of breast cancer defined by the absence of three common therapeutic targets, estrogen receptors, progesterone receptors, and HER2, limiting the applicability of many targeted treatments used in other forms of breast cancer. Patients with advanced or metastatic disease continue to face a significant need for additional treatment options.

The multicenter, open-label Phase 1/2 study is designed to move Telomir-Zn from initial human dosing through dose selection and into an efficacy-focused expansion. The Phase 1 portion will evaluate safety, tolerability, and dose selection while also assessing pharmacodynamic biomarkers and preliminary signals of antitumor activity. The Phase 2 expansion is designed to build on those findings with a greater focus on efficacy, providing an initial clinical proof-of-concept assessment of Telomir-Zn in advanced or metastatic TNBC.

A New Epigenetic Approach to Treating Cancer

Telomir-Zn is being developed as a potentially first-in-class oral epigenetic therapy designed to modulate intracellular metal homeostasis, particularly iron and copper, and influence gene-control pathways implicated in cancer. Preclinical studies have demonstrated inhibition of multiple iron-dependent histone demethylases (KDMs), supporting the Company’s hypothesis that Telomir-Zn may help restore more normal epigenetic regulation and potentially reactivate tumor-suppressor pathways that cancer has silenced.

(Press release, Telomir Pharmaceutical, OCT 6, 2026, View Source [SID1234673245])