Inventiva: FDA Fast Track designation granted to lanifibranor in NASH, cirrhosis

 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively.

https://finance.yahoo.com/news/inventiva-announces-fda-decision-fast-200000436.html

Incyte: FDA OKs Opzelura™ (ruxolitinib) to Treat Atopic Dermatitis

 Opzelura is the first and only topical Janus kinase (JAK) inhibitor approved in the United States

- In Phase 3 studies, Opzelura significantly reduced the skin inflammation and itch associated with AD

- Investor conference call and webcast scheduled for September 22, 2021, at 8:00 a.m. ET

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction1.

"Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease," said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences. "As a clinician, I am excited to have a non-steroidal topical cream like Opzelura."

"The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation," said Hervé Hoppenot, Chief Executive Officer, Incyte. "At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases."

Conference Call Information

Incyte will host an analyst and investor conference call and webcast on September 22, 2021, at 8:00 a.m. ET. The live and archived webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers (conference identification number 13723195).

If you are unable to participate, a replay will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415 (conference identification number 13723195).

https://finance.yahoo.com/news/incyte-announces-u-fda-approval-201300422.html

PROCEPT BioRobotics Announces Closing of Upsized IPO

 PROCEPT BioRobotics Corporation (Nasdaq: PRCT) (“PROCEPT”), a commercial-stage surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced the closing of its upsized initial public offering of 7,539,400 shares of its common stock, including the full exercise of the underwriters’ option to purchase up to 983,400 additional shares of common stock, at a public offering price of $25.00 per share. All of the shares were offered by PROCEPT. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $188.5 million. The shares began trading on the Nasdaq Global Market on September 15, 2021 under the ticker symbol "PRCT."

BofA Securities and Goldman Sachs & Co. LLC acted as joint lead bookrunning managers for the offering. Cowen, Guggenheim Securities and SVB Leerink acted as co-managers.

https://www.bakersfield.com/ap/news/procept-biorobotics-corporation-announces-closing-of-upsized-initial-public-offering-and-full/article_d1703e0a-be24-55c6-bf75-129c0fdd044a.html

Denali started at Outperform by Oppenheimer

 Target $85

https://finviz.com/quote.ashx?t=DNLI&ty=c&ta=1&p=d

Why Shares of Solid Biosciences Are Jumping

 Shares of Solid Biosciences (NASDAQ:SLDB) are up 24% as of 11:15 a.m. EDT as the company prepares to present long-term data for three patients in a phase 1/2 study of its treatment for Duchenne muscular dystrophy. The presentation will take place at the World Muscle Society Virtual Congress. 

Solid's drug candidate -- SGT-001 -- is a gene transfer therapy designed to address the absence of the dystrophin protein in those with the disease. Early data suggests SGT-001 could slow or stop the progression of Duchenne muscular dystrophy regardless of how far the disease has progressed.

The market for treatments is estimated to be slightly less than $1 billion, but it is growing more than 40% per year. To date, only one drug has been approved by the Food and Drug Administration (FDA) to treat Duchenne. That's a weekly hourlong infusion created by a subsidiary of a Japanese pharmaceutical company. Notably, that treatment from is a piece of synthetic messenger RNA. That's the same method both Moderna and BioNTech used to create their COVID-19 vaccines.

Shareholders will eagerly await the data on the three high-dose patients. In 2018, the drug was put on clinical hold by the FDA. Another hold was placed in 2019 when the agency determined a trial participant had suffered a kidney injury associated with SGT-001. In May, Solid shared yet another safety event during its first-quarter earnings call. 

Despite the concerns, Ultragenyx Pharmaceutical (NASDAQ:RARE) established a partnership with Solid last October. The deal gave Ultragenyx an exclusive license to certain products in exchange for a $40 million investment. It could be worth $255 million based on milestone payments. If the data today is positive, it should give the company negotiating leverage for any potential buyout. It might also give it a leg up in the race for a treatment. Sarepta Therapeutics (NASDAQ:SRPT) and Pfizer (NYSE:PFE) have Duchenne programs of their own. 

https://www.fool.com/investing/2021/09/21/why-shares-of-solid-biosciences-are-jumping-today/

Booster of J&J COVID-19 vaccine provides stronger protection-company

 A second dose of Johnson & Johnson’s COVID-19 vaccine given about two months after the first increased its effectiveness to 94 percent against symptomatic infection, the company said Tuesday.

The company said in a statement that the new data showed that a booster shot could also increase antibody levels and provide better protection against severe disease.

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases,” Dr. Mathai Mammen, global head of Janssen Research & Development, said in a statement.

Johnson & Johnson’s single-dose vaccine shot had only provided 70 percent protection.

The drugmaker’s ongoing phase 2 trials showed that the two doses administered about 56 days apart provided 100 percent protection against severe cases and 94 percent protection against moderate to severe infection.

The results put the shot on par with Pfizer and Moderna’s two-dose vaccines, which are 95 percent and 94 percent, respectively, against symptomatic illness.

The company also said a booster given two months after the first dose increased antibody levels four- to six-fold. When administered six months after the first dose, antibody levels jumped 12-fold, data shows.

“This suggests that the efficacy might be even greater when the booster is given at this later point in time,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News.

The company is in talks with regulators from the Food and Drug Administration, the European Medicines Agency and others regarding using booster doses of its vaccine.

https://nypost.com/2021/09/21/booster-shot-of-jj-covid-19-vaccine-provides-stronger-protection/

Health Authorities Claim 'Performers' (Rich & Famous) Are Exempt From Mask Rules

 by Paul Joseph Watson via Summit News,

The LA County Department of Public Health responded to criticism of the maskless Emmys by claiming the rules didn’t apply because it was a television production event – despite the fact that workers were still made to wear masks.

There was uproar on Sunday as celebrities packed themselves into the Event Deck at LA Live without a mask amongst them as they kissed and hugged all night long.

Irate respondents on Twitter asked why celebrities were exempt from the rules yet their 4-year-old kids had to wear masks in class.

Under Los Angeles County’s Department of Health guidelines, everyone aged two years and older must wear a face covering in “all indoor public settings, venues, gatherings, and public and private businesses.”

However, after it was asserted that the rules don’t appear to apply to the rich and famous, the department was forced to respond.

New: LA County Department of Public Health tells me that the mask-less Emmys were not in violation of the county's mask mandate because "exceptions are made for film, television, and music productions” since “additional safety modifications” are made for such events. pic.twitter.com/6S105zYjbJ

— Oliver Darcy (@oliverdarcy) September 20, 2021

“LA County Department of Public Health tells me that the mask-less Emmys were not in violation of the county’s mask mandate because “exceptions are made for film, television, and music productions” since “additional safety modifications” are made for such events,” tweeted CNN’s Oliver Darcy.

So apparently, so long as you’re making a television production, COVID-19 recognizes that fact and doesn’t show up for the night, much like it disappears as soon as people sit down to eat at a restaurant, but not while they walk to the table.

Health authorities went further, insisting that the event organizers “exceeded the baseline requirements for television and film productions,” before asserting that the full vaccination of all those present was “one of the most powerful ways to achieve a safe environment” (despite the fully vaccinated being able to pass on the virus).

“The Emmy Award Show is a television production and persons appearing on the show are considered performers,” they added.

So apparently, if you’re a “performer,” or in other words rich and famous, you don’t have to wear a mask.

But if you’re merely a lowly worker drone, you still have to wear a mask, as dozens of staffers were seen doing at the event.

Makes perfect sense.

Meanwhile, San Francisco Mayor London Breed responded to criticism of her not wearing a mask inside a club by saying the “fun police” were making a story out of nothing.

Maybe she’s a “performer” too?

https://www.zerohedge.com/political/health-authorities-claim-performers-rich-famous-are-exempt-mask-rules