Sumitovant Biopharma Portfolio Delivers Major Wins Across Clinical and Commercial Fronts in Q4 2021

Sumitovant Biopharma, the global biopharmaceutical powerhouse operating through five subsidiary entities, marked its fourth quarter (ending March 31, 2021) with a flurry of regulatory approvals, clinical breakthroughs, and strategic corporate moves. The portfolio of companies—Myovant Sciences (NYSE: MYOV), Urovant Sciences, Altavant Sciences, Spirovant Sciences, and Enzyvant—collectively advanced several promising therapeutic candidates while reshaping their corporate structure.

Myovant Sciences Charts Path Forward in Women’s and Men’s Health

The standout performer across the Sumitovant Biopharma portfolio has been Myovant Sciences, which secured multiple regulatory and commercial victories. Most notably, the company’s flagship product ORGOVYX™ (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, became commercially available in the U.S. market in January 2021. This launch represented a historic moment—relugolix is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer treatment.

The momentum continued on the European front when the European Medicines Agency (EMA) officially validated Myovant’s Marketing Authorization Application (MAA) for relugolix in late March. This validation step confirms the submission meets completeness standards and signals the beginning of formal EMA review. If approved, relugolix would claim the same “first and only” distinction in Europe as it enjoys in the U.S.

Beyond prostate cancer, relugolix combination therapy demonstrated compelling clinical results in women’s health indications. During the quarter, Myovant and partner Pfizer released positive Phase 3 data from the LIBERTY randomized withdrawal study, examining relugolix combination therapy (40 mg relugolix, 1.0 mg estradiol, 0.5 mg norethindrone acetate) in uterine fibroids. This was followed by publication of Phase 3 LIBERTY trial results in the New England Journal of Medicine, solidifying the scientific evidence base. The company also presented positive one-year extension data from the SPIRIT study in endometriosis patients, further expanding relugolix’s potential patient population.

On the corporate side, Myovant appointed David Marek, an industry veteran, as Chief Executive Officer and board member in January. The company also launched “Voices of Periods” alongside HealthyWomen, a nonprofit health information organization, to combat menstrual stigma through educational initiatives. Additionally, Myovant announced “Forward for Health Equity” grants aimed at improving healthcare access for patients with prostate cancer and uterine fibroids.

Urovant Completes Strategic Transition to Wholly Owned Subsidiary

Urovant Sciences experienced a transformative corporate event during the quarter when Sumitovant Biopharma completed its full acquisition, transitioning Urovant from a publicly traded company to a wholly owned subsidiary. The merger process unfolded across three key dates: board approval in February, shareholder vote approval in March, and final completion on March 29, 2021. As a result of the transaction, Urovant’s stock ceased trading on the Nasdaq.

From a clinical standpoint, Urovant advanced its lead gene therapy candidate URO-902 into continued Phase 2a testing. The company announced that the study’s Data and Safety Monitoring Board provided a positive recommendation to proceed, enabling further evaluation in patients with overactive bladder (OAB) and urinary incontinence. This development builds on Urovant’s existing FDA-approved product, GEMTESA® (vibegron), which received approval in December 2020 as an oral, once-daily small molecule beta-3 agonist for OAB.

Altavant Launches Collaboration on Respiratory Disease Treatment

Altavant Sciences initiated a new collaborative program targeting chemical lung injury, partnering with BARDA (Biomedical Advanced Research and Development Authority) and NIAID (National Institute of Allergy and Infectious Diseases). The program centers on ALTA-2350, an inhaled formulation of recombinant interleukin-1 receptor antagonist (IL-1Ra) being evaluated through in vivo nonclinical proof-of-concept studies for acute and chronic lung injuries.

This initiative complements Altavant’s existing pipeline, which includes rodatristat ethyl, a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for pulmonary arterial hypertension, and ALTA-2530, an inhaled interleukin-1 receptor antagonist candidate for bronchiolitis obliterans syndrome (BOS), a severe form of chronic lung allograft dysfunction following lung transplantation.

Spirovant Expands Infrastructure and Leadership Team

Spirovant Sciences, the gene therapy company focused on cystic fibrosis and other respiratory diseases, made strategic investments in its operational capacity during the quarter. The company leased new and expanded headquarters and laboratory facilities in Philadelphia’s University City and strengthened its leadership bench by appointing Eric Pastor as Senior Vice President of Technology Development and Operations, along with Maria Limberis, PhD, as Vice President of Research.

The Bigger Picture for Sumitovant Biopharma

The quarter’s achievements underscore the Sumitovant Biopharma model: operating a diversified portfolio of focused biopharmaceutical companies, each targeting unmet medical needs across distinct therapeutic areas. With offices in New York and London, Sumitovant Biopharma itself operates as a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., one of Japan’s top ten pharmaceutical companies with a global footprint spanning Japan, the U.S., China, and the European Union.

As Myrtle Potter, CEO of Sumitovant Biopharma, noted, the quarter reflected “tremendous strides” including clinical advancement, regulatory progress, commercialization success, and corporate accomplishments. Looking forward, the portfolio’s combination of approved products (ORGOVYX, GEMTESA), late-stage candidates (relugolix combination therapy), and early-stage investigational medicines positions Sumitovant Biopharma for continued clinical and commercial momentum across multiple disease areas targeting significant unmet patient needs.