Shares of Viridian Therapeutics Inc. (NASDAQ:VRDN) were trading at $18.12, down $9.28, or 33%, after disclosing top-line data from the elegrobart Reveal-1 phase III trial in active thyroid eye disease. A subcutaneously delivered, half-life-extended monoclonal antibody (mAb) targeting the insulin-like growth factor-1 receptor (IGF-1R), elegrobart was tested at two dosing regimens, every four weeks and every eight weeks vs. placebo. Wall Street was stacking the compound against Waltham, Mass.-based Viridian’s other IGF-1R prospect veligrotug, given intravenously, as well as Amgen Inc.’s infused IGF-1R mAb Tepezza (teprotumumab), first approved by the U.S. FDA in January 2020.
United’s Tyvaso nails endpoints in second phase III IPF trial
United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027. Tyvaso, delivered as a nebulized inhalation solution, showed superiority over placebo in the change of absolute forced vital capacity by 130.1 mL and reduced the risk of clinical worsening in patients with IPF, while the safety results showed treatment with the prostacyclin mimetic to be well-tolerated.
Boston Sci boasts Champion-AF data but strokes signal a concern
Boston Scientific Corp. revealed much-anticipated data from the Champion-AF trial, which showed that its Watchman FLX device provides superior protection from bleeding compared to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation. The left atrial appendage closure device also proved noninferior to NOACs in reducing stroke, cardiovascular death, or systemic embolism.
Lilly taps Insilico AI in $2.75B deal to expand pipeline options
Eli Lilly and Co. is deepening its investment in AI-driven drug discovery through a multibillion-dollar expansion of its collaboration with Hong-Kong listed Insilico Medicine Inc. in a move that could broaden its reach into next-generation metabolic therapies. Under the deal terms, Insilico is eligible to receive $115 million up front, plus development, regulatory, and commercial milestone payments worth $2.75 billion, in addition to sales-based royalties. In exchange, Lilly gains exclusive global rights to develop and commercialize multiple candidates generated using Insilico’s AI platform, including preclinical oral therapies. While neither company has disclosed specific targets, the partnership sits at the intersection of Lilly’s expanding metabolic franchise and Insilico’s growing pipeline of AI-designed small molecules.
US FDA pondering next steps for CNPV
Introduced last year as a U.S. FDA pilot program, the Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV in June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway” for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency. So far, the program has yielded four approvals, all supplementary applications, including two for cancer drugs delivered 44 and 55 days after the applications were filed. Looking to improve the program, the FDA is seeking feedback through written comments and a public hearing.
AAD 2026: Targeted oral therapies challenge injected biologics
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment. Leading this charge is Protagonist Therapeutics Inc. and partner Johnson & Johnson’s oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, which won FDA approval for treating moderate to severe plaque psoriasis earlier this month.
Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal
Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. Under the terms announced March 27, Otsuka’s San Francisco-based subsidiary, Otsuka America Inc., will pay $700 million up front to Transcend shareholders at closing, expected in the second quarter of 2026. New York-based Transcend is also eligible to receive up to $525 million in future sales-based milestone payments. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.
Also in the news
Abcuro, Anaptys, Apogee, ARS, Astrazeneca, Bavarian Nordic, Beyond Air, Bioretec, Crinetics, CVC, Dizal, Eisai, Eos Senolytix, Esobiotec, First Tracks Biotherapeutics, Galapagos, GE Healthcare, GSK, Innate, Irenic, Johnson & Johnson, Eli Lilly, Long Bridge Medical, Medtronic, Novo Nordisk, Nuvation Bio, Onkure, Organon, OS Therapies, Pharming Group, Precision Optics, Pulmatrix, Recordati, Rocket, Sanofi, Sensus Healthcare, Siga, Skincure Oncology, Sonorous, Stanford Radiology, Teleflex, UCB, Vor, Xaira, Ysios Capital, Zenas