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Welcome to PharmaShots Weekly
| | | Feb 02 Edition
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| | 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.
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AstraZeneca & CSPC Launch $18.5B Obesity Peptide Alliance
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| | Seamless and Eli Lilly Team Up on $1.1B Gene Editing Therapy for Hearing Loss
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| | Boehringer Ingelheim & Simcere Strike $1.26B Deal for Next-Gen IBD Therapy
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| | Repertoire & Lilly Partner on $1.84B Autoimmune Tolerance Therapy Program
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Stay Curious.
| | | Stay informed!
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| | Stay ahead with PharmaShots Weekly!
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Cover Story
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AstraZeneca & CSPC Launch $18.5B Obesity Peptide Alliance
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| • | Landmark partnership advancing 8 long-acting peptide programs.
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| • | Combines AI-driven discovery with sustained-release technology.
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| • | Financial scale: $1.2B upfront, $3.5B R&D milestones, $13.8B sales milestones + royalties.
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| • | Why it matters: Broad portfolio, technology convergence, market-leading timing.
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Big Deals Driving Innovation
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Boehringer Ingelheim & Simcere – $1.26B IBD Bispecific
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| • | Dual-target SIM0709 shows preclinical synergy; global rights ex-Greater China.
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| • | Potential next-gen option for IBD patients.
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Seamless & Eli Lilly – $1.1B Gene Editing for Hearing Loss
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| • | Programmable recombinase therapy could correct hearing-loss mutations.
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| • | Global license and significant milestones + royalties.
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Repertoire & Eli Lilly – $1.84B Autoimmune Tolerance Therapy
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| • | Targets immune dysfunction at the source using DECODE TCR-epitope platform.
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| • | Goal: Durable immune modulation without broad immunosuppression.
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Recordati & Moderna – mRNA-3927 for Propionic Acidemia
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| • | Early clinical data shows metabolic improvement; global commercialization strategy.
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| • | Milestones and royalties valued at $160M+.
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Cardiology & Metabolic Highlights
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Cytokinetics Myqorzo Launch
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| • | Once-daily oral myosin inhibitor for obstructive HCM.
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| • | Improves functional capacity, approved under REMS.
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Milestone Cardamyst Launch
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| • | Self-administered nasal spray for PSVT; rapid on-demand relief.
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| • | Patient assistance program ensures affordability.
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Ascletis ASC30 – Phase II in T2DM
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| • | Oral small-molecule GLP-1RA; topline data expected Q3 2026.
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| • | Previous obesity study showed meaningful weight loss with favorable safety.
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Roche CT-388 – Positive Phase II Topline in Obesity
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| • | 22.5% placebo-adjusted weight loss at 48 weeks; Phase III underway.
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nChroma CRMA-1001 – First Patient Dosed in CHB
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| • | Epigenetic silencer targeting hepatitis B; CTA approvals in NZ, UK, Hong Kong.
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Regulatory Momentum
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Global Approvals, INDs & BLAs
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| • | Novaliq IND clearance: P-II trial for non-infectious anterior uveitis.
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| • | Roche: Health Canada approval for Gazyva in lupus nephritis.
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| • | GSK: Arexvy EC approval for RSV prevention.
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| • | J&J: Darzalex FASPRO FDA approval for NDMM.
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| • | Tenpoint: Yuvezzi FDA approval for presbyopia.
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| • | Almirall: Seysara NMPA approval for acne.
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| • | Summit: Ivonescimab BLA acceptance for NSCLC.
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| • | NEXTBIOMEDICAL: Nexsphere-F Health Canada approval for musculoskeletal pain embolization.
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| • | ALK: EURneffy CHMP positive opinion for pediatric allergic reactions.
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MedTech Regulatory Pulse
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| • | BlueOcean Global – FDA 510(k) clearance for Excelsior External Fixation System.
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| • | ABANZA – FDA 510(k) clearance for QuadLock ACL fixation.
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| • | KORU Medical Systems – FDA clearance for FreedomEDGE system to deliver Rystiggo in gMG patients.
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Stay Ahead with PharmaShots Weekly
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| • | Monday, 8 AM EST: concise, credible insights on pipelines, regulatory moves, and deals.
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| • | Share with colleagues in R&D, CI, Strategy, or BD.
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| • | The industry moves fast. Your intelligence should move faster.
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AstraZeneca & CSPC Ink Transformational ~$18.5B Obesity Alliance Centered on Long-Acting Peptide Innovation
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CSPC Pharmaceutical Group and AstraZeneca have forged a landmark strategic collaboration and licensing agreement to advance next-generation long-acting peptide therapies for obesity, uniting CSPC’s sustained-release delivery technology with its AI-enabled peptide discovery platform.
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Under the agreement, AstraZeneca secures exclusive global rights outside Greater China to CSPC’s injectable weight management portfolio, spanning eight programs — including Phase I candidate SYH2082, three additional preclinical assets, and four co-developed pipeline candidates. The companies will jointly pursue novel peptide discovery and long-acting delivery strategies aimed at improving durability, adherence, and therapeutic impact in metabolic disease.
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Financially, the scale of the partnership underscores the opportunity: CSPC will receive a $1.2 billion upfront payment, up to $3.5 billion in R&D milestone payments, and approximately $13.8 billion in sales milestones, alongside tiered royalties reaching double digits on annual net sales of licensed products.
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Why This Collaboration Matters
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This deal signals a defining moment in the obesity treatment race:
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Portfolio depth: Eight peptide programs position AstraZeneca with a broad, differentiated metabolic pipeline.
Deal magnitude: With total potential value approaching $18.5 billion, the alliance ranks among the largest obesity-focused platform deals to date.
Technology convergence: AI-driven peptide discovery paired with sustained-release delivery could unlock longer-lasting efficacy and improved patient adherence.
Strategic timing: The partnership lands amid surging global demand for advanced weight management therapies beyond first-generation incretin drugs.
A Strategic Step Forward
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This alliance positions AstraZeneca to become a major force in long-acting metabolic therapeutics, while validating CSPC’s technology platforms on a global stage. Together, the companies are aiming to shape the next wave of obesity innovation—where durability, precision, and platform science define competitive advantage.
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| | Breaking Ground: Multi-Billion-Dollar Deals Paving the Future of Precision Therapies
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Boehringer & Simcere Advance Next-Gen IBD Therapy
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Boehringer Ingelheim & Simcere Join Forces on Dual-Target IBD Bispecific Worth Up to €1.06B
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Boehringer Ingelheim and Simcere have entered a license and collaboration agreement for SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody for inflammatory bowel disease (IBD). Boehringer Ingelheim gains global rights outside Greater China, while Simcere retains regional rights and is eligible for an upfront payment, milestones up to €1.058 billion ($1.26 billion), and tiered royalties on ex-Greater China net sales.
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SIM0709 is a long-acting, humanized bispecific antibody targeting TL1A and IL-23p19—two key inflammatory pathways in IBD. Preclinical data show synergistic efficacy superior to monotherapies or combinations, offering a potential next-generation option in IBD treatment.
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Why This Collaboration Matters
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The deal bolsters Boehringer Ingelheim’s IBD pipeline:
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| • | Global reach: Rights to SIM0709 ex-Greater China, with Simcere handling the region.
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| • | High-value economics: Up to €1.058 billion in milestones plus upfront and royalties for Simcere.
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| • | Innovative mechanism: Dual-target bispecific with strong preclinical synergy on TL1A/IL-23 pathways.
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| • | Market potential: Addresses unmet needs in IBD amid demand for differentiated biologics.
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A Strategic Step Forward
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This partnership accelerates SIM0709 toward clinical proof-of-concept, strengthening Boehringer Ingelheim’s leadership in immunology and advancing precision therapies for inflammatory bowel disease.
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Seamless & Eli Lilly Partner on Programmable Gene Editing Therapies for Hearing Loss in Deal Worth Over $1.1B
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Seamless Therapeutics and Eli Lilly have entered a strategic global research collaboration and licensing agreement to develop and commercialize programmable recombinase-based genetic therapies for hearing loss, using Seamless’ proprietary recombinase platform. Seamless will engineer site-specific recombinases to precisely correct gene mutations linked to hearing loss, while Eli Lilly gains an exclusive global license for preclinical/clinical development and commercialization.
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Seamless receives an upfront payment, R&D funding, over $1.12 billion in development and commercial milestones, plus tiered royalties on product sales.
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Why This Collaboration Matters
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The partnership validates programmable gene editing for genetic diseases:
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| • | Global scope: Eli Lilly’s exclusive license for development and commercialization worldwide.
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| • | Substantial economics: Over $1.12 billion in milestones for Seamless, plus upfront, funding, and royalties.
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| • | Precision innovation: Site-specific recombinases target hearing loss mutations for durable fixes.
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| • | Industry momentum: Builds confidence in next-gen gene therapies beyond traditional editing tools.
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A Strategic Step Forward
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This deal accelerates mutation-specific treatments for hearing loss, positioning Eli Lilly at the forefront of programmable gene editing and addressing unmet needs in genetic disorders
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Repertoire & Eli Lilly Team Up on Antigen-Specific Tolerance Therapies in Autoimmunity Deal Worth Up to $1.84B
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Repertoire Immune Medicines and Eli Lilly have entered a strategic collaboration to discover and develop tolerizing therapies for multiple autoimmune diseases, targeting immune dysfunction at its source. Repertoire uses its DECODE TCR-epitope platform to identify disease-relevant T cell targets and nominate candidates; Eli Lilly then handles clinical development, manufacturing, regulatory activities, and global commercialization.
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Financial terms include an $85 million upfront payment to Repertoire, up to approximately $1.84 billion in development and commercial milestones, plus tiered royalties on net sales.
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Why This Collaboration Matters
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The deal advances antigen-specific immune tolerance:
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| • | Division of expertise: Repertoire’s DECODE platform for discovery; Lilly for clinical/commercial execution.
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| • | Strong economics: $85 million upfront, $1.84 billion milestones, and royalties for Repertoire.
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| • | Innovative approach: Retrains immune system selectively, avoiding broad immunosuppression.
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| • | Paradigm shift: Fuels momentum in precision autoimmune therapies.
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A Strategic Step Forward
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This partnership harnesses Repertoire’s T cell insights with Lilly’s scale to pioneer durable treatments for autoimmune diseases, meeting rising demand for targeted immunomodulation.
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Recordati & Moderna Partner to Advance mRNA Therapy for Rare Metabolic Disorder in Deal Valued Beyond $160M
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Recordati and Moderna have entered a collaboration and licensing agreement to develop and commercialize mRNA-3927 globally for propionic acidemia, a rare life-threatening metabolic disorder. Moderna co-develops the asset, while Recordati leads global commercialization upon approval.
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Moderna receives a $50 million upfront payment, ~$110 million in development/regulatory milestones, plus commercial/sales milestones and tiered royalties on net sales.
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Why This Collaboration Matters
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The deal expands mRNA applications in rare diseases:
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| • | Global commercialization: Recordati handles sales; Moderna focuses on development.
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| • | Attractive economics: Over $160 million potential value for Moderna via milestones and royalties.
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| • | Clinical momentum: Interim Nature-published data show improvements; topline registrational results by end-2026.
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| • | Platform validation: Extends mRNA tech from vaccines to metabolic disorders.
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A Strategic Step Forward
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This partnership accelerates mRNA-3927 toward approval, leveraging Moderna’s expertise and Recordati’s rare disease reach to tackle high unmet needs in propionic acidemia.
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| | Breaking Ground: Next-Gen Therapies in Diabetes, Obesity, TD, and Hepatitis B
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Phase II for Oral GLP-1 in Type 2 Diabetes
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Type 2 Diabetes
Ascletis Pharma starts US Phase II: ASC30 (oral small-molecule GLP-1RA) in ~100 adults with type 2 diabetes mellitus (T2DM). Topline data expected Q3 2026.
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Key Details
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| • | Design: 13-week study; primary endpoint HbA1c reduction; secondaries include fasting glucose, body weight, safety. Once-daily dosing with weekly titration (1 mg start to 40/60/80 mg targets).
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| • | Prior data: Phase II obesity study (n=125) showed up to 7.7% weight loss at 60 mg; favorable GI tolerability, no liver signals.
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| • | Asset: Positions as next-gen oral GLP-1 with pill convenience and incretin efficacy.
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This trial builds momentum in oral GLP-1RAs, targeting T2DM after obesity proof-of-concept.
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Tardive Dyskinesia
Neurocrine Biosciences starts Phase II: NBI-1065890 (selective oral VMAT2 inhibitor) in ~100 adults with tardive dyskinesia (TD).
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Key Details
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| • | Design: Efficacy, safety, tolerability; primary endpoint change in AIMS total score at Week 8.
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| • | Asset: Targets dopamine signaling for involuntary movements; expands Neurocrine's movement disorder pipeline.
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| • | Context: Builds on VMAT2 class for better symptom control and tolerability.
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This trial highlights innovation in TD treatments.
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Obesity
Roche reports positive Phase II CT388-103 topline: CT-388 (dual GLP-1/GIP RA) achieves 22.5% placebo-adjusted weight loss at 48 weeks (24 mg dose, p<0.001).
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Key Details
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| • | Results: No plateau; 54% reached BMI <30 kg/m² (vs 13% placebo). Safety aligns with incretin class.
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| • | Next: Phase III (Enith1/Enith2) initiation Q1 2026.
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| • | Asset: Positions Roche in competitive obesity market with next-gen incretin.
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These data strengthen CT-388's late-stage potential.
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Chronic Hepatitis B
nChroma Bio doses first patient in Phase I/II: CRMA-1001 (epigenetic silencer) for chronic hepatitis B (CHB) in adults.
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Key Details
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| • | Design: Open-label; safety, PK/PD, prelim efficacy; single/multiple-ascending dose cohorts; enrollment ongoing.
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| • | Regulatory: CTA approvals in New Zealand, UK (plus prior Hong Kong).
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| • | Asset: Novel epigenetic silencing of HBV genes for potential functional cure.
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This advances nChroma's antiviral pipeline globally.
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| | Regulatory Momentum: Global Approvals Driving Care
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Global Regulatory Highlights: Immunology, Oncology & Vaccines
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Regulatory activity accelerated worldwide this week, with multiple approvals, clearances, and filing milestones signaling continued progress across inflammatory diseases, oncology, vaccines, and specialty therapeutics.
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Key Developments:
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| • | Novaliq received US FDA IND clearance to advance NOV05 into a Phase II trial for non-infectious anterior uveitis, expanding options in ocular inflammation.
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| • | Roche secured Health Canada approval for Gazyva in active lupus nephritis, reinforcing biologic advances in autoimmune kidney disease.
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| • | GSK’s Arexvy gained European Commission approval for the prevention of respiratory syncytial virus (RSV) disease, strengthening adult RSV vaccine coverage in Europe.
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| • | Johnson & Johnson earned US FDA approval for a Darzalex FASPRO–based regimen for newly diagnosed multiple myeloma (NDMM), broadening frontline hematology treatment options.
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| • | Elevar Therapeutics submitted for US FDA approval of lirafugratinib for cholangiocarcinoma, targeting a high unmet need in biliary tract cancers.
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| • | Tenpoint Therapeutics reported US FDA approval of Yuvezzi for presbyopia, advancing pharmacologic solutions in vision care.
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| • | Almirall announced NMPA approval of Seysara for acne, expanding its dermatology footprint in China.
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| • | Summit Therapeutics achieved US FDA BLA acceptance for ivonescimab in EGFR-mutated non-squamous NSCLC, marking a key regulatory step in lung cancer.
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| • | NEXTBIOMEDICAL’s Nexsphere-F received Health Canada approval for musculoskeletal pain embolization, supporting growth in interventional therapies.
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| • | ALK secured a positive CHMP opinion for EURneffy 1 mg for treating allergic reactions in children, advancing pediatric emergency allergy care.
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This wave of regulatory progress highlights sustained innovation across immune-mediated disease, oncology, infectious disease prevention, ophthalmology, and interventional medicine, underscoring how global health agencies continue to fast-track therapies addressing both chronic and acute care gaps.
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| | MedTech Regulatory Pulse: Innovation in Orthopedics and Drug Delivery
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MedTech Moves: FDA Clears Next-Gen Devices
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Image credit: Abanza Inc.
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Regulatory momentum continues in the medical technology space, with fresh US FDA clearances advancing next-generation solutions in orthopedic fixation and specialty drug delivery.
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Key Developments:
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| • | BlueOcean Global received US FDA 510(k) clearance for the Excelsior External Fixation System, expanding surgical options for fracture stabilization and complex orthopedic procedures.
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| • | ABANZA secured US FDA 510(k) clearance for its QuadLock Fixation System for ACL reconstruction, supporting innovation in sports medicine and ligament repair technologies.
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| • | KORU Medical Systems obtained US FDA clearance for its FreedomEDGE System to deliver Rystiggo in patients with generalized myasthenia gravis (gMG), enhancing precision subcutaneous drug delivery in neurology care.
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These clearances reflect ongoing advances in procedure efficiency, surgical precision, and patient-centered delivery systems, reinforcing how MedTech innovation continues to evolve alongside complex therapeutic needs in orthopedics and specialty medicine.
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| | Cardiology Breakthroughs: HCM & PSVT Advances
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Cytokinetics Launches Myqorzo (Aficamten) in the US, Expanding Treatment Options for Obstructive HCM
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Cytokinetics has launched Myqorzo (aficamten) in the United States for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aiming to improve functional capacity and relieve symptoms. Myqorzo is a once-daily oral cardiac myosin inhibitor (5, 10, 15, 20 mg tablets) that targets cardiac hypercontractility and left ventricular outflow tract (LVOT) obstruction.
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Approval stems from the Phase III SEQUOIA-HCM trial (published in NEJM), showing meaningful clinical benefits; it's available only via a REMS program to monitor heart failure risks.
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Why This Launch Matters
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The rollout strengthens oHCM treatment:
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| • | Precision mechanism: Directly inhibits myosin to reduce hypercontractility and LVOT obstruction.
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| • | Robust data: Backed by pivotal SEQUOIA-HCM results in symptomatic patients.
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| • | Safety controls: REMS ensures monitoring for systolic dysfunction risks.
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| • | Dosing convenience: Once-daily oral tablets across multiple strengths.
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A Strategic Step Forward
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Myqorzo’s availability advances targeted therapies for HCM’s core pathology, offering new hope for functional improvement in obstructive cases.
Milestone Pharma Launches Cardamyst in the US, Bringing Rapid, Self-Administered Relief to PSVT Patients
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Milestone Pharmaceuticals has launched Cardamyst (etripamil) in the United States for paroxysmal supraventricular tachycardia (PSVT), with a dedicated national sales force deploying in mid-February 2026. Cardamyst is a novel, self-administered calcium channel blocker delivered via a Bidose liquid nasal spray for rapid PSVT episode relief.
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A comprehensive patient assistance program supports access, including coverage/reimbursement guidance and copay assistance—dropping out-of-pocket costs to as low as $25 per prescription for eligible commercially insured patients.
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Why This Launch Matters
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The rollout advances self-management in cardiology:
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| • | Rapid delivery: Nasal spray enables on-demand intervention without healthcare visits.
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| • | Access focus: Patient program ensures affordability and broad reach.
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| • | Pipeline expansion: Phase II for pediatric PSVT; Phase III for AFib-RVR in adults.
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| • | Market entry: Positions Milestone in acute rhythm management with first-mover potential.
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A Strategic Step Forward
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Cardamyst’s US availability transforms PSVT care toward patient empowerment, with etripamil’s ongoing trials signaling broader impact in cardiovascular acute therapies.
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| | ViVE 2026: Where Healthcare Leadership Meets Technology
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ViVE 2026 is returning to Los Angeles, bringing together over 9,000 executives from across the healthcare ecosystem to explore the future of digital health and innovation. Co-created by HLTH Inc. and CHIME, the event is the premier forum where health system and payer leaders connect with innovators, investors, and solution providers driving measurable transformation in healthcare delivery.
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This is where CIOs, CTOs, CMIOs, and digital health executives come to accelerate strategy, evaluate what truly works, and build collaborations beyond the noise. In just a few days, ViVE delivers insights and connections that would otherwise take months to achieve.
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Attendees can expect thought-provoking sessions, hands-on demonstrations, and peer-to-peer networking with leaders shaping the next era of healthcare technology. From breakthrough solutions in telehealth, AI, and patient engagement to strategic discussions on digital transformation and operational efficiency, ViVE 2026 provides an immersive environment for actionable insights.
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Whether you’re looking to discover new technologies, foster partnerships, or gain executive-level insights, ViVE is the destination for those shaping what’s next in healthcare.
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Exclusive for the PharmaShots community:
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| • | Get $250 off ViVE General Attendee passes
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| • | Use discount code: V26PHARMASHOTS
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Los Angeles | 2026 – don’t miss your chance to be part of the future of digital health.
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| | That’s a Wrap for This Week
We will see you next week
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PharmaShots Weekly: Key Advances and What They Mean for Patients and the Industry
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The pace of innovation in pharma and MedTech never slows, and this week was no exception. From major collaborations to first-in-human trials and regulatory milestones, the developments are shaping not just pipelines, but also patient care and market dynamics.
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Big Deals Driving Innovation
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AstraZeneca & CSPC (~$18.5B): This partnership advances eight long-acting peptide programs for obesity. The combination of AI-driven discovery and sustained-release technology aims to improve weight loss durability and patient adherence while expanding global reach.
Boehringer Ingelheim & Simcere: Their dual-target IBD bispecific antibody has strong preclinical synergy, potentially offering a more effective treatment for patients with inflammatory bowel disease.
Seamless & Eli Lilly (~$1.1B): Programmable gene therapies for hearing loss could correct disease-causing mutations, representing a step toward precision genetic interventions.
Repertoire & Eli Lilly (~$1.84B): Tolerizing therapies for autoimmune disease aim to retrain the immune system, offering targeted, long-lasting control without broad immunosuppression.
Recordati & Moderna: mRNA-3927 for propionic acidemia shows early signs of clinical benefit, with potential to reduce metabolic crises in this rare disease.
Cardiology and Metabolic Highlights
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Cytokinetics’ Myqorzo is now available in the US, helping adults with obstructive HCM improve functional capacity and manage symptoms.
Milestone’s Cardamyst nasal spray offers rapid, self-administered relief for PSVT, putting control in patients’ hands.
Ascletis’ ASC30 enters US Phase II for type 2 diabetes, building on obesity data showing meaningful weight loss and favorable safety.
Roche CT-388 reports 22.5% placebo-adjusted weight loss at 48 weeks, positioning the therapy strongly in the competitive obesity market.
nChroma Bio dosed the first patient with CRMA-1001 for chronic hepatitis B, exploring an epigenetic approach that could provide a functional cure.
Regulatory Momentum
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This week’s approvals span multiple areas, including Novaliq, Roche, GSK, J&J, Tenpoint, Almirall, and Summit Therapeutics, expanding treatment options in immunology, oncology, vaccines, and rare diseases.
MedTech advances include FDA 510(k) clearances for BlueOcean, ABANZA, and KORU, enabling safer, more precise orthopedic procedures and drug delivery.
These developments aren’t just milestones—they reflect real progress for patients. Therapies are becoming more precise, durable, and patient-centered, while strategic collaborations are accelerating access to innovation globally. For industry leaders, staying on top of these trends is essential: the decisions made this week could shape the next wave of therapeutic breakthroughs.
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Stay Ahead with PharmaShots Weekly
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The pharma world never slows—and neither should your intelligence. PharmaShots Weekly delivers the week’s most critical insights on pipelines, regulatory moves, competitive shifts, and strategic deals—all in minutes, not hours.
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Every Monday at 8:00 AM EST, get a clear, decision-ready snapshot of what’s shaping the industry. If this issue sparked ideas, make it a habit. Subscribe to PharmaShots Weekly for insights that are concise, credible, and designed for leaders who can’t afford to wade through fragmented noise.
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The industry moves fast. Your intelligence should move faster.
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| | Questions?
Reach out to us [email protected] for any collaboration comments, questions, and media inquiry.
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