Roivant Sciences (ROIV)

[MWM]

Very interesting. Full approval not far off?

Wonder how Tapinarof stacks up against standard of care?

https://www.dermavant.com/dermavant-announces-200-million-of-financing/

https://www.dermavant.com/dermavant-announces-fda-acceptance-for-filing-of-new-drug-application-nda-for-tapinarof-cream/

[aries4747]

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

- 58.2% of patients who entered the study with a PGA score ≥2 achieved a PGA score of 0 or 1-

- Long-term use of tapinarof cream provided improved and durable effects for up to 52 weeks and demonstrated a remittive effect with a median duration of four months for patients entering with a PGA score of 0 -

- Tapinarof cream was well tolerated consistent with the previously reported interim analysis -

September 30, 2021 09:45 AM Eastern Daylight Time

LONG BEACH, Calif., & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced final results from the Phase 3 PSOARING 3 long-term extension study of its investigational product tapinarof, a 1% once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults. The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. In addition, in the study tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

“As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.”

“For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options,” said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. “These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.”

Eligible patients completing PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a 4-week follow-up. Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks. PSOARING 3, which enrolled 763 patients, was designed to assess the safety and real-world use of tapinarof, and included prespecified analyses of duration of remittive effect off-therapy (defined as off-therapy maintenance of a PGA score of 0 or 1) and durability of response on-therapy. Outcomes were based on Physician Global Assessment (PGA) scores. Results from a planned interim analysis of data from PSOARING 3 were previously announced in February 2021.

Efficacy Data

58.2% (302/519) of patients who entered the PSOARING 3 study with a PGA score ≥2 achieved a PGA score of 0 or 1, demonstrating tapinarof's continued improvement in efficacy beyond the 12-week pivotal studies.
40.9% (312/763) of all patients achieved complete disease clearance (PGA score of 0).
Remittive effect, which was defined as off-therapy maintenance of a PGA score of 0 or 1, was observed in the study:
Median duration of remittive effect off-therapy was 115 days (approximately 4 months) for patients entering the study with a PGA score of 0 (n=79).
Among patients entering the study with or achieving a PGA score of 0 (n=312), the mean duration of remittive effect off-therapy was 130 days.
Durability of response, which was defined as no tachyphylaxis over time, was demonstrated for up to 52 weeks.
“With a high rate of complete disease clearance, a 4-month median remittive effect for patients entering with a PGA score of 0, and durable response with long-term use demonstrated in the PSOARING 3 study, the data for tapinarof continues to impress me over time,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, and PSOARING 3 study investigator. “As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.”

Safety Data

Treatment-emergent adverse events (TEAEs) were consistent with those from the interim analysis of data from PSOARING 3 and from the PSOARING 1 and 2 trials, with no new safety signals observed with long-term use.
TEAEs were mostly mild to moderate, at application sites, and associated with a low discontinuation rate (5.4%).
Incidence and severity of folliculitis and contact dermatitis remained stable with long-term use and were associated with low discontinuation rates (1.2% and 1.4%, respectively).
Results from the interim analysis of PSOARING 3, along with results from the previously reported Phase 3 PSOARING 1 and PSOARING 2 trials, served as the basis for the New Drug Application that Dermavant submitted to the U.S. Food and Drug Administration (FDA) in May 2021. The FDA accepted the application and assigned a Prescription Drug User Fee Act target action date in Q2 2022.

“We are excited to offer a more detailed picture at EADV of the long-term efficacy and safety profile of tapinarof in PSOARING 3,” said Philip M. Brown, MD, J.D., Chief Medical Officer of Dermavant. “We look forward to engaging with the FDA on our NDA in due course, as we work to bring tapinarof to plaque psoriasis patients as expeditiously as possible.”

About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis

Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).



Contacts
Gilmartin:
Laurence Watts
Managing Director
[e-mail]
619-916-7620

dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
[e-mail]
212-445-8219

[rstar]

an effective cream for psoriasis would be groundbreaking- the biologics are very effective- but incredibly expensive so very limited in who can get those- Humira - was- before the covid vaccine- the best selling drug in the world- used for both psoriasis and rheumatoid arthritis among other indications.
indeed w the float here and the many advanced stage high demand drugs- this should be a big winner from these levels. $ROIV

[aries4747]

Nine current ROIV Vants. Wonder which six could also be sold to Sumitomo Dainippon Pharma should the Pharma decide to exercise the 2024 option.

https://roivant.com/

[aries4747]

Since that deal, two Sumitovant companies, Urovant and Myovant, have seen their first FDA approvals—in overactive bladder and prostate cancer, respectively. As for the Vants still under the Roivant umbrella, Dermavant delivered two successful phase 3 studies for a psoriasis cream picked up from GlaxoSmithKline."


https://www.fiercebiotech.com/biotech/after-selling-off-most-vants-roivant-ceo-ramaswamy-moves-upstairs-to-executive-chair

[aries4747]

The only thing I learned from Fridays opening day see-saw trading on ROIV was that the float, indeed, must be tiny.

[aries4747]

Enzyvant was part of this deal.

Sumitomo, Roivant close $3 billion deal, forming Sumitovant

Phil TaylorPhil Taylor
December 31, 2019

A new international biotech – Sumitovant Biopharma – has been created after Sumitomo Dainippon’s strategic alliance with Roivant Sciences came to fruition as 2019 drew to a close.

The $3 billion transaction announced earlier this year involves the transfer of five of the Roivant group companies formed by biotech entrepreneur Vivek Ramaswamy – Myovant, Urovant, Enzyvant, Altavant, and Spirovant – to the newly-formed company.

Sumitomo has taken an 11% stake in Roivant as part of the deal and also has an option on six more companies in the Roivant umbrella group, which could also be rolled into the new company between now and 2024.

Sumitovant will operate as a wholly-owned subsidiary of Sumitomo, and will be led by ex-Genentech executive Myrtle Potter, who has been operating chair of Roivant since July 2018.

Other members of the new biotech’s leadership team include chief medical officer Sam Azoulay, commercial chief Adele Gulfo and chief digital officer Dan Rothman, who are all making the switch from Roivant. The new company will have offices in London and New York.

The deal is viewed as a bolt-on pipeline deal for Sumitomo, which has fallen behind its peers of late in bringing new candidates through its R&D pipeline, adding new clinical-stage candidates for women’s health, urology, prostate cancer, and multiple rare diseases including cystic fibrosis.

The Japanese company needs new products to bring to market as it prepares for the loss of patent protection to Latuda (lurasidone), a $1.6 billion drug for schizophrenia and bipolar depression that is facing a generics hit in 2023, and after some late-stage pipeline failures including napabucasin in pancreatic cancer.

“We are thrilled to have Sumitovant as one of the core growth engines for Sumitomo Dainippon,” said Sumitomo’s chief executive Hiroshi Nomura, who added that it is a key part of the company’s plan to become a ‘global specialised player’ by 2033.

Sumitovant comes into being with several drugs in its late-stage pipeline that could be launched in the next five years, including relugolix for uterine fibroids, endometriosis and advanced prostate cancer, vibegron for overactive bladder, RVT-802 for ultra-rare disease congenital athymia and rodatristat ethyl for pulmonary arterial hypertension (PAH).

[aries4747]

An FDA mistake signals likely approval for Vivek Ramaswamy’s first therapy for children born without a thymus

https://endpts.com/an-fda-mistake-signals-likely-approval-for-vivek-ramaswamys-first-therapy-for-children-born-without-a-thymus/

October 1, 2021 10:27 AM EDTUpdated 02:52 PM PharmaFDA+

Zachary Brennan
Senior Editor

The FDA on Thursday accidentally published a notice announcing the award of a priority review voucher to rare disease drug developer Enzyvant for its new regenerative therapy for the treatment of pediatric patients with congenital athymia.

The only problem? The treatment still hasn’t won FDA approval. The agency told Endpoints the notice was published in error and will be withdrawn. The release of the PRV notice, which typically come days or weeks after an approval is announced, puzzled the company.

Vivek Ramaswamy’s Enzyvant, sold as part of a $3 billion deal with Sumitomo Dainippon Pharma, said in an emailed statement that it “has not received approval notification from the FDA. Our PDUFA date remains October 8. Enzyvant found out about the PRV when it was published in the Federal Register and is working with the agency to determine what this means.”

The treatment in question, potentially to be known as Rethymic (allogeneic processed thymus tissue-agdc), would be the first for the ultra-rare condition in which children are born without a thymus, known as congenital athymia, which can lead to profound immunodeficiency issues and make them highly susceptible to infections. According to Enzyvant, patients with congenital athymia, usually about 20 per year in the US, die from infections or autoimmune manifestations by age two or three.

This has been a long road to approval (if an approval occurs) as Enzyvant received a CRL for the treatment in December 2019 due to several regulatory requests related to chemistry, manufacturing and controls.

Enzyvant CEO Rachelle Jacques told Endpoints News in April that it resolved issues related to the CRL:

We did need to do some facilities construction and we did that during Covid. That’s something that we didn’t anticipate immediately when we had the letter in our hands, but certainly as we talked with the agency that was very clear that was a solution. A lot of the other work was really just documenting at a very granular level some of the processes and so on as well as some additional studies we did to supplement the data we provided on the overall manufacturing process — and those were long lead time items as well.
Editor’s note: Article updated with comment from FDA.

AUTHOR

Zachary Brennan
Senior Editor
[e-mail]
@ZacharyBrennan
Zachary Brennan on LinkedIn

[aries4747]

ROIV: Roivant Sciences Announces Close of Business Combination with Montes Archimedes Acquisition Corp. and Concurrent PIPE Financing

October 01 2021 - 08:00AM
GlobeNewswire Inc.

Roivant Sciences, a biopharmaceutical company dedicated to improving the delivery of healthcare to patients, today announced that it has closed its business combination with Montes Archimedes Acquisition Corp. (Nasdaq: MAAC), a special purpose acquisition company, as well as a concurrent PIPE financing.

Outstanding shares and warrants of MAAC have been exchanged for newly issued Roivant shares and warrants, which will begin trading on Nasdaq under the ticker symbols "ROIV" and “ROIVW” later today. At the close of this transaction on September 30, 2021, Roivant’s consolidated cash position is approximately $2.5 billion.

“Roivant was founded to address inefficiencies in the traditional pharma model. As we begin our life as a public company, we now have the opportunity to accelerate that vision and create significant value for patients, shareholders, and society,” said Matt Gline, Chief Executive Officer of Roivant Sciences. “I would like to thank our new investors for their support as we continue to advance transformational medicines and novel modalities.”

In addition, the company announced that Richard Pulik has joined Roivant as Chief Financial Officer. Mr. Pulik brings over twenty years of industry experience.

Prior to joining Roivant, Mr. Pulik was the Global Head of Business Development & Licensing and Portfolio Management, Oncology at Novartis and a member of Novartis’s Innovation Management Board and the Novartis Oncology Leadership Team. Mr. Pulik joined Novartis in 2012 as a Senior Director, Mergers & Acquisitions based in Basel, Switzerland. Earlier in his career Mr. Pulik worked at Bank of America Merrill Lynch, Monitor Group and UBS Investment Bank, focusing on mergers and acquisitions and strategy in the healthcare sector. Mr. Pulik received a B.S. in Finance from The Wharton School and a B.A. in Economics and International Relations at the University of Pennsylvania in 2001.

“I am humbled to join a company that has accomplished so much over the last seven years,” said Mr. Pulik. “I look forward to working with its leadership to create a next-generation biopharma company that develops meaningful medicines for patients around the world.”

Roivant R&D Day

Roivant held a virtual R&D Day on the afternoon of September 28th highlighting the company’s drug discovery platform and recent clinical milestones. Recordings of R&D Day presentations and corresponding slides are available at https://investor.roivant.com/news-events/events.

Advisors

J.P. Morgan Securities LLC served as a financial advisor and capital markets advisor to Roivant and as a lead placement agent for the PIPE. SVB Leerink LLC served as a capital markets advisor to Roivant and as a lead placement agent for the PIPE. Goldman Sachs & Co. LLC served as a financial advisor to Roivant. Cowen and Company, LLC served as a financial advisor and capital markets advisor to Roivant. Citigroup Global Markets Inc. served as a placement agent for the PIPE. Truist Securities, Inc. served as a capital markets advisor to Roivant and as a placement agent for the PIPE. Davis Polk & Wardwell LLP acted as legal counsel to Roivant. Kirkland & Ellis LLP acted as legal counsel to MAAC. Okapi Partners served as the proxy solicitor for MAAC.

About Roivant Sciences

Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch 'Vants' – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com.

Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates and the availability and success of topline results from our ongoing clinical trials and preclinical studies. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on September 21, 2021. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors

Roivant Investor Relations
[phone]
[e-mail]

Media

Paul Davis
[e-mail]



Primary Logo

[MWM]

I caught the dip at about 1:10, $1.40-$1.45

[aries4747]

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

https://www.argus-press.com/news/national/article_fee46e23-135c-5a33-a043-cacef69ca5a7.html

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

LONG BEACH, Calif., & BASEL, Switzerland--(BUSINESS WIRE)--Sep 30, 2021--

Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced final results from the Phase 3 PSOARING 3 long-term extension study of its investigational product tapinarof, a 1% once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults. The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. In addition, in the study tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

“For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options,” said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. “These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.”

Eligible patients completing PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a 4-week follow-up. Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks. PSOARING 3, which enrolled 763 patients, was designed to assess the safety and real-world use of tapinarof, and included prespecified analyses of duration of remittive effect off-therapy (defined as off-therapy maintenance of a PGA score of 0 or 1) and durability of response on-therapy. Outcomes were based on Physician Global Assessment (PGA) scores. Results from a planned interim analysis of data from PSOARING 3 were previously announced in February 2021.

Efficacy Data

58.2% (302/519) of patients who entered the PSOARING 3 study with a PGA score ≥2 achieved a PGA score of 0 or 1, demonstrating tapinarof's continued improvement in efficacy beyond the 12-week pivotal studies.
40.9% (312/763) of all patients achieved complete disease clearance (PGA score of 0).
Remittive effect, which was defined as off-therapy maintenance of a PGA score of 0 or 1, was observed in the study:
Median duration of remittive effect off-therapy was 115 days (approximately 4 months) for patients entering the study with a PGA score of 0 (n=79).
Among patients entering the study with or achieving a PGA score of 0 (n=312), the mean duration of remittive effect off-therapy was 130 days.
Durability of response, which was defined as no tachyphylaxis over time, was demonstrated for up to 52 weeks.
“With a high rate of complete disease clearance, a 4-month median remittive effect for patients entering with a PGA score of 0, and durable response with long-term use demonstrated in the PSOARING 3 study, the data for tapinarof continues to impress me over time,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, and PSOARING 3 study investigator. “As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.”


Safety Data

Treatment-emergent adverse events (TEAEs) were consistent with those from the interim analysis of data from PSOARING 3 and from the PSOARING 1 and 2 trials, with no new safety signals observed with long-term use.
TEAEs were mostly mild to moderate, at application sites, and associated with a low discontinuation rate (5.4%).
Incidence and severity of folliculitis and contact dermatitis remained stable with long-term use and were associated with low discontinuation rates (1.2% and 1.4%, respectively).
Results from the interim analysis of PSOARING 3, along with results from the previously reported Phase 3 PSOARING 1 and PSOARING 2 trials, served as the basis for the New Drug Application that Dermavant submitted to the U.S. Food and Drug Administration (FDA) in May 2021. The FDA accepted the application and assigned a Prescription Drug User Fee Act target action date in Q2 2022.

“We are excited to offer a more detailed picture at EADV of the long-term efficacy and safety profile of tapinarof in PSOARING 3,” said Philip M. Brown, MD, J.D., Chief Medical Officer of Dermavant. “We look forward to engaging with the FDA on our NDA in due course, as we work to bring tapinarof to plaque psoriasis patients as expeditiously as possible.”

About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis

Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.


PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older. For more information, please visit www.dermavant.com, and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).


View source version on businesswire.com:https://www.businesswire.com/news/home/20210930005071/en/

CONTACT: Gilmartin:

Laurence Watts

Managing Director

[e-mail]

619-916-7620

dna Communications:

Angela Salerno-Robin

Senior Vice President, Media Relations, Healthcare

[e-mail]

212-445-8219

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS RESEARCH PHARMACEUTICAL SCIENCE BIOTECHNOLOGY

SOURCE: Dermavant Sciences

Copyright Business Wire 2021.

PUB: 09/30/2021 09:45 AM/DISC: 09/30/2021 09:46 AM

http://www.businesswire.com/news/home/20210930005071/en

Copyright Business Wire 2021.

This article originally ran on businesswire.com.

[aries4747]

$9.32 was low of day. ROIV tomorrow.

Tripled my position with the hope of flipping some with ticker change. Think we might see some crazy swings. What did you pay for warrants?

[MWM]

Amazed it's under $6. I added some warrants on the dip.

[aries4747]

Roivant’s move to go public reveals just how much its drug strategy has changed

https://medcitynews.com/2021/05/roivants-move-to-go-public-reveals-just-how-much-its-drug-strategy-has-changed/

Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company's vision and its strategy.

By FRANK VINLUAN
May 3, 2021 at 8:39 PM
Roivant Sciences built a business out of scouting for overlooked drug candidates that stalled in the labs of pharmaceutical companies or universities and bringing them in-house to develop under subsidiaries formed around each asset. The company has assembled a pipeline spanning multiple therapeutic areas, and many of those molecules are making clinical progress. But Roivant’s business is now much more than searching for drugs shelved by others. By going public in a merger deal, Roivant is revealing just how much its business and its vision has changed in its short history.

New York and Basel, Switzerland-based Roivant announced Monday that it has agreed to a merger with publicly traded Montes Archimedes Acquisition Corp., a special purpose acquisition company (SPAC). According to the deal terms, Montes Archimedes shareholders will convert their shares and warrants into common shares and warrants of Roivant. The combined company will operate under the Roivant name and about 92% of the firm will be owned by shareholders of the original Roivant, assuming the Montes Archimedes shareholders don’t cash out. (Some of the equity holders have agreed to lockups that prevent them from selling at least half of their shares for the next three years.) The new Roivant will have an expected market capitalization of $7.3 billion, which includes a $2.3 billion net cash balance.

The new Roivant will continue to operate under the drug company’s current management team, which is led by CEO Matthew Gline. Vivek Ramaswamy, the company’s founder and former CEO, will continue to serve as executive chairman. When the deal closes, shares of the new Roivant will trade on the Nasdaq under the stock symbol “ROIV.”

Since its 2014 launch, Roivant has formed more than 20 “vants,” which is what it calls its subsidiaries. Those companies have advanced the development of more than 40 drug candidates. One of Roivant’s earliest bets was also perhaps its biggest failure. The same year that Roivant launched, it announced the acquisition of a drug candidate for neurological disorders that was shelved by GlaxoSmithKline. Axovant, the subsidiary formed to develop the compound, eventually went public as it advanced the neuro drug’s development. But the compound failed a Phase 3 test in Alzheimer’s disease, and months later flunked a mid-stage study in dementia with Lewy bodies. Roivant went on to shake up the subsidiary and its management; the unit’s new focus was reflected in its new name: Sio Gene Therapies.

Since Axovant’s Phase 3 failure, Roivant’s subsidiaries have had better success, producing successful results in eight Phase 3 studies. Some vants have turned into acquisitions by other companies. In 2019, Sumitomo Dainippon Pharma began a research alliance with Roivant, spanning the development of up to 11 companies and 25 drug programs. As part of the deal, the Japanese pharma company paid $3 billion to buy five vants and take a 10% equity stake in Roivant. Two FDA-approved drugs emerged from those vants: prostate cancer drug relugolix and overactive bladder treatment vibregon. That Sumitomo deal was transformative for Roivant, Ramaswamy said, speaking during an investor conference call.

“We took the cash and we invested in various areas of our platform,” he said. “And even though we believe that’s been a good acquisition for Sumitomo, we’re even happier with what it’s allowed us to do in taking our discovery and development platform to the next level.”

Though Roivant’s initial vision was to find overlooked drugs that were discovered by others, the company has expanded its scope. Gline said that of the vants that Roivant has built, the ones that are technology companies have computational tools that make the firm better at developing or commercializing medicines. As an example, he pointed to Lokavant, which provides real-time analysis of clinical trials. The technology was initially developed by Roivant for its own clinical trials. Gline said that a contract research organization Roivant worked with, Parexel, saw the technology and decided to become a user—one of the first customers of Lokavant.

Another subsidiary, Datavant, takes patient data from databases, strips out identifying information, and follows data across siloed datasets to better understand patient populations. Yet another subsidiary, Alyvant, is using AI and machine learning to help sales representatives target physicians for the commercialization of drugs.

Roivant’s transformation included a move into drug discovery, precipitated in part, Gline said, by the company’s difficulty finding the right drug candidates to in-license. So Roivant modified its AI technology, using it for finding molecules that could become new medicines. That move led to VantAI, Roivant’s machine-learning platform for drug discovery. The company has poured about $750 million into computational drug discovery tools, according to Gline. The company has also added to these capabilities via the $450 million acquisition of Silicon Therapeutics, a startup that uses AI and machine learning to identify promising drug candidates. Silicon Therapeutics brought its pipeline of internally discovered drugs and its technology gives Roivant the ability to discover more.

Going forward, Roivant will be infused with $611 million to support the strategies started under its transformation. The cash breaks down to $411 million from Montes Archimedes and $200 million from institutional investors that have agreed to purchase Roivant stock at $10 per share. The investors participating in this financing include Fidelity Management & Research Company, Eventide Asset Management, Suvretta Capital, Palantir Technologies, RTW Investments, LP, Viking Global Investors, Sumitomo Dainippon Pharma, and SB Management, a subsidiary of SoftBank Group.

The transaction still needs approval of Montes Archimedes shareholders but is expected to close in the third quarter of this year. Roivant said that the proceeds from the merger are expected to support the company through mid-2024.

Photo: Lisa Lake, Getty Images

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8-K filed this morning.

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001819263/000110465921120466/tm2128608d1_8k.htm

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Think the current OS is around 50 million and the lock-up period for the SPAC shares is the standard six months.

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$MAAC releases redemption numbers for its merger with Roivant Sciences

38.4M shares were redeemed or an estimated 94% of the public shares (leaving ~2.7M public shares at this time)https://t.co/XA4cxWs7oe

— ListingTrack (@listingtrack) September 29, 2021

looks like 2.7m float nice one! $MAAC

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There are many more ROIV Vants than the examples detailed in the posts below. Scroll down in the Roivant Sciences link for a full listing

https://roivant.com/

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What are the Roivant Vants?

https://roivant.com/
From Roivant Sciences website:

We develop transformative medicines faster by building technologies and developing talent in creative ways.

We do that by leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies.

We have unique principles that shape our culture. We’re focused on creating value. We are contrarian. When we hit a wall, we climb the wall. We sweat the details. We accept that we must evolve or die.

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ROIV Vant: Genevant. Arbutus and Roivant Launch Genevant Sciences with Industry-Leading Platform to Develop Broad Range of RNA Therapeutics for Genetic Diseases

https://roivant.com/arbutus-and-roivant-launch-genevant-sciences-with-industry-leading-platform-to-develop-broad-range-of-rna-therapeutics-for-genetic-diseases.html

Arbutus and Roivant Launch Genevant Sciences with Industry-Leading Platform to Develop Broad Range of RNA Therapeutics for Genetic Diseases

April 11, 2018

Genevant aims to advance 5-10 product candidates into the clinic by 2020 across RNAi, mRNA, and gene editing modalities using Arbutus’ LNP and ligand conjugate platforms

Genevant will be led by Executive Chairman Paris Panayiotopoulos, former CEO of ARIAD Pharmaceuticals through its 2017 acquisition by Takeda, who is assembling a team of RNA experts
Dr. Bo Rode Hansen, Global Head of RNA Therapeutics at Roche, will be joining Genevant as President, Chief Scientific Officer, and Head of R&D; Dr. Peter Lutwyche, who led the development of the Arbutus delivery platforms, will join as Chief Technology Officer; Dr. Konstantin Linnik, former Lead Patent Counsel for Oligonucleotide Therapeutics at Pfizer, will join as General Counsel; Dr. James Heyes, key inventor on Arbutus LNP and ligand conjugate patents, will join as SVP; additionally, a scientific team with decades of RNA development and delivery experience will be joining Genevant

CAMBRIDGE, MA, VANCOUVER, BC, and BASEL, Switzerland, April 11, 2018 — Arbutus Biopharma Corporation (Nasdaq: ABUS) and Roivant Sciences today announced that they have entered into an agreement to launch Genevant Sciences, a jointly-owned company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by Arbutus’ proprietary lipid nanoparticle (LNP) and ligand conjugate delivery technologies.

Arbutus will license exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of hepatitis B virus. Through its expert team and dominant intellectual property in RNA delivery, Genevant plans to develop products in-house and pursue industry partnerships to build a diverse pipeline of therapeutics across multiple modalities, including RNAi, mRNA, and gene editing.

The industry-leading LNP platform developed by Arbutus is the only clinically-validated LNP delivery technology with safety and efficacy evaluated in over 400 patients across multiple clinical programs. It is the first and only LNP platform to enable an approved therapy, and has enabled a second NDA filing through its licensed use by Alnylam Pharmaceuticals for the delivery of patisiran, a therapy to treat patients with hereditary ATTR amyloidosis. This platform is protected by over 125 international patent families. Genevant will also receive a license to a proprietary ligand conjugate technology developed by Arbutus to enable subcutaneous delivery of RNA-based therapeutics.

Biopharmaceutical companies developing nucleic acid therapeutics today include companies singularly focused on individual treatment modalities. Through its proprietary delivery platforms, Genevant is able to pursue mRNA, RNAi, and gene editing modalities and select the optimal approach for any given disease. By 2020, Genevant aims to have 5 to 10 RNA programs in the clinic targeting a range of genetic disorders with limited or no treatment options.

Genevant’s Executive Chairman will be Paris Panayiotopoulos. Mr. Panayiotopoulos most recently served as President and Chief Executive Officer and member of the Board of Directors of ARIAD Pharmaceuticals through its acquisition by Takeda Pharmaceuticals in 2017 for $5.2 billion. Prior to joining ARIAD, Mr. Panayiotopoulos was President of the North American and Japanese biopharmaceutical businesses of Merck KGaA, and President of the Serono Research & Development Institute. Mr. Panayiotopoulos currently serves as a director of The Medicines Company and Corbus Pharmaceuticals, and has previously served on the boards of BIO, MassBio, and EFPIA.

Bo Rode Hansen, Ph.D., will be joining Genevant as President, Chief Scientific Officer, and Head of Research & Development. Dr. Hansen currently serves as Global Head of RNA Therapeutics at Roche and General Manager of the Roche Innovation Center Copenhagen. Dr. Hansen was Vice President for Drug Discovery and Alliance at Santaris Pharma A/S through its acquisition by Roche in 2014. Peter Lutwyche, Ph.D., will join Genevant as Chief Technology Officer and Vancouver Site Head. Dr. Lutwyche most recently served as Chief Technology Officer at Arbutus where he led the development of the company’s delivery technologies. Konstantin Linnik, J.D., Ph.D., will join Genevant as General Counsel and Senior Vice President of Intellectual Property and Legal Affairs. Dr. Linnik formerly served as Lead Patent Counsel for Oligonucleotide Therapeutics at Pfizer and was a partner at Nutter McClennen & Fish LLP. James Heyes, Ph.D., will join Genevant as Senior Vice President of Technology Development. Dr. Heyes has 17 years of experience as a lipid chemist discovering and developing novel nucleic acid-delivery platforms. He most recently served as Vice President of Drug Delivery at Arbutus where he was a key inventor on a majority of the company’s lipid chemistry and ligand conjugate patents.

Genevant intends to establish its US headquarters in Cambridge, Massachusetts and its principal operating company in Basel, Switzerland. Genevant will also establish its R&D Center of Excellence in Burnaby, British Columbia with a team of core scientists from Arbutus who will join Genevant as part of the transaction. This scientific team has decades of experience in developing RNA therapeutics and delivery technologies.

Under the terms of the agreement, Roivant will contribute $37.5 million in transaction-related seed capital for Genevant. Roivant is committed to financially support Genevant in its aim to advance 5 to 10 product candidates into the clinic by 2020. Arbutus will retain all rights to the LNP and conjugate delivery platforms for HBV, and will be entitled to a tiered royalty from Genevant on future sales of products enabled by those delivery platforms. Arbutus will also retain the entirety of its royalty entitlement on the commercialization of Alnylam’s patisiran, which could see regulatory approval as early as the second half of 2018.

About RNA Therapeutics
RNA therapeutics, which include RNAi, mRNA, and gene editing approaches, have the potential to modulate and regulate gene expression by up-regulating, down-regulating, eliminating, or correcting disease-causing proteins. The successful application of such therapeutics requires safe and efficacious intracellular delivery.

About Arbutus
Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen for HBV. For more information, visit www.arbutusbio.com.

About Roivant
Roivant Sciences is a privately-held company dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients. Roivant’s long-range mission is to reduce the time and cost of the drug development process. For more information, please visit www.roivant.com.
About the Arbutus Special Committee

The Board of Directors of Arbutus approved the formation of a Special Committee of independent directors, (the “Special Committee”) to ascertain whether it would be in the best interests of Arbutus to enter into these agreements with Roivant, and to provide a recommendation to the Board in that regard. MTS Health Partners served as financial advisor for the Special Committee of the Board of Directors of Arbutus and has provided a fairness opinion to the Special Committee.
Further details regarding the partnership with Roivant and Genevant are provided in Arbutus’ Form 8-K to be filed with the Securities and Exchange Commission (SEC), and in a material change report being filed with Canadian securities regulators that includes supplementary information required under MI 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”), which has been adopted by certain of the Canadian securities regulators.

Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”), including, without limitation, statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions, and the negative of such expressions. These statements are only predictions.
Forward-looking statements should be considered carefully. Undue reliance should not be placed on forward-looking statements and information as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements and information involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, which contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements and information will not occur and may cause actual results or events to differ materially from those anticipated in such forward-looking statements and information.
There are known and unknown risk factors which could cause Arbutus' or Genevant’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: Genevant may not produce the expected level of value for Arbutus and its shareholders, if at all; expected payments, financings, and royalties may not be as large or as timely as expected, if at all; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus and Genevant may not receive the necessary regulatory approvals for the clinical development of their products on a timely basis, if at all; key management personnel may become unavailable; Genevant may need to shift operating centres; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K and Arbutus' continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
As closing of the transaction is contemplated as soon as practicable, this could result in Arbutus’ material change report being filed with the Canadian securities regulators less than 21 days before completion of the transaction. In such a circumstance, Arbutus is required, under MI 61-101, to explain why a shorter period is reasonable or necessary in the circumstances. Arbutus believes that a shorter period is both reasonable and necessary given its assessment that closing of the transaction as soon as practicable is in the best interests of Arbutus.

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ROIV Vant: Immunovant (IMVT). Article from today.

https://myastheniagravisnews.com/news-posts/2021/09/28/1st-patient-dosed-in-phase-3-trial-of-batoclimab-in-china/

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ROIV Vant: Aruvant. Roivant Launches Aruvant Sciences and Roivant Foundation in Partnership with Cincinnati Children’s Hospital Medical Center

November 26, 2018

Aruvant’s pipeline anchored by RVT-1801, an investigational gene therapy for sickle cell disease and ß-thalassemia

Clinical data for RVT-1801 to be presented in an oral session at ASH on December 3rd
Roivant establishes nonprofit Roivant Foundation to improve access to therapies for patients with sickle cell disease in the developing world

BASEL, Switzerland and CINCINNATI, November 26, 2018 / PRNewswire/ ­— Roivant Sciences and Cincinnati Children’s Hospital Medical Center today announced the launch of Aruvant Sciences, a biopharmaceutical company focused on developing innovative gene therapies for hematological conditions, and the formation of a new nonprofit foundation with the mission of improving access to medical care for patients with sickle cell disease in the developing world. The launch of Aruvant builds on a partnership between Roivant and Innovation Ventures, the commercialization arm of Cincinnati Children’s, dating back to early 2015.

The lead candidate in Aruvant’s pipeline, RVT-1801, is an investigational gene therapy for sickle cell disease and ß-thalassemia. RVT-1801 utilizes proprietary technology intended to increase functioning red blood cells by inserting a modified fetal hemoglobin gene into autologous stem cells through a lentiviral vector. Studies have indicated that sickle cell patients with elevated levels of fetal hemoglobin have fewer vaso-occlusive crises and hospitalizations, due in part to improved characteristics of fetal hemoglobin relative to adult hemoglobin. RVT-1801 is the only known clinical-stage gene therapy to deliver the gene encoding fetal hemoglobin, which has been modified to optimize oxygen carrying capacity and anti-sickling properties. Myrtle Potter, Vant Operating Chair at Roivant Pharma, will serve as Chairman of Aruvant.

RVT-1801 was developed in the laboratory of Dr. Punam Malik, Director of the Cincinnati Comprehensive Sickle Cell Center at Cincinnati Children’s. Preliminary clinical data from an ongoing Phase 1/2 study of RVT-1801 in patients with sickle cell disease conducted using a reduced-intensity conditioning (RIC) regimen enabled by the unique properties of modified fetal hemoglobin will be presented by Dr. Malik in an oral presentation at 6:15pm PST next Monday, December 3rd, at the Annual Meeting and Exposition of the American Society of Hematology in San Diego, CA. Additional information on the presentation is available here.

“Treating sickle cell anemia and ß-thalassemia has been my passion since I first trained as a physician in India,” said Dr. Malik. “I look forward to sharing important data next week at ASH on RVT-1801, which has been designed to improve patient experience and access through our RIC regimen. I am excited to work with the team at Roivant to rapidly advance the development of this potentially transformative therapy. A critical reason why we chose to work with Roivant on this program was their authentic commitment to patients globally.”

“We are excited to develop this novel modified fetal hemoglobin gene therapy for sickle cell disease,” said Dr. Mayukh Sukhatme, President of Roivant Pharma. “Our partnership with Cincinnati Children’s represents Roivant’s commitment to the development of novel, transformational therapies, including gene therapies that have the potential to shift treatment paradigms for serious diseases.”
Under the terms of the agreement, Cincinnati Children’s will receive an upfront payment and shares of Aruvant and will be eligible for milestone payments and tiered royalties. Specific terms were not disclosed.

Roivant Foundation
In addition to establishing Aruvant, Roivant has created a nonprofit organization, the Roivant Foundation, focused on improving access to therapies for sickle cell disease for patients in the developing world. Over 70% of individuals with sickle cell disease live in Sub-Saharan Africa.
“As a native of Cincinnati, I am particularly excited about Roivant’s sustained partnership with Cincinnati Children’s, which dates back to our first year of operations,” said Vivek Ramaswamy, Founder and CEO of Roivant. “I am also proud of our creative efforts to improve access to care in the developing world through the work of the Roivant Foundation.”
“Roivant has been a valued partner of Cincinnati Children’s for several years, and we are delighted to work together on the launch of Aruvant, a new company which will have staff based right here in Cincinnati,” said Dr. Peggy Hostetter, Chief Medical Officer of Cincinnati Children’s and Director of the Cincinnati Children’s Research Foundation. “An important goal of our research enterprise is to facilitate the translation of promising discoveries from bench to bedside, and the closing of this deal represents a significant step in ensuring this program has the potential to impact patients here in Cincinnati and around the world.”

About Sickle Cell Disease and ß-Thalassemia
Sickle cell disease is a progressively debilitating and life-threatening inherited red blood cell disorder that causes a patient’s oxygen-carrying cells to be abnormally inflexible and sickle-shaped. This genetic defect leads to lowered oxygen-carrying capacity in the hemoglobin protein of these red blood cells. Sickle cell disease can cause inflammation of extremities, bacterial infections, stroke, anemia, and attacks of pain called sickle cell crises.
ß-thalassemia is an inherited red blood cell disorder distinguished by reduced or nonexistent production of functional ß-globin, a critical component of adult hemoglobin. Patients with the disorder suffer from anemia, which can cause weakness, fatigue, and more serious complications. Individuals with ß-thalassemia are at an increased risk of developing abnormal blood clots.

About Aruvant Sciences
Aruvant Sciences is a clinical-stage gene therapy company focused on hematological conditions, with an emphasis on helping patients suffering from sickle cell disease and ß-thalassemia. The company’s lead candidate, RVT-1801, is a modified fetal hemoglobin gene therapy for sickle cell disease and related hemoglobinopathies.

About Roivant Pharma
Roivant Pharma is a business unit of Roivant Sciences. Roivant Pharma is focused on end-to-end biopharmaceutical company creation, launch, and oversight. Roivant Pharma companies include Axovant, Myovant, Dermavant, Enzyvant, Urovant, Metavant, Genevant, Altavant, Immunovant, Respivant, Aruvant, and Arbutus.

About Roivant Sciences
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. We do this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization.
For more information, please visit www.roivant.com.

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ROIV Vant: Datavant Datavant, Ciox Health ink $7B deal for wide-ranging access to medical research data

https://www.fiercebiotech.com/medtech/datavant-to-absorb-ciox-health-7b-medical-data-deal
by Conor Hale | Jun 9, 2021 10:45am

The companies aim to provide data services to more than 2,000 hospitals and 15,000 clinics—as well as more than 30 life science companies and 70 academic research institutions and non-profits—for an expected $700 million in combined annual revenue. (whiteMocca/Shutterstock)

With the goal of making data a facet of every healthcare decision—and spinning that information back into life science research—Datavant and the medical records platform developer Ciox Health, plus their VC backers, have agreed to lay out $7 billion to combine their enterprises.

The deal promises to expand Datavant's reach to thousands of U.S. clinics. The resulting company plans to offer a joint technology ecosystem that brings disparate health records together and allow for secure, anonymous exchanges among patients, providers and biopharma companies alike.

It's the largest transaction by far among recent deals in the space, which focuses in part on de-identifying patient data so researchers can easily—and legally—use it.

Healthcare mapmaker Komodo Health raised at least $260 million over two funding rounds in the last year, and it acquired the cloud-based software developer Mavens alongside a new partnership with the drugmaker Janssen. Meanwhile, in April, the health IT provider Cerner finalized its $375 million cash buyout of Kantar's health and real-world evidence division in a big data play for the drug discovery and clinical research markets.

“The fragmentation of health data is one of the single greatest challenges facing the healthcare system today,” said Ciox CEO Pete McCabe, who will become chief executive of the new company set to emerge under Datavant's banner. Datavant’s current CEO, Travis May, will serve as the company's president and join its board of directors.

Datavant's technology encrypts patient-identifying information within health records—such as names, addresses and birthdays—and replaces them with a unique code, which allows an individual's medical history to be matched up across different systems, while maintaining their anonymity.

On the researchers' end, all they see a single large data set collated from multiple sources, spanning the course of a patient's treatment as they may move from provider to provider—useful data that could otherwise end up siloed away in different institutions, according to McCabe.

Together, the companies aim to provide data management services to more than 2,000 hospitals and 15,000 clinics, as well as more than 30 life science companies and 70 academic research institutions and non-profits, for an expected $700 million in combined annual revenue.

The $7 billion deal was supported by a slate of the companies’ existing investors—including Ciox’s New Mountain Capital and Datavant’s corporate parent Roivant Sciences, alongside Transformation Capital, Merck Global Health Innovation Fund, Labcorp, Cigna Ventures, Johnson & Johnson Innovation and Flex Capital.

The transaction also includes “a significant new investment” by Sixth Street, earning it a seat on the board, plus funds from Goldman Sachs’ West Street Strategic Solutions.

“Datavant’s groundbreaking tokenization technology and the strength of Ciox’s expanded network across providers, payers, health application developers, and life sciences markets makes this combination compelling,” said Sixth Street partner and Vice Chairman R. Martin Chavez.

At the same time, the deal will give the overarching Roivant greater reach in its own drug development efforts, spread across its various “vants” focused on autoimmune conditions, dermatology and rare diseases. “We look forward to developing additional differentiated technologies at Roivant going forward,” said Roivant CEO Matthew Gline.

The deal is expected to close in the third quarter of this year.

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ROIV Vant: Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis
August 10, 2021

- Psoriasis Impacts Approximately 8 Million Americans and 125 Million People Worldwide -

- NDA Is Supported by Positive Data From the Phase 3 PSOARING 1 and PSOARING 2 Pivotal Efficacy Trials and Interim Results From the PSOARING 3 Long-Term Safety Study -

- FDA PDUFA Action Expected in Q2 2022 -

LONG BEACH, Calif. & BASEL, Switzerland, August 10, 2021--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New Drug Application (NDA) for tapinarof for the treatment of plaque psoriasis in adult patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210810005299/en/


Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022. The company submitted the NDA to the FDA on May 26, 2021.

Estimates suggest that psoriasis, a chronic and debilitating condition, impacts 8 million people in the United States and 125 million people worldwide. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80–90% of people with psoriasis.

"With the FDA acceptance of our NDA for filing, Dermavant is one step closer to potentially providing a new option for adults with mild, moderate, and severe plaque psoriasis, who often deal with itch, pain, disfiguring appearance, and significant emotional and physical distress," said Todd Zavodnick, Chief Executive Officer of Dermavant. "The entire Dermavant team is now working diligently to prepare for the commercial launch of tapinarof, subject to FDA approval, and we look forward to further discussions with the FDA during the review process of this novel product candidate.

The regulatory application is supported by positive Phase 3 data from PSOARING 1 and PSOARING 2, two replicate, multi-center, randomized, vehicle-controlled, double-blind studies, as well as the interim results from PSOARING 3, a 40-week, open-label safety study.

About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis

Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 completed PSOARING 3, having received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

View source version on businesswire.com: https://www.businesswire.com/news/home/20210810005299/en/

Contacts

Gilmartin:
Laurence Watts
Managing Director
[e-mail]
619-916-7620

dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
[e-mail]
212-445-8219

[aries4747]

MAAC finished up 4.05% on vote day.

[aries4747]

Roivant Discovery Channel launches on YouTube.

https://www.youtube.com/channel/UC4Y4qmA71iaSQtHmXpOlODA

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Roivant ditches plan to reacquire Immunovant, putting up $200M investment instead

https://www.fiercebiotech.com/biotech/roivant-ditches-plan-to-reacquire-immunovant-putting-up-200m-investment-instead

[aries4747]

(3 weeks ago):Immunovant, Inc. (IMVT) Up 9.3% Since Last Earnings Report: Can It Continue?

https://www.nasdaq.com/articles/immunovant-inc.-imvt-up-9.3-since-last-earnings-report%3A-can-it-continue-2021-09-08

[aries4747]

Immunovant to Participate in Roivant R&D Day 2021

https://www.globenewswire.com/news-release/2021/09/27/2303557/0/en/Immunovant-to-Participate-in-Roivant-R-D-Day-2021.html

[aries4747]

MAAC: Roivant May Investor Presentation

From Prospectus

https://www.sec.gov/Archives/edgar/data/0001819263/000110465921059580/tm2114865d1_ex99-2.htm

[aries4747]

MAAC PIPE investors include Palentir (PLTR).

Roivant will also be a Palentir client.

From Barrons:

"Roivant Sciences is a growing collection of pharmaceutical companies which has agreed to merge with Montes Archimedes Acquisition Corp. (MAAC). Investors in the deal’s $200 million PIPE offering also include SoftBank (SFTBY), Fidelity, and Sumitomo Dainippon Pharma, among others. Palantir is investing $30 million in Roivant, which also signed a five-year software contract. "

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Roivant R & D Day Tuesday, as is SPAC vote.

On September 28, Roivant will host its annual R&D Day, at which the Company will provide updates on clinical development at the Vants and Roivant's new small molecule discovery engine. The webcast for this virtual event will begin at 1 p.m. ET and can be accessed at https://tinyurl.com/Roivant.

[aries4747]

MAAC Roivant Sciences Reports First Fiscal Quarter 2021 Financial Results and Provides Business Update

Tue, September 21, 2021, 5:40 PM·

- Roivant on track to close business combination with Montes Archimedes Acquisition Corp. ("MAAC") and concurrent PIPE financing, and commence trading on Nasdaq on October 1 under the symbol "ROIV"

- Dermavant's NDA for tapinarof for the treatment of plaque psoriasis accepted for filing by FDA

- First patient dosed in Phase 3 Dermavant trial of tapinarof for the treatment of atopic dermatitis

- Datavant completed its merger with Ciox Health; at closing, Roivant received approximately $320 million in cash and a minority equity stake in the combined company

- Roivant made a $200 million strategic investment in Immunovant

- On September 28, Roivant will host its annual R&D Day, providing an update on clinical development at the Vants and Roivant's new small molecule discovery engine

BASEL, Switzerland and LONDON and NEW YORK, Sept. 21, 2021 /PRNewswire/ -- Roivant Sciences Ltd. ("Roivant" or the "Company"), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, today reported its financial results for the fiscal quarter ended June 30, 2021 and provided an update on the Company's operations.

"Over the past quarter we have made significant progress as a business, both at Roivant centrally and across our family of companies," said Matthew Gline, Chief Executive Officer of Roivant. "I look forward to providing an update on these developments and an overview of key milestones to come at our R&D Day next week."

On September 28, Roivant will host its annual R&D Day, at which the Company will provide updates on clinical development at the Vants and Roivant's new small molecule discovery engine. The webcast for this virtual event will begin at 1 p.m. ET and can be accessed at https://tinyurl.com/Roivant.

Recent Developments

Datavant: In June 2021, Datavant and Ciox Health entered into a definitive agreement to merge the two companies. The combined entity, named Datavant, is the nation's largest health data ecosystem, enabling patients, providers, payers, health data analytics companies, patient-facing applications, government agencies and life science companies to securely exchange their patient-level data. The merger closed on July 27, 2021. At closing, Roivant received approximately $320 million in cash and a minority equity stake in the combined company.

Aruvant: In June 2021, Aruvant announced data published on ARU-2801, an investigational gene therapy, that showed improved survival out to 18 months in hypophosphatasia mice.

Immunovant: In August 2021, Roivant made a $200 million investment in Immunovant. Following this transaction, Roivant owns 73,398,664 shares of Immunovant common stock, representing approximately a 63.8% ownership interest.

Dermavant: In August 2021, the FDA accepted for filing Dermavant's NDA for tapinarof for the treatment of plaque psoriasis in adult patients. The FDA has assigned a PDUFA target action date in the second calendar quarter of 2022. In September 2021, Dermavant dosed the first patient in a Phase 3 trial of tapinarof for the treatment of atopic dermatitis.

Genevant: In August 2021, Genevant entered into a global collaboration and license agreement with Takeda for the development and commercialization of novel nonviral gene therapies for up to two rare liver diseases. Genevant will be eligible for up to $303 million in upfront and potential milestone payments, plus royalties on product sales. This is the second collaboration between Genevant and Takeda.

Major Upcoming Milestones

Roivant: We expect to close our business combination with MAAC, along with a concurrent PIPE financing, and commence trading on Nasdaq on October 1 under the symbol "ROIV." Assuming no redemptions by MAAC shareholders, the business combination and concurrent PIPE financing are expected to deliver approximately $575 million in net proceeds to Roivant.

Dermavant: We expect a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second calendar quarter of 2022. We also expect to report topline data from Dermavant's Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.

Immunovant: Contingent upon FDA feedback, Immunovant plans to initiate a pivotal trial evaluating IMVT-1401 for the treatment of myasthenia gravis in the early part of calendar year 2022. Immunovant also plans to announce at least two new indications and submit INDs with their trial designs to the FDA over the next 12 months.

Aruvant: We expect Aruvant to report additional clinical data from the ongoing Phase 1/2 trial of ARU-1801 in sickle cell disease patients in the second half of calendar year 2021.

First Fiscal Quarter 2021 Financial Summary

Research and Development Expenses

Research and development expenses increased by $19.9 million to $78.6 million for the three months ended June 30, 2021 compared to $58.7 million for the three months ended June 30, 2020. The increase is primarily due to an increase in personnel-related expenses, which is partially driven by additional headcount to support drug discovery efforts using our computational discovery technology and targeted protein degradation platform, following the acquisition of Silicon Therapeutics in March 2021 and Oncopia Therapeutics, Inc. in November 2020.

General and Administrative Expenses

General and administrative expenses increased by $25.6 million to $82.8 million for the three months ended June 30, 2021 compared to $57.1 million for the three months ended June 30, 2020. The increase was primarily due to increases in professional and transaction fees, personnel-related expenses and share-based compensation expense.

Capital Resources

As of June 30, 2021, we had cash and cash equivalents of approximately $2.0 billion.

ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)


June 30, 2021

March 31, 2021




Cash, cash equivalents and restricted cash
$
2,008,377


$
2,141,676

Total assets

2,454,697



2,589,692

Total liabilities
474,865


527,687

Total shareholders' equity
1,957,341


2,039,514

Total liabilities, redeemable noncontrolling interest and shareholders' equity

2,454,697



2,589,692










ROIVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)


Three Months Ended June 30,

2021

2020




Revenue, net
$
7,735


$
1,576

Operating expenses:



Cost of revenues
742


180

Research and development
78,626


58,734

General and administrative
82,754


57,115

Total operating expenses
162,122


116,029





Loss from operations
(154,387)


(114,453)





Change in fair value of investments
8,619


(41,148)

Change in fair value of debt and liability instruments
4,585


17,125

Gain on termination of Sumitomo Options
(66,472)


—

Gain on deconsolidation of subsidiary
—


(86,516)

Other (income) expense, net
(134)


2,842

Loss before income taxes
(100,985)


(6,756)

Income tax expense
93


1,221

Net loss
(101,078)


(7,977)

Net loss attributable to noncontrolling interests
(18,895)


(4,734)

Net loss attributable to Roivant Sciences Ltd.
$
(82,183)


$
(3,243)

Net loss per common share—basic and diluted
$
(0.37)


$
(0.02)

Weighted average shares outstanding—basic and diluted
222,081,975


214,879,058

About Roivant Sciences

Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch "Vants" – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com.

Roivant Sciences Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and matters relating to the merger (the "Business Combination") pursuant to the Business Combination Agreement, dated as of May 1, 2021, by and among Roivant, Montes Archimedes Acquisition Corp. ("MAAC") and Rhine Merger Sub, Inc., as amended on June 9, 2021 and as may be further amended, supplemented or otherwise modified from time to time. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our proxy statement/prospectus filed with the SEC on August 10, 2021. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investors
Roivant Investor Relations
[e-mail]

Media
Paul Davis
Roivant Sciences
[e-mail]

Cision
Cision
View original content:https://www.prnewswire.com/news-releases/roivant-sciences-reports-first-fiscal-quarter-2021-financial-results-and-provides-business-update-301382074.html

SOURCE Roivant Sciences

[aries4747]

MAAC will be ROIV next week. (October 1)