Benzinga | May 26, 2021 08:09AM EDT

Myovant Sciences, Sumitovant Report Clinical, Corporate Milestones During Co.'s Q4

-- Urovant became a wholly owned subsidiary of Sumitovant and announced the continuation of its Phase 2a study with novel gene therapy, URO-902 in OAB and urinary incontinence --

-- Myovant, a publicly listed company that is majority owned by Sumitovant, made key executive appointments and announced product and pipeline accomplishments including the commercial availability of its first FDA approved product, ORGOVYX(tm) (relugolix) for advanced prostate cancer, and positive Phase 3 trial results for relugolix in uterine fibroids and endometriosis --

LONDON and NEW YORK, May 26, 2021 /PRNewswire/ -- Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant Sciences (NYSE:MYOV), a publicly listed company that is majority owned by Sumitovant, achieved significant clinical and corporate milestones in the company's fourth quarter ending on March 31, 2021.



Sumitovant Biopharma Has a Strong Fourth Quarter Across its Portfolio of Companies

"We were delighted to see tremendous strides across the Sumitovant portfolio of companies in the fourth quarter including progress across clinical development, regulatory and commercialization milestones. Significant corporate accomplishments included Urovant transitioning from publicly traded to a wholly owned subsidiary of Sumitovant Biopharma and the appointment of executives in key roles for two of our subsidiary companies," said Myrtle Potter, CEO of Sumitovant Biopharma. "In addition, progress was made in supporting health equity and access and formed collaborations to support educational and clinical initiatives. This was an exciting quarter and I'm proud of what we've accomplished."

CLINICAL HIGHLIGHTSMyovant Sciences (NYSE:MYOV), a majority-owned subsidiary

On March 29, the European Medicines Agency (EMA) validated Myovant Science's Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process. If approved, relugolix would be the first and only oral androgen deprivation therapy for advanced prostate cancer in Europe.

On March 24, Myovant Sciences and its partner, Pfizer, announced positive data from Phase 3 LIBERTY randomized withdrawal study of once-daily relugolix combination therapy in women with uterine fibroids.

On February 17, Myovant Sciences and Pfizer announced publication in the New England Journal of Medicine of Phase 3 LIBERTY studies of once-daily relugolix combination therapy in women with uterine fibroids.

On January 26, Myovant Sciences and its partner, Pfizer, announced positive one-year data from its Phase 3 SPIRIT extension study of once-daily relugolix combination therapy in women with endometriosis

Urovant Sciences

On February 11, Urovant Sciences announced the continuation of a Phase 2a trial with URO-902, a novel gene therapy product in patients with overactive bladder and urinary incontinence following a positive recommendation from the study's Data and Safety Monitoring Board.

Altavant Sciences

On February 18, Altavant Sciences announced initiation of a chemical lung injury program in collaboration with BARDA and NIAID. The in vivo nonclinical proof-of-concept pilot study will evaluate ALTA-2350, a novel inhaled formulation of a recombinant IL-1Ra for the treatment of acute and chronic lung injuries

Corporate Highlights

Myovant Sciences

On March 23, Myovant Sciences announced recipients of "Forward for Health Equity" grants to improve healthcare access in prostate cancer and uterine fibroids.

On February 16, Myovant Sciences and HealthyWomen, the nation's leading independent, nonprofit health information source for women, launched "Voices of Periods", an educational campaign to fight menstrual stigma.

On January 5, Myovant Sciences announced the U.S. availability of ORGOVYX(tm) (relugolix) for the treatment of advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. More information about ORGOYYX, including the full product prescribing information, can be found here.

On January 4, Myovant Sciences announced the appointment of industry veteran David Marek as its new Chief Executive Officer and as a member of its board of directors.

Urovant Sciences

On February 12, Urovant announced that the Urovant Board authorized and approved the definitive merger agreement in which Sumitovant Biopharma would acquire all outstanding shares of Urovant that are not held by Sumitovant Biopharma.

On March 23, Urovant shareholders voted to approve the definitive merger agreement with Sumitovant Biopharma by an affirmative vote of holders of a majority of Urovant's outstanding shares, and by holders of a majority of Urovant's outstanding shares that were not held by Sumitovant Biopharma.

On March 29, Urovant and Sumitovant Biopharma jointly announced the completion of the merger in which Sumitovant acquired all outstanding shares of Urovant. Urovant became a wholly owned subsidiary of Sumitovant Biopharma and Urovant's stock ceased trading on the Nasdaq stock market.

Spirovant Sciences

On January 26, Spirovant Sciences announced that the leasing of new and expanded headquarters and laboratories in Philadelphia's University City and that the company expanded its leadership team with the appointments of Eric Pastor as Senior Vice President of Technology Development and Operations and Maria Limberis, PhD, as Vice President of Research.