The biotech sector witnessed a few regulatory setbacks, Type B meetings that went well, noteworthy approvals, acquisitions, and clinical trials that met primary endpoints across key therapeutic areas, including achondroplasia, asthma, skin cancers, and actinic keratoses.
Let us unpack the key developments and milestones in the biotech space this week.
FDA Approvals & Rejections
Regenxbio Hit With FDA CRL for RGX-121 Gene Therapy BLA
REGENXBIO Inc. (RGNX) announced that the FDA has issued a Complete Response Letter (CRL) for its BLA for RGX-121, a one-time gene therapy candidate for MPS II. The agency cited issues including eligibility criteria for the neuronopathic population, comparability of the natural-history external control group, and the suitability of CSF HS D2S6 as a surrogate endpoint. Regenxbio plans to request a Type A meeting and provide additional expert evidence and longer-term clinical data to support a future resubmission.
RGNX closed Thursday's trading (February 12, 2026) at $8.35, down 1.76%.
BioRestorative Announced Positive Outcomes from Type B Meeting with FDA
BioRestorative Therapies, Inc. (BTRX) announced a positive outcome from its Type B meeting with the U.S. FDA regarding a potential accelerated BLA for its Fast-Track-Designated BRTX-100 program in chronic lumbar disc disease (cLDD). The FDA raised no safety concerns from the ongoing Phase 2 trial and endorsed the proposed Phase 3 study design, while also confirming alignment of chemistry, manufacturing and control activities.
BioRestorative has initiated Phase 3, enabling activities to submit the IND later in 2026.
BTRX closed Thursday's trading at $, up %.
Outlook Therapeutics Submits Type A Meeting Request to FDA Following CRL
Outlook Therapeutics, Inc. (OTLK) announced it has submitted a Type A request to the U.S. FDA after receiving a Complete Response Letter for its BLA for ONS-5010/LYTENAVA (bevacizumab-vikg), in the proposed indication of wet age-related macular degeneration. The CRL cited a lack of substantial evidence of effectiveness, and the company plans to use data from its NORSE TWO and NORSE EIGHT trials to address the concerns.LYTENAVA has already been approved in Europe and the UK, where it has been commercially available since June 2025. However, in the U.S. the therapy still remains investigational.
OTLK closed Thursday's trading at $0.44, down 6.05%.
Novocure Secures FDA Approval for Optune Pax in Pancreatic Cancer
Novocure (NVCR) received U.S. FDA approval for Optune Pax, a wearable Tumor Treating Fields (TTFields) device, for use with gemcitabine and nab-paclitaxel in adults with locally advanced pancreatic cancer. The decision was supported by the Phase 3 PANOVA-3 trial, which showed a significant overall survival benefit and delayed pain progression versus chemotherapy alone.
Optune Pax becomes Novocure's first FDA- approved therapy in this setting, with the device demonstrating a favorable safety profile marked mainly by mild-to-moderate skin reactions.
NVCR closed Thursday's trading at $12.53, up 19.33%.
Moderna Receives FDA Refusal-to-File Letter for mRNA-1010 Influenza Vaccine BLA
Moderna Inc (MRNA) said the FDA's Center for Biologics Evaluation and Research has issued a Refusal-to-File letter for its BLA for the investigational influenza vaccine mRNA-1010, citing concerns over the choice of a licensed standard-dose comparator and the lack of an adequate, well-controlled study reflecting the best available standard of care. Moderna has requested a Type A meeting to understand the basis for the decision and noted that the RTF does not affect its 2026 financial guidance. The company highlighted that mRNA-1010 met all primary endpoints in Phase 3 studies and is currently under review in the EU, Canada, and Australia, with potential approvals expected in late 2026 or early 2027.
MRNA closed Thursday's trading at $40.11, down 0.99%.
Median Technologies Secures FDA 510(k) Clearance for AI Lung Cancer Screening Software
Median Technologies SA (4ZG.F,ALMDT.PA) announced it has received FDA 510(k) clearance for eyonis LCS, its AI/ML-powered computer-aided detection and diagnosis software designed to support lung cancer screening. The company said the clearance marks a key step toward expanding access to AI-assisted screening in the U.S., with commercialization planned through direct enterprise sales, strategic distribution partnerships, and integration into existing clinical workflows. Median is also advancing its European regulatory pathway, with CE marking expected in the second quarter of 2026.
4ZG.F closed Thursday's trading at 6.10 Euros.
Deals
Onconetix To Acquire Realbotix Acquisition
Onconetix, Inc. (ONCO), a commercial-stage biotechnology company, has signed a definitive share exchange agreement to acquire Realbotix LLC, a U.S.-based developer of AI-powered humanoid robotics, in an all-stock transaction.
Realbotix, a wholly owned subsidiary of Realbotix Crop. (TSX-V: XBOT), designs and manufactures lifelike humanoid robots for customer-facing roles in healthcare, education, hospitality, and entertainment.
Upon closing, Realbotix parent will own between 75% and 90% of the fully diluted common shares of the combined company, depending on Onconetix's cash position.
The transaction is expected to close in the second half of 2026, subject to shareholder and regulatory approvals.
ONCO closed Thursday's trade at $1.06, down 42.70%.
BioSyent To Acquire Oral Science For $25.5 Mln
BioSyent Inc. (BIOYF,RX.V) has entered into a Share Purchase Agreement to acquire Oral Science Inc., a privately-owned Canadian dental company, for $25.5 million, in a share and cash deal. Under the terms of the agreement, BioSyent will acquire 100% shares of Oral Science for a $25.5 million, consisting of $22.5 million of cash and 0.23 million BioSyent shares at a price of at $12.81 per share.
This also includes a portion of the consideration shares subject to a two-year escrow, and the balance is subject to a two-year lock-up, with 25% of the locked-up shares released every six months. This purchase price is inclusive of a $6.3 million net working capital requirement on closing.
Oral Science will also be entitled to a contingent cash earn-out payment in 2027 based on the performance of the Oral Science business in 2025 and 2026, as well as contingent royalty payments until 2033 based on the future sales of one product up to a maximum value of $6.0 million.
The transaction is expected to close before the end of February 2026.
BioSyent's acquisition of Oral Science delivers substantial revenue growth and immediate diversification of the combined product portfolio, market segments, customer bases, and sales channels for long-term growth and value creation.
BIOYF closed Thursday's trade at $10.72, down 0.28%.
Clinical Trials - Breakthroughs
BridgeBio's Infigratinib Meets Primary Endpoint In Phase 3 Achondroplasia Trial
BridgeBio Pharma Inc. (BBIO) reported positive topline results from its Phase 3 PROPEL 3 study evaluating oral infigratinib in children with achondroplasia, a genetic bone growth disorder and the most common form of dwarfism.
PROPEL 3 is a one-year pivotal trial that enrolled children aged 3 to less than 18 years with open growth plates.
The study met its primary endpoint, demonstrating a statistically significant improvement in annualized height velocity (AHV) at Week 52 compared with placebo.
BridgeBio plans to submit a New Drug Application (NDA) and Marketing Authorization Application (MAA) for achondroplasia in the second half of 2026.
BBIO closed Thursday's trade at $76.06, up 3.72%.
Bioxytran's ProLectin-M Achieves 100% Viral Clearance In Phase 2 Trial
Bioxytran Inc. (BIXT) announced positive Phase 2 results for its lead candidate, ProLectin-M, showing complete elimination of viral load in 100% of participants at day 7 compared to placebo.
The Phase 2 trial's key findings include complete viral clearance in all treated subjects by day 7 versus placebo, no viral rebounds observed during the 14-day post-treatment observation period and early clearance observed in some subjects as early as day 3, with 16 of 38 cleared by day 5.
BIXT closed Thursday's trade at $0.04, at 3.03%
Upstream Bio's Phase 2 VALIANT Study Meets Primary Endpoint
Upstream Bio Inc. (UPB) announced that the Phase 2 VALIANT study of verekitug in adults with severe asthma met its primary endpoint.
Verekitug achieved statistically significant and clinically meaningful reductions in the annualized asthma exacerbation rate. The drug reduced exacerbations by 56% with 100 mg dosing every 12 weeks and by 39% with 400 mg dosing every 24 weeks, compared with placebo.
At week 60, verekitug also suppressed exhaled nitric oxide (FeNO) compared to placebo by 20.4 ppb when dosed at 100 mg q12w, and by 26.3 ppb when dosed at 400 mg q24w.
Verekitug was generally well tolerated across all active doses, demonstrating a favorable safety profile consistent with previous studies.
"We intend to rapidly advance verekitug into Phase 3 trials in severe asthma and CRSwNP", stated Rand Sutherland, CEO of Upstream Bio.
UPB closed Thursday's trading at $12.80
Phio Pharmaceuticals Reports Positive Safety Review Of PH-762 In Skin Cancer Trial
Phio Pharmaceuticals Corp. (PHIO) announced that the Safety Monitoring Committee (SMC) has completed its planned safety review of the company's lead clinical candidate, PH-762, in a Phase 1b trial for skin cancer.
The trial demonstrated 85% pathological response in the final cohort (6 of 7 patients), including complete response (100% tumor clearance) in 4 of 6 responders.
Among 20 patients with cutaneous squamous cell carcinoma,65% were classified as pathologic responders, including 9 complete responses, 2 near-complete responses (greater than 90% clearance), and 2 partial responses (greater than 50% clearance).
Notably, one patient with metastatic Merkel cell carcinoma achieved a partial response and no patients experienced disease progression.
An FDA submission to propose and seek guidance on future clinical study design is targeted for the second quarter of 2026.
PHIO closed Thursday's trade at $1.22, down 5.43%.
Evommune Reports Encouraging Phase 2a Results of EVO301 In Atopic Dermatitis
Evommune Inc. (EVMN) announced positive top-line data from its Phase 2a proof-of-concept trial of EVO301, with the study meeting its primary efficacy endpoint at Week 12 and demonstrating rapid, statistically significant improvements across multiple time points in adults with moderate-to-severe atopic dermatitis.
The trial used a Bayesian success criterion that measures the difference between active treatment and placebo in per cent improvement from baseline in the Eczema Area and Severity Index (EASI) as its primary endpoint.
While the threshold required at least 75% of the posterior distribution to show an 8% or greater improvement over placebo, EVO301 achieved 99.8%, far surpassing the requirement. Frequentist analysis also showed statistical significance at Weeks 4,8, and 12.
At Week 12, patients receiving EVO301 achieved a 33% placebo-adjusted reduction in EASI, and 23% reached vIGA-AD 0/1, compared with 0% in the placebo group.
EVMN closed Thursday's trade at $27.88, down 2.04%.
Nektar Therapeutics Announces Durable One-Year Results For Rezpegaldesleukin
Nektar Therapeutics (NKTR) reported new long-term results from its REZOLVE-AD Phase 2b study showing that Rezpegaldesleukin continued to deliver durable and new responses in patients with moderate-to-severe atopic dermatitis through 52 weeks of treatment.
The new data come from the 36-week maintenance period of the 52-week REZOLVE-AD trial, in which patients received either monthly (Q4W) or quarterly (Q12W) dosing of Rezpegaldesleukin.
The company reported that 71% and 83% of patients maintained EASI-75 responses and 85% and 63% maintained vIGA-AD 0/1 responses with 24 µg/kg monthly and quarterly dosing, respectively.
The company said it plans to advance Rezpegaldesleukin into Phase 3 studies with the intention to submit a BLA in 2029.
NKTR closed Thursday's trade at $71, up 7.05%
Zenas Meets Key Goal In Phase 2 MoonStone Trial Of Obexelimab In R/Multiple Sclerosis
Zenas BioPharma, Inc. (ZBIO), a clinical-stage global biopharmaceutical company, announced that its lead drug candidate Obexelimab met the primary endpoint of the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis or RMS.
Orelabrutinib is a selective central nervous system (CNS)-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor.
Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo.
Near-complete suppression of new GdE T1 hyperintense lesions, markers of active inflammation, was observed with obexelimab by 8 weeks of treatment and was sustained through week 12.
ZBIO closed Thursday's trade at $26.11, up 12.20%.
Biofrontera Reports Promising Phase 3 Results For Ameluz PDT In Actinic Keratoses
Biofrontera Inc. (BFRI) announced positive results from its Phase 3 clinical trial evaluating Ameluz photodynamic therapy (PDT) with RhodoLED red-light lamp for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, successfully meeting the study's primary endpoint.
The primary endpoint- subject complete clearance rate at 12 weeks after the last PDT session- showed highly statistically significant superiority for Ameluz PDT. In the Full Analysis Set (FAS), complete clearance was achieved in 45.6% of Ameluz-treated patients versus 16.7% for vehicle. Results were similarly strong in the per-protocol set (PPS), with clearance rates of 53.2% versus 22.2%.
Key secondary outcomes supporting the efficacy of Ameluz PDT included AK lesion clearance rates of 73.1% (FAS) and 80.3% (PPS).
Based on the positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application to the U.S. FDA in the third quarter of 2026.
BFRI closed Thursday's trade at $0.79, up 2.61%.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.