This week, the biotech sector saw FDA approvals, alongside study halts, layoffs, strategic collaborations, acquisitions, deal closures, and encouraging data readouts.
Positive clinical readouts spanning therapeutic areas include Prader-Willi syndrome, Chronic Lymphocytic Leukaemia, Angioedema, and Chronic Spontaneous Urticaria, bolstering innovation in therapeutic breadth.
Let's unpack the specifics.
FDA Approvals
Spero's Oral Antibiotic Milestone
Spero Therapeutics (SPRO)and GSK plc (GSK) announced FDA approval of Utebzi (tebipenem pivoxil), the first oral carbapenem for complicated urinary tract infections in adults with limited treatment options. The decision follows a prior CRL in 2022 and a resubmission backed by Phase 3 PIVOT-PO data showing non-inferiority to IV therapy.
SPRO closed Thursday's (June 18, 2026) trading at $2.28, up 8.06%
FDA Approves Expanded Use of AbbVie's Hyaluronic Acid Injectable
AbbVie (ABBV) said its Allergan Aesthetics unit has received FDA approval for SKINVIVE by JUVÉDERM to improve the appearance of neck lines in adults over 21, expanding beyond its prior cheek indication. In pivotal studies, nearly 75% of patients achieved significant improvement at one month, with results maintained in most through six months.
ABBV closed Thursday's trading at $216.49, down 2.14%
FDA Clears Cuprina's Maggot Therapy
Cuprina Holdings (CUPR) said its subsidiary, Cuprina Pte. Ltd., received a 510(k) clearance for MEDIFLY Maggots in wound debridement, a biological approach to removing infected and necrotic tissue in chronic non-healing wounds such as diabetic foot ulcers and pressure injuries. The clearance follows the company's earlier FDA approval in 2004 for its Medical Maggots product.
CUPR closed Thursday's trading at $4.37, down 16.92%
Bayer AG (BAYN.DE) received FDA approval for AMBELVIST (gadoquatrane), a next-generation gadolinium -based contrast agent for use in contrast-enhanced MRI scans. The macrocyclic agent delivers effective image enhancement with a 60% lower gadolinium dose than traditional agents, as supported by Phase 3 QUANTI studies in adults and children. Approved for both CNS and non-CNS imaging, AMBELVIST aims to reduce gadolinium exposure while maintaining diagnostic performance.
BAYN.DE closed Thursday's trading at 37.15 Euros.
LayOffs
Neumora Halts KOASTAL Program; Plans Layoffs
Neumora Therapeutics Inc. (NMRA) ended its Phase 3 KOASTAL studies of Navacaprant in major depressive disorder after failing to meet primary and secondary endpoints, with results showing no statistical difference versus placebo. The company also announced plans to lay off about 35% of its workforce, aiming to save $10 million annually.
NMRA closed Thursday's trading at $1.51, down 1.31%
enGene Announces Workforce Cuts
enGene Therapeutics Inc. (ENGN) said it will reduce its workforce by approximately 50% as part of a restructuring plan. The company said the decision is aimed at extending cash runway and focusing resources on prior programs, while lowering operational expenses to support long-term sustainability.
ENGN closed Thursday's trading at $1.72, down 1.15%
Deals
Biogen to Acquire RayThera in $1 Bln Deal to Expand Immunology Portfolio
Biogen Inc. (BIIB) has agreed to acquire RayThera Inc. in a transaction valued at up to $1 billion, including an upfront payment and additional milestone payments for its anti-inflammatory assets designed to target immune-mediated diseases. The acquisition will enable Biogen to expand into immunology. The transaction is expected to close in the third quarter of 2026.
BIIB closed Thursday's trading at $196.58, down 1.05%.
FocalTherics Partners with MellingMedical to Improve Access to Focal One for Prostate Cancer
FocalTherics (FOCL) has entered into an agreement with MellingMedical, an SBA-verified Service-Disabled Veteran-Owned Small Business, to expand access to the Focal One Robotic High-Intensity Focused Ultrasound (HIFU) system for veterans with prostate cancer and active-duty military personnel throughout the U.S. Department of Veterans Affairs (VA) and Department of Defence healthcare systems.
FOCL closed Thursday's trading at $4.81, down 1.84%.
Cosmos Enters Five-Year Manufacturing Deal With Pharmex For 2.86 Mln Units
Cosmos Health Inc. (COSM) entered into a five-year contract manufacturing agreement with Pharmex S.A. via its wholly owned subsidiary, Cana Laboratories. As per the deal, over the five-year term, the Cosmos plans to manufacture a combined output of 2.86 million estimated units of three pharmaceutical products at Cana's EU-GMP-licensed, EMA-certified facility.
COSM closed Thursday's trading at $0.21, down 11.92%
Jazz Pharma Signs Multi-Program Antibody Discovery Deal with AbCellera
Jazz Pharmaceuticals plc (JAZZ) has entered into a collaboration with AbCellera Biologics Inc. (ABCL) to develop next-generation T-cell-engaging multispecific antibodies. Under the agreement, AbCellera will lead discovery and early research for two initial programs and launch a third within 12 months. AbCellera will receive $56 million upfront for the first two programs and an additional $28 million when the third program begins. If development milestones are achieved, AbCellera could earn up to $792 million per program in option fees and milestone payments.
JAZZ closed Thursday's trading at $224.66, down 1.00%
Accenture to Acquire Alfahealth, Expanding Digital Health Capabilities in Italy
Accenture (ACN) has agreed to acquire Alfahealth, a subsidiary of the engineering Group, to bolster its digital health capabilities. The acquisition will add approximately 1,200 specialised professionals to Accenture Italy's Health practice, strengthening its position in the Italian healthcare sector and supporting national programs in a regulated environment.
ACN closed Thursday's trading at $127.98, down 17.97%
Neurizon Unveils Five-Year Supply Agreement for Monepantel to Advance NUZ-001
Neurizon Therapeutics Ltd (NUZ.AX) announced the execution of a strategic long-term supply agreement with Elanco Animal Health for Monepantel, an active ingredient in developing its lead investigational oral therapy NUZ-001 for Amyotrophic Lateral Sclerosis. The agreement is being executed with an initial five-year term and includes provisions relating to forecasting, production scheduling, and supply.
NUZ.AX closed Thursday's trading at $0.06, down 4.62%
Clinical Trials - Breakthroughs & Setbacks
Neurocrine Biosciences, Inc. (NBIX) presented late-breaking results from the Phase 3 extension study of VYKAT XR extended-release tablets in Prader-Willi syndrome (PWS). The study showed patients resuming treatment following a 16-week randomized withdrawal period regained durable improvements in hyperphagia and behavioural symptoms, with benefits maintained through two years.
VYKAT XR was first FDA-approved in 2025 for hyperphagia in PWS.
NBIX closed Thursday's trading at $158.29, down 0.45%
Celldex Highlights Angioedema Data
Celldex (CLDX) reported positive Phase 2b data for Barzolvolimab,an investigational humanised monoclonal antibody in chronic spontaneous urticaria patients with angioedema, showing sustained symptom reduction through week 76 after treatment withdrawal. Results presented at the EAACI 2026 meeting highlighted that up to 64% of patients remained angioedema-free seven months post-dose. The company plans Phase 3 readouts in late 2026, with a BLA submission targeted for 2027.
CLDX closed Thursday's trading at $32.43, down 1.52%
Intellia Advances Phase 3 HAELO Trial Of Lonvoguran Ziclumeran
Intellia Therapeutics Inc. (NTLA) reported additional positive Phase 3 results from the HAELO trial of Lonvoguran Ziclumeran or Lonvo-z in hereditary angioedema, confirming key secondary endpoints including an 89% reduction in monthly attacks requiring on-demand treatment and a 91% drop in moderate or severe attacks. Patients also showed a clinically meaningful improvement in quality-of-life scores. A rolling BLA submission began in April 2026, with U.S. approval and launch anticipated in the first half of 2027.
NTLA closed Thursday's trading at $15.67, up 3.09%.
Rhythm Posts Positive Setmelanotide Data in Prader-Willi Syndrome
Rhythm Pharmaceuticals Inc. (RYTM) announced positive Phase 2 results of Setmelanotide in Prader-Willi syndrome, showing meaningful reductions in Prader-Willi syndrome, showing meaningful reductions in hyperphagia scores and improvements in body weight among treated patients. The company said the findings support further development of Setmelanotide as a potential therapy for PWS, with plans to advance into late-stage studies.
RYTM closed Thursday's trading at $96.79, up 1.00%.
Lilly's Jayprica Combo Succeeds in Phase 3 CLL Trial
Eli Lilly and Co. (LLY) announced positive Phase 3 BRUIN CLL-322 trial results showing Jaypirca (pirtobrutinib) combined with venetoclax and rituximab versus venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The regimen met its primary endpoint of progression-free survival, with secondary measures such as time to next treatment also favouring the Jayprica arm, and safety consistent with known profiles.
LLY closed Thursday's trading at $1,098.57, down 1.21%.
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