BASEL (dpa-AFX) - This week's biotech landscape witnessed regulatory approvals across the U.S., EU, and China, acquisitions, a few key trial goal misses and positive clinical trial data readouts across therapeutic areas like Psoriasis, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Atopic Dermatitis, IgA nephropathy, Non-small cell lung cancer, and Thyroid eye disease.
Let's dive into the details.
FDA and EU Approvals & Rejections
ARS Pharma Gains FDA Approval to Broaden Neffy Label for Allergic Reactions
ARS Pharmaceuticals (SPRY) received FDA approval to update the label for Neffy 1mg, its needle-free epinephrine nasal spray, removing the prior age restriction. It can now be used by anyone weighing 33 lbs or more - both children and adults - for emergency treatment of Type 1 allergic reactions, including anaphylaxis. The update also advises patients to carry Neffy in its blister pack or carrying case.
SPRY closed Thursday's trading at $8.30, up 2.34%.
Novo Nordisk Wins FDA Approval for Awiqli, First Once-Weekly Basal Insulin
Novo Nordisk A/S (NVO) received FDA approval for Awiqli (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, following a prior 2024 CRL tied to manufacturing and type 1 diabetes concerns.
The resubmitted application focuses solely on type 2 diabetes and was supported by the ONWARD Phase 3a program (2,680 adults), where Awiqli showed significant HbA1c reductions versus daily basal insulin with a consistent safety profile. The U.S. launch is planned for 2H 2026 via the FlexTouch device; Awiqli is already approved in the EU and 13 other countries.
NVO closed Thursday's trading at $36.98, up 1.37%.
Lupin Receives Tentative FDA Nod for Generic Sugammadex Injection
Lupin Limited (LUPIN.NS) secured tentative FDA approval for its generic Sugammadex Injection (200 mg/2 mL and 500 mg/5 mL), a therapeutic equivalent to Merck's Bridion, used to reverse neuromuscular blockade in adults and children aged 2 years and older.
The product- manufactured at Lupin's Nagpur facility- can launch once the reference drug's patents and exclusivities expire, marking another expansion of Lupin's U.S. hospital-focused injectable portfolio.
LUPIN.NS closed Thursday's trading at INR 2,274.50, down 0,02 %.
Teva Wins FDA Approval for Prolia Biosimilar PONLIMSI; Xolair Biosimilar Filings Accepted
Teva Pharmaceutical Industries Limited (TEVA) received FDA approval for PONLIMSI, its biosimilar to Amgen's Prolia for multiple bone-related conditions, supported by analytical and clinical data showing comparable efficacy, safety, and immunogenicity. The company also announced that its biosimilar candidate to Xolair has been accepted for review by both the FDA and EMA, reinforcing Teva's expanding global biosimilars portfolio.
TEVA closed Thursday's trading at $ , up %.
Bayer Secures EU Approval for Expanded Use of Kerendia
Bayer (BYR.L, BAYN.DE) received European Commission approval to expand Kerendia (finerenone) to treat adults with symptomatic heart failure with left ventricular ejection fraction 40% or higher, broadening its use beyond CKD associated with type 2 diabetes. The decision is supported by positive Phase 3 FINEARTS-HF results.
BAYN.DE closed Thursday's trading at EUR 39.70, down 1.06%
GSK's Exdensur Approved in China for Severe Eosinophilic Asthma
GSK plc (GSK, GSK.L) announced that China's National Medical Products Administration has approved Exdensur or depemokimab as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.
The decision is supported by positive Phase III SWIFT-1 and SWIFT-2 data, expanding Exdensur's global footprint across major markets.
GSK closed Thursday's trading at $56.69, up 1.25%.
Biogen Secures FDA Approval for High-Dose SPINRAZA Regimen in SMA
Biogen (BIIB) received FDA approval for a new high-dose SPINRAZA regimen for spinal muscular atrophy, enabling higher loading and maintenance doses to boost drug exposure. The decision is backed by DEVOTE Phase 2/3 data, which showed improved motor outcomes with a safety profile consistent with the standard dose. The high-dose version will roll out in the U.S. within weeks and is already approved in the EU, Switzerland and Japan.
BIIB closed Thursday's trading at $177.34, down 3.50%.
Deals
Lilly To Acquire Centessa Pharma In An Approx.$6.3 Bln Cash And $1.5 Bln CVR Deal
Eli Lilly and Co. (LLY) and Centessa Pharmaceuticals plc (CNTA) announced a definitive agreement under which Lilly will acquire Centessa in a cash-and-contingent value rights (CVR) deal.
Under the terms of the acquisition transaction agreement, Lilly will acquire all of the issued and to be issued share capital of Centessa for $38.00 in cash per share, along with one non-transferable contingent value right (CVR), for a total potential per-share consideration of up to $47.00.
The acquisition will enable Lilly to gain ownership of Centessa's orexin receptor 2 (OX2R) agonist pipeline designed for sleep-wake disorders.
The transaction is expected to close in the third quarter of 2026.
LLY closed Thursday's trade at $935.58, down 1.98%.
Biogen To Acquire Apellis To Expand Immnology And Rare Disease Portfolio
Biogen Inc. (BIIB) has agreed to acquire Apellis Pharmaceuticals (APLS) in a deal that strengthens its position in immunology, rare disease and nephrology.
As per the agreement, Biogen will acquire all outstanding Apellis shares for $41.00 per share in cash, valuing the upfront equity component at approximately $5.6 billion.In addition, Apellis shareholders will receive a non-transferable contingent value right (CVR) tied to future global net sales milestones for SYFOVRE.
For Biogen, the transaction is expected to bolster near- and long-term revenue growth, with EMPAVELI and SYFOVRE generating $689 million in combined net sales in 2025 and projected to grow at a mid-to-high-teens rate through at least 2028. The deal is expected to become accretive to non-GAAP EPS starting in 2027.
The deal is expected to close in the second quarter of 2026.
BIIB closed Thursday's trade at $177.34,down 3.50%
Aurinia Pharma To Acquire Kezar Life Sciences For $6.96 In Cash Per Share And CVR Deal
Aurinia Pharmaceuticals Inc. (AUPH), a biopharmaceutical company, announced it has entered into a definitive merger agreement to acquire Kezar Life Sciences, Inc. (KZR), a clinical-stage biotechnology company, for $6.955 in cash per share of common stock and one non-transferable contingent value right (CVR).
As per the terms of the agreement, Aurinia through its wholly owned subsidiary, Aurinia Pharma U.S., Inc., and its merger subsidiary, Aurinia Merger Sub, Inc., will commence a tender offer by April 13, 2026, to acquire all outstanding shares of Kezar common stock.
The transaction is expected to close in the second quarter of 2026.
AUPH closed Thursday's trade at $15.61, up 0.90%.
Clinical Trials - Breakthroughs & Setbacks
Takeda's Zasocitinib Shows Rapid, Durable Skin Clearance In Phase 3 Psoriasis Trials
Takeda Pharmaceutical Co. (TAK) announced new data from two pivotal Phase 3 studies of Zasocitinib (TAK-279), its next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).
Notably, about 70% of patients treated with Zasocitinib achieved clear or almost clear skin, with a static Physician Global Assessment (sPGA) score of 0/1 at week 16 in Phase 3 plaque psoriasis studies.
The results showed that once-daily oral Zasocitinib achieved rapid and durable skin clearance, with a safety profile consistent with that observed in earlier Phase 2b studies.
Takeda noted that it remains on track to submit a New Drug Application in 2026.
TAK closed Thursday's trade at $18.74, down 0.16%.
Arcutis Reports New Positive Phase 2 Results For ZORYVE Cream In Infant Atopic Dermatitis
Arcutis Biotherapeutics, Inc. (ARQT), a commercial-stage biopharmaceutical company, announced new positive data from the INTEGUMENT-INFANT Phase 2 trial of ZORYVE (roflumilast) 0.05% cream, demonstrating reduced signs and symptoms of atopic dermatitis(AD) in infants aged 3 months to less than 24 months with mild to moderate disease.
Among 96 patients who completed four weeks of treatment, 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of 0 (Clear) or 1 (Almost Clear) with a 2-grade improvement.
Also, Investigational ZORYVE (Roflumilast) cream 0.05% was well tolerated, with safety findings consistent with prior paediatric experience. Arcutis plans to submit an NDA for ZORYVE cream 0.05% for infants in the second quarter of 2026.
ARQT closed Thursday's trade at $23.63, down 1.95%
Connect Biopharma Posts Positive Rademikibart Data in Asthma, COPD and atopic dermatitis
Connect Biopharma Holding Ltd. (CNTB) announced positive clinical data from its Phase 1 clinical pharmacology study evaluating a single 300 mg intravenous (IV) push of Rademikibart, a fully human monoclonal antibody, in patients with asthma or COPD.
According to the company, many patients experienced rapid improvements in lung function (FEV1) of 200 ml or more as early as 15 minutes after dosing, confirming preclinical observations that Rademikibart may have a unique bronchodilator-like effects.
In addition, Connect Biopharma shared 52-week results from the Phase 3 RADIANT-AD study conducted by its partner, Simcere Pharmaceutical Co., Ltd., in China.
Rademikibart achieved rapid and durable efficacy across all key endpoints, with 96.6% achieving EASI-75; 87.1% achieving IGA 0/1, and 85.3% achieving EASI-90.
CNTB closed Thursday's trade at $2.99, up 9.93%
Novartis Reports Fabhalta Cut Kidney Function Decline By 49.3% In IgAN
Novartis (NVS) reported final two-year results from its Phase 3 APPLAUSE IgA nephropathy (IgAN) study, showing that Fabhalta (iptacopan) slowed the decline in kidney function by 49.3% compared with placebo.
In the APPLAUSE Phase 3 study, Fabhalta was evaluated in adults with biopsy-confirmed IgAN who continued to exhibit high proteinuria despite optimised supportive care.
Over the 24 months, Fabhalta slowed the decline in kidney function by nearly half compared with placebo. Patients receiving Fabhalta experienced an average annual eGFR decline of -3.10 mL/min/1.73 m²/y, while those on placebo experienced a decline of -6.12 mL/min/1.73 m²/y.
NVS closed Thursday's trade at $154.03,down 0.68%.
Viridian's Elegrobart Delivers Strong Phase 3 Results In Thyroid Eye Disease
Viridian Therapeutics, Inc. (VRDN) reported positive topline results from its Phase 3 REVEAL-1 trial, showing that Elegrobart, a half-life-extended monoclonal antibody, met the primary endpoint with a highly statistically significant improvement in proptosis responder rate in patients with active thyroid eye disease.
Elegrobart achieved a 54% proptosis rate in the Q4W arm and 63% in the Q8W arm, versus 18% placebo arm, meeting the primary endpoint with high statistical significance.
The therapy also produced meaningful improvements in diplopia(double vision), with 51% achieving complete resolution compared with 16% on placebo.
VRDN closed Thursday's trade at $18.84, down 1.62%.
MAIA's Phase 2 Trial Shows 8 Lung Cancer Patients Surpassing Two Years Of Survival
MAIA Biotechnology (MAIA) announced an important milestone in its ongoing Phase 2 THIO-101 trial, with 8 non-small cell lung cancer patients surviving beyond two years after treatment with its investigational therapy sequence of Ateganosine followed by Cemiplimab.
The company is currently enrolling patients in the THIO-101 Part C expansion and is also advancing its Phase 3 pivotal program.
MAIA closed Thursday's trade at $1.33, down 0.75%
Immunovant's Batoclimab Misses Key Goals In Both Phase 3 Thyroid Eye Disease Trials
Immunovant, Inc. (IMVT), a clinical-stage immunology company, announced that both its Phase 3 studies of Batoclimab or IMVT-1401 in Thyroid eye disease (TED) failed to meet their primary endpoints.
The studies failed to meet their primary endpoint of a proptosis responder rate of 2mm or more at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose Batoclimab treatment.
In addition, the firm noted that patients in the TED studies showed greater proptosis improvement from baseline after the initial 12-week high-dose period than after the subsequent 12-week low-dose period.
IMVT closed Thursday's trade at $24.50, down 2.39%.
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