Weekly Buzz : NRXP Sets The Path For NRX - 100 NDA ; IRON Gets FDA CRL ; TOVX Licenses SYN - 020

finanznachrichten.de · Feb 20, 2026 · Collected from GDELT

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NEW BRUNSWICK (dpa-AFX) - The biotech space this week witnessed significant key milestones, including FDA approvals, NDA path-setting meetings, rejections, licensing agreements, and oncology drug acquisitions. The clinical trial arena achieved positive results in therapeutic areas such as idiopathic nephrotic syndrome, age-related macular degeneration, ulcerative colitis, plaque psoriasis, obesity, autoimmune and inflammatory diseases.Let us unpack the key developments and milestones of this week.FDA Approvals & RejectionsNRx Pharmaceuticals Charts Approval Path for NRX-100 NRx Pharmaceuticals, Inc. (NRXP) has completed a Type C guidance meeting with the U.S. FDA related to NRX-100 (preservative-free ketamine). The FDA indicated that existing clinical trial data plus Real-World Evidence from over 65,000 patients could support an NDA under Fast Track Designation, with no additional nonclinical or bridging studies required. NRx plans to seek a broader indication in treatment-resistant depression with suicidality and will finalize its Real-World Evidence analysis protocol in the coming weeks. The meeting included input from Osmind, Inc., Psychiatry Products, and leadership of FDA's CDER and OSMID. NRXP closed Thursday's (February 19, 2026) trading at $1.84, up 3.66%. Kane Biotech Secures FDA Clearance for Revyve CleanserKane Biotech Inc. (KNBIF) announced that the U.S. FDA has granted 510(k) clearance for its Revyve Antimicrobial Skin and Wound Cleanser, supporting its use across a broad range of acute and chronic dermal lesions. The clearance reinforces the reyvye platform's ability to target wound bacteria and biofilms, with manufacturing scale-up and technology transfer planned for later in 2026. The company also expanded its ISO certification under MDSAP to include distribution and wound cleaners, aligning with the FDA's new Quality Management System Regulation. The revyve product line-including the Antimicrobial Wound Gel and Wound Gel Spray- is already FDA-cleared and approved by Health Canada. KNBIF closed Thursday's trading at $0.02, down 1.69%. Johnson & Johnson Gains FDA Nod for Monthly RYBREVANT FASPRO DosingThe FDA has approved Johnson & Johnson's (JNJ) simplified monthly dosing schedule for RYBREVANT FASPRO or amivantamab and hyaluronidase-lpuj, allowing patients to transition to monthly dosing as early as week 5. The company noted that when combined with oral LAZCLUZE for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer, the monthly regimen delivers consistent outcomes with the previously approved bi-weekly subcutaneous schedule. JNJ closed Thursday's trading at $246.91, up 0.78%. Spruce Biosciences Reports Positive FDA Type B Meetings on TA-ERTSpruce Biosciences Inc. (SPRB) announced positive feedback from two FDA Type B meetings supporting its planned BLA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo syndrome type B. The agency indicated that integrated clinical and natural-history data may support accelerated approval using CSF HS- NRE as a reasonably likely surrogate endpoint and outlined CMC requirements ahead of a targeted fourth-quarter 2026 filing. SPRB closed Thursday's trading at $52.62, down 1.61%. Moderna Says FDA Will Initiate Review of Its Seasonal Influenza Vaccine SubmissionModerna, Inc. (MRNA) announced that the U.S. FDA has agreed to initiate the review of its BLA for mRNA-1010, the company's investigational seasonal influenza vaccine, following a recent Type A meeting. The agency had previously issued a Refusal-to-File letter, but Moderna resubmitted an amended application seeking full approval for adults 50-64 and accelerated approval for adults 65 and older, along with a post-marketing study requirement. The FDA has now accepted the filing and set a PDUFA date of August 5, 2026, with potential U.S. availability for the 2026/2027 flu season. Moderna added that mRNA-1010 is also under review in Europe, Canada, and Australia. MRNA closed Thursday's trading at $49.70, up 6.65%. Disc Medicine Receives CRL for Bitopertin in EPPDisc Medicine, Inc. (IRON) announced receipt of a Complete Response Letter (CRL) from the U.S. FDA for its NDA seeking accelerated approval of Biopertin for erythropoietic protoporphyria (EPP). While the agency acknowledged Biopertin's ability to lower PPIX levels and supported the biomarker's mechanistic rationale, it cited insufficient correlation with sunlight exposure endpoints. Disc plans to submit results from the ongoing Phase 3 APOLLO trial, with topline data expected in Q4 2026, and will request a Type A meeting to discuss next steps toward traditional approval. IRON closed Thursday's trading at $63.35, down 1.75%. AbbVie Wins FDA Approval for VENCLEXTA and Acalabrutinib in CLLAbbVie Inc. (ABBV) and Genetech, a member of Roche Holding AG (RHHBY), announced FDA approval of the combination regimen of VENCLEXTA (venetoclax) and Acalabrutinib for previously untreated patients with chronic lymphocytic leukemia (CLL). The approval was supported by results from the Phase III AMPLIFY study, which showed the regimen reduced the risk of disease progression or death by 35% compared with standard chemoimmunotherapy. VENCLEXTA is already approved across CLL, SLL, and AML indications, and the new frontline approval expands its reach as a chemotherapy-free option. The companies jointly commercialize VENCLEXTA in the U.S., with AbbVie marketing the therapy outside the U.S. ABBV closed Thursday's trading at $224.35, down 1.91%. DealsTheriva Licenses SYN-020 To Rasayana For Multiple IndicationsTheriva Biologics, Inc. (TOVX), a clinical-stage company, has entered into an exclusive worldwide license agreement with Rasayana Therapeutics for the development and commercialisation of SYN-020, an oral recombinant intestinal alkaline phosphatase enzyme. SYN-020 is designed to restore intestinal barrier function and reduce systemic inflammation by targeting gut-organ axis biology.Under the terms of the deal, Theriva received a $3 million upfront payment and is eligible for up to $38M in development, regulatory, and sales milestones along with tiered single-digit royalties on net product sales. Rasayana will assume full responsibility and costs for advancing SYN-020 through clinical development and commercialisation. TOVX closed Thursday's trading at $0.19, up at 2.45%. Sensei Acquires Faeth TherapeuticsSensei Biotherapeutics, Inc. (SNSE), a clinical-stage oncology firm, announced it has acquired Faeth Therapeutics Inc., a clinical-stage biotechnology company developing multi-node therapies that target tumour metabolism and signalling. The deal brings Faeth's lead asset, PIKTOR- an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway- into Sensei's portfolio, expanding its development focus across endometrial and breast cancer. Concurrently, Sensei announced a concurrent private placement of $200 million, and intend to use the gross proceeds primarily to advance the acquired PIKTOR through key clinical milestones, including topline data from an ongoing Phase 2 trial in second-line advanced endometrial cancer, as well as the initiation of a Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026. SNSE closed Thursday's trading at $27.22, up 3.70%. Clinical Trials - BreakthroughsEli Lilly's Taltz-Zepbound Shows Positive Results In Psoriasis and ObesityEli Lilly and Co. (LLY) announced positive topline results from the TOGETHER-PsO open-label Phase 3b clinical trial evaluating the concomitant use of Taltz and Zepbound compared to Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight. At 36 weeks, treatment with Taltz and Zepbound met the primary and all key secondary endpoints, delivering superior skin clearance and weight loss versus Taltz monotherapy. In the study, 27.1% of participants receiving Taltz and Zepbound reached complete skin clearance or PASI 100 and at least 10% weight loss, compared to 5.8% of patients treated with Taltz alone.In a key secondary endpoint, Taltz plus Zepbound delivered a 40% relative increase over Taltz monotherapy in the proportion of patients who achieved PASI 100, demonstrating that treatment of obesity or overweight with Zepbound reduced the burden of psoriasis. LLY closed Thursday's trading at $1023.22, up 0.26% Zealand Pharma Reports Positive Phase 1a Results For Kv1.3 Channel Blocker ZP9830Zealand Pharma A/S (ZEAL) reported positive topline results from its Phase 1a clinical trial of ZP9830, which is a Kv1.3 channel blocker for autoimmune and inflammatory diseases. The first-in-human single ascending dose (SAD) part of the combined SAD/multiple ascending dose (MAD) Phase 1a trial was conducted in healthy male participants to investigate the effects of single ascending doses of ZP9830 administered subcutaneously across a wide dose range, as well as intravenously at one dose level. The study met its primary endpoint, demonstrating safety and tolerability in healthy volunteers. Secondary endpoints also confirmed target engagement, supporting further development of the candidate. In addition, results showed dose-dependent target engagement with no serious adverse events reported. Zealand Pharma expects Phase 1a multiple ascending dose data and Phase 1b/2a initiation in H2 2026. ZEAL.CO closed Thursday's trade at $382.80 DKK, down 0.25%. Novartis' Phase 3 Trial of Remibrutinib Meets Primary Endpoint In Chronic Inducible UrticariaNovartis AG (NVS, NOVN.SW), a healthcare firm, announced positive results from a phase 3 trial of its oral drug, Remibrutinib, in chronic inducible urticaria. Remibrutinib is a selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling. In the phase 3 trial, dubbed RemIND, Remibrutinib achieved significantly higher complete response rates than placebo at Week 12, i.e., the primary endpoint for the s