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More going on than SPAC drop, but don't know what. It was pinned around $10 while still MAAC and dropped immediately and hard after debuting at $10. Take a look at the chart...it's so bad it cracks me up.
Cashed in the $300's for a double. If it goes above $310 again, I'll probably jump back in, though I'm usually wary of playing tickers that have already fallen this far. However, you're right....can't hold the 100 ma and that gap looks tempting.
ROIV has been an absolute train wreck every single day since emerging from the MAAC SPAC last Friday. Still don't see any fundamental reason why and I've added all the way down to $6. To add to my frustration, ROIV stock ticker isn't recognized by Finviz or StockTwits. However, I will continue to post any news over here and await a rebound.
Sold MRNA.
ABUS: Wonder if receiving the patent next Tuesday will serve as a catalyst for news and possibly nudge MRNA into making a deal.
SNDL popping on news. Sundial Growers to Acquire Alcanna Inc.
6:00 PM ET 10/7/21 | Dow Jones
CALGARY, AB, Oct. 7, 2021 /PRNewswire/ - Sundial Growers Inc. (NASDAQ: SNDL) ("Sundial" or the "Company") is pleased to announce today that it has entered into an arrangement agreement (the "Agreement") with Alcanna Inc. (TSX: CLIQ) ("Alcanna") pursuant to which Sundial will acquire all of the issued and outstanding common shares of Alcanna ("Alcanna Shares") by way of a statutory plan of arrangement for total consideration of approximately $346 million (the "Transaction"). For more information on the announcement, a presentation deck can be found here.
Joined you with MRNA $300 Puts for next week.
Pfizer and BioNTech are less likely targets because of BioNTech's ongoing relationship with Genevant.
July 10, 2018 01:00 AM Eastern Daylight Time
MAINZ, Germany & CAMBRIDGE, Mass. & BASEL, Switzerland--(BUSINESS WIRE)--BioNTech AG and Genevant Sciences today announced that they have entered into a collaboration to develop five mRNA therapeutic programs for rare diseases with high unmet medical need. The companies have also agreed a series of exclusive licenses covering the application of Genevant’s delivery technology to five of BioNTech’s oncology programs. Genevant is eligible to receive significant commercial milestones for the oncology licenses.
Also, Genevant appears in all BioNTech PR's
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
Patent case mentioned by Motley Fool
Why Moderna Stock Is Rebounding Today
The company plans to build a new manufacturing facility in Africa.
Keith Speights
(TMFFishBiz)
Oct 7, 2021 at 11:33AM
Finland halted the use of Moderna's vaccine in younger men.
The company's new facility in Africa could help it ease tensions with the White House.
Investors are also cautiously optimistic about Moderna's ongoing patent litigation.
What happened
Shares of Moderna (NASDAQ:MRNA) were rebounding somewhat on Thursday after several days of declines. The stock was up 4.6% as of 10:59 a.m. EDT today.
Moderna actually had more bad news today. Finland joined Denmark and Sweden in pausing the use of the company's COVID-19 vaccine for some individuals due to concerns about a rare heart inflammation issue. Finland's pause applies to men under age 30, the demographic with the highest risk for the cardiovascular problems.
However, Moderna also announced plans to build a new facility in Africa that will be able to produce up to 500 million doses of its messenger RNA (mRNA) vaccine each year.
In addition, the company's appeal to a Federal Circuit Court to invalidate two of Arbutus Biopharma's (NASDAQ:ABUS) patents is underway. Some investors appear to be cautiously optimistic about Moderna's chances with this case, although the most likely outcome is a settlement.
A healthcare professional giving a shot to a person.
IMAGE SOURCE: GETTY IMAGES.
So what
Why would the news about the African manufacturing facility and the federal court appeal have a bigger impact on the vaccine stock than Finland's pause of giving Moderna's vaccine to young men? Politics seems to be a likely factor with the former matter.
Politico reported earlier today that Moderna has been at odds with the Biden administration over producing more doses for use internationally. So the company's announcement about its plans to build the facility in Africa could help reduce the tensions with the White House.
As for the federal case, anything that emerges from the hearing that indicates a scenario where Moderna would pay less to Arbutus could be a positive sign for the biotech.
Now what
Moderna didn't provide any details about when construction would begin for its facility in Africa. The company also stated that it "expects to begin a process for country and site selection soon." That might not be enough to satisfy U.S. government officials.
Again, the odds seem stacked against Moderna in the patent case. However, the company could reach a settlement with Arbutus that investors like.
As for the heart inflammation issues, so far only Scandinavian countries have paused the use of Moderna's vaccine for some groups. If more nations follow suit, this could become a bigger problem for the company.
Nice reaction now for both ABUS and ROIV.
Patent Pundit's reaction to hearing.
@PunditPatent
·
39s
$ABUS Just listened to the oral arguments at the Federal Circuit. I think ABUS wins the '435 appeal based on standing, and it wins the '069 appeal on the merits.
Were we listening to the same hearing, DTGoody?
Seemed to me that even the Judge questioned the MRNA's lawyer rationale. At one point, she even said "I don't understand your argument."
Can't wait to read what Patent Pundit says.
https://twitter.com/PunditPatent
Moderna wants Fed. Cir. Help to Avoid Covid Vaccine Patent Suits
https://news.bloomberglaw.com/ip-law/moderna-wants-fed-cir-help-to-avoid-covid-vaccine-patent-suits
Did you notice that the tag line from the URL is different than the headline?
https://www.biospace.com/article/moderna-covid-19-vaccine-revenue-could-be-jeopardized-due-to-patent-claims-report/
Moderna Seeks to Shore Up Patent Protection on COVID-19 Vaccine
https://www.biospace.com/article/moderna-covid-19-vaccine-revenue-could-be-jeopardized-due-to-patent-claims-report/
Why Merck’s Celebrated Covid Pill Could Be Riskier Than People Think
https://www.barrons.com/articles/merck-covid-pill-risks-51633398722
Why Merck’s Celebrated Covid Pill Could Be Riskier Than People Think
https://www.barrons.com/articles/merck-covid-pill-risks-51633398722
GTE making second run today at a buck. Nice volume.
ABUS: Price and volume burst a few minutes ago.
Sudden ABUS price/volume burst.
Near term, if the Covid patent battle (court date this week) between MRNA and ABUS heats up, the results should spill over here.
The patent battle attention is warranted. Seeing it reflected in the price will hopefully be worth the wait.
Added close to bottom. Just don't see any reason for the fall.
Wish I had the answer to that question, Green Gold. Today was the second day of trading as ROIV and both days have seen drops on low volume. Thursday pre-market, when it was still trading as MAAC, it rose above $12 briefly on over 200K volume to fall during normal trading hours. For now, I'm using the fall as an opportunity to build a decent position.
Look what $3 billion bought.....
Check out the recent news below for each Vant. Won't be long before Sumitomo is knocking on Roivant's door to add to the Vants they've already acquired from them, IMO.
"November 1, 2019
Six weeks after Sumitomo Dainippon Pharma agreed a $3 billion deal to license a host of drug candidates developed by companies in Vivek Ramaswamy’s Roivant group, the detail of the transaction has been revealed.
The Japanese drugmaker is taking over Roivant’s stake in five of its subsidiaries, with an option on six more until 2024.
The five companies are women’s health specialist Myovant, urology company Urovant, Enzyvant and Altavant in the rare disease category, and Spirovant, a newly-unveiled company focused on developing innovative gene therapies for cystic fibrosis (CF).
Along with the $3 billion upfront fee to kick off the alliance, Sumitomo will also provide a $350 million loan facility to Myovant to help fund the launch of its late-stage candidate for uterine fibroids – relugolix – if it gets approved for marketing, plus a $200 million loan to Urovant for its overactive bladder drug vibegron.
If Sumitomo takes the option on the other six, it will have effectively bolted on a ready-made pipeline consisting of more than 25 clinical programmes, with multiple potential launches in the 2020 to 2022 timeframe."
Myovant: MYOVANT SCIENCES AND PFIZER ANNOUNCE FDA ACCEPTANCE OF SUPPLEMENTAL NEW DRUG APPLICATION FOR MYFEMBREE® FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Thursday, September 09, 2021 - 06:58am EST
Filing in endometriosis is supported by data from the Phase 3 SPIRIT program
FDA PDUFA target action date is May 6, 2022
https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-fda-acceptance
Enzyvant: Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval
30 Sep 2021
https://pink.pharmaintelligence.informa.com/PS145021/Premature-PRV-US-FDA-Mistakenly-Announces-Voucher-Award-For-Enzyvant-Ahead-Of-ApprovalNEWS
Altavant: Altavant Sciences Highlights Ongoing Phase 2b ELEVATE 2 Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension at European Respiratory Society Annual Congress
Altavant Sciences logo (PRNewsfoto/Altavant Sciences)
NEWS PROVIDED BY
Altavant Sciences
Sep 13, 2021, 10:06 ET
https://www.prnewswire.com/news-releases/altavant-sciences-highlights-ongoing-phase-2b-elevate-2-study-of-rodatristat-ethyl-in-patients-with-pulmonary-arterial-hypertension-at-european-respiratory-society-annual-congress-301375357.html
Urovant: Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate
New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate
Phase 3 EMPOWUR trial post-hoc subgroup analyses showed once-daily GEMTESA was associated with significantly reduced daily urgency episodes and micturitions in patients with OAB wet and dry (with and without urge urinary incontinence [UUI] per diary day, respectively) vs. placebo
Presented at the virtual AUA 2021 annual meeting, these data further support safety and efficacy of GEMTESA for treatment of OAB in patients with symptoms of UUI, urgency, and urinary frequency
September 13, 2021 07:30 AM Eastern Daylight Time
https://www.businesswire.com/news/home/20210913005249/en/Urovant-Sciences-Presents-Positive-Ambulatory-Blood-Pressure-Data-Showing-That-GEMTESA®-vibegron-75-mg-in-Overactive-Bladder-Was-Not-Associated-with-Statistically-Significant-or-Clinically-Meaningful-Effects-on-Blood-Pressure-or-Heart-Rate
Spirovant: Spirovant Continues Rapid Growth with New Headquarters and Expanded Leadership
https://www.globenewswire.com/news-release/2021/01/26/2164134/0/en/Spirovant-Continues-Rapid-Growth-with-New-Headquarters-and-Expanded-Leadership.html
Dermavant Closer to FDA Approval for Tapinarof
https://labusinessjournal.com/news/2021/sep/13/dermavant-fda-approved-tapinarof-forte-biosciences/
7 Companies Using AI for Drug Discovery
April 2021 article
https://www.nanalyze.com/2021/04/companies-ai-drug-discovery/
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
laurence@gilmartinir.com
619-916-7620
dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
ASalerno-Robin@dna-comms.com
212-445-8219
ABUS: 5 Penny Stocks To Watch This Week With Potential Biotech Catalysts
https://finance.yahoo.com/news/5-penny-stocks-watch-week-144500155.html
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/
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
The only thing I learned from Fridays opening day see-saw trading on ROIV was that the float, indeed, must be tiny.
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).
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
zachary@endpointsnews.com
@ZacharyBrennan
Zachary Brennan on LinkedIn
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
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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.
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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:
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619-916-7620
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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.
$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?
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
Thanks for UPST. Just sold yesterday's Put.