On October 29, 2025 Recursion Pharmaceuticals, Inc. (the "Company" or "Recursion") reported the exercise of the option by Roche (as defined below) for a Microglia Map—a first-of-its-kind whole genome map of the brain’s immune cells—generated by Recursion under the Collaboration and License Agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd (collectively "Roche") dated December 5, 2021 (the "Agreement"). Pursuant to the terms of the Agreement, Roche will pay to the Company an Acceptance Fee of $30 million.

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(Press release, Recursion Pharmaceuticals, OCT 29, 2025, View Source [SID1234657113])

On October 29, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration ("FDA") to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival (PFS) as an earlier primary endpoint in addition to median overall survival (mOS). If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company’s trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused.

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"The final survival results and durable clinical responses from our VERSATILE-002 trial are very exciting. It’s the first time that a trial in the recurrent/metastatic HNSCC population has reported a mOS of almost 40 months," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "The fact that our Phase 3 study has mOS as its primary endpoint and PFS as a secondary endpoint inherently lengthens the duration of the trial. To shorten the trial duration, we believe a meeting with the FDA to discuss changes to the current trial protocol to include PFS as an earlier primary endpoint independent of mOS is warranted. We look forward to keeping all PDS Biotech stakeholders informed as our discussions with the FDA progress."

Dr. Kirk Shepard, MD, Chief Medical Officer added, "Based on the increasing incidence of HPV16-positive head and neck cancer, our goal is to seek the fastest and most cost-effective regulatory pathway to approval. Our goal is to be efficient in providing a well-tolerated treatment without chemotherapy as an option for patients who currently have no effective therapies for this deadly disease. Treatment with PDS0101 for currently enrolled patients in our VERSATILE-003 Phase 3 trial will continue during the temporary pause of the trial."

About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy’s impact on patients who are either naive to or refractory to immune checkpoint inhibitors. The full data set from VERSATILE-002 is mature and expected to be submitted for publication later this year.

(Press release, PDS Biotechnology, OCT 29, 2025, View Source [SID1234657111])

On October 29, 2025 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported that it has entered into a license and collaboration agreement with Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) to discover and develop multispecific antibodies for several therapeutic indications of mutual interest. The collaboration will apply ModeX’s MSTAR platform and Regeneron’s proprietary binders to develop multispecific antibody candidates that target multiple distinct biological pathways in a single molecule.

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Under the terms of the agreement, ModeX will receive an upfront payment of USD $7 million, and potential future product selection payments, clinical and regulatory milestone payments, and commercial milestone payments exceeding USD $200 million per selected molecule. The overall value of the collaboration potentially exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered global net sales royalties, up to low double digits at the highest tier. Regeneron will fund and lead any preclinical, clinical development and commercialization activities for any products it elects to advance.

"This agreement allows us to work closely with Regeneron, world leaders in the development of antibody medicines, to explore the promise of multispecific antibodies in new indications, including immunology, oncology and metabolic diseases. ModeX’s mission is to develop innovative antibodies that recognize multiple targets in a single molecule to treat life-threatening diseases," said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX and Chief Innovation Officer of OPKO Health.

"We have dramatically expanded the therapeutic potential of antibodies through our MSTAR platform. Our antibody candidates are already in clinical trials, providing unique disease target combinations and reliable manufacturing," said Elias Zerhouni, M.D., President and Vice Chairman of OPKO. "We believe this collaboration, with Regeneron’s outstanding team, will advance the development of multispecific antibodies across a spectrum of chosen indications in several disease areas of high interest to both parties."

"Like Regeneron, ModeX has a team of scientist entrepreneurs who think creatively about science and technology," said George D. Yancopoluos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron. "By pairing Regeneron’s expertise in drug development with ModeX’s platform for multispecific antibodies, we are building on Regeneron’s longstanding work in bi-and multi-specific antibodies and increasing our shots on goal by identifying more candidates faster to potentially help patients across multiple disease categories."

Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)

Multispecific antibody therapeutics can help generate medicines of the future by targeting three or more disease pathways simultaneously. Many untreatable or complex conditions arise from multiple disease pathways; yet, most medicines only act on a single target. ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.

(Press release, Opko Health, OCT 29, 2025, View Source [SID1234657109])

On October 29, 2025 OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reported business highlights and financial results for the three and nine months ended September 30, 2025.

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Highlights from the third quarter of 2025 and recent weeks include the following:

Entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies. This new partnership leverages ModeX’s MSTAR technology platform with Regeneron’s proprietary binders to develop single molecule candidates that target multiple distinct biological pathways in several indications. ModeX is entitled to receive an upfront payment and potential milestone payments exceeding $200 million for each program. The overall value of the collaboration potentially exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered royalties on global net sales, up to low double digits at the highest tier. Regeneron is responsible for funding all preclinical and clinical development, as well as all commercialization activities.
Completed the sale of BioReference Health (BioReference) oncology and related clinical assets to Labcorp for $225 million. The purchase included $192.5 million that was paid at closing and up to $32.5 million in a performance-based earnout. BioReference will continue to offer its core clinical testing services in the New York and New Jersey region and its 4Kscore Test franchise, which represented approximately $300 million in revenue for 2024. This transaction streamlines BioReference’s laboratory services business and better positions the company to optimize its test menu and achieve sustained profitability. OPKO intends to utilize a portion of the proceeds to fund its share repurchase program.
Merck advanced the Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck and evaluates safety and tolerability in up to 200 healthy adults. Enrollment in this ongoing trial is progressing well and the safety and immunogenicity data obtained from this trial will inform the Phase 2 trial design.
First patient dosed in MDX2004 Phase 1/2a study for the treatment of advanced cancers (NCT07110584). This study is designed to evaluate the safety, tolerability and biologic activity of MDX2004, a first-in-class trispecific antibody-fusion protein, as an immunotherapy for advanced cancers. Preclinical proof-of-concept data, as well as clinical dose selection analyses to support MDX2004 development will be showcased in two poster presentations at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 5-9, 2025.
Abstract for MDX-2001 CMet-Trop2/CD3-CD28, a first-in-class tetraspecific T-cell engager, was presented at ESMO (Free ESMO Whitepaper) 2025. In October, the abstract titled "A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors" was presented at ESMO (Free ESMO Whitepaper) Congress 2025, the annual meeting of the European Society for Medical Oncology. The MDX2001 CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in select solid tumors expected to begin in early 2026.
Abstract for first-in-class dual GLP-1/glucagon tablet candidate was presented at the ENDO 2025 annual meeting. In July, the abstract titled "First-in-Class Oral Dual GLP-1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders: In Vivo Pharmacokinetic and Pharmacodynamic Results" highlighting preclinical animal data was presented at ENDO 2025, the annual meeting of the Endocrine Society. Oral OPK-88006 is being developed pursuant to a collaboration and license agreement between OPKO and Entera Bio (Entera) whereby the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment with OPK-88006 and Entera’s proprietary N-Tab technology.
Abstract on the pharmacokinetics/pharmacodynamics of oral GLP-2 tablet for the treatment of short bowel syndrome was presented at the 2025 ESPEN Congress. In September, the abstract "A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome" highlighting in vivo animal data was presented at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress. Pursuant to a research collaboration agreement with Entera, the companies are developing an oral GLP-2 tablet that combines a proprietary long-acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab technology, for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption.
FDA approved the supplemental application for the 4Kscore Test regarding the availability of digital rectal examination information. In July, the U.S. Food and Drug Administration (FDA) approved OPKO’s supplemental application enabling the performance of the 4Kscore Test without digital rectal examination (DRE) information. The 4Kscore Test is indicated for the assessment of the likelihood of aggressive prostate cancer in men age 45 and older who have age-specific elevated/abnormal screening PSA results. Two prospective controlled clinical studies (n=937) concluded that the 4Kscore Test is a reliable (>96% sensitivity and accuracy) blood test to assess the probability of aggressive prostate cancer, before biopsy decisions. In the U.S., over 90% of PSA screening tests are ordered by primary care providers, potential users of the 4Kscore Test who don’t routinely perform a DRE.
Third Quarter Financial Results

Consolidated: Consolidated total revenues for the third quarter of 2025 were $151.7 million compared with $173.6 million for the comparable period of 2024. Operating income for the third quarter of 2025 was $48.1 million compared with $14.2 million for the 2024 quarter. Net income for the third quarter of 2025 included a gain of $101.6 million from the sale of the BioReference oncology assets. The prior-year period included a gain of $121.5 million from the sale of certain BioReference clinical assets and income of $45.9 million related to the investment in GeneDx shares. Net income for the third quarter of 2025 was $21.6 million, or $0.03 per diluted share, compared with $24.9 million, or $0.03 per diluted share, for the 2024 quarter.
Pharmaceuticals: Revenue from products in the third quarter of 2025 was $37.7 million compared with $39.1 million in the third quarter of 2024, reflecting lower sales volumes in certain international operations primarily due to the timing of customer orders and product mix, partially offset by an increase in Rayaldee sales. Revenue from sales of Rayaldee was $7.5 million compared with $5.8 million in the comparable prior-year period. Revenue from the transfer of intellectual property and other was $18.8 million in the third quarter of 2025 compared with $13.2 million in the 2024 period. The increase was driven by higher revenue from the BARDA contract and higher gross profit share payments for NGENLA, which totaled $8.8 million in the 2025 period compared with $7.0 million in the 2024 period. Total costs and expenses decreased to $80.6 million in the third quarter of 2025 from $84.6 million in the prior-year period, primarily due to lower cost of revenue related to lower sales volume and reduced employee-related expense, partially offset by higher research and development expenses driven by progress in the BARDA collaboration and advancements in early-stage programs. Operating loss was $24.2 million in the third quarter of 2025 compared with $32.2 million in the third quarter of 2024, with both periods including $18.0 million of depreciation and amortization expense.
Diagnostics: Revenue from services in the third quarter of 2025 was $95.2 million compared with $121.3 million in the prior-year period, with the decrease primarily due to lower clinical test volume principally as a result of the sale of certain BioReference assets in 2024, partially offset by higher clinical test reimbursement rates. Total costs and expenses, net of the gain on the sale of assets in both periods, were $13.6 million in the third quarter of 2025 compared with $62.7 million in the third quarter of 2024. The decrease was primarily attributable to the assets sold and continued cost-reduction initiatives at BioReference. Operating income was $81.6 million in the third quarter of 2025, which included $4.7 million of depreciation and amortization expense, compared with $58.5 million in the 2024 period, which included $6.1 million of depreciation and amortization expense. The third quarter of 2025 included revenue of $19.5 million and costs and expenses of $25.2 million from the oncology assets that were sold to Labcorp on September 15, 2025.
Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents and restricted cash were $428.9 million as of September 30, 2025. In September 2025, OPKO received $173.3 million in cash consideration and an escrow of $19.2 million subject to any outstanding indemnity claims upon closing of the Labcorp transaction. As of September 30, 2025, approximately $73.8 million of OPKO’s common stock had been repurchased under the program since its authorization in July 2024, and approximately $126.2 million remains authorized and available for future repurchases.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until November 5, 2025, by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 8678248. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

(Press release, Opko Health, OCT 29, 2025, View Source [SID1234657108])

On October 29, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported that the Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE," with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. This patent further expands the Company’s intellectual property portfolio globally.

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Walter Klemp, Chairman and CEO of Moleculin, commented, "As we continue our mission to provide patients with Annamycin, a potentially transformative therapeutic candidate for hard-to-treat tumors, we remain focused on building our global patent protection to strengthen our competitive moat in oncology and bolster our position as a leader in the space. I am proud of our team’s diligent work in securing patent protection across key markets, and adding this Australian patent to our growing global IP portfolio underscores our commitment and belief in the potential of Annamycin. We remain encouraged by the data demonstrated by Annamycin to date and look forward to its continued advancement."

Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly granted Australian patent, this patent family relating to the preparation of preliposomal Annamycin includes an expected Canadian patent and previously issued U.S. and allowed European patents. Moleculin also has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

(Press release, Moleculin, OCT 29, 2025, View Source [SID1234657107])