<div id="readability-page-1"><div id="ctl00_CPI_dvBody"><div><div>Add <img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png"/> as your preferred news source on Google<div><img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png"/> Add Now</div></div></div> Despite the typical year-end slowdown, the week saw a steady stream of high-impact news, highlighted by global approvals, clinical trial readouts, new product launches, and strategic buyouts.-- ARS Pharma's neffy, an emergency treatment for allergic reactions, received regulatory approval in China, while Vanda's NEREUS secured FDA approval in the United States. -- FONAR Corp., the inventor of MR Scanning, is set to be taken private by its CEO-LED group. -- New analyses from InflaRx's halted phase 3 Vilobelimab trial have indicated potential efficacy signals and improved outcomes with longer treatment in pyoderma gangrenosum.-- SELLAS reported findings from its pivotal phase 3 REGAL trial that suggest a meaningful probability of a positive outcome, while Ultragenyx and Genmab disappointed investors with late-stage clinical and development setbacks.Let us unpack the specifics. FDA Approvals &amp; Rejections ARS Pharma's neffy Wins Approval in China for Emergency Allergy Treatment ARS Pharmaceuticals Inc. (SPRY) has received approval from China's NMPA for neffy, the first and only needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions in adults and children weighing at least 30 kg. Pediatrix Therapeutics, which holds marketing rights in China for the product, expects commercial availability in spring 2026. Neffy is already approved in other countries like the U.S., the U.K. E.U., Japan and Australia. The product generated $31.3 million in U.S. product revenue in the third quarter of 2025, reflecting early market adoption.SPRY closed Wednesday's (Dec.31, 2025) trading at $11.65, up 0.09 %.Vanda Pharma Gains FDA Nod for NEREUS to Prevent Motion-Induced Vomiting <div>Vanda Pharmaceuticals Inc. (VNDA) received FDA approval for NEREUS (tradipitant), an oral NK-1 receptor antagonist, to prevent motion-induced vomiting. This marks the first new pharmacologic treatment for motion sickness in over forty years. The approval was supported by pivotal Phase 3 clinical trials conducted in real-world motion settings, where NEREUS consistently demonstrated a meaningful reduction in vomiting compared to placebo and showed a favourable safety profile. </div>Vanda plans to launch NEREUS soon and is also exploring the drug for gastroparesis and GLP-1-induced nausea. VNDA closed Wednesday's trading at $8.82, up 25.46%. Outlook Therapeutics Faces FDA Setback on ONS-5010 for Wet AMD <div>Outlook Therapeutics Inc. (OTLK) received a Complete Response Letter (CRL) from the U.S. FDA for its resubmitted BLA, seeking approval of INS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD. The agency said the additional mechanistic and natural-history data did not change its prior conclusion- that a single adequate and well-controlled study was insufficient to support approval- and again requested confirmatory evidence of efficacy, without specifying what type would be acceptable. </div>The resubmission was supported by the full NORSE clinical program, including the pivotal NORSE TWO trial and additional safety and efficacy data from NORSE EIGHT and other studies. Outlook Therapeutics maintains that the totality of evidence meets regulatory expectations and reiterated its commitment to pursuing a viable U.S. approval pathway. Meanwhile, the company continues expanding its commercial footprint in Europe, where LYTENAVA (bevacizumab gamma) already holds marketing authorization in the EU and UK and is available in Germany and the UK for the treatment of wet AMD. OTLK closed Wednesday's trading at $1.58, down 15.51 %.Corcept Receives FDA CRL for Relacorilant in Hypercortisolism Corcept Therapeutics Inc. (CORT) received a Complete Response Letter from the FDA for Relacorilant, proposed as a treatment for hypertension secondary to hypercortisolism. The U.S. regulatory agency acknowledged that the pivotal GRACE trial met its primary endpoint and that the GRADIENT study provided supportive evidence, but said it could not reach a favourable benefit-risk assessment without additional proof of effectiveness. <div>Corcept said it was surprised by the decision and plans to meet with the FDA to determine the next steps. Relacorilant, a selective glucocorticoid receptor antagonist, is also being developed for multiple other indications. The FDA decision in the proposed indication of platinum-resistant ovarian cancer is due on July 11, 2026. </div>CORT closed Wednesday's trading at $34.80, down 50.42 %Deal or No Deal FONAR To Be Taken Private In CEO-Led Buyout FONAR Corporation (FONR), the inventor of MR Scanning, has agreed to be taken private by an acquisition group led by CEO Timothy Damadian. Under the definitive merger agreement, the buyer group will acquire all outstanding shares of FONAR for $19.00 per share in cash, valuing the transaction at a significant premium to recent trading levels. <div>The deal includes $19.00 per share for common and Class B stock, $6.34 per share for Class C stock, and $10.50 per share for Class A non-voting preferred shares. The transaction is expected to close in Q3 2026, subject to shareholder approval and customary conditions, and is not contingent on financing. Upon completion, FONAR will be delisted from the Nasdaq Stock Market. </div>FONR closed Wednesday's trading at trading at $18.56, down 0.22%. Clinical Trials - Breakthroughs &amp; Setbacks InflaRx Shows Efficacy Signals In Terminated Phase 3 Study Of Vilobelimab In Pyoderma Gangrenosum InflaRx N.V. (IFRX) released detailed analyses from its terminated Phase 3 trial of Vilobelimab in pyoderma gangrenosum, suggesting that longer treatment duration may improve outcomes in this difficult-to-treat patient population. InflaRx now plans to meet with the FDA to discuss possible alternative endpoints, and noted that future development in pyoderma gangrenosum would likely be pursued in collaboration with a partner, given its current focus on advancing its oral C5aR inhibitor, Izicopan (INF904). The study was stopped in May 2025 after an Independent Data Monitoring Committee recommended discontinuation for futility, and subsequent post-hoc analyses of the full dataset have revealed signals of efficacy that the company believes warrant further consideration. Also, InflaRx emphasised that the trial's early termination was based on interim data from the first 30 patients, which did not show sufficient efficacy signals at that stage. <div>IFRX closed Wednesday's trading at $1.01, down 0.98%. SELLAS Reports Continued Progress In Phase 3 REGAL Trial Of GPS In Acute Myeloid Leukaemia</div>SELLAS Life Sciences Group Inc. (SLS) reported that survival in its pivotal Phase 3 REGAL trial, evaluating Galinpepimut-S (GPS), is extending longer than anticipated, delaying the occurrence of the 80th event required to trigger the final overall survival analysis. GPS, a WT1-targeting immunotherapeutic, is being studied for its potential to extend survival in patients with acute myeloid leukaemia (AML) who have achieved a second complete remission. The company noted that longer-than-expected survival may increase the likelihood of a positive outcome, as highlighted by key opinion leaders at its recent R&amp;D event. SLS closed Wednesday's trading at $3.77, up 13.89%. Ultragenyx Tumbles As Phase 3 Setrusumab Trials In Brittle Bone Disease Fail Ultragenyx Pharmaceutical Inc. (RARE) announced that its Phase 3 Orbit and Cosmic studies evaluating Setrusumab in Osteogenesis Imperfecta failed to meet their primary endpoints. <div>In the Phase 3 portion of the Phase 2/3 Orbit study, setrusumab did not demonstrate a statistically significant benefit on the primary endpoint measuring the annualised clinical fracture rate. In addition, the Phase 3 Cosmic study also missed its primary goal to evaluate if setrusumab could reduce the annualised fracture rate in children aged 2 to under 7 years, compared with standard bisphosphonate treatment. </div>RARE closed Wednesday's trading at $23, up 0.97%. Genmab To Discontinue Clinical Development Of Acasunlimab To Focus On Priority Programs <div>Genmab A/S (GMAB) has decided to discontinue further clinical development of Acasunlimab, including its study in non-small cell lung cancer, to focus on programs with the highest potential impact, such as EPKINLY, petosemtamab, and rinatabart sesutecan. Acasunlimab was being evaluated in phase 3 trials for solid tumors, including metastatic non-small cell lung cancer (NSCLC).</div>This decision is expected to have no impact on Genmab's full-year 2025 financial guidance. GMAB closed Wednesday's trading at $30.80, down 2.19%. SoftOx Received Danish Medicines Agency's Nod For Phase 2a Trial Of Inhaled Antimicrobial Therapy <div>SoftOx Solutions AS (SOFTOX-ME.OL), on Monday, announced that the Danish Medicines Agency, or DMA, approved the company's clinical trial application for a combined Phase 2a dose-escalation and proof-of-concept study of its SoftOx Inhalation Solution. The combined study design represents a pivotal milestone in SoftOx's clinical program and marks the first human efficacy-oriented assessment of SoftOx Inhalation Solution (SIS) in a target patient population. </div>On Friday, SOFTOX-ME.OL was trading at 0.08 Norwegian Kroner, up 0.22%. Alphamab Oncology's JSKN033 Cleared for Phase 2 Cervical Cancer Trial by Chinese Regulatory Agency Alphamab Oncology (9966.HK) announced that its Investigational New Drug (IND) application for a phase II clinical trial of JSKN033 as a first-line therapy for advanced cervical cancer has been accepted by the Center for Drug Evaluation under China's National Medical Products Administration. 9966.HK closed Friday's trading at HK$9.58, down 2.24%. For comments and feedback contact: editorial@rttnews.comBusiness News</div></div>

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This week saw significant developments in the pharmaceutical sector, including ARS Pharma's neffy receiving regulatory approval in China for emergency allergy treatment, and Vanda's NEREUS gaining FDA approval for motion-induced vomiting. FONAR Corp. is set to be taken private by its CEO-led group. However, Outlook Therapeutics and Corcept faced FDA setbacks for their respective treatments. Overall, the week was marked by a mix of approvals, clinical trial results, and strategic corporate moves.

Weekly Buzz: ARS Pharma's Neffy Goes East, SLS Advances, A Signal Of Hope For IFRX?