Analysts were sounding pleased and the company intends to go ahead with a regulatory filing, but investors seem to have wanted more from Viridian Therapeutics Inc.’s top-line data from the elegrobart (formerly VRDN-003) Reveal-1 phase III trial in active thyroid eye disease (TED). Viridian shares (NASDAQ:VRDN) closed March 30 at $18.53, down $8.86, or 32%.
Following a May phase II readout and a recent presentation of Tourmaline Bio Inc.’s long-acting anti-IL-6 IgG2 monoclonal antibody, pacibekitug, for atherosclerotic cardiovascular disease (ASCVD), Novartis AG offered $1.4 billion, or $48 per share, to buy the barely 4-year-old company. Previously shelved by Pfizer Inc., which had been developing it for autoimmune disorders, pacibekitug fell into the hands of New York-based Tourmaline through a May 2022 license agreement. In addition to the Tranquility phase II trial in ASCVD, the company’s lead product is also in the phase IIb Spirited trial for thyroid eye disease, a readout for which is expected in early 2026.
Graves disease (GD)-associated hyperthyroidism is an autoimmune disorder characterized by the presence of autoantibodies that stimulate the thyroid-stimulating hormone receptor (TSHR), leading to excessive production of thyroid hormones.
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
Day two of the J.P Morgan Healthcare Conference rolled on with positive data from Sling Therapeutics Inc. that is leading the company to a phase III study in treating thyroid eye disease. The privately held company posted top-line efficacy and safety results from a phase IIb/III study of its lead candidate, linsitinib, which hits its primary endpoint with statistical significance at the twice-daily, 150-mg oral dose.
Implications for Amgen Inc.’s same-class Tepezza (teprotumumab) of positive phase III data from Viridian Therapeutics Inc. with veligrotug in thyroid eye disease became a topic of talk on Wall Street talk. “I’m not drawing any clinical trial comparisons, you’ll have to reach your own conclusions,” CEO Steve Mahoney said during a conference call on the results.
With favorable data from the phase III trial testing izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS), Acelyrin Inc. CEO Mina Kim said the firm will “look at all the options and do what’s best for the program.” The phase III trial hit its primary endpoint of Hidradenitis Suppurativa Clinical Response 75 at 12 weeks. At the same time, the Los Angeles-based firm made known a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend its cash runway.
