Key Outcomes:
- Neurocrine (NBIP-‘1968, Obesity) – Initiated P1 FIH study of long-acting GLP-1/GIP/glucagon triple agonist; QW SC; SAD assessment across BMI categories; part of broader obesity portfolio with planned FDC combo.
- Taiho/Cullinan Zipalertinib (1L EGFR Ex20ins NSCLC) – P3 REZILIENT3 met primary PFS endpoint at interim analysis; combo with chemo showed statistically significant, clinically meaningful benefit; IDMC recommended unblinding; FDA discussions planned.
- JW Pharmaceutical Epaminurad (Gout) – P3 met primary endpoint at 6mg dose (superior to febuxostat 40mg: 50% vs 38.3% achieving sUA<6); 9mg dose failed non-inferiority vs febuxostat 80mg; NDA submission targeted for South Korea in 2027.
- Arrowhead (Plozasiran PRV) – Acquired FDA Rare Pediatric Disease Priority Review Voucher for sNDA submission (sHTG indication); subject to HSR Act waiting period; sNDA expected by YE’26.
- Novo Nordisk Awiqli (T2D) – US launch of first FDA-approved once-weekly basal insulin; reduces injections from 7x to 1x/week; based on P3a ONWARDS program (5 studies); available at 70,000+ pharmacies, as low as $35/month with affordability programs.
- Enigma Biomedical/Lantheus TAUKLARIFY (Alzheimer’s Imaging) – FDA approval for tau PET imaging radiodiagnostic; supported by two blinded reader studies (617 subjects); PPA 68-88%, NPA 93-99%; previously had Fast Track designation.
- Curium/Lantheus – Merger agreement valued up to $8B ($102.50/share cash + up to $12/share CVRs = up to $114.50/share); 38% premium to 60-day VWAP; creates combined radiopharmaceutical company across 70+ countries; closing expected H1’27.
- Jazz Pharmaceuticals/Actio Biosciences – Acquisition for $820M upfront + up to $500M contingent; adds ABS-1230 (KCNT1 inhibitor for ultra-rare epilepsy); has Fast Track, Rare Pediatric Disease, Orphan Drug designations; Actio spins out separate entity for other pipeline assets; closing Q4’26.
- Expedition Therapeutics – $115M Series B (led by General Atlantic) to advance EXPD-101 (DPP1 inhibitor) in COPD; first patient dosed in global P2 trial; well-tolerated in P1 with dose-proportional PK.
- LifeMine Therapeutics – $263M raised (oversubscribed $188M Series E led by Milky Way Investments); builds on prior $75M Series D; advances LIFE-001 (CNai) for organ transplant rejection; P1 SAD/MAD study (>120 adults) shows no major safety signals vs legacy calcineurin inhibitors; P2 kidney transplant study planned early 2027.
- Veloxis Pharmaceuticals – Agreed to pay $46M ($10M criminal + $36M civil) to resolve Envarsus XR kickback fraud allegations; admitted Anti-Kickback Statute violations (2016-23); entered 3-year Deferred Prosecution Agreement; originated from qui tam whistleblower lawsuit.
August 7, 2026
Neurocrine Initiates P1 study of NBIP-‘1968 for Obesity
Neurocrine Biosciences initiated a P1 FIH study evaluating safety and tolerability of NBIP-‘1968, an investigational long-acting GLP-1/GIP/glucagon receptor triple agonist being developed for obesity. The study will initially assess the safety and tolerability of SAD of NBIP-‘1968 in adults across a range of BMI categories, including overweight and obese. NBIP-1968 is designed for QW SC administration, targeting GLP-1, GIP and glucagon receptors to modulate appetite regulation, energy balance and glycemic control. The program is part of Neurocrine’s broader obesity portfolio and is intended for FDC with NBIP-‘2118, an investigational corticotropin-releasing factor type 2 (CRF2) receptor agonist currently in P1 development.
Source: PR Newswire PR Aug 7, 2026
August 12, 2026
Zipalertinib Meets PFS Endpoint in P3 REZILIENT3 Study in 1L EGFR Ex20ins nsq NSCLC
Taiho Oncology and Cullinan Therapeutics announced that the P3 REZILIENT3study evaluating zipalertinib + platinum-based chemotherapy vs chemotherapy alone in 1L treatment of adults with previously untreated, locally advanced or metastatic nsq NSCLC harboring EGFR ex20ins mutations met its primary endpoint PFS at a planned interim analysis. The combination demonstrated a statistically significant and clinically meaningful improvement in PFS, with observed safety for the zipalertinib containing arm being manageable. The IDMC recommended unblinding, while the study will continue to monitor efficacy and safety. Based on the results, the companies plan to discuss the data with the US FDA and pursue US regulatory approval of zipalertinib + chemotherapy in the 1L setting. Full results from REZILIENT3 study will be presented at an upcoming international medical conference.
Source: Business Wire PR Aug 12, 2026
August 13, 2026
JW Pharmaceutical Reports Positive P3 Data for Epaminurad in Gout
JW Pharmaceutical reported positive results from the multinational P3study of epaminurad (URC102), an oral uricosuric agent, evaluating 6mg and 9mg doses vs febuxostat in 612 patients with gout across five Asian countries, including South Korea, Taiwan, Thailand, Malaysia and Singapore. The 6mg dose demonstrated excellent serum uric acid-lowering effects and statistical superiority over febuxostat 40mg, with 50% of patients achieving sUA <6 mg/dL vs 38.3% with Febuxostat, while maintaining a favorable safety profile with similar rates of TEAEs, ADRs, SAEs, SADRs, AESIs and no drug-related deaths. The high 9mg dose did not meet the non-inferiority criteria for the primary efficacy endpoint vs Febuxostat 80mg, with 59.6% vs 63.3% of patients achieving sUA <6 mg/dL, although JW Pharmaceutical plans to further assess its efficacy in specific patient populations and explore approval strategies for the high dose. The company plans to submit an NDA aiming for regulatory approval in South Korea in 2027, following completion of two pre-NDA meetings with MFDS, and will continue exploring out-licensing opportunities for global market entry.
Efficacy Results:
Source: Business Wire PR Aug 13, 2026
August 4, 2026
Arrowhead Pharmaceuticals secures US FDA Priority Review Voucher for Plozasiran
Arrowhead acquired an US FDA Rare Pediatric Disease Priority Review Voucher (PRV) from an undisclosed third party, which it plans to use for sNDA submission for plozasiran, to seek approval to expand the approved indication to include patients with severe hypertriglyceridemia (sHTG), anticipated before the YE’26. The planned sNDA is supported by P3 SHASTA-3 & SHASTA-4study results. Plozasiran is currently approved as REDEMPLO for adults with familial chylomicronemia syndrome (FCS), the most severe form of sHTG, in the US, EU, China, Australia and Canada. The transaction remains subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.
Source: Business Wire PR Aug 4, 2026
August 11, 2026
Novo Nordisk Launches Awiqli, First Once-Weekly Basal Insulin for Adults with T2D in US
Novo Nordisk launched Awiqli (insulin icodec-abae) injection 700 units/mL in the US, the first and only US FDA approved QW basal insulin as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults with type 2 diabetes (T2D), following US FDA approval in Q1’26. Awiqli reduces basal insulin injection frequency from seven to one/wk and is administered using a prefilled FlexTouch pen. The approval was supported by the P3a ONWARDS program, comprising five studies (NCT04460885, NCT04770532, NCT04795531, NCT04880850, NCT04760626), in which QW Awiqli demonstrated non-inferiority to daily basal insulin in mean change in HbA1c from baseline to study end, with a safety profile generally consistent with the daily basal insulin, with common AEs including hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet and weight gain. Awiqli will be available at >70,000 US retail pharmacies, with Novo Nordisk’s affordability programs offering eligible patients access for as little as $35/mos.
Source: PR Newswire PR Aug 11, 2026
August 14, 2026
Enigma Biomedical USA Receives FDA Approval for TAUKLARIFY for Alzheimer’s Disease
Enigma Biomedical received US FDA approval for TAUKLARIFY (florquinitau F 18 injection; MK-6240), a radiodiagnostic agent for brain PET imaging in adults with cognitive impairment being evaluated for Alzheimer’s disease (AD) to identify tau neurofibrillary tangle (NFT) pathology. The approval was supported by two blinded reader studies evaluating scans for tau NFT pathology from 617 subjects, including 152 with mild Alzheimer’s disease dementia, 157 with mild cognitive impairment, and 308 cognitively unimpaired individuals, with both studies meeting their pre-specified success criteria and demonstrating high inter-reader agreement. Across the studies, positive percent agreement (PPA) ranged from 68%-88% and negative percent agreement (NPA) from 93%-99%. TAUKLARIFY had previously received US FDA’s Fast Track designation. Enigma sold Cerveau technologies to Lantheus in 2023 for complete development and commercialization of TAUKLARIFY, and the companies continued collaborating through the US FDA approval.
Clinical Results:
Safety Profile:
Safety was evaluated in 1,734 subjects, with the most common adverse reactions being headache (0.7%), nausea (0.2%), injection site reactions (0.1%), dizziness (0.1%) and abdominal discomfort (0.1%).
Source: Business Wire PR Aug 14, 2026
August 03, 2026
Curium to Merge with Lantheus in Transaction Valued at up to $8B
Curium and Lantheus entered into a definitive agreement under which Curium US will acquire all outstanding Lantheus shares for $102.50 per share in cash at closing, plus non-transferable CVRs for up to $12 per share in potential additional cash payments, subject to achievement of specified commercial milestones for Lantheus products through 2030, representing a total per share consideration of up to $114.50 and a total transaction value of up to ~$8B. The transaction combines Curium’s theranostics portfolio and global manufacturing platform together with Lantheus’ complementary US radio-diagnostics business, creating a radiopharmaceutical company spanning diagnostics and therapeutics across oncology, neurology and cardiology in more than 70 countries. The transaction represents a 38% premium to Lantheus unaffected 60-day VWAP, a premium of 29% to Lantheus unaffected 30-day VWAP, and a premium of 21% to Lantheus unaffected closing price, in each case as of May 21, 2026 and is expected to close in H1’27, subject to satisfaction of customary closing conditions, including shareholder and regulatory approvals.
Source: GlobeNewswire PR Aug 03, 2026
August 10, 2026
Jazz Pharmaceuticals Expands Rare Epilepsy Portfolio with Actio Biosciences Acquisition
Jazz Pharmaceuticals entered into a definitive agreement to acquire Actio Biosciences for $820M upfront and up to $500M in contingent consideration, adding ABS-1230, a novel, FIC oral small molecule precision therapy KCNT1 ion channel inhibitor, for the treatment of KCNT1+ epilepsy, an ultra-rare genetic epilepsy with no FDA approved therapies. ABS-1230 has recently demonstrated meaningful seizure reductions in an early POC study in children and is currently being evaluated in the P1b/2a KYRONstudy, which is intended to support a potential US NDA submission. ABS-1230 has received US FDA’s Fast Track, Rare Pediatric Disease and Orphan Drug Product designations and was accepted into the FDA’s Rare Disease Evidence Principles (RDEP) program which aims to facilitate rapid development of ultra-rare disease therapies. Actio will spin out a new privately-held entity retaining other genetic rare neurological programs, including clinical-stage small molecule TRPV4 inhibitor, ABS-0871, for Charcot-Marie-Tooth type 2C and other early-stage programs. The transaction is expected to close in Q4’26, subject to customary closing conditions.
Source: PR Newswire PR Aug 10, 2026
August 5, 2026
Expedition Therapeutics Raises $115M Series B to Advance EXPD-101 in COPD
Expedition Therapeutics raised $115M in an oversubscribed Series B financing led by General Atlantic, with participation from RA Capital, Vivo Capital and existing investors Sofinnova Investments, Novo Holdings, Forbion, Dawn Biopharma (a platform controlled by KKR), Adage Capital Management, Balyasny Asset Management, Logos Capital, Sanofi Ventures, BVF Partners, and Venrock Healthcare Capital Partners, to advance its lead DPP1 inhibitor EXPD-101 through P2development and expand its inflammatory disease pipeline. The company also dosed the first patient in its global P2 trial evaluating EXPD-101 in COPD, designed to target neutrophilic inflammation, a key driver of COPD across the disease spectrum. EXPD-101 was well tolerated in P1, with no DLTs and demonstrated dose-proportional PKs supporting QD oral dosing.
Source: Business Wire PR Aug 5, 2026
August 6, 2026
LifeMine Therapeutics Raises $263M to Advance LIFE-001 for Organ Transplant Rejection
LifeMine Therapeutics raised $263M through an oversubscribed $188M Series E financing led by Milky Way Investments, with participation from new investors including Bezos Expeditions, Gates Frontier, and RA Capital Management, alongside continued support from existing investors including GV (Google Ventures), LoLa Capital Partners, GlaxoSmithKline (GSK), Invus and ARCH Venture Partners and builds on previously completed $75M Series D round with existing investors plus LoLa Capital Partners, to advance its lead program LIFE-001 and expand its transplantation and immunology pipeline. LIFE-001, a long-acting injectable, immunophilin-independent calcineurin activation inhibitor (CNai), is being evaluated in an ongoing P1SAD/ MAD study of >120 adults for prevention of organ transplant rejection, with no clinically meaningful renal, metabolic or CV safety signals observed to date, vs. legacy calcineurin inhibitors (CNis) such as cyclosporin, voclosporin and tacrolimus. The company plans to initiate a P2 kidney transplant study and P1b islet cell transplant study in early 2027.
Source: Business Wire PR Aug 6, 2026
August 15, 2026
Veloxis Pharmaceuticals to Pay $46M to Resolve Envarsus XR Fraud Case
Veloxis Pharmaceuticals has agreed to pay $46M to resolve allegations related to kickbacks involving Envarsus XR, an immunosuppressant used in adult kidney transplant recipients. The resolution includes a $10M criminal penalty and $36M in civil penalties under the False Claims Act. Veloxis also entered into a three-year Deferred Prosecution Agreement (DPA) and admitted to conspiring to violate the Federal Anti-Kickback Statute between 2016-23. The case originated from a qui tam whistleblower lawsuit filed on behalf of the U.S. government, with the U.S. Attorney’s Office for the District of Massachusetts leading the enforcement action. The whistleblower may receive up to 25% of the recovery.
Source: PR Newswire PR Aug 15, 2026
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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.
