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Dec 01 Edition

PharmaShots Weekly is your Monday signal check: a fast, story-driven run-through of the deals, data, approvals, and platforms that actually shift the biopharma landscape.

This Thanksgiving, Lilly Puts Alzheimer’s in the Spotlight, and Family at the Center

Gilead Secures Sprint Bioscience’s TREX1 Program, Expanding Its Cancer Arsenal

Tuznue Gains Momentum in LATAM as Prestige Biopharma and Biosidus Launch Regional Rollout

Imugene and JW Therapeutics Fuse Oncolytic Viruses With CAR-T in a Bold New Solid Tumor Strategy

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The Thanksgiving Moment That Made America Talk About Alzheimer’s

A film, a celebrity partnership, and a perfectly timed message reframe Alzheimer’s through empathy, not fear.

This Thanksgiving, Eli Lilly delivered a message that cuts through the noise of parades, football, and family chatter: the gift of a “good day” with someone you love.

Timed to the holiday, Lilly’s unbranded Alzheimer’s campaign — including its moving short film Good Days and Chris Hemsworth’s deeply personal TV special A Road Trip to Remember, reached millions just as families were gathered across the country.

The goal wasn’t promotion, but perspective. Thanksgiving often reveals the small changes in memory and behavior that busy weeks hide. By anchoring the campaign to this moment, Lilly turned a national holiday into a national reminder:
Talk about brain health. Notice the signs. Cherish the moments that matter.

A simple, emotional takeaway emerged for every household tuning in:
This season, gratitude isn’t just about the meal; it’s about the memories that make it meaningful.

Gilead Bags Sprint Bioscience’s TREX1 Program in High-Impact Move

Gilead Snaps Up Sprint Bioscience’s TREX1 Cancer Program

Sprint Bioscience Sells Its TREX1 Cancer Program to Gilead Sciences

Sprint Bioscience has converted its preclinical TREX1 immuno-oncology program into a high‑value, non-dilutive capital source, while Gilead Sciences adds a first‑in‑class immune‑modulating asset that strengthens its next‑generation oncology strategy. The transaction is structured as a full asset sale with meaningful upside tied to clinical, regulatory, and commercial success, giving both companies strategic leverage as TREX1 advances toward the clinic.

Sprint Bioscience hands off TREX1

Sprint Bioscience has sold its preclinical TREX1 cancer program to Gilead, completing a full transfer of the asset rather than a traditional license. The move fits Sprint’s model of monetizing early-stage, first‑in‑class small‑molecule programs while redirecting resources into its broader discovery pipeline.

Deal economics

•	Sprint Bioscience receives a 14-million-dollar upfront payment from Gilead at signing, providing immediate, non‑dilutive funding.

•	The agreement includes up to 400M dollars in additional potential milestone payments tied to clinical progress, regulatory approvals, and commercial performance, bringing total deal value to as much as 414M dollars.

Program potential in oncology

The TREX1 program targets three-prime repair exonuclease 1, an innate immunity regulator that tumors use to clear cytosolic DNA and blunt antitumor immune responses. Sprint’s preclinical data suggests that TREX1 inhibition can boost immune activation, slow tumor growth, and potentially enhance responses to immunotherapies, radiotherapy, and chemotherapy across multiple solid tumor settings.

Strategic lift for both partners

For Gilead, TREX1 adds a differentiated innate immune–activating mechanism into its expanding oncology portfolio and aligns with its push into next‑generation immuno‑oncology combinations. For Sprint Bioscience, the asset sale validates its discovery engine, extends cash runway, and exemplifies its strategy of pursuing flexible, value‑driven exits while large pharma partners take promising programs through development to patients.

LATAM Rollout Ignites: Prestige Biopharma and Biosidus Propel Tuznue Forward

Prestige Biopharma & Biosidus Team Up to Launch Tuznue Across Latin America

Prestige Biopharma has structured a regional biosimilar push by granting Biosidus exclusive rights to launch Tuznue, its trastuzumab biosimilar referencing Herceptin, across key Latin American markets while retaining centralized control of drug substance manufacturing and supply. With European approval already in hand, the alliance positions Tuznue for broad uptake in HER2‑positive breast and gastric cancer across Latin America.

Exclusive Latin American launch

Prestige Biopharma has entered an exclusive license and supply agreement with Biosidus to bring Tuznue, a biosimilar of Herceptin (trastuzumab), to Argentina, Mexico, Bolivia, and Paraguay. Under the deal, Biosidus holds sole rights to market and distribute Tuznue in these territories, leveraging its established commercial network and oncology footprint in the region.

Manufacturing and supply model

Prestige Biopharma will oversee production and supply of the Tuznue drug substance from its high‑tech, EU‑GMP‑certified facility, ensuring consistent global quality standards. Biosidus will then manufacture the final drug product at its Buenos Aires site and handle both local supply and exports to Mexico, Paraguay, and Bolivia, enabling localized fill‑finish with streamlined regional distribution.

Regulatory momentum sets the stage

Tuznue, a trastuzumab biosimilar, has secured European Commission marketing authorization for HER2‑positive metastatic and early breast cancer as well as HER2‑positive metastatic gastric cancer. That late‑stage regulatory traction underpins the Latin American strategy, setting the stage for a major regional launch that can expand access to a cost‑effective HER2‑targeted therapy across multiple tumor types.

Oncolytic Viruses x CAR-T: Imugene and JW Spark a New Front in Solid Tumor Therapy

Oncolytic Viruses Meet CAR-T: Imugene and JW Therapeutics Ignite a New Strategy Against Solid Tumors

Imugene and JW Therapeutics Unite to Push CAR-T Into Solid Tumors

Imugene has entered a strategic co-development alliance with JW Therapeutics to push CAR-T therapy into solid tumors by pairing Imugene’s oncolytic virus CF33-CD19 (onCARlytics) with JW’s CD19-directed CAR-T cell therapy, Carteyva. The partners aim to validate a first-in-class “mark-and-kill” strategy that could extend CAR-T’s impact well beyond blood cancers and into difficult-to-treat solid tumors.

Collaboration blueprint

Imugene and JW Therapeutics will jointly run a preclinical program spanning in vitro and in vivo studies to establish safety, potency, and combination mechanics for CF33-CD19 plus Carteyva. Once this preclinical package is in place, the program will advance into a Phase I investigator-initiated trial conducted exclusively at leading CAR-T centers across China, focusing on patients with advanced solid tumors.

How the “mark-and-kill” strategy works

CF33-CD19 is a genetically engineered oncolytic virus designed to infect tumor cells and force them to express the CD19 antigen on their surface. By “painting” solid tumor cells with CD19, the virus turns previously CAR-T–resistant cancers into viable targets for CD19-directed therapies like Carteyva, enabling CAR-T cells to recognize, bind, and destroy these tumors.

Strategic significance for solid tumors

This approach is designed to overcome one of CAR-T’s biggest limitations: the lack of suitable, tumor-restricted surface targets in solid cancers. If successful, the Imugene–JW Therapeutics program could open a scalable path for repurposing proven CD19 CAR-T platforms against a broad range of solid tumors, reshaping treatment options for patients with few effective alternatives.

Biogen & Dayra Forge a Powerhouse Immunology Alliance

Biogen Strikes High-Value Immunology Pact with Dayra Therapeutics

Biogen is scaling up its immunology ambitions through a discovery-heavy alliance with Dayra Therapeutics that pairs cutting-edge oral macrocyclic peptide science with late-stage development and global commercialization muscle. The pact is structured around a $50M upfront payment, program-by-program acquisition options, and substantial preclinical and clinical milestones, positioning it as a potentially high-value, multi-asset engine for next‑generation immune therapies.

Biogen & Dayra’s new immunology engine

Biogen has entered a research collaboration with Dayra Therapeutics to discover and develop orally delivered macrocyclic peptides directed at high-priority immunological targets, aiming to create a new class of small, potent, oral agents with biologic-like performance. The partnership is designed to reshape Biogen’s early immunology pipeline by unlocking macrocycles that can reach complex binding sites that traditional small molecules often cannot.

How the collaboration runs

Working side by side in discovery, Biogen and Dayra will jointly identify, validate, and optimize a new wave of oral macrocyclic peptide candidates for key immune pathways. Once promising molecules emerge, Biogen will lead clinical development, manufacturing, and potential commercialization, using its global scale to move successful programs through late-stage trials and into market.

Deal economics and upside

Dayra locks in a $50M upfront payment, reflecting Biogen’s conviction in the macrocycle discovery platform and the strategic importance of oral immunology assets. On top of this, Biogen holds options to acquire individual development candidates for additional program-specific payments plus layered preclinical and clinical milestones, creating a flexible, multi-program framework that can grow in value as the science delivers.

Why this alliance matters

The collaboration fuses Dayra’s macrocyclic peptide discovery expertise with Biogen’s immunology know‑how and development infrastructure, building a powerful engine to advance oral therapies for immune‑mediated diseases. If successful, the alliance could expand the treatment toolbox beyond injectable biologics, improving patient convenience while generating meaningful pipeline and economic value across multiple programs for both partners.

Italy in Focus: Klinge Pharma Snaps Up Exclusive FYB203 Launch Rights

Italy Next: Klinge Pharma Locks Exclusive Rights to Roll Out FYB203

Klinge Pharma Secures Exclusive FYB203 Deal in Italy

Klinge Pharma has locked in exclusive Italian rights to commercialize FYB203, Formycon’s biosimilar to Eylea (aflibercept), while Formycon retains a meaningful economic stake through royalties, service fees, and profit‑share linked to commercial supply. FYB203 is already approved by major regulators in the US, EU, and UK, setting up the product for a coordinated European rollout under the Ahzantive and Baiama brands.

Exclusive Italian commercialization

Klinge Pharma, which holds global commercialization rights for FYB203, has signed an exclusive agreement with NTC to market the aflibercept biosimilar in Italy. Under this structure, NTC leads local commercialization while Klinge remains the central rights holder, aligning with broader regional partnerships already in place for Europe and other key markets.

Economics for Klinge and Formycon

Klinge will receive royalties on FYB203 net sales in Italy, with Formycon participating in those royalty streams at a mid‑single to low‑double‑digit percentage level. Beyond this, Formycon serves as authorized designee for the FYB203 supply chain, earning additional service payments plus a volume‑based profit component for organizing commercial supply on Klinge’s behalf.

Regulatory momentum for FYB203

FYB203 secured US Food and Drug Administration approval in June 2024, establishing it as an Eylea biosimilar for major retinal indications. The European Commission then approved the product in January 2025 under the Ahzantive and Baiama brand names, followed by UK MHRA authorization in February 2025, collectively paving the way for a broad European launch that includes the newly structured Italian partnership.

This Week in Biopharma: Major Phase II & III Readouts You Can’t Miss

From Bayer’s stroke milestone to Celltrion’s Crohn’s success and Kelun’s NSCLC leap, late-stage pipelines are accelerating fast.

1. Stroke Prevention

Highlights from the P-III OCEANIC-STROKE by Bayer

Bayer has released promising Phase III OCEANIC-STROKE results for asundexian (50 mg, once daily, oral) in 12,300 patients recovering from a non-cardioembolic ischemic stroke or high-risk TIA. The therapy—tested against placebo on top of standard antiplatelet treatment—met both its primary efficacy and safety endpoints.

Key Outcome
Asundexian showed a significant reduction in ischemic stroke risk with no increase in ISTH major bleeding, highlighting strong efficacy and safety in secondary stroke prevention.

Regulatory Path Ahead

Bayer is preparing global marketing authorization submissions to advance asundexian toward approval.

What’s Next

The company plans to present full Phase III data at an upcoming scientific meeting, reinforcing asundexian’s potential as a next-generation stroke prevention therapy.

2. Prurigo Nodularis

Global Phase II Trial of Soficitinib by InnoCare

InnoCare has dosed the first patient in its global Phase II trial evaluating soficitinib (ICP-332) for prurigo nodularis in China—an important step toward addressing this highly debilitating, itch-driven dermatologic condition.

Phase II Momentum:
Soficitinib has already shown encouraging data—its Phase II trial in moderate to severe atopic dermatitis demonstrated superior efficacy and a favorable safety profile, with findings presented at AAD 2025.

How It Works:
As a selective TYK2 inhibitor, soficitinib blocks key cytokine pathways such as IL-4, IL-13, and IL-31, which drive neurogenic itch, skin inflammation, and broader T-cell–mediated autoimmune activity.

Why It Matters:
By precisely modulating these pathways, soficitinib is being positioned as a next-generation therapy for autoimmune skin disorders—one that could offer improved outcomes with a differentiated safety and tolerability profile.

3. Crohn’s Disease

Insights from the P-III LIBERTY-CD Study by Celltrion

Celltrion has unveiled a post-hoc analysis from its Phase III LIBERTY-CD study evaluating Zymfentra (infliximab-dyyb, SC) in patients with moderate to severe Crohn’s disease. The findings, now published in Clinical Gastroenterology and Hepatology, highlight robust efficacy regardless of disease location.

In the 329-patient dataset, 52.6% had colon-dominant and 47.4% had ileum-dominant disease. By Week 54, Zymfentra delivered clear superiority over placebo across all key endpoints:

•	Clinical remission: • Ileum-dominant: 60.95% vs 37.25% • Colon-dominant: 66.95% vs 29.09%

•	Clinical response: • Ileum-dominant: 62.86% vs 41.18% • Colon-dominant: 67.80% vs 38.18%

•	Endoscopic response: • Ileum-dominant: 53.33% vs 19.61% • Colon-dominant: 52.54% vs 18.18%

Zymfentra also demonstrated superior endoscopic improvements across all ileocolonic segments, including the terminal ileum, reinforcing consistent treatment effects independent of disease dominance.

These results add meaningful clinical weight to Zymfentra’s profile as a potent, convenient SC infliximab option for Crohn’s disease management. 

4. Non-Small Cell Lung Cancer

Insights from the P-III OptiTROP-Lung05 Study by Kelun-Biotech

Kelun-Biotech has released promising Phase III OptiTROP-Lung05 results evaluating sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda versus Keytruda monotherapy as first-line treatment for PD-L1–positive locally advanced or metastatic NSCLC (TPS ≥1%).

Efficacy Signal

The combo of sac-TMT + Keytruda achieved the primary endpoint, with the IDMC confirming a significant improvement in PFS, strengthening its case as a more effective first-line option than Keytruda alone.

Survival Outlook

A favorable OS trend was observed, suggesting the regimen may offer longer-term survival benefits—a key consideration in reshaping care for PD-L1–positive NSCLC.

Regulatory Momentum

Kelun-Biotech plans to engage China’s CDE to move forward with a supplemental NDA, positioning sac-TMT for potential approval and future commercial rollout in the PD-L1+ NSCLC population.

Renalys Pharma has announced encouraging topline Phase III results for sparsentan (RE-021, oral) in Japanese patients with IgA nephropathy (IgAN).

5. Obesity or Overweight

Gan & Lee Advances Bofanglutide Into New Phase III Obesity Study

Gan & Lee Pharmaceuticals has launched its Phase III GRADUAL-3 trial evaluating bofanglutide (GZR18) in adults living with obesity or overweight. The study will assess the safety and efficacy of once-monthly SC bofanglutide (Q4W) over 24 weeks, with the primary endpoint focused on both absolute and percentage reduction in body weight at Week 24.

Late-Stage Pipeline
Bofanglutide is advancing through two additional Phase III programs:
• GRADUAL-1: ~630 adults with obesity or overweight who have not achieved sufficient weight loss through lifestyle changes.
• GRADUAL-2: A head-to-head trial vs Wegovy, enrolling ~471 adults with or without type 2 diabetes.

Strategic Positioning
With three Phase III trials running in parallel, Gan & Lee is positioning bofanglutide as a next-generation, long-acting GLP-1 therapy poised to compete in the rapidly growing global obesity market.

A Global Wave of Wins: This Week’s Biggest Regulatory Greenlights

Regulatory Radar: Breakthroughs Making Headlines This Week

This week brought a wave of high-impact regulatory wins across immunology, oncology, neurology, dermatology, and rare diseases—fueling fresh momentum for next-generation therapies around the globe. Dive into the most influential approvals, designations, and advancements now reshaping the biopharma landscape.

Key milestones:

1.	FDA approves Astellas & Pfizer’s perioperative Padcev + Keytruda for muscle-invasive bladder cancer (MIBC), marking a major advancement in early-stage urothelial cancer care.

2.	Cothera Bioscience’s Zotiraciclib earns FDA Fast Track Designation for recurrent IDH-mutated high-grade glioma, accelerating development for this hard-to-treat brain cancer.

3.	BMS’ Breyanzi secures EC approval for relapsed/refractory mantle cell lymphoma, expanding its footprint in aggressive B-cell malignancies.

4.	Novartis’ Itvisma receives FDA approval for spinal muscular atrophy, adding a new therapeutic option for this rare neuromuscular disorder.

5.	Regeneron and Sanofi’s Dupixent wins EC approval for chronic spontaneous urticaria (CSU), broadening its reach across allergic and inflammatory diseases.

6.	Otsuka Pharmaceutical’s Gains FDA accelerated approval for a treatment targeting primary IgA nephropathy (IgAN)—a key milestone in kidney disease care.

7.	AstraZeneca’s Imfinzi earns FDA approval as a perioperative therapy for gastric and gastroesophageal junction cancers, strengthening AZ’s immunotherapy portfolio.

8.	The FDA accepts the BeOne Medicines’ NDA for sonrotoclax with Priority Review to treat relapsed/refractory mantle cell lymphoma.

9.	Novo Nordisk Submits an sNDA to the FDA for a higher-dose Wegovy formulation aimed at enhancing outcomes in weight management.

10.	Innovent Biologics Receives NMPA approval for Pecondle (picankibart) in plaque psoriasis, bringing a new biologic option to the Chinese market.

11.	Eisai & Biogen Seek PMDA’s approval for Leqembi SC (lecanemab) in early Alzheimer’s disease, aiming to expand patient access through a more convenient route of administration.

MedTech Ignites: The Week’s High-Impact Regulatory Wins

MedTech Momentum: Key Regulatory Greenlights This Week

1. Transmural Systems Receives FDA 510(k) clearance for TELLTALE, a device designed to prevent coronary obstruction during TAVR, offering a promising safety enhancement for transcatheter valve procedures.

2. GE HealthCare Secures FDA Premarket Authorization for Pristina Recon DL, its advanced mammography solution, aimed at improving breast cancer detection and diagnostic accuracy.

With this wave of regulatory approvals and clearances, the biopharma and MedTech sectors are making tangible strides toward improving patient outcomes across cancer, rare diseases, neurology, kidney disorders, and cardiovascular care.

Europe’s Biosimilar Boom: Momentum Hits a New High

Biosimilars Gaining Ground in Europe

•	Alvotech Receives European Commission approval for AVT03, a biosimilar of Prolia and Xgeva, marking a key milestone in expanding access to therapies for bone and skeletal disorders.

•	Teva Secures EC approval for Ponlimsi and Degevma, also biosimilars of Prolia and Xgeva, strengthening treatment options for patients across Europe managing osteoporosis and related bone conditions.

•	Celltrion’s Eydenzelt, its Eylea biosimilar, receives Health Canada approval for multiple retinal diseases, including wet AMD and DME.

These approvals highlight the growing role of biosimilars in improving accessibility and affordability of critical therapies for skeletal health.

Breakthroughs in Animal Care: Key Approvals Driving Innovation

Animal Health Innovations: Regulatory Wins

•	Elanco’s Credelio CAT (Lotilaner) receives the US FDA Emergency Use Authorization to protect cats against New World Screwworm, offering a critical tool for animal health and biosecurity.

•	Zoetis’ Lenivia (Izenivetmab) secures European Commission approval for osteoarthritis pain relief in dogs, providing a new option to improve comfort and quality of life for pets.

These approvals underscore the rapid innovation and regulatory momentum in the animal health sector, bringing safer and more effective solutions to pets worldwide.

That’s a Wrap for This Week
We will se you next week

Final Take: A Week of Bold Moves and Breakthrough Momentum

As this week’s wave of approvals, partnerships, and late-stage readouts shows, biopharma isn’t just advancing—it’s accelerating. From next-generation immunology engines and innovative oncology strategies to biosimilars expanding access and MedTech enhancing precision care, the global pipeline is firing on all cylinders. The science is getting sharper, the targets more refined, and the path to patients faster than ever.
The months ahead promise even more breakthroughs—and we’ll be here to keep you ahead of the curve.

Stay curious, stay informed, and stay ahead with PharmaShots Weekly.

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PharmaShots Weekly | Dec 01 Edition

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