--- title: "Weekly Buzz: FDA Okays Saphnelo Pen, EC Clears Acromegaly Drug, SNGX Slumps, LGND Snaps Up XOMA" type: "News" locale: "en" url: "https://longbridge.com/en/news/284786732.md" description: "This week's biotech news highlights significant regulatory approvals and acquisitions. Crinetics received EU approval for PALSONIFY for acromegaly, while Novartis' Rhapsido was approved for chronic spontaneous urticaria. AstraZeneca's Saphnelo Pen was cleared by the FDA for lupus treatment. Teva acquired Emalex Biosciences for $700 million, and Ligand Pharmaceuticals is set to acquire XOMA Royalty for $739 million. However, Soligenix halted its Phase 3 trial for HyBryte due to futility, while Biomea reported positive results for Icovamenib in Type 1 diabetes." datetime: "2026-04-30T13:54:03.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/284786732.md) - [en](https://longbridge.com/en/news/284786732.md) - [zh-HK](https://longbridge.com/zh-HK/news/284786732.md) --- # Weekly Buzz: FDA Okays Saphnelo Pen, EC Clears Acromegaly Drug, SNGX Slumps, LGND Snaps Up XOMA Add as your preferred news source on Google Add Now This week's biotech landscape witnessed regulatory approvals in the US and Europe, acquisitions, and a few trial halts, alongside positive data readouts spanning multiple therapeutic areas, including Type 1 Diabetes, Male Pattern Hair Loss, and Hereditary angioedema. Let's unpack the specifics. **FDA and EU Approvals & Rejections** **Crinetics - EC Clears PALSONIFY for Acromegaly** Crinetics Pharmaceuticals, Inc. (CRNX) received European Commission approval for PALSONIFY to treat adults with acromegaly, expanding its reach beyond last year's U.S. approval. The decision covers all 27 EU member states and three EEA countries, supported by positive data from the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials. PALSONIFY becomes the first once-daily oral therapy approved for the treatment of acromegaly in Europe. **CRNX** closed Wednesday's trading (April 29, 2026) at $38.44, up 0.76%. **NVS Receives EC Approval for Rhapsido in CSU** Novartis (NVS) has received European Commission approval for Rhapsido (remibrutinib) to treat adults with chronic spontaneous urticaria (CSU) who remain symptomatic on H1-antihistamines. The decision follows FDA approval last year and positive Phase 3 REMIX-1 and REMIX-2 data showing significant reductions in itch, hives and urticaria activity. Rhapsido becomes the first BTK inhibitor approved for CSU in Europe. **NVS** closed Wednesday's trading at $142.94, down 1.76%. **FDA Clears AstraZeneca's Saphnelo Autoinjector for SLE** AstraZeneca (AZN) received FDA approval for the Saphnelo Pen, allowing once-weekly self-administration of Saphnelo for adults with systemic lupus erythematosus on standard therapy. The decision is backed by the Phase III TULIP-SC trial and follows prior approvals for subcutaneous dosing in the EU and Japan. Under its updated agreement, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty on U.S. sales. **AZN** closed Wednesday's trading at $185.20, down 0.79%. **Deals** **Teva Acquires Emalex Biosciences, Expands Neuroscience Pipeline** Teva Pharmaceuticals Industries Ltd. (TEVA) has agreed to acquire Emalex Bioscience, a clinical-stage biopharmaceutical company focused on central nervous system disorders, for a $700 million cash deal. Emulex's lead investigational candidate, Ecopipam, is for paediatric Tourette syndrome. An NDA submission for Ecopipam is anticipated in the second half of 2026. **TEVA** closed Wednesday's trade at $35.38, up 11.89%. **Ligand To Acquire XOMA Royalty** Ligand Pharmaceuticals Inc. (LGND) has agreed to acquire XOMA Royalty Corporation (XOMA) for $39.00 per share in cash, valuing the transaction at approximately $739 million. The acquisition adds more than 120 commercial, clinical, and preclinical assets to Lignad's portfolio, including seven marketed products. XOMA Royalty stockholders will also receive a non-transferable Contingent Value Right (CVR) tied to 75% of potential net proceeds from certain pending litigation. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions. **LGND** closed Wednesday's trade at $224.86, down 3.21%. **Lilly Acquires Ajax Therapeutics** Eli Lilly and Company (LLY) has agreed to acquire Ajax Therapeutics, Inc., a clinical-stage biotech developing next-generation JAK2 inhibitors, for up to $2.3 billion, including an upfront payment and milestone-based payments tied to clinical and regulatory achievements. The acquisition aims to strengthen Lilly's position in blood cancers and accelerate the development of Ajax's lead candidate, AJ1-11095. **LLY** closed Wednesday's trade at $851.21, down 2.61%. **Clinical Trials - Breakthroughs & Setbacks** **Soligenix Halts Phase 3 FLASH2 HyBryte Trial In CTCL After Futility Analysis** Soligenix, Inc. (SNGX), announced that the Data Monitoring Committee, after the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial evaluating its lead investigational product, HyBryte (Synthetic Hypericin), for the treatment of cutaneous T-cell lymphoma, recommended halting the trial due to futility. Soligenix will determine the reasons for the study not meeting expectations and, if further analysis of the dataset provides clarity, may communicate its findings and explore follow-up discussions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). **SNGX** closed Wednesday's trade at $0.33, down 19.70%. **Biomea Unveils Positive 52-Week Data From Phase 2 COVALENT-112 Trial Of Icovamenib In T1 Diabetes** Biomea Fusion, Inc. (BMEA), announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating Icovamenib, an orally administered investigational small molecule, in patients with type 1 diabetes (T1D). The key findings of the trial include that in patients diagnosed within 0-3 years, treatment with Icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 and was generally safe and well-tolerated. **BMEA** closed Wednesday's trade at $1.45, down 5.23%. **Compass Therapeutics' Tovecimig Misses Overall Survival Secondary Endpoint In Biliary Tract Cancer Trial** Compass Therapeutics Inc. (CMPX) reported that its investigational antibody Tovecimig achieved a highly statistically significant improvement in progression-free survival (PFS) in the COMPANION-002 Phase 2/3 study in biliary tract cancer, but the Overall survival (OS) did not reach statistical significance. This is because 54% of control-arm patients crossed over to receive Tovecimig after progression. These crossover patients had a median OS of 12.8 months, compared with 6.1 months for those who remained on paclitaxel alone. Tovecimig was generally well tolerated, with no new safety signals observed. **CMPX** closed Wednesday's trade at $1.67, down 9.24%. **Veradermics' VDPHL01 Shows Robust Hair Growth In Male Pattern Hair Loss Trial** Veradermics, Incorporated (MANE), reported positive topline results from the Phase 2/3 trial of VDPHL01, an oral minoxidil formulation for the treatment of male pattern hair loss. VDPHL01 met all primary endpoints, showing clinically meaningful and statistically significant increases in non-vellus Target Area Hair Count (TAHC), and a patient-reported outcome (PRO) of 'improved' or 'much improved' on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. VDPHL01 showed a robust increase in hair count and was generally well tolerated, with no adverse effects reported. **MANE** closed Wednesday's trade at $106.55, up 3.35%. **Intellia Therapeutics Reports Positive Phase 3 Results For HAE Gene Therapy** Intellia Therapeutics, Inc. (NTLA) reported positive topline results from its Phase 3 HAELO trial of Lonvo-z, a CRISPR-based gene-editing therapy for Hereditary angioedema (HAE), with the study meeting its primary endpoint. Results showed a one-time infusion of lonvo-z cut attack rates by 87% versus placebo over six months, with monthly attacks averaging 0.26 compared with 2.10 in the placebo group. Lonvo-z demonstrated a favourable safety profile, with all reported adverse events being mild to moderate. **NTLA** closed Wednesday's trading at $12.45, down 5.72%. **Oruka's ORKA-001 Shows Positive Signs in Phase 2a EVERLAST-A trial for Mid-Stage Psoriasis** Oruka Therapeutics, Inc. (ORKA) reported positive interim results from its Phase 2a EVERLAST-A trial of ORKA-001, an investigational monoclonal antibody in moderate-to-severe plaque psoriasis. In the study, 63.5% of patients treated with ORKA-001 achieved PASI 100 at Week 16, indicating complete skin clearance, with similar results seen on the Investigator's Global Assessment (IGA 0). Further, ORKA-001 was well tolerated, with no serious treatment-emergent adverse events reported. **ORKA** closed Wednesday's trade at $68.10, down 7.96%. 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