NEW BRUNSWICK (dpa-AFX) - This week's biotech landscape saw a wave of regulatory approvals across HIV, rare diseases, immunology, and diagnostics, alongside strategic licensing deals, manufacturing collaborations, and mixed clinical trial readouts.
Key developments included FDA approvals for Gilead's Bixlenvo, Roivant's LISRAYA, and Johnson & Johnson's IMAAVY, while Biohaven, Celularity, and Lilly advanced partnerships to expand their pipelines and commercial capabilities. Clinical readouts spanned therapeutic areas including eosinophilic esophagitis and biliary tract cancer
Let's take a closer look at the details.
FDA Approvals
Gilead's Bixlenvo Wins FDA Nod in HIV
Gilead Sciences, Inc. (GILD) secured FDA approval for Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the first single-tablet regimen designed for virologically suppressed adults unable to take existing STRs.
The approval was supported by the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which demonstrated sustained suppression and improved treatment satisfaction among patients switching from complex regimens to Bixlenvo. The regimen combines bictegravir with Sunlenca (lenacapavir), a novel capsid inhibitor, offering a simplified once-daily option with favourable tolerability and improved lipid profile.
GILD closed Thursday's trading (August 27, 2026) at $148.86, up 0.52%
Roivant's LISRAYA Breaks Ground in Dermatomyositis
Roivant Sciences (ROIV) won FDA approval for LISRAYA (brepocitinib), the first targeted therapy for adult patients with dermatomyositis. Backed by Phase 3 VALOR trial data, the once-daily TYK2/JAK1inhibitor reduced skin lesions, muscle weakness, and steroid dependence, with over half of patients tapering off steroids by week 52. The drug has Orphan Drug and Priority Review designations and is also being explored for chronic infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris.
ROIV closed Thursday's trading at $37.58, up 2.26%.
ViiV's Tivicay PD Extends HIV Care to Newborns
ViiV Healthcare, majority-owned by GSK plc. (GSK), gained FDA approval for Tivicay PD (dolutegravir) in combination with other antiretrovirals for pediatric patients weighing at least 2 kg, including eligible newborns.
Supported by NIH-funded IMPAACT 2023 data, Tivicay PD achieved therapeutic levels in neonates with a safety profile consistent across age groups. As the first second-generation integrase inhibitor approved for this age group, it addresses a critical treatment gap, offering families an age-appropriate option from birth.
This milestone builds on Tivicay's 2013 adult approval, reinforcing its role across the full HIV treatment journey.
GSK closed Thursday's trading at $50.27, down 2.26%
BioCryst's ORLADEYO Approved in Japan for Pediatric HAE
BioCryst Pharmaceuticals Inc. (BCRX) secured Japanese approval for ORLADEYO for prophylactic hereditary angioedema attacks. The decision was supported by global Phase 3 APeX-P trial, which demonstrated significant reduction in monthly attack rates with no new safety signals identified.
This marks the second regulatory approval for ORLADEYO in Japan, following its 2021 approval for adults and adolescents. Already marketed in 45 countries, the therapy now extends to pediatric patients, with additional filings underway in Europe and Canada to broaden access further.
BCRX closed Thursday's trading at $9.87, up 0.41%
JNJ's IMAAVY Secures FDA Approval in wAIHA
Johnson & Johnson's (JNJ) IMAAVY (nipocalimab-aahu) received FDA approval for warm autoimmune hemolytic anaemia (wAIHA) in adults and adolescents 12+, following Priority Review. The decision was based on pivotal Phase 2/3 ENERGY trial data showing durable haemoglobin responses. IMAAVY is the first FDA-approved therapy for wAIHA and adds to its prior approval in generalised myasthenia gravis, marking a significant expansion of its immunology portfolio.
JNJ closed Thursday's trading at $265.77, down 1.57%
Rhythm's IMCIVREE Approved in Japan for Hypothalamic Obesity
Rhythm Pharmaceuticals Inc. (RYTM) received approval from the Japanese Ministry of Health for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity (HO), expanding its rare disease portfolio. The approval was supported by data from the Phase 3 TRANSCEND trial showing durable BMI reductions and improved hunger control. Rhythm expects to launch IMCIVREE in Japan by the end of 2026.
RYTM closed Thursday's trading at $112.53, up 0.59%
Takeda's ORZEYFUL Secures Japanese Approval
Takeda (TAK) secured Japan's Ministry of Health, Labour and Welfare (MHLW) approval for ORZEYFUL (oveporexton), an oral orexin receptor 2 (OX2R) agonist for narcolepsy type 1 in adults.
The approval was based on pivotal Phase 3 FirstLight and RadiantLight trials, which demonstrated significant improvements in excessive daytime sleepiness and cataplexy.
Already FDA-approved in the U.S., ORZEYFUL now expands into Japan, reinforcing its role as the first therapy to directly address orexin deficiency in NT1.
TAK closed Thursday's trading at $18.03, down 1.10%
Roche's Elecsys Blood Test Cleared by FDA
Roche (RHHBY) received FDA clearance for the Elecsys Phospho-Tau Plasma (pTau217) blood test to aid in assessing Alzheimer's in patients aged 55+ with cognitive decline. Developed in collaboration with Eli Lilly, it is the first FDA-cleared blood test supporting rule-in and rule-out of amyloid pathology. The assay runs on Roche's 4,500+ cobas instruments, enabling broad access through existing laboratory infrastructure, and potentially transforming early diagnostic pathway.
RHHBY closed Thursday's trading at $56.39, down 0.88%
Insmed's BRINSUPRI Approved in Japan
Insmed Inc. (INSM) gained Japanese approval for BRINSUPRI (brensocatib) for non-cystic fibrosis bronchiectasis, marking the first therapy cleared for this indication.
The approval was supported by Phase 3 ASPEN trial data showing reduced exacerbations and improved lung function.
INSM closed Thursday's trading at $121.39, down 2.41%
Layoffs
Cellares Trims Workforce After BMY Partnership Ends
Cellares announced job cuts after Bristol-Myers Squibb (BMY) ended its $380 million manufacturing partnership inked in 2024. The partnership, which centred on cell therapy manufacturing, ended due to BMY's internal decision to discontinue the collaboration. No financial distress was cited, but termination directly triggered the layoff.
BMY closed Thursday's trading at $66.95, down 0.92%
Deals
Celularity Expands Cellular Medicine Manufacturing With MuseCell Innovations Partnership
Celularity Inc. (CELU) announced a U.S. manufacturing collaboration with MuseCell Innovations (MCI) to establish production of Dezawa MuseCells (DMCs) at Celularity's Florham Park, New Jersey facility. The initial program will focus on producing MCI-certified DMCs using qualified perinatal tissue and MCI's licensed manufacturing process. Based on current market conditions and MCI's projections, the expanded relationship could generate more than $300 million in aggregate purchases from Celularity over the next five years.
CELU closed Thursday's trading at $2.10, up 138.53%.
Femasys Partners With UNC Health To Expand Fertility Care Access
Femasys Inc. (FEMY) announced a partnership with UNC Health to expand its fertility portfolio across UNC Health OB/GYN practice locations in North Carolina, allowing physicians to offer fertility evaluation and first-line treatment options within community-based care settings
Under the agreement terms, OB/GYN providers within the UNC Health system will have access to FemVue fertility evaluation, SpermVue male fertility screening and FemaSeed Complete, an in-office intratubal insemination solution designed as a first-line fertility treatment.
FEMY closed Thursday's trade at $2.79, down 4.45%.
4basebio & Genezen Expand Collaboration For Viral Vector Manufacturing
4basebio PLC (4BB.L), a biotech company and Genezen, a CDMO, entered into a commercial collaboration to combine 4basebio's synthetic DNA technology with Genezen's viral vector development and manufacturing expertise to support gene therapy program development.
Under the collaboration, Genezen will provide drug developers with access to 4basebio's research-use-only, high-quality, GMP-grade hairpin DNA (hpDNA) for viral vector applications.
4BB.L closed Thursday's trade at $492.50, up 3.68%.
Biohaven and SK Biopharmaceuticals Enter Strategic Global Licensing Agreement
Biohaven Ltd. (BHVN) and SK Biopharmaceuticals Co., Ltd. announced a global licensing and collaboration agreement for Biohaven's Kv7 ion channel platform, led by Opakalim (BHV-7000). This investigational candidate is in phase 2/3 development for focal epilepsy, with topline results expected in the second half of 2026.
Under the terms, SK Biopharmaceuticals will provide upfront and milestone payments of up to $795 million, along with tiered royalties ranging from the mid-teens to low twenties on U.S. net sales of Opakalim.
BHVN closed Thursday's trade at $16.12, down 4.90%.
ResMed Announces Collaboration With Tyler Reddick, 23XI Racing For Sleep Apnea Awareness
ResMed Inc. (RMD), a sleep and breathing health company, has partnered with 23XI Racing and NASCAR Cup Series driver Tyler Reddick to raise awareness of sleep apnea, with the 2026 Daytona 500 champion sharing how ResMed's Continuous positive airway pressure (CPAP) therapy helps manage his condition and supports his recovery and performance.
Throughout the remainder of the 2026 NASCAR season, ResMed and Reddick plan to share information about sleep health and Reddick's experience with sleep apnea as part of the awareness initiative and ResMed branding will appear on Reddick's No. 45 Toyota Camry XSE at select NASCAR Cup Series races during the 2026 season.
RMD closed Thursday's trade at $235.76, up 0.03%.
Innovative Eyewear Partners With HTC
Innovative Eyewear, Inc. (LUCY), which develops smart eyewear under the Lucyd, Lucyd Armour, Reebok, Eddie Bauer, and Nautica brands, announced a strategic alliance with HTC of Taiwan.
The alliance focuses on the U.S. commercialization of HTC's VIVE Eagle smart eyewear line, a new entrant in the AI camera glasses segment, with plans to offer the product through the Lucyd.co online store. The VIVE Eagle product line will launch in the USA in September 2026.
LUCY closed Thursday's trade at $0.94, down 16.70%.
Amplitude Therapeutics, Lilly Partner To Develop TaRNA Vaccines
Amplitude Therapeutics and Eli Lilly and Company (LLY) entered into a strategic research collaboration and licensing agreement to discover and develop trans-amplifying RNA (taRNA) vaccine candidates for infectious diseases, combining Amplitude's proprietary taRNA with Lilly's development, manufacturing, and commercialization capabilities.
Initial programs target infectious diseases with high unmet need, and Lilly retains options for up to two additional targets.
LLY closed Thursday's trade at $1176.10, down 1.12%.
Clinical Trials - Breakthroughs & Setbacks
Propanc Reports Significant Tumour Growth Inhibition in Preclinical Pancreatic Cancer Study
Propanc Biopharma, Inc. (PPCB) announced positive preclinical and early translational data for its lead candidate, PRP, a fixed-ratio combination of the two pancreatic proenzymes, trypsinogen and chymotrypsinogen, in pancreatic ductal adenocarcinoma (PDAC).
According to the company, three-times-weekly intravenous PRP achieved more than 90 per cent mean inhibition of tumour growth compared with vehicle controls in orthotopic and patient-derived xenograft models of PDAC. In addition, the treatment reduced metastatic burden in the liver and peritoneum and extended median overall survival by more than 2.5-fold in treated animals compared with controls.
PPCB closed Thursday's trade at $2.23, up 108.41%.
AstraZeneca, Amgen's Tezspire Meets Key Goals In Phase 3 EoE Trial
AstraZeneca PLC (AZN) and Amgen Inc. (AMGN) reported positive top-line results from the Phase 3 CROSSING trial of Tezspire, an investigational human monoclonal antibody in eosinophilic esophagitis.
According to the company, the treatment achieved statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, and sustained these improvements through week 52, with a safety profile consistent with its approved indications.
AZN closed Thursday's trade at $164.52, down 1.05%.
AMGN closed Thursday's trade at $436.99, down 0.76%.
Spyre's SPY072 Shows Mixed Phase 2 RA Results, Misses Monotherapy Goal
Spyre Therapeutics (SYRE) announced topline results from the rheumatoid arthritis (RA) sub-study of its Phase 2 SKYWAY basket trial evaluating SPY072, a half-life-extended monoclonal antibody, with both doses showing benefits on one or more efficacy endpoints. Meanwhile, the company said the magnitude of the effect did not meet its threshold for prioritising SPY072 monotherapy development in rheumatoid arthritis.
According to the company, both doses of SPY072 demonstrated statistically significant benefits compared to placebo in changes from baseline in the Disease Activity Score in 28 joints (DAS28-CRP), the key secondary endpoint (ACR20), and the exploratory endpoint (ACR50).
Topline results from SKYWAY, which evaluates SPY072 in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), are expected in the fourth quarter of 2026.
SYRE closed Thursday's trade at $93.62, up 0.01%.
RenovoRx Publishes Positive RenovoCath Tumour Drug Delivery Data
RenovoRx Inc. (RNXT) reported the publication of pharmacokinetic and pharmacodynamic data in the journal Cancer Chemotherapy and Pharmacology from the Phase 3 TIGeR-PaC trial for RenovoCath, a patented drug delivery system.
In the 16-patient study that analysed the systemic effects of intra-arterial gemcitabine (IAG) administered via RenovoCath, compared with traditional intravenous gemcitabine (IVG) delivery, trans-arterial micro-perfusion (TAMP) occurred at the tumour site, thereby mediating the delivery of concentrated chemotherapy.
RenovoCath retained roughly 51% of the drug before it entered the bloodstream. The findings suggest TAMP enabled more concentrated drug delivery to tumours while reducing systemic exposure. Initial topline data is anticipated in the second half of 2027.
RNXT closed Thursday's trade at $1.48, down 0.67%.
Summit and Akeso's Ivonescimab Plus Chemotherapy Shows Significant PFS Benefit In Phase III HARMONi Trial
Summit Therapeutics Inc.'s (SMMT) partner Akeso Inc.(9926.HK) announced positive primary analysis data from the global Phase 3 HARMONi trial evaluating investigational Ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC).
According to the company, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival compared to the durvalumab-based regimen., In addition, the trial also met the key secondary endpoints of progression-free survival and objective response rate.
9926.HK closed Thursday's trade at HK$ 95.35, down 5.78%. SMMT closed Thursday's trade at $14.33, up 0.70%.
Regenxbio's RGX-121 Placed on FDA Clinical Hold After Spine MRI Findings in Hunter Syndrome Study
Regenxbio Inc. (RGNX) announced that the U.S. FDA has placed a clinical hold on RGX-121, an investigational gene therapy for Hunter syndrome. The clinical hold follows the identification of asymptomatic spinal findings, including a small nodule or cystic mass on MRI, in five participants who received RGX-121 approximately three to six years ago in the CAMPSIITE study.
Regenxbio and partner NS Pharma are reviewing additional imaging data, long-term follow-up findings and FDA feedback before deciding on the next steps for RGX-121, with no near-term BLA resubmission planned.
RGNX closed Thursday's trade at $9.37, down 0.11%.
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