KENILWORTH (NJ) (dpa-AFX) - This week's biotech landscape witnessed regulatory approvals across the U.S. and Japan, EU withdrawals, mergers, and clinical trial data readouts spanning lung disease, Lyme disease, kidney disease, ovarian cancer and Type 1 Diabetes.
Let's dive into the details.
FDA and EU Approvals & RejectionsAnavex Withdraws EU Filing for Alzheimer's Drug BlarcamesineAnavex Life Sciences Corp. (AVXL) has withdrawn its EU marketing application for Blarcamesine after the EMA's CHMP indicated it could not issue a positive opinion. The decision marks a setback for the company's lead Alzheimer's candidate, which has completed multiple Phase 2/3 studies.
Anavex said it will review regulatory feedback and gather additional data to address concerns. The company emphasised continued support from the patient groups, including Alzheimer Europe.
AVXL closed Thursday's (March 26, 2026) trading at $2.88, up 5.11%.
Quoin Gets FDA Alignment on Phase 3 Path for QRX003 in Netherton SyndromeQuoin Pharmaceuticals Ltd. (QNRX) reported positive FDA feedback from a recent Type C meeting, confirming that a single Phase 3 trial may be sufficient to support U.S. approval of its lead topical therapy, QRX003, for Netherton Syndrome.
The FDA also signalled openness to alternative pivotal designs, including randomised withdrawal or delayed-start approaches. Quoin plans to submit ongoing Phase 2 and paediatric study data and will request another meeting before launching Phase 3.
The company remains on track to start Phase 3 in 2026, complete enrolment by year-end, and potentially file an NDA in 2027.
QNRX closed Thursday's trading at $7.57, down 18.39%.
Corcept's Lifyorli Combo Wins FDA Approval for Platinum-Resistant Ovarian CancerCorcept Therapeutics Inc. (CORT) secured FDA approval for Lifyorli (relacorilant) combined with nab-paclitaxel to treat adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior regimens, including Bevacizumab.
The approval is backed by the Phase 3 ROSELLA trial, in 381 patients and marks the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).
Corcept is also advancing relacorilant across multiple cancers and has submitted an MAA to the EMA.
CORT closed Thursday's trading at $38.53, down 4.79%.
Denali's AVLAYAH Secures FDA Accelerated Approval for Hunter SyndromeDenali Therapeutics Inc. (DNLI) received FDA accelerated approval for AVLAYAH (tividenofusp alfa-eknm), the first new Hunters syndrome treatment in nearly 20 years and the first biologic engineered to cross the blood-brain barrier.
AVLAYAH is approved for pediatric patients with neurologic manifestations of MPS II. The approval was based on Phase 1/2 data showing a 91% reduction in cerebrospinal fluid heparan sulfate, with most patients reaching near-normal biomarker levels.
Continued approval will depend on results from the ongoing Phase 2/3 COMPASS trial. Denali also received a Rare Pediatric Disease Priority Review Voucher. The therapy is not yet approved outside the U.S.
DNLI closed Thursday's trading at $19.74, down 12.17%.
AEON Gets FDA Supportive Feedback on ABP-450 Botox Biosimilar ProgramAEON Biopharma, Inc. (AEON) received constructive FDA feedback following its BPD Type 2a meeting for ABP-450, a proposed biosimilar to Botox (OnabotulinumtoxinA). The agency supported AEON's analytical similarity strategy and acknowledged challenges related to the 900 kDa neurotoxin complex, while agreeing that the company's methodologies are reasonable for advancing development.
AEON plans to complete most analytical comparability work in 2026 and will request a BPD Type 2b meeting to discuss next steps toward full-label biosimilar approval. The company holds exclusive rights for therapeutic indications across major global markets.
AEON closed Thursday's trading at $1.00, down 1.96%.
Sanofi: Japan Approved Dupixent for Bullous PemphigoidSanofi (SNY) and Regeneron (REGN) secured approval in Japan for Dupixent (dupilumab) to treat adults with moderate-to-severe bullous pemphigoid, making it the first targeted therapy for this painful autoimmune blistering disease.
The decision is supported by the Phase 2/3 LIBERTY-BP-ADEPT trial, in which patients receiving Dupixent were more than 4 times as likely to achieve sustained remission compared with placebo. Additionally, these patients were able to taper off steroids earlier, thereby reducing long-term exposure to immunosuppressants. Safety remained consistent with Dupixent's established profile.
This marks Dupixent's seventh indication in Japan, adding to its broad global footprint. The drug remains Sanofi's top growth driver, generating €15.7 billion in global sales in 2025, up 25% from €13.1 billion in 2024.
SNY closed Thursday's trading at $46.62, up 1.28%.
Galderma's Restylane Contour Gains FDA Approval for Temple HollowingGalderma (GDERF) has received expanded U.S. FDA approval for Restylane Contour to treat temple hollowing in adults over 21, adding to its existing indications in cheek augmentation and midface contouring.
The decision is supported by an 18-month multicentre study using a dual-layer injection technique, showing a 91% response rate at 3 months with results lasting up to 18 months and no serious treatment-related adverse events. Temple hollowing affects an estimated 40% of people by age 40.
Restylane is a key product in Galderma's aesthetics franchise, which generated $5.027 billion in 2025 net sales, up 17.7% from $4.410 billion, with Injectable Aesthetics contributing $2.572 billion, up 11.5% from $2.30 billion year-over-year.
GDERF closed Thursday's trading at $181.77, down 4.35%.
Deals
Merck To Acquire Terns For $6.7 Bln Merck (MRK) announced that it has entered into a definitive agreement to acquire California-based cancer biotech, Terns Pharmaceuticals (TERN), for $53.00 per share in cash or an estimated equity value of $6.7 billion.
The acquisition of Terns may help expand Merck's haematology presence with TERN-701, a potential treatment for certain patients with chronic myeloid leukaemia.
The transaction is expected to close in the second quarter of 2026.
MRK closed Thursday's trade at $118.93, down 0.37%.
Olaplex To Be Acquired By Henkel For $1.4 BillionOlaplex Holdings, Inc. (OLPX), a hair care brand, has entered into a definitive agreement to be acquired by Henkel AG & Co. KGaA for $2.06 per share in a cash transaction, representing an equity value of approximately $1.4 billion.
The transaction is expected to accelerate Olaplex's product innovation and broaden its global footprint.
Upon completion of the transaction, Olaplex will continue to operate under its name and brand but will no longer be listed on Nasdaq. Advent International, which has backed Olaplex since 2019, will fully exit its investment at closing.
Olaplex stockholders will receive $2.06 per share, representing a premium of about 55% over the company's closing price on March 25, 2026, and 45% over its 30-day volume-weighted average price.
The acquisition is expected to close in the second half of 2026.
OLPX closed Thursday's trade at $2.01, up 51.13%.
Pulmatrix And Eos SENOLYTIX Announce Merger To Advance Mitochondrial TherapiesPulmatrix Inc. (PULM) has agreed to merge with Eos SENOLYTIX, Inc and has entered into definitive agreements for concurrent private financings of $19 million in aggregate gross proceeds.
The net proceeds are expected to help advance Eos's lead candidate, PTC-2105, a mitochondrial-targeted geropeptide being developed for sarcopenia and sarcopenic obesity.
The combined company will operate as Eos SENOLYTIX, Inc. and is expected to trade on Nasdaq under the ticker 'EOSX'.
The merger is currently expected to close in mid-2026.
PLUM closed Thursday's trade at $1.51, down 28.77%.
Clinical Trials - Breakthroughs & Setbacks
Insmed Meets Primary Endpoint in Phase 3b ENCORE Data for ARIKAYCE in Lung Infection
Insmed Inc. (INSM) reported positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE in patients with on-cavitary lung disease and a newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who had not yet begun antibiotics.
The ENCORE trial assessed once-daily ARIKAYCE plus azithromycin and ethambutol versus placebo plus azithromycin and ethambutol over 12 months.
INSM closed Thursday's trade at $147.60, down 0.48%.
Valneva's Lyme Vaccine PF-07307405 Misses Key Goal In Phase 3 Trial Pfizer Inc. (PFE) and Valneva SE's Phase 3 VALOR study of investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V) missed the primary endpoint but demonstrated more than 70% efficacy.
Pfizer plans to move forward with regulatory submissions, citing the strong efficacy and safety profile. If approved, PF-07307405 would become the first human Lyme disease vaccine available in decades.
VALN closed Thursday's trade at $6.32, down 2.47%.
Karyopharm Reports Mixed Results in Phase 3 Data For Selinexor Combo In MyelofibrosisKaryopharm Therapeutics Inc. (KPTI) reported mixed topline results from its Phase 3 SENTRY trial of Selinexor in combination with Ruxolitinib in frontline myelofibrosis/ The trial met the first co-primary endpoint, demonstrating a statistically significant 35% reduction in spleen volume.
However, the second co-primary endpoint, the mean change in absolute total symptom score (Abs-TSS) at week 24 relative to baseline, was not met as the difference was not statistically significant.
Notably, the topline results suggest a promising signal in overall survival (OS) for the combination arm.
Karyopharm plans to meet with the FDA to discuss the data and potential sNDA filing.
KPTI closed Thursday's trade up 6.91% at $5.57.
Maze Therapeutics Reports Positive Phase 2 Data For MZE829 in Kidney DiseaseMaze Therapeutics Inc. (MAZE), a clinical-stage biopharmaceutical company, has announced positive topline data from its phase 2 trial of MZE829, an oral, small-molecule, dual-mechanism APOL1 inhibitor in patients with broad APOL1-mediated kidney disease (AKMD), dubbed HORIZON.
The results demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12 in broad AMKD patients, with 50% of patients achieving a greater than 30% reduction in uACR.
MZE829 was well tolerated across all doses, and no serious adverse events (AEs) or severe treatment-related adverse events (TRAEs) were reported, the company added.
Maze expects to continue enrollment in the HORIZON trial and to advance MZE829 into a pivotal program for AKMD.
MAZE closed Thursday's trade at $31.71, down 0.06%.
Triple-G Agonist UBT251 Lowers HbA1c By Up To 2.16% In Chinese Phase 2 Diabetes TrialThe United Laboratories International Holdings Ltd. (TUL) and Novo Nordisk A/S (NVO) have announced promising topline results from a phase 2 trial of investigational drug UBT251, a triple agonist targeting the GLP-1, GIP, and glucagon receptors (triple G) in Chinese patients with type 2 diabetes.
In the phase 2 trial conducted by United Biotechnology, once-weekly injectable doses of 2 mg, 4 mg, and 6 mg of UBT251 were compared with placebo and Semaglutide 1 mg in Chinese people with type 2 diabetes.
After 24 weeks of treatment, UBT251 achieved the highest mean reduction in HbA1c of 2.16%, compared with 1.77% for Semaglutide 1 mg and 0.66% for placebo. Over the same period, UBT251 also reduced body weight by up to 9.8%, versus 4.8% for Semaglutide 1 mg and 1.4% for placebo.
In addition, UBT251 also showed improvements over placebo on key secondary endpoints, including waist circumference, blood pressure, and lipid levels.
United Biotechnology is planning to initiate two phase 3 trials with UBT251 in Chinese patients with type 2 diabetes.
NVO closed Thursday's trade at $36.40, up 0.19%.
IMUNON's IMNN-001 Shows Continued Positivity In OVATION 2 Trial IMUNON Inc. (IMNN) reported an increase in median overall survival among women treated with IMNN-001 in the final clinical data from the Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy in women with newly diagnosed advanced ovarian cancer.
The median overall survival (OS) among women treated with IMNN-001 increased from the previously reported 11.1 months to 14.7 months following final data analysis.
In addition, patients treated with PARP inhibitor therapy, in combination with IMNN-001 and standard of care chemotherapy, demonstrated a median OS of 24.2 months.
The firm also noted that enrollment in the Phase 3 pivotal trial for IMNN-001 remains ahead of plan, driven by investor support.
IMNN closed Thursday's trade at $2.71, down 2.52%.
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