Cara Therapeutics Inc. (NASDAQ:CARA) and Vifor Pharma have announced that the US FDA has accepted and given Priority Review for KORSUVA™’s New Drug Application (NDA). KORSUVA (difelikefalin) is a solution for moderate-to-severe pruritus treatment in hemodialysis patients.
Phase II studies’ data supported NDA filing
The PDUFA target date has been set for 23 August 2021, and the regulatory agency confirmed that it is not planning any advisory committee meeting to discuss the NDA. Drug applications receive Priority Review from the FDA for potential therapies that, if approved, will have a considerable improvement in effectiveness or safety of diagnosis, prevention, or treatment of a serious condition relative to standard applications. Data from the pivotal Phase II trials KALM-1 carried in the US and global KALN-2 conducted globally, and supportive data from other additional 32 clinical trials will support the NDA filing.
Cara Therapeutics CEO Derek Chalmers said that the FDA acceptance and granting of the Priority Review for KORSUCA NDA is a massive milestone for the company and several hemodialysis patients battling chronic intractable pruritus. He added that the agency’s agreement to accelerate the timeline through Priority Review designation aligns with its understanding of KORSUVA’s therapeutic potential to change the treatment paradigm for the patient population. Chalmers added that they are looking forward to collaborating with the FDA through review alongside Virfor Pharma with the optimism of potential KORSUVA injection launch in the US once approved.
KORSUVA to launch in the US immediately it is approved
Stefan Schulze, Vifor Pharma CEO, said that they are delighted to receive a Priority Review from the FDA for the breakthrough therapy. Schulze said that chronic pruritus is a debilitating condition in hemodialysis patients, which impacts the quality of life significantly as well as increases hospitalization and mortality risk. The condition affects around 40% of dialysis patients globally; thus, if KORSUVA™ receives approval, there will be a medicine for the condition. This will be in line with Vifor Pharma’s vision of delivering innovative drugs to patients with significant unmet medical needs. Schulzer said that they expect to bring the new treatment to patients as soon as possible.
Lexaria Bioscience Corp (NASDAQ: LEXX) Announces Expansion Of Its Intellectual Property Portfolio
Lexaria Bioscience Corp (NASDAQ: LEXX) announced an expansion of its intellectual property portfolio. The news comes after the global innovator in drug delivery platforms was granted its debut patent in Japan.
According to sources, this is the 20th patent granted to the company. With the patent titled “Stable ready-to-drink beverage compositions comprising lipophilic active agents, Lexaria Bioscience Corp is granted patent protection in Japan.
CEO comments on the 20th patent granted to the company
“With our 20th patent granted worldwide, Lexaria continues to demonstrate the versatility of our DehydraTECH drug delivery platform, encouraging innovation in the consumable liquid category around the world,” said Chris Bunka, CEO of Lexaria. “This new patent adds to our existing suite of granted patents spanning the EU, the U.S., India and Australia, and continues to build value for Lexaria shareholders and clients.”
Information about the patent
From the third patent family, this is the third patent granted. As many as 13 patent families have made it to Lexaria’s patent application suite. According to sources, non-psychoactive cannabinoids and NSAIDS are the active ingredients permitted for use under the new patent.
Patent applications progressing at a global level
According to reports, Lexaria Bioscience Corp currently has ongoing patent applications in countries across the globe. News about developments and progress about the patent status will be made available by the company as information becomes available.
DehydraTECH™ is a drug delivery technology that is reportedly used to enhance active pharmaceutical ingredients (APIs) enter the bloodstream. Formulated by Lexaria Bioscience Corp, it enhances the effectiveness of fat-soluble active molecules by reducing the overall dosing. The technology that the company develops can be used in a range of ingestible product formats like foods, beverages, oral suspensions, tablets, and capsules.
According to reports, the introduction of DehydraTECH, with cannabinoids and nicotine, has increased bio-absorption is by up to 5-10x. Additionally, this has also brought down the time of onset from 1-2 hours to minutes.
OrganiGram Holdings Inc (NASDAQ: OGI) Reports Gross Revenue Of $29.1 Million For 3Q 2021
OrganiGram Holdings Inc (NASDAQ: OGI) recently declared its third-quarter earnings. The company reported gross revenue of $29.1 million for the third quarter of 2021. The corporate house recorded an increase in earnings 39% sequentially to $20.3 million in Q3 this year, from Q2 2021, and 13% from the same prior-year period. The company is a leading licensed producer of cannabis.
Chief Strategy Officer comments on the growth in revenue
“We are pleased with the growth in revenue in Q3 as we were better staffed to fulfill the demand for our revitalized product portfolio, which continues to resonate well with consumers,” said Paolo De Luca, Chief Strategy Officer. “The ongoing investment in our genetics and cultivation program has yielded some exciting new dried flower products with more genetics and derivative product launches planned for the near term. Sales are trending higher to date in Q4 supported by a strong outlook for the industry as the number of cannabis retail stores continues to grow and existing stores are permitted to re-open their doors to customers.”
A plethora of new products launched this year
This year, various products were launched. Starting with March 2021, OrganiGram Holdings Inc introduced its Edison Black Cherry Punch, I.C.C.and Slurricane strains. They were introduced in a package of three half-gram pre-rolls.
In the following month in the same year, GMO Cookies and MAC-1, which are high potency Edison dried flower strains, were introduced by the company. The products contain 20-26% THC range and are available in the market in 3.5g format. They can also be purchased as packages of three half-gram pre-rolls.
Another product was made available in the market in March this year. As part of the Indi portfolio, Skyway Kush, the debut strain which offers a 20% to 23% THC range, was introduced. In June 2021, in 3.5g formats, two Indi dried flower strains were made available at quarter-end. While Biscotti Gelato has a THC range of 20-26%, Gelato #33 has a THC range of 17-23%.
Neptune Wellness Solutions Inc (NASDAQ: NEPT) Reported Net Loss of $60.3 Million In Fourth Quarter 2021
Neptune Wellness Solutions Inc (NASDAQ: NEPT) a fully integrated wellness company, reported the financial performance for the fourth quarter of 2021 and the year ended 2021. During the fourth quarter, the company reported a loss of $60.3 million, which was higher than the corresponding period last year.
In Red for the second consecutive year: 2021 was the challenging year for the company and industry due to pandemic and transformation activities undertaken by the company. The company reported revenue of $6.8 million for the fourth quarter, and the year ended 2021, the revenue stood at $46.8 million, a 56% growth compared to the revenue in 2020. However, due to pandemic and transformation activities, the cost increased year on year. As a result, the company reported a loss of $24.8 million during the quarter, and for the whole year, the gross loss stood at $36.2 million.
Given the increase in cost, the adjusted EBITDA came in at a negative $24.7 million in the fourth quarter, and for the entire year, it was negative $52.7 million. Loss ad adjusted EBITDA level coupled with an increase in depreciation and interest outgo, the company reported a loss in Q4 2021 and for 2021. The loss at the end of the year stood at $52.7 million. During the quarter, the company raised $55 million by placing the equity with investors.
Guidance: The company indicated the guidance for the revenue in the range of $10 to $12 million, and the company is well place to achieve top-line growth. Management further indicated, given the cost initiatives taken by Neptune Wellness in the last year, the benefit of the same is expected to come in 2022. In addition, Neptune will continue to drive the growth in its organic brand through innovation and extensive distribution of its products. Further, the company is also looking at acquisitions (acquired majority stake in Sprout Food, baby food brand in the U.S. in Q4 2021), which will drive the earnings immediately. Both these factors should result in higher margins in the medium to long term and ultimately enhanced value for its shareholders.