FOSTER CITY (dpa-AFX) - This week, the biotech space witnessed significant milestones, including FDA approvals, oncology drug acquisitions, and collaborations. Positive clinical trial results were reported across multiple therapeutic areas, including radiographic and non-radiographic axial spondyloarthritis, microcystic lymphatic malformations, pulmonary arterial hypertension, and obesity.
Here's a closer look at the details.
FDA Approvals & Rejections
Armata Pharma Secures FDA QIDP Designation for AP-SA02
Armata Pharmaceuticals, Inc. (ARMP) announced that the U.S. FDA has granted Qualified Infectious Disease Product (QIDP) designation to AP-SA02, its bacteriophage-based candidate for complicated Staphylococcus aureus bacteremia, including MRSA.
The designation provides five years of added market exclusivity under the GAIN Act and makes AP-SA02 eligible for Fast Track status, priority review, and rolling submission. Armata plans to advance the program into a Phase 3 superiority study in 2026, building on positive Phase 2a results.
ARMP closed Thursday's (February 26, 2026) trading at $10.83, up 1.88%.
Allurion Technologies Wins FDA PMA Approval for Gastric Balloon System
Allurion Technologies Inc. (ALUR) announced that the U.S. FDA has approved the pre-market approval application for the Allurion Gastric Balloon System, featuring the swallowable Smart Capsule.
The capsule, which, can be placed during a short office visit, expands in the stomach to promote fullness for about four months, and then naturally passes from the body. Approval was supported by data from the AUDACITY trial and real-world use outside the U.S., demonstrating safety and efficacy.
The company highlighted the Smart Capsule as a non-surgical option for patients with a BMI of 30-40, offering a structured alternative to medications or bariatric surgery.
ALUR closed Thursday's trading a $1.25, up 1.63%.
MaxroGenics Pauses Enrollment in LINNET Trial
MacroGenics, Inc. (MGNX) announced that the U.S. FDA has placed a partial clinical hold on its Phase 2 LINNET study of Lorigerlimab in gynecologic cancers. As a result, no new patients will be enrolled until the FDA lifts the restriction, though current participants may continue treatment.
The decision follows recent safety events across four patients, including cases of Grade 4 thrombocytopenia, myocarditis, neutropenia and concurrent septic shock. MacroGenics emphasized that patient safety remains its top priority and is working closely with the FDA to resolve the hold and resume enrollment.
Lorigerlimab, is a bispecific DART molecule targeting PD-1 and CTLA-4, with objective response rate as the primary endpoint.
MGNX closed Thursday's trading at $1.98, up 3.13%.
Eton Pharma Gains FDA Approval for DESMODA Oral Solution
Eton Pharmaceuticals Inc. (ETON) announced that the U.S. FDA has approved DESMODA?(desmopressin acetate) oral solution for the management of central diabetes insipidus, as an antidiuretic replacement therapy for patients of all ages.
DESMODA is the first FDA-approved oral liquid formulation of desmopressin, designed to support precise dosing without the need for tablet splitting or refrigeration. The product will be available beginning March 9, 2026, exclusively through Anovo Co Ltd, with patent protection extending through 2044.
Eton estimates more than 13,000 U.S. patients are affected by central diabetes insipidus, including 3,000-4,000 pediatric patients, and expects DESMODA to achieve peak annual sales of $30 million - $50 million. The approval marks the company's ninth commercial product, further strengthening its rare-disease portfolio.
ETON closed Thursday's trading at $17.25, down 2.27%.
Deals
Gilead Sciences To Acquire Arcellx
Gilead Sciences (GILD) has entered into a definitive agreement to acquire Arcellx (ACLX) for $115 per share in cash at closing, plus one contingent value right of $5 per share, representing an implied equity value of $7.8 billion payable at closing. Gilead currently owns approximately 11.5 per cent of Arcellx's outstanding common stock.
The transaction bolsters its existing partnership through Kite Pharma, a Gilead company and strengthens Gilead's position in cell therapy.
Kite and Arcellx have an existing collaboration to co-develop and co-commercialise Arcellx's lead pipeline candidate, anitocabtagene autoleucel (anito-cel).
GILD closed Thursday's trade at $143.77, down 2.28%.
Vir Biotech Collaborates With Astellas for VIR-5500
Vir Biotechnology, Inc. (VIR) announced a global strategic collaboration with Astellas Pharma Inc. (ALPMF), sharing both development costs and future revenues for its PSMA-targeting T-cell engager, VIR-5500, designed for metastatic prostate cancer.
Under the terms of the agreement, Vir will receive $335 million in upfront and near-term payments, including $240 million in cash, a $75 million equity investment at a 50% premium, and a near-term $20 million milestone payment.
The company is also eligible for up to an additional $1.37 billion in development, regulatory, and sales milestones, as well as tiered, double-digit royalties on ex-U.S. net sales.
Astellas will lead U.S. commercialisation, with Vir retaining an option to co-promote. Outside the U.S., Astellas will hold exclusive rights. Development costs will be shared, with Astellas covering 60% and Vir Biotechnology 40%.
VIR closed Thursday's trade at $9.32, down 6.80%.
ALPMF closed Thursday's trade at $16.05, up 7.72%.
Kairos Pharma Signs Term Sheet To Acquire Two Oncology Assets From Celyn Therapeutics
Kairos Pharma Ltd. (KAPA), a clinical-stage biopharmaceutical company focused on cancer therapeutics, announced the signing of a term sheet to acquire two clinical oncology assets from privately held Celyn Therapeutics, Inc. However, financial details were not disclosed.
The acquisition includes CL-273, a pre-IND, reversible, wild-type-sparing pan-EGFR inhibitor, and CL-741, a Phase 1-ready, orally available c-MET kinase inhibitor.
CL-273, developed using a proprietary AI-driven drug discovery platform, targets EGFR-mutated lung cancer, a market valued at $16.2B in 2026 (Source: Future Market Insights). The program is currently pre-IND, with first-in-human clinical trials projected to commence in 2026.
CL-741 addresses the cMet inhibitor market valued at more than $2B and projected to reach over $10B by 2030 with a CAGR in excess of 17% (Source: Biospace).
Both assets are designed to address non-small cell lung cancer (NSCLC), one of the most common and difficult-to-treat cancers worldwide.
KAPA closed Thursday's trade at $0.55, down 12.15%.
Clinical Trials - Breakthroughs
MoonLake Reports Positive Data From Phase 2 Trial Of Sonelokimab In Axial Spondyloarthritis
MoonLake Immunotherapeutics (MLTX) announced positive results from its phase 2 trial of Investigational drug Sonelokimab in patients with radiographic and non-radiographic axial spondyloarthritis.
In the phase 2 trial, dubbed S-OLARIS, Sonelokimab demonstrated a clinically meaningful and statistically significant benefit, according to the company.
At Week 12, 81% of patients treated with Sonelokimab achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response.
In the study, more than 80% of patients also achieved a clinically meaningful improvement by Week 12, as measured by the ASDAS-CRP score, which assesses overall disease activity, and by SPARCC MRI scores, which evaluate visible inflammation in the sacroiliac joints.
Also, the firm noted that PET imaging showed a significant reduction of inflammation and osteoblast activity in sacroiliac joints affected by axSpA, a key driver of irreversible ossification in the disease.
MLTX closed Thursday's trading at $17.68, down 2.96%.
Novo Nordisk's CagriSema Misses Key Goal In Head-to-Head Trial Against Zepbound
Novo Nordisk A/S (NVO) announced disappointing results from its Phase 3 study evaluating CagriSema in people with obesity, with the primary non-inferiority endpoint not being met.
In the trial, dubbed REDEFINE 4, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) was compared to Lilly's Zepbound (tirzepatide 15 mg), both administered once-weekly and subcutaneously, in adults with obesity.
At 84 weeks, CagriSema 2.4/2.4 mg helped patients lose 23% of their body weight, compared with 25.5% with Tirzepatide 15 mg.
Results also included an analysis that reflects real-world use, where CagriSema resulted in 20.2% weight loss compared to 23.6% with tirzepatide
The REDEFINE 4 trial enrolled 809 participants with obesity and at least one comorbidity, with a mean baseline body weight of 114.2 kg.
While the primary endpoint of non-inferiority was not met, CagriSema demonstrated a safe and well-tolerated profile, the company noted.
NVO closed Thursday's trading at $37.62, down 1.42%.
Gossamer Bio Announces Topline Results from Phase 3 PROSERA Study
Gossamer Bio (GOSS) announced topline results for the PROSERA Phase 3 Study of seralutinib in patients with Pulmonary Arterial Hypertension, in which seralutinib missed the prespecified alpha threshold of its primary endpoint. Gossamer Bio and the Chiesi Group together co-develop seralutinib.
Seralutinib is an investigational, inhaled tyrosine kinase inhibitor delivered via dry powder inhalation. Serelutinib aims to provide direct pulmonary delivery for enhanced local activity while minimising systemic exposure.
The PROSERA Study is a double-blind, placebo-controlled, global registrational clinical trial evaluating seralutinib in PAH patients, on top of background PAH therapy.
Seralutinib showed a placebo-adjusted improvement in Six-Minute Walk Distance (6MWD) of +13.3 meters at Week 24, missing the prespecified alpha threshold of 0.025.
At week 24, patients receiving seralutinib had a median change from baseline of +28.2 meters, while those receiving placebo had a median change of +13.5 meters.
Seralutinib was generally well tolerated with safety consistent with prior experience, the according to the firm. Gossamer plans to meet with the U.S. FDA to discuss the path forward.
Also, the firm noted the need to pause enrollment in the SERANATA Study to evaluate the impact of PROSERA results, particularly regional discrepancies in placebo response.
GOSS closed Thursday's trading at $0.40, up 5.76%.
Novo Nordisk Reports Positive Results From Chinese Phase 2 Trial Of UBT251 In Obesity
Novo Nordisk A/S (NVO) and The United Laboratories International Holdings Limited (ULIHF, UNJ.F) on Tuesday announced topline results from a Chinese phase 2 trial evaluating UBT251, jointly developed for overweight or obese patients at 24 weeks.
UBT251 is a synthetic peptide triple agonist targeting the receptors for GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide) and glucagon.
This phase 2 trial is a randomised, double-blind, placebo-controlled trial that enrolled a total of 205 Chinese patients with obesity with at least one weight-related comorbidity. The baseline mean body weight of the patients was 92.2 kg, with a baseline mean BMI of 33.1 kg/m².
The primary endpoint of the trial was the percentage change in body weight from baseline after 24 weeks of treatment.
The results showed a 19.7% weight loss in the UBT251 group compared with 2% in the placebo group after 24 weeks of treatment.
In the trial, UBT251 appeared to have a safe and well-tolerated profile, according to the firm.
Based on the results of this trial, the company is planning to initiate a phase 3 trial in Chinese patients with overweight or obesity.
NVO closed Thursday's trade at $37.52, down 0.27%.
Palvella's QTORIN Meets Goals in Phase 3 Study In Microcystic Lymphatic Malformations
Palvella Therapeutics, Inc. (PVLA) reported positive topline results from its pivotal Phase 3 SELVA clinical study evaluating QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations.
The SELVA study, a single-arm, baseline-controlled Phase 3 trial, evaluated once-daily QTORIN rapamycin in individuals aged three years and older.
The trial met its primary endpoint, demonstrating a statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA), with a mean change of +2.13.
The therapy also achieved statistical significance across its key secondary endpoint- the blinded mLM Multi-Component Static Scale- which improved by 3.36 points.
Palvella plans to submit a New Drug Application to the FDA in the second half of 2026.
PVLA closed Thursday's trade at $148.34, up 15.35%.
Argenx's VYVGART Meets Primary Goals in Phase 3 DAPT OCULUS trial Results in Ocular MG
Argenx SE (ARGX) announced that its phase 3 ADAPT OCULUS trial evaluating VYVGART in ocular myasthenia gravis has met the primary endpoint.
In the trial, VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo.
In the overall population, the mean change from baseline in patients treated with VYVGART was a 4.04-point improvement in MGII PRO, compared with a mean change of 1.99 points in patients treated with placebo.
Also, patients treated with VYVGART experienced a marked reduction of key ocular symptoms: diplopia (double vision) and ptosis (drooping of the upper eyelids).
The therapy was well tolerated, and no new safety concerns were identified. The results support a planned sBLA to the U.S. FDA for the treatment of ocular myasthenia gravis, a condition with no approved therapies.
ARGX closed Thursday's trade at $771.53, up 5.59%.
AtaiBeckley's Phase 2a Study Of EMP 01 In Social Anxiety Disorder Meets Key Goal
AtaiBeckley Inc. (ATAI) has announced positive topline results from its exploratory, double blind, placebo-controlled, first-in-patient phase 2a study of EMP 01 in adults with Social Anxiety Disorder.
The multi-centre study enrolled 71 adults with moderate-to-severe SAD across 7 clinical sites in the UK.
The primary endpoint of the phase 2a study of EMP 01 was safety and tolerability through Day 43, and the secondary endpoint was the change in social anxiety symptoms from baseline to Day 43, using the Liebowitz Social Anxiety Scale (LSAS).
With respect to the trial's primary objective, EMP-01 demonstrated a favourable and manageable safety and tolerability profile, and no serious adverse events were observed according to AtaiBeckley.
Secondary and exploratory efficacy endpoints showed encouraging signals in which EMP-01 produced a numerically greater symptom reduction than placebo, as measured by LSAS, at Day 43 relative to baseline.
ATAI closed Thursday's trade at $3.73, down 14.06%.
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