NEW BRUNSWICK (dpa-AFX) - This week's biotech landscape witnessed key FDA approvals, EU approvals, IND clearances, acquisitions, and clinical trial data readouts across key therapeutic areas such as Chronic Inflammatory Demyelinating Polyneuropathy, Atopic Dermatitis, Ornithine Transcarbamylase (OTC) deficiency and focal onset seizures.
Let us unpack the key developments and milestones in the biotech space this week.
FDA and EU Approvals & Rejections
FDA Approves BMY's Sotyktu for Psoriatic Arthritis
Bristol Myers Squibb (BMY) won FDA approval for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA), marking the first TYK2 inhibitor cleared for this indication.
The drug was initially approved in 2022 for moderate-to-severe plaque psoriasis.
The latest approval is backed by Phase 3 POETYK PsA trials showing significant disease activity improvement.
BMY closed Thursday's trading (March 12, 2026,) at $58.95, down 1.72%.
EU Approves Incyte's Zynyz for Anal Cancer
Incyte (INCY) received European Commission approval for Zynyz (retifanlimab) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
This marks the second EU indication for Zynyz, which was previously cleared for Merkel cell carcinoma. Approval was supported by Phase 3 POD1UM-303/InterAACT2 trial data.
INCY closed Thursday's trading at $92.03, down 2.78%.
Health Canada Approves AstraZeneca's Koselugo for NF1
AstraZeneca (AZN) gained Health Canada approval for Koselugo (selumetinib) to treat adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas.
The decision was supported by Phase 3 KOMET trial results. Koselugo has already been approved in the US, EU, Japan and other regions.
AZN closed Thursday's trading at $192.50, down 0.42%.
EU Approves J&J's AKEEGA for BRCA-Mutated Prostate Cancer
Johnson & Johnson (JNJ) received European Commission approval for AKEEGA, a dual-action tablet combining Niraparib and Abitaterone acetate, for adults with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC).
The decision expands its prior EU clearance in mCRPC. Approval was supported by Phase 3 AMPLITUDE trial data, following earlier FDA approval in 2023.
JNJ closed Thursday's trading at $242.04, down 0.39%.
FDA Approves IceCure's Post-Marketing Study for ProSense
IceCure Medical Ltd. (ICCM) received FDA approval to launch the ChoICE post-marketing evaluation of its ProSense cryoablation system in low-risk breast cancer.
This follows the 2025 FDA clearance of ProSense as the first cryoablation device authorised for breast cancer treatment in the U.S.
The study will collect real-world data on safety and effectiveness, aiming to validate cryoablation as a minimally invasive alternative to surgery.
ICCMclosed Thursday's trading at $0.68, up 2.97%.
Ipsen Withdraws Tazverik
Ipsen (IPSEY) announced it is voluntarily withdrawing Tazverik (tazemetostat) from all markets and indications, including follicular lymphoma (FL) and epithelioid sarcoma (ES).
The move follows safety concerns from the Phase Ib/III SYMPHONY-1 trial, where secondary hematologic malignancies were observed. All active trials and expanded access programs are being discontinued.
Tazverik received FDA accelerated approval in 2020, contingent on confirmatory data.
IPSEY closed Thursday's trading at $45.90, up 1.37%.
Deals
Servier Acquires Day One Biopharmaceuticals for $2.5 Billion
Servier, a France-based global pharmaceutical group, has agreed to acquire Day One Biopharmaceuticals, Inc. (DAWN) for $21.50 per share in cash, valuing the company at approximately $2.5 billion.
The deal is designed to expand Servier's rare oncology portfolio, particularly in pediatric cancers, an area where Day One has built its scientific and clinical focus.
As per the agreement, Servier will launch a tender offer to purchase all outstanding Day One shares at the agreed price, representing a 68% premium to Day One's closing share price on March 5, 2026, and an 86% premium to its one-month volume-weighted average price.
The deal is expected to close in the second quarter of 2026.
DAWN closed Thursday's trade at $21.27, up 0.09%.
NEXGEL Signs Agreement with Celularity
NEXGEL, Inc. (NXGL) announced the signing of a definitive agreement to license and acquire a portfolio of six commercial-stage regenerative biomaterial products from Celularity Inc (CELU).
As per the terms of the agreement, consideration for the portfolio will include a $15 million upfront cash payment and, potentially, an additional $20 million in milestone payments based on various annual net sales targets for the portfolio.
For NEXGEL, the transaction is expected to approximately triple its annual revenue to about $35 million, making the company immediately profitable upon deal closure.
NXGL closed Thursday's trade at $0.95, up 15.82%. Clinical Trials - Breakthroughs
Dianthus Reports a positive interim 'GO' decision in Phase 3 CAPTIVATE trial of Claseprubart
Dianthus Therapeutics, Inc. (DNTH) announced a positive interim 'GO' decision in its Phase 3 CAPTIVATE trial of Claseprubart, a monoclonal antibody in Chronic Inflammatory Demyelinating Polyneuropathy.
CAPTIVATE is a single, two-part, randomized withdrawal Phase 3 trial of claseprubart in CIDP. Part A of this trial included an interim responder analysis of a pre-defined number of participants.
Claseprubart achieved an early GO decision in the Phase 3 CAPTIVATE trial, confirming 20 responders in Part A ahead of schedule. Top-line data for Part B are expected by the end of 2026.
DNTH closed Thursday's trade at $80.32, down 6.43%.
Pfizer's Tilrekimig Meets Primary Goal In Phase 2 Atopic Dermatitis Trial
Pfizer, Inc. (PFE) announced positive topline results from a Phase 2 study investigating tilrekimig (PF-07275315), an investigational trispecific antibody, in adults with moderate to severe atopic dermatitis.
The Phase 2 study is an ongoing randomised, double-blind, placebo-controlled trial in adults with moderate to severe atopic dermatitis
The study met its primary endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (at least a 75% reduction in the Eczema Area and Severity Index) at Week 16 across all doses tested compared with placebo.
Based on encouraging results, Pfizer plans to accelerate Tilrekimig into Phase 3 development for atopic dermatitis, with a pivotal study on track for this year.
PFEclosed Thursday's trade at $26.86, down 1.61%.
Abbott FreeDM2 Trial Data Shows Libre Technology Achieves 0.6% Greater Reduction in HbA1c
Abbott (ABT) announced results from the FreeDM2 randomised controlled trial (RCT) evaluating its FreeStyle Libre continuous glucose monitoring (CGM) technology, which demonstrated better glucose outcomes than those using traditional fingerstick testing.
The FreeDM2 randomised controlled trial was designed to determine whether real-time continuous glucose monitoring can help people using basal insulin improve their glucose management.
To be specific, at 4 months, participants using an Abbott FreeStyle Libre continuous glucose monitoring system had a 0.6% greater reduction in HbA1c than those using traditional finger-stick testing.
Abbot estimates that Libre technology is used by approximately 8 million people across more than 60 countries.
ABT closed Thursday's trade at $108.14, down 1.91%.
Xenon Pharma's Azetukalner Meets primary endpoint in focal onset seizures
Xenon Pharmaceuticals Inc. (XENE) announced that its Phase 3 X-TOLE2 study of Azetukalner, its lead KV7 potassium channel opener to stabilise electrical activity in the brain, met its primary endpoint in focal onset seizures, delivering one of the strongest efficacy signals ever reported in a pivotal epilepsy trial.
The study showed that patients receiving Azetukalner experienced a 53.2% median reduction in monthly seizure frequency with the 25 mg dose, compared to just 10.4% for placebo.
Even the lower 15 mg dose achieved a 34.5% reduction, reinforcing the drug's potential benefit. Safety findings were consistent with earlier studies, with Azetukalner generally well-tolerated.
Xenon said it plans to submit an NDA to the U.S. FDA in the third quarter of 2026.
XENE closed Thursday's trade at $57.90, down 1.93%.
Genentech's persevERA Breast Cancer Study Misses Goal
Genentech, part of Roche (RHHBY), reported that its Phase 3 persevERA trial of Giredestrant in combination with Palbociclib in ER+/HER2- metastatic breast cancer failed to meet its primary endpoint of progression-free survival versus letrozole plus palbociclib.
A numerical improvement was observed, and the FDA has already accepted an NDA based on earlier evERA data.
Roche plans to submit lidERA Phase 3 results in early-stage breast cancer soon.
RHHBY closed Thursday's trading at $51.93, down 2.75%
Ultragenyx Gene Therapy Delivers Strong Phase 3 Results in OTC Deficiency
Ultragenyx Pharmaceutical Inc. (RARE) reported positive 36-week Phase 3 Enh3ance data for DTX301, its investigational AAV8 gene therapy for ornithine transcarbamylase (OTC) deficiency.
The therapy achieved an 18% reduction in plasma ammonia levels versus placebo, with most patients normalising ammonia control and reducing reliance on scavenger medications and restricted diets.
Patient-reported outcomes also favoured DTX301, and the therapy was generally well tolerated.
RARE closed Thursday's trading at $21.71, down 2.25%.
60 Degree's Tafenoquine Shows 100% Cure in Babesiosis
60 Degree Pharmaceuticals, Inc. (SXTP) announced that all three patients in its expanded-use trial of Tafenoquine (ARAKODA) achieved sustained clearance of relapsing babesiosis, a serious tick-borne illness often resistant to standard therapies.
Results align with Yale's earlier study showing 100% cure rate when Tafenoquine was added to Atovaquone-based regimens.
The company is urging the review of treatment guidelines and pursuing new indications beyond malaria prophylaxis.
SXTP closed Thursday's trading at $2.91, down 9.63%.
BridgeBio's BBP-418 Shows Strong Phase 3 Results in LGMD2I/R9
BridgeBio Pharma, Inc. (BBIO) reported positive interim Phase 3 FORTIFY data for BBP-418 in patients with limb-girdle muscular dystrophy type 2I/R9.
The therapy demonstrated consistent efficacy, including improved ambulation and sustained reductions in serum creatine kinase, with a favourable safety profile.
Based on these results, BridgeBio plans to submit an NDA in the first half of 2026, positioning BBP-418 as a potential first-approved therapy for LGMD2I/R9.
BBIO closed Thursday's trading at $67.98, down 4.78%.
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