Palm Beach, FL –December 8, 2021 – FinancialNewsMedia.com News Commentary – Systemic Lupus Erythematosus is also known as lupus. It is an autoimmune disease that affects all parts of your body. The reason for the occurrence of autoimmune disease is because the immune system attacks our body as it perceives it as something foreign. People with this disease can live a normal life. The symptoms of lupus may include arthritis, adnominal pain, hair loss, kidney disease, rashes, headaches, etc. Depending upon the type of lupus and the result from blood tests, a patient will receive different diagnosis and treatment for him or her. The number of cases of systemic lupus erythematosus has seen a rise, which is increasing demand for systemic lupus erythematosus treatment, contributing to the growth of the global market. The arrival of key pipeline agents and recent drug, approvals have driven the growth of the Systemic Lupus Erythematosus market and are factors that are playing a substantial role in the market.   A report from Grand View Research projected that the global systemic lupus erythematosus market size is expected to reach USD 3.08 billion by 2025, exhibiting a CAGR of 7.0% during the forecast period, while another report from Verified Market Research said that: “The systemic Lupus Erythematosus Treatment Market was valued at USD 2 Billion in 2019 and is projected to reach USD 3.56 Billion by 2027, growing at a CAGR of 7.1% from 2020 to 2027.”   Active companies in the markets today include:  Hoth Therapeutics, Inc. (NASDAQ: HOTH), Longeveron Inc. (NASDAQ: LGVN), AbbVie Inc (NYSE: ABBV). PetVivo Holdings, Inc. (NASDAQ: PETV), Amgen (NASDAQ: AMGN).

Verified added: “The number of cases of systemic lupus erythematosus has seen a rise, which is increasing demand for systemic lupus erythematosus treatment, contributing to the growth of the global market. According to the lupus foundation of America, approximately 1.5 million people in the U.S. and globally 6 million people are diagnosed with it. The arrival of key pipeline agents and recent drug, approvals have driven the growth of the Systemic Lupus Erythematosus market.  North America was the major contributor for the SLE market revenue in (recent years) and is anticipated to rise at a CAGR of 8.1% during the forecast period (2025). This is due to availability of reimbursement and better healthcare infrastructure and accessibility to biologics. Europe was ranked as the second largest regional market in the SLE market and is expected to register a CAGR of 5.5% over the forecast period.”

Hoth Therapeutics, Inc. (NASDAQ: HOTH) BREAKING NEWS: Hoth Therapeutics Licenses Lupus Therapeutic Back to Zylö Therapeutics – Hoth to receive shares in Zylö and potential future sales royalties – Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, is pleased to announce that it has entered into an agreement with Zylö Therapeutics (“Zylö”) to license its novel cannabinoid therapeutic, HT-005 for lupus patients, back to Zylö.

Hoth’s CEO, Robb Knie, stated “The licensing of HT-005 back to Zylö after proving its efficacy and safety in animals is a win-win for both companies. We are excited about Zylö’s expertise in the cannabinoid space and are pleased to receive both further equity in Zylö and the potential upside through royalties. Hoth will also reap cost savings, as Zylö will be responsible for future development cost.”

Scott Pancoast, Zylö’s CEO, stated, “Hoth has been a great partner, working closely with the Zylö team to confirm efficacy in an animal model and to strategize about the preclinical development plan.”

Therapeutic options for CLE are limited to steroids (topical and oral), topical calcineurin inhibitors, and other immunomodulating therapies that could have adverse effects during long-term use. Zylö Therapeutics has developed a patented topical delivery system using xerogel-derived particles called Z-pods. Hoth had an exclusive license to develop HT-005, a drug that targets the endocannabinoid pathway, encapsulated in the Z-pods to enhance absorption into the skin. To investigate proof-of concept efficacy of HT-005 loaded Z-pods, Zylö Therapeutics conducted a study in MRL/lpr mice, an established animal model that shows symptoms similar to systemic lupus erythematosus (SLE) in humans. Results from the study demonstrated that the novel HT-005 loaded Z-pods were effective in reducing skin plaques associated with CLE, with statistical significance demonstrated in the overall average skin score as well as individual skin scores on the head and scapula.  CONTINUED…  Read the Hoth Therapeutics full press release by going to:  https://ir.hoththerapeutics.com/news-releases

In other news and developments of note in the markets this week: 

AbbVie Inc (NYSE: ABBV) recently announced positive top-line results from a late-stage study, U-EXCEED, on Rinvoq (upadacitinib), a selective and reversible JAK inhibitor.  AbbVie’s study enrolled patients with moderate-to-severe Crohn’s disease who had an inadequate response or were intolerant to biologic therapy, with over 60% having previously failed two or more biologics.

In the U-EXCEED study, a significantly higher proportion of patients with moderate-to-severe Crohn’s disease treated with Rinvoq (45 mg once daily for induction) achieved both primary endpoints of clinical remission and endoscopic response compared to placebo at week 12. Clinical remission was measured by the Crohn’s Disease Activity Index (CDAI) and by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).

Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, recently announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants.

ODD is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases or conditions. ODD positions Longeveron to be able to potentially leverage a range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a marketing application, and certain tax credits. Receiving ODD may also result in the product receiving seven years market exclusivity upon approval for use in the rare disease or condition for which the product was designated if all of the statutory and regulatory requirements are met.

PetVivo Holdings, Inc. (NASDAQ: PETV), an emerging biomedical device company focused on the commercialization of innovative medical therapeutics for animals, recently announced the launch of a digital media campaign, which includes the production, broadcasting, and distribution of technical interviews, commercials and digital billboards ads. The digital media campaign was produced and organized by FMW Media Corp., the creator/producer of “New to The Street T.V.”

The digital media campaign includes the production and broadcast of at least 40 interviews, as well as the production of 30-second T.V. commercials, wherein at least 50 commercials shall be broadcast per month, for a total of 600 commercials. For the next 12 months, the interviews and commercials shall air on Newsmax TV, Bloomberg, Fox Business Network, and CNBC. Additionally, the PetVivo will run at least two thousand four hundred (2400) 15-second commercial ads per day. These ads will be displayed on digital billboards that are located throughout lower Manhattan, New York City, NY.

Amgen (NASDAQ: AMGN) recently announced new data from its hematology pipeline and marketed portfolio to be presented at the 63^rd American Society of Hematology (ASH) Annual Meeting & Exposition in Atlanta, Georgia, and virtually, from Dec. 11-14, 2021.

“The data being presented at ASH demonstrates Amgen’s commitment to reaching more patients with our innovative hematology medicines and improving the patient experience by exploring more convenient administrations for people living with blood cancers,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “By accelerating the development and delivery of transformative medicines in difficult to treat and vulnerable patient populations, including children and pregnant women, we continue to focus on the relentless pursuit of breakthroughs for blood cancer patients and their families.”

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