Key Outcomes:
- CureGene (CG-0416) – Dosed first participant in P1 study of oral, liver-targeted THR-β agonist for MASH/obesity; Preclinical data show GLP-1-comparable weight loss while preserving muscle; synergy seen when combined with GLP-1 agents
- Astellas (ASP2138) – Dosed first patient in global P3 study for CLDN18.2-positive gastric/GEJ cancer; 570-patient trial testing ASP2138 + chemo + pembrolizumab vs. placebo; OS/PFS co-primary endpoints
- BMS (CAMZYOS) – Released 5-year EXPLORER-LTE data (231 patients, week 252) for oHCM; 69.6% improved ≥1 NYHA class; 59.2% became asymptomatic; no new safety signals
- Arrowhead (plozasiran) – Positive P3 SHASTA-3/4 results for severe hypertriglyceridemia (757 patients); ~80% median TG reduction; 78% reduction in acute pancreatitis events; planning FDA sNDA by YE’26
- AbelZeta (Prizlon-cel) – Regained global rights from Janssen; FDA IND clearance for CAR-T therapy in R/R LBCL; Early data: ORR 91.5%, CR rate 85.1%, median PFS 60.1 months
- Amygdala Neurosciences (ANS-858) – FDA IND clearance for oral ALDH2 inhibitor targeting alcohol use disorder; Also being explored for binge eating, obesity, and precision oncology
- Roche (HER2 diagnostics) – FDA approved expanded use of PATHWAY HER2 and VENTANA HER2 tests as companion diagnostics for gastroesophageal cancer; First approved HER2 test for esophageal adenocarcinoma patient selection
- Henlius/Sandoz – Strategic collaboration covering up to 10 biosimilars (3 initial + 1 option); Includes cetuximab, evolocumab, belimumab biosimilars; Sandoz pays up to $322M
- IDEAYA/Genentech – Clinical collaboration combining IDE892 (PRMT5 inhibitor) with Genentech’s KRAS G12D inhibitor; Targets MTAP-deleted, KRAS G12D-mutant pancreatic cancer (~15% of PDAC cases)
- Lundbeck/EVERSANA – Expanded partnership to scale AI-powered commercialization across Lundbeck’s U.S. operations; Covers marketing, medical communications, market access, and media operations
- Ascendis/BioMarin – Global settlement resolving YUVIWEL (navepegritide) litigation; BioMarin grants non-exclusive license; Ascendis pays royalties (20% U.S., 18% EU/South Korea/Brazil) through May 2030
- Shape Memory Medical – Closed $10M convertible note financing to advance aortic clinical programs (AAA-SHAPE, FLAGSHIP trials)
- Jazz Pharmaceuticals – Priced upsized $1.1B private offering of exchangeable senior notes (1.875%, due 2032); Concurrent ~$225M share repurchase
- AusperBio – Raised $120M Series C for hepatitis B therapy AHB-137 (now in P3 in China); P2a data: 30% functional cure rate at week 72
- Genentech – Announced $750M U.S. manufacturing expansion in Hillsboro, Oregon; Adds fill-finish capacity for pre-filled syringes/autoinjectors; ~250 jobs; part of Roche’s $50B U.S. commitment
- India regulatory action – Restricted chlorpheniramine + phenylephrine combination products in children under 4; Mandatory warning labels required on packaging and promotional materials
August 21, 2026
CureGene Dose First Participant in P1 Study of CG-0416
CureGene has dosed the first participant in Australia in a randomized, double-blind, placebo-controlled P1 study of CG-0416, a novel oral, liver-targeted THR-β agonist/prodrug being developed for MASH and obesity-related metabolic complications. The study will evaluate safety, tolerability, PK & PD following SAD & MAD. CG-0416 is designed to deliver high liver exposure while limiting systemic/off-target effects and uses a non-CYP activation pathway, potentially reducing drug-drug interactions. Preclinical data showed significant reductions in liver fat, improvements in lipid and glucose parameters, and effects on inflammation and fibrosis; as monotherapy it demonstrated weight-loss efficacy comparable to GLP-1 therapies while preserving muscle, with additional synergistic effects when combined with GLP-1 agents. The P1 study is intended to generate data supporting global development and expansion into additional metabolic indications.
Source: BioSpace PR Aug 21, 2026
August 24, 2026
Astellas Doses First Patient in P3 ASP2138 Study for CLDN18.2-Positive Gastric/GEJ Cancer
Astellas has dosed the first patient in a global P3 study of ASP2138, an investigational SC bispecific antibody targeting CLDN18.2 & CD3, in adults with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The 1L trial will evaluate ASP2138 + CTx (CAPOX or mFOLFOX6) + pembrolizumab vs pbo + CTx ± pembrolizumab. The randomized, double-blind, pbo-controlled study plans to enrol 570 patients, with OS & PFS as co-primary endpoints. The program represents Astellas’ continued expansion of its CLDN18.2-focused oncology portfolio and supports its goal of initiating five or more P3/pivotal studies by FY2027.
Source: PR NewsWire PR Aug 24, 2026
August 29, 2026
BMS Releases Long-Term EXPLORER-LTE Data Showing Sustained CAMZYOS Efficacy Through Five Years
BMS presented five-year data at the ESC’26 supporting the long-term efficacy and safety of CAMZYOS (mavacamten) in symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The key data came from the EXPLORER-LTE cohort of the MAVA-LTE study, a single-arm, open-label, dose-blinded extension of the P3 EXPLORER-HCM study, in which 231 patients from the US, EU, and Israel who completed the original study enrolled in LTFU; this makes it the largest and longest evaluation of oHCM patients treated with Camzyos, the most-studied cardiac myosin inhibitor (CMI) & SoC for NYHA class II-III oHCM. At 252 wks, mavacamten showed durable reductions in LVOT obstruction and improvements in NYHA class, echocardiographic measures, and biomarkers, with no new safety signals. Real-world data from global, German, and Swedish studies supported its effectiveness and safety. Camzyos is approved in over 60 countries for symptomatic NYHA class II-III oHCM. However, it carries a boxed warning for systolic dysfunction related heart failure and is available only through the CAMZYOS REMS Program.
EXPLORER-LTE 5-Year (Wk 252) Efficacy Results:
Source: BMS PR Aug 29, 2026
August 30, 2026
Arrowhead Reports Positive P3 SHASTA-3 and SHASTA-4 Results for Plozasiran
Arrowhead released data from the pivotal P3 SHASTA-3 and SHASTA-4 studies of plozasiran to treat severe hypertriglyceridemia (sHTG) in adults during a Hot Line Late-Breaking Science session at the ESC’26. Both studies achieved their primary and all prespecified secondary endpoints. The studies evaluated a 25 mg SC Q3M dose of plozasiran, with a combined enrolment of 757 randomized patients. Results showed substantial and sustained reductions in triglyceride levels, along with a significant decrease in acute pancreatitis events an effect that was especially pronounced among patients at greater baseline risk.
Efficacy Result:
Acute Pancreatitis – Prespecified Pooled Analysis:
Safety Result:
No anaphylaxis/systemic hypersensitivity or clinically meaningful platelet, liver-enzyme, or hepatic-fat changes were observed. Three deaths occurred in the plozasiran group, all attributed to pre-existing conditions and assessed as unrelated to treatment.
Additional Information:
Arrowhead plans to combine data from SHASTA-3, SHASTA-4 and MUIR-3 to seek broader approval for sHTG globally, beginning with a U.S. FDA sNDA by YE’26. The company plans to use its purchased FDA PRV with the application.
August 16, 2026
AbelZeta Regains Global Rights to Prizlon-cel and Receives FDA IND Clearance in LBCL
AbelZeta Pharma received FDA clearance of an IND application for C-CAR039 (Prizloncabtagene Autoleucel/ Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T therapy, for treating R/R LBCL. In Jul’26, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights from Janssen Biotech. AbelZeta is now working with the FDA to finalize protocols for clinical development in two patient groups: ≥3L LBCL patients previously treated with CAR-T therapies, and 2L LBCL patients who are CAR-T-naïve. Clinical data was presented at the EBMT in Mar’ 26, and were drawn from 48 patients with R/R B-cell NHL enrolled in AbelZeta’s early clinical trials in China. Separately, a registrational P2 study of C-CAR039 for CAR-T-naïve R/R LBCL patients is still ongoing in China.
Efficacy Result:
Safety Profile:
Safety profile is favourable, with deep and durable responses.
Source: PR Newswire PR Aug 16, 2026
August 18, 2026
Amygdala Neurosciences Receives FDA IND Clearance for ANS-858
Amygdala Neurosciences reported that the FDA has cleared the IND application for ANS-858, its lead clinical candidate, enabling the company to begin clinical development. ANS-858 is a selective, reversible, orally bioavailable ALDH2 inhibitor initially being developed for alcohol use disorder and other substance use disorders, with the aim of reducing pathological craving. The company plans to initiate a P1 study, followed by P2 studies across multiple indications. Beyond addiction, ANS-858 is being evaluated for compulsive/binge eating and obesity, including potential use as a standalone therapy or alongside GLP-1 drugs, while the broader ALDH2 platform is being explored in precision oncology, including APC-mutated CRC. The program is supported by human genetic and clinical evidence linking reduced ALDH2 activity with lower alcohol consumption, as well as NIH grants and ABMRF/The Foundation for Alcohol Research funding.
Source: PR Newswire PR Aug 18, 2026
August 26, 2026
Roche Receives FDA Approval for HER2 Companion Diagnostics in Gastroesophageal Cancer
Roche received FDA approval to expand the use of PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail as CDx tests for identifying HER2-positive metastatic gastroesophageal adenocarcinoma (GEA), including gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. The tests help determine patients who may be eligible for ZIIHERA (zanidatamab-hrii), which now has two FDA-approved 1L regimens for adults with unresectable locally advanced or metastatic HER2-positive GEA. The approval is particularly significant for esophageal adenocarcinoma, where no HER2 tests had previously been approved for selecting patients for targeted therapy.
Source: PR NewsWire PR Aug 26, 2026
August 17, 2026
Henlius and Sandoz Enter Strategic Collaboration Covering Up to 10 Biosimilars
Shanghai Henlius Biotech and Sandoz have formed a strategic partnership covering up to 10 proposed mAb and/or ADC biosimilars, with terms signed for three initial products plus an option on a fourth. This expands their Apr’25 partnership on HLX13 (ipilimumab biosimilar) across 46 countries. Henlius grants Sandoz exclusive ex-China registration and commercialization rights, while Henlius handles development, manufacturing and supply; Sandoz brings its global reach to drive market access and launch. They named initial assets are HLX05-N (cetuximab biosimilar), HLX16 (evolocumab biosimilar), and a belimumab biosimilar, with an option on HLXTE-HAase1001 (a hyaluronidase). Sandoz will pay Henlius up to $322M total in upfront, milestone and option fees, with up to $100.5M expected to be invoiced in 2026 alone. Territory rights vary HLX05-N covers the US, Canada, EU, UK/Switzerland, Japan, Australia and New Zealand (exclusive) plus parts of Asia (semi-exclusive), while HLX16 and belimumab cover all markets outside China exclusively. The deal is positioned as a key step in Henlius’ globalization strategy and validates its biosimilars platform. HLX05-N’s P1 study in China dosed its first patient in July 2026, targeting a global cetuximab market worth about $1.696B in 2025.
Source: PR Newswire PR Aug 17, 2026
August 19, 2026
IDEAYA and Genentech Collaborate on IDE892 + KRAS G12D Inhibitor in Pancreatic Cancer
IDEAYA Biosciences and Genentech (Roche) have entered in a clinical collaboration to evaluate IDE892, IDEAYA’s investigational MTA-cooperative PRMT5 inhibitor, in combination with GDC-7035 (RG6620), Genentech’s investigational KRAS G12D inhibitor, in patients with MTAP-deleted, KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC). Genentech will sponsor the clinical trial, while IDEAYA will supply IDE892, with both companies sharing joint governance. MTAP deletions and KRAS G12D mutations are estimated to co-occur in up to ~15% of PDAC patients, a population with no approved targeted treatment options. IDE892 is currently being evaluated in a P1 dose-escalation/expansion study in MTAP-deleted solid tumors, and the new collaboration adds GDC-7035 as another KRAS-directed combination partner. Both companies will retain commercial rights to their respective compounds, including monotherapy and combination use.
Source: PR Newswire PR Aug 19, 2026
August 25, 2026
Lundbeck and EVERSANA Expand Partnership to Scale AI-Powered Commercialization
Lundbeck and EVERSANA have entered a strategic partnership to expand the use of EVERSANA’s AI Agency platform across Lundbeck’s U.S. commercial organization. The collaboration builds on an earlier implementation of AI-driven workflows for strategic planning, content development and commercial execution and will now extend AI-enabled capabilities to marketing, medical communications, market access and media operations, while the companies explore additional use cases to improve operational performance and commercial effectiveness. EVERSANA’s AI Agency, launched in 2025 and developed with Google Cloud, combines agentic AI, advanced automation and human expertise to accelerate strategy, content creation and omnichannel engagement. Importantly, the companies will maintain medical, legal and regulatory review, compliance, quality, scientific rigor and governance throughout deployment. The partnership supports Lundbeck’s Focused Innovator strategy and “bionic capabilities” ambition, which combines human expertise with AI to improve the speed and quality of commercial decision-making and execution.
Source: Lundbeck PR Aug 25, 2026
August 31, 2026
Ascendis and BioMarin Reach Global Settlement and License Agreement for YUVIWEL
Ascendis Pharma and BioMarin have entered into a binding term sheet to resolve all litigation and disputes related to YUVIWEL (navepegritide). BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license allowing continued research, development, manufacturing, and commercialization of navepegritide products. BioMarin will also waive certain regulatory rights and exclusivities, dismiss its proceedings, and provide a covenant not to sue for the covered IP, while Ascendis will dismiss its claims against BioMarin. In return, Ascendis will pay BioMarin royalties on net sales of navepegritide-related products: 20% in the U.S. and 18% in the EU, South Korea, and Brazil, from first commercial sale in each country through May 20, 2030. YUVIWEL was FDA-approved in February 2026 for increasing linear growth in children aged ≥2 years with achondroplasia and open epiphyses, its EMA review is ongoing. Ascendis expects >€500M ($579M) in 2026 operating cash flow and continues to target €5B ($5.7B) revenue by 2030.
Source: Ascendis Pharma PR Aug 31, 2026
August 23, 2026
Shape Memory Medical Secures $10M Financing to Advance Aortic Clinical Programs
Shape Memory Medical has closed a $10M convertible note financing led by new investor August Global Partners (AGP), with participation from fellow new investor Taiwania Capital. The company will use the funding to advance its aortic clinical portfolio, including patient follow-up and data collection for the AAA-SHAPE Pivotal Trial and advancement of the FLAGSHIP feasibility trial evaluating its investigational False Lumen Embolization (FLE) System for aortic dissection. Shape Memory Medical’s existing global investor syndicate includes HBM Healthcare Investments (Cayman) Ltd., Earlybird Venture Capital, and WexMed II, LLC. The company’s shape memory polymer technology is designed for catheter-delivered embolization and has been used in more than 3,500 patients worldwide, with products approved in more than 40 countries.
Source: Business Wire PR Aug 23, 2026
August 27, 2026
Jazz Pharmaceuticals Prices Upsized $1.1B Private Offering
Jazz Pharmaceuticals priced an upsized private offering of $1.1B of 1.875% exchangeable senior notes due 2032, increased from the previously planned $1.0B. The notes carry a 1.875% annual interest rate and mature in Sep 2032. The initial exchange rate will be 2.8150 ordinary shares per $1,000 principal amount of notes, equivalent to an initial exchange price of approximately $355.24 per share, representing a 42.5% premium to the Aug 26 share price. Jazz expects approximately $1.079B in net proceeds, or $1.226B if the additional-notes option is fully exercised, for general corporate purposes. Additionally, Jazz also granted the initial purchasers an option to purchase up to an additional $150M of the notes, exercisable within 13 days from and including the date the notes are first issued. Concurrently, Jazz agreed to repurchase approximately $225M of its ordinary shares at $249.29 per share, using existing cash. The notes are expected to close on Aug 31, 2026.
Source: Jazz Pharmaceuticals PR Aug 27, 2026
August 28, 2026
AusperBio Raises $120M to Advance Hepatitis B Therapy
AusperBio Therapeutics, a Bay Area biotech developing oligonucleotide therapies for chronic hepatitis B (CHB), has raised $120M in a Series C financing led by RA Capital Management, with participation from existing investors HanKang Capital, Qiming Venture Partners, YuanBio Venture Capital, and CDH Investments. The financing follows the company’s $37M Series A in 2024 and three Series B tranches completed across 2024-2025 that totaled $18M, bringing its disclosed funding to $343M. Proceeds will support P3 development and planned commercialization of its lead program, AHB-137. The candidate is currently being evaluated in a late-stage P3 study in China. In a completed P2a monotherapy study, AHB-137 achieved a 30% functional cure rate at week 72 among patients with CHB, with no drug-related serious adverse events reported.
Source: Fierce Pharma PR Aug 28, 2026
August 20, 2026
Genentech Announces $750M U.S. Manufacturing Expansion
Genentech, Roche’s U.S. subsidiary, has reported an investment of ~$750M to expand its manufacturing capabilities in Hillsboro, Oregon. The expansion will more than double the size of its existing facility and add advanced device fill-finish capabilities for pre-filled syringes and autoinjectors, supporting more convenient administration of medicines outside traditional hospital settings. The flexible facility will be designed to handle both high- and low-volume production, helping Genentech respond to changing demand and support its future medicine pipeline. The project is expected to create ~250 specialized manufacturing jobs and 200 construction jobs, with commercial operations targeted to begin in 2031. The investment is part of Roche and Genentech’s broader $50B commitment to U.S. research and manufacturing, strengthening domestic production and supply-chain capabilities.
Source: GlobeNewswire PR Aug 20, 2026
August 22, 2026
India Restricts Pediatric Use of Chlorpheniramine Phenylephrine Cold-Medicine Combinations
India has restricted all FDCs of chlorpheniramine maleate + phenylephrine hydrochloride for use in children below 4 years of age, citing potential safety risks and the availability of safer alternatives. The decision followed reviews by a Central Government-appointed Subject Expert Committee and the Drugs Technical Advisory Board (DTAB), which recommended that all formulations, rather than only specific strengths or dosage forms, should not be used in this age group.
New Warning for Manufacturers
The latest notification requires manufacturers to display the warning “Fixed Dose Combination shall not be used in children below four years of age” on all formulations containing Chlorpheniramine Maleate + Phenylephrine Hydrochloride, expanding the earlier Apr’25 restriction that covered certain FDCs. The move follows safety concerns regarding use in children under 4 and the availability of safer alternatives. Manufacturers must ensure the warning appears on packaging, prescribing information and promotional materials, including products already covered by the expanded requirement. The restriction was issued under Section 26A of the Drugs and Cosmetics Act, 1940, reinforcing India’s focus on pediatric drug safety and manufacturer compliance.
Source: BW Healthcareworld PR Aug 22, 2026
Thank you for your attention! For any queries, contact us at bd@octavusconsulting.com
Babli Singh is a Senior Analyst with strong analytical skills and a deep understanding of the biopharmaceutical and healthcare industries. She specializes in monitoring emerging trends and distilling complex information into concise, insightful summaries that deliver clear value and actionable intelligence for a global professional audience.
