NEW BRUNSWICK (dpa-AFX) - This week, the biotech sector saw a surge of FDA, EU, and China approvals spanning oncology, dermatology, autoimmune and rare disease indications. Strategic acquisitions and licensing deals drove pipeline expansion, while positive clinical readouts in obesity, MASLD, and autoimmune disorders reinforced investor confidence in innovation and therapeutic breadth.
Let's dive into the details.
FDA Approvals
Guardant Expands Reach
Guardant Health, Inc. (GH) secured FDA approval for its Guardant360 CDx, a liquid biopsy test, as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer (NSCLC).
The blood-based test enables rapid genomic profiling to guide treatment decisions, underscoring the growing role of liquid biopsy in advanced cancer care.
GH closed Thursday's trading (June 11, 2026) at $130.90, up 0.15%
Lilly's EBGLYSS Wins FDA Approval for Extended Dosing in Atopic Dermatitis
Eli Lilly and Company (LLY) received FDA approval for an every-eight-week maintenance dose of EBGLYSS or lebrikizumab-lbkz (250 mg/2 mL) in moderate-to-severe atopic dermatitis, expanding beyond its once-monthly schedule. Backed by Phase 3 Adjoin extension data, the regimen showed durable disease control with no new safety signals, offering patients fewer injections-just six times a year.
EBGLYSS sales surged 141% in Q1 2026 to $145 million from $60 million in the prior year, reflecting strong uptake in Lilly's growing immunology portfolio.
LLY closed Thursday's trading at $1,160.95, up 2.16%
VorBio Wins China Nod
Vor Bio (VOR) announced that Telitacicept (developed by RemeGen) has received approval from China's NMPA for the treatment of adult patients with Sjögren's disease.
This marks the first and only approved therapy for the chronic autoimmune condition in China, supported by positive Phase 3 trial data showing improvements in systemic disease activity and patient-reported outcomes.
VOR closed Thursday's trading at $14.09, up 8.38%
Sanofi Secures EU Nod
Sanofi (SNY) announced European Commission approved Sarclisa Sc (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patietns eligible for transplant. The clearance expands Sarclisa's use beyond relapsed settings, supported by Phase 3 IRAKLIA trial results which showed significant progression-free survival benefit. The decision expands Sarclisa's use into the frontline transplant-eligible setting, reinforcing its role in advancing treatment options for multiple myeloma.
SNY closed Thursday's trading at $44.11, up 1.24%
Pfizer's HYMPAVZI Gains FDA Nod for Pediatric Hemophilia
Pfizer Inc. (PFE) announced that the FDA has approved HYMPAVZI for additional patient groups, including individuals aged 12 and older with hemophilia A or B who develop inhibitors, and children aged 6-11 with or without inhibitors.
Supported by Phase 3 BASIS trial data, the therapy demonstrated a 93% reduction in annualized bleeding rates and consistent safety. This marks the first subcutaneous non-factor therapy available for pediatric hemophilia B, reinforcing Pfizer's commitment to advancing rare disease care.
PFE closed Thursday's trading at $26.17, up 2.23%
Amneal Revives Romidepsin
Amneal Pharmaceuticals, Inc. (AMRX) announced FDA approval of Romidepsin injection solution as a single-dose supply in a ready-to-use vial for the treatment of cutaneous T-cell lymphoma.
The product was previously manufactured by Teva under the brand name ISTODAX, but later withdrawn from the U.S. market. Amneal's relaunch brings the therapy back to market in a streamlined format.
AMRX closed Thursday's trading at $16.34, up 6.66%
Deals
Teva Acquires Emalex For $700 Mln
Teva Pharmaceutical Industries Limited (TEVA) completed the acquisition of Emalex Biosciences for $700 million in consideration, with the potential for up to an additional $200 million in commercial milestone payments, as well as other contingent payments.
The acquisition adds Ecopipam, an investigational asset in a Phase 3 trial for pediatric Tourette syndrome, to Teva's pipeline. NDA submission is expected in H2 2026.
TEVA closed Thursday's trade at $34.56, up 2.92%.
GSK Strikes $10.6B Nuvalent Deal To Bolster Cancer Pipeline
GSK plc (GSK) entered into an agreement to acquire Nuvalent, Inc (NUVL), which develops targeted cancer therapies, in a transaction valued at $10.6 billion (£8.0 billion) to bolster its oncology pipeline.
Under the terms, GSK will commence a tender offer to acquire all outstanding Nuvalent shares at $124 each in cash, and the transaction is expected to close in the third quarter of 2026, subject to regulatory conditions.
GSK closed Thursday's trade at $53.15, up 0.55%.
NUVL closed Thursday's trade at $123.45, up 0.08%.
Johnson & Johnson To Acquire Firefly Bio For $1 Bln Cash Deal for Oncology Pipeline Expansion
Johnson & Johnson (JNJ) entered into a definitive agreement to acquire Firefly Bio, Inc., including its proprietary Firelink degrader antibody conjugate (DAC) platform for KRAS-driven tumours, for $1 billion in cash and the transaction is expected to occur later this year, subject to approvals. The deal is expected to help JNJ expand its oncology portfolio.
JNJ closed Thursday's trade at $238.33, down 0.07%.
Cartesian Enters Licensing Deal with WestGene
Cartesian Therapeutics Inc. (RNAC) has inked a strategic licensing agreement with WestGene Biopharma Co., Ltd. to advance the development of novel in vivo chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases.
Cartesian's lead asset is Descartes-08, an autologous mRNA CAR-T targeting B-cell maturation antigen (BCMA).
In partnership with WestGene, Cartesian will conduct a Phase 1 dose-escalation study of the mRNA used in Descartes-08 delivered via WestGene's proprietary targeted lipid nanoparticles (tLNPs) in patients with generalized myasthenia gravis. This study is expected to be initiated in 2H 2026, with topline data anticipated in 1H 2027.
RNAC closed Thursday's trade at $8.06, up 8.48%
Galmed To Acquire Colospan For GI-Focused Platform
Galmed Pharmaceuticals Ltd. (GLMD) announced a definitive agreement to acquire Colospan Ltd., a commercial-stage medical device company focused on colorectal surgery. The acquisition includes Colospan's flagship product, CG-100, an intraluminal bypass device placed inside the bowel after colorectal surgery that allows waste to pass through it while protecting the stitched connection for healing.
CG-100 has the FDA BDD designation and is CE-marked, and Colospan is also conducting a pivotal U.S. clinical trial. Galmed plans to invest $6 million to launch the device in Europe during the second half of 2026, initially targeting Germany, Austria, and Switzerland.
GLMD closed Thursday's trade at $0.61, up 17.31%
LENZ Therapeutics Grants Rights for VIZZ in Greater China To Everest Medicines
LENZ Therapeutics, Inc. (LENZ) announced that Everest Medicines (1952.HK) has acquired rights to develop, manufacture and commercialise VIZZ (aceclidine ophthalmic solution 1.44%) in Greater China, including mainland China, Hong Kong (SAR), Macao (SAR) and Taiwan.
In return for the rights granted, LENZ is eligible to receive up to $85 million in regulatory sales milestones, along with tiered royalties ranging from mid-single digits to low double-digit percentages on net sales in Greater China. The NDA for VIZZ in China is due for decision in the first quarter of 2027.
LENZ closed Thursday's trade at $6.50, down 1.22%. 1952.HK closed Thursday's trade at HK$27.4.
GNI Group To Acquire Ayumi Pharma For JPY 44.8 Bln
GNI Group Ltd. (2160.T) has entered into an agreement to acquire Ayumi Pharmaceutical Holdings Co., Ltd. for approximately 44.8 billion Japanese Yen. The transaction includes Ayumi Pharma's flagship product, Calonal, also known as acetaminophen, which holds more than 80% of Japan's acetaminophen market.
2160.T closed Thursday's trade at 2,685 Japanese Yen.
Clinical Trials - Breakthroughs & Setbacks
Johnson & Johnson's IMAAVY Shows Rapid and Durable Haemoglobin Improvements in Pivotal Phase 2/3WAIHA Study
Johnson & Johnson (JNJ) reported that its investigational immunoselective treatment IMAAVY (nipocalimab-aahu) delivered a rapid and durable improvement in haemoglobin levels in patients with warm autoimmune hemolytic anaemia (wAIHA) from its Phase 2/3 ENERGY study. wAIHA has no FDA-approved treatments.
In the study, IMAAVY demonstrated a safety profile consistent with its safety profile in the approved indication of generalised myasthenia gravis, the company stated.
JNJ closed Thursday's trade at $238.33, down 0.07%
Humacyte's ATEV Meets Primary Goal In Phase3 V012 Trial For Dialysis Access
Humacyte, Inc. (HUMA), announced positive top-line interim results from the Phase 3 study, dubbed V012, evaluating the Acellular Tissue-Engineered Vessel (ATEV) in female patients undergoing dialysis access.
The trial met its primary endpoint, which is total days free from indwelling catheter until 365 days after access placement, or until access abandonment, whichever occurs first.
Notably, patients implanted with the ATEV had an average of 220 catheter-free days, compared with 129 for patients who received an AV fistula. In primary safety-related factors, patients receiving the ATEV experienced infections at a rate of 6 per 100 patient-years, compared with 23 per 100 patient-years in patients receiving the AV fistula procedure.
HUMA closed Thursday's trade at $1.08, down 19.40.
Lilly's Retatrutide Delivers Positive Phase 3 Results
Eli Lilly and Company (LLY) announced additional positive results from pivotal Phase 3 trials dubbed the TRIUMPH-1 trial for adults with obesity and TRANSCEND-T2D-1 in adults with type 2 diabetes evaluating Retatrutide, an investigational GIP, GLP-1, and glucagon triple-hormone receptor agonist.
In the trials, Retatrutide showed substantial weight loss along with meaningful improvements in knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, and A1C reductions, as well as weight loss in type 2 diabetes. The types of adverse events seen in the trials were generally consistent with those seen in trials of other incretin-based therapies, noted the firm.
LLY closed Thursday's trade at 1160.95, up 2.16%
Sanofi Halts Phase 3 MOBILIZE Trial For Riliprubart In Treating CIDP For In efficacy
Sanofi (SNY) discontinued its Phase 3 MOBILIZE trial of Riliprubart for the treatment of chronic inflammatory demyelinating polyneuropathy, or CIDP, based on findings from an independent data monitoring committee that Riliprubart was unlikely to yield sufficient efficacy in treating CIDP.
Meanwhile, the ongoing Phase 3 VITALIZE trial for Riliprubart in IVIg-treated CIDP patients will continue as planned.
SNY closed Thursday's trade at $44.11, up 1.24
Zealand's Partner Reports Positive Survodutide Phase 3 Data In Obesity, MASLD Trials
Zealand Pharma A/S (ZEAL.CO)'s partner Boehringer Ingelheim reported positive trial readouts from two global Phase III trials named SYNCHRONIZE-1 for adults living with obesity or overweight, without type 2 diabetes and the SYNCHRONIZE-MASLD study for adults with overweight or obesity with metabolic dysfunction-associated steatotic liver disease (MASLD), which evaluated its investigational glucagon/GLP-1 receptor dual agonist Survodutide.
In SYNCHRONIZE-1, Survodutide showed an average sustained weight loss of up to 16.6% compared with 3.2% in the placebo arm, along with a 34.0% relative reduction in fat loss.
In the SYNCHRONIZE-MASLD trial, Survodutide met its other co-primary endpoint with a relative reduction in body weight of up to 12.2% compared to 1.0% in the placebo arm, and 6 out of 10 patients (61.0%) achieved liver fat normalisation compared to 5.7% in the placebo arm.
Meanwhile, treatment discontinuation rates due to GI adverse events were 19% in the Survodutide arm compared with 2.9% in the placebo arm.
ZEAL.CO closed Thursday's trade at 294.30 Danish Kroner.
Lilly's Foundayo Demonstrates Weight Loss Across Menopause Stages
Eli Lilly and Company (LLY) unveiled new findings based on post-hoc analyses of more than 1,500 female participants in the ATTAIN-1 and ATTAIN-2 clinical trials that evaluated Foundayo, an oral GLP-1 therapy.
In the ATTAIN-1 study, women in perimenopause lost up to 30.4 lbs (14.4%), while those in postmenopause lost up to 28.2 lbs (14.1%). In ATTAIN-2, women taking Foundayo experienced significant weight loss across all stages of menopause, even when living with type 2 diabetes.
LLY closed Thursday's trade at 1160.95, up 2.16%
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