Palm Beach, FL –November 23, 2021 – FinancialNewsMedia.com News Commentary – The COVID-19 pandemic is expected to have a significant positive impact on the growth of the global antidepressant market. The pandemic is predicted to have a long and short term impact on the individual’s mental illness, given the hurdles faced during the crisis, such as social isolation due to lockdown, job insecurity, and fear of being infected by coronavirus. According to the survey conducted by Kaiser Family Foundation, in August 2020, 64% of the household who had a healthcare worker reported having experienced at least one adverse effect, such as difficulty sleeping or eating, increase in alcohol consumption or substance use, and worsening chronic conditions, on their mental health and wellbeing during the COVID-19 pandemic. Additionally, the Coronavirus Aid, Relief and Economic Security Act (CARES) provided USD 425 million to the Substance Abuse and Mental Health Services Administration for the expansion of mental health services to isolated veterans through telehealth and other related services. Thus, given the increasing incidence of depression and anxiety among the global population over the pandemic, the antidepressant market is expected to have a significant impact during the COVID-19 crisis.  A report from Mordor Intelligence said that the global antidepressant market was valued at approximately USD 14,538 million in 2020, and it is expected to witness a revenue of USD 17,233 million in 2026, with a CAGR of 2.68% over the forecast period.   Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), Voyager Therapeutics, Inc. (NASDAQ: VYGR), Denali Therapeutics Inc. (NASDAQ: DNLI), Relmada Therapeutics, Inc. (NASDAQ: RLMD), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD).

The report said: “The major depressive disorder segment by depressive disorder is projected to account for the significant share over the forecast period and North America has been dominant and is projected to have significant share in the global market.  The increasing cases of depression are one of the major factors that are expected to drive the overall growth of the antidepressant market in North America, particularly in the United States over the forecast period. Moreover, there is a rise in the geriatric population in the United States, which is expected to create more opportunities for market players in the region.   Additionally, the growing FDA approvals and increasing pipeline products by key players concentrated in the region drive the studied market. For instance, in March 2019, the US FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of resistant depression in adults. Thus, in view of the aforementioned factors, the antidepressant market is expected to witness significant growth over the forecast period in North America.”

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Adds Esketamine Nasal Spray to its Clinic Offerings in the U.K. – Pasithea Clinics is one of only three accredited clinics in the U.K. approved to offer esketamine nasal spray (SPRAVATO®) for treatment of mental health disorders –– Pasithea erapeutics Corp. (Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, has been approved to provide esketamine nasal spray (SPRAVATO®) for treatment-resistant depression in adults, and has begun offering the treatment in its Knightsbridge, London location. Only three clinics in the U.K. have been accredited to offer this treatment.

“This is an important milestone for our U.K. clinics and their patients,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics. “Major Depression is the leading cause of long-term disability worldwide. Current treatments have limited success and up to 30% of patients with depression do not respond to consecutive trials of antidepressant treatment. These patients are considered to have treatment-resistant depression and new treatment options are urgently needed.”

“Esketamine is safe and effective, especially when combined with ongoing psychiatric support. Due to some risks associated with this drug, patients treated in outpatient settings must be enrolled in a specific program. We are extremely proud to have been accredited to provide this treatment, a reflection of our high standards of care,” said Dr. Yassine Bendiabdallah, Managing Director of Pasithea Clinics in the U.K.   CONTINUED…  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

Voyager Therapeutics, Inc. (NASDAQ: VYGR), a gene therapy company developing life-changing treatments and next-generation adeno-associated virus (AAV) platform technologies, recently presented preclinical data demonstrating that IV dosing of a proprietary AAV vector identified by the TRACER screening technology, encoding an anti-HER2 antibody payload, prevented tumor growth in models of HER2+ brain metastases.

“The findings demonstrate that AAV gene transfer of HER2-directed antibodies to the central nervous system shows promise to treat brain metastases in patients with HER2+ breast cancer,” said Glenn Pierce, M.D., Ph.D., interim chief scientific officer of Voyager. “While approved anti-HER2 therapies are effective for peripheral disease, they have limited ability to reach the CNS in sufficient concentrations to treat brain metastases. By using a proprietary, TRACER AAV capsid to deliver Voyager’s vectorized payload, and by utilizing brain cells to produce therapeutic antibodies, we have demonstrated a durable effect against CNS tumors in several mouse models. We look forward to continued optimization of this innovative gene therapy approach as we progress toward clinical development.”

Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, recently reported financial results for the third quarter ended September 30, 2021, and provided business highlights.

“We continue to advance our broad therapeutic pipeline, strengthen our strategic collaborations, and build out our manufacturing and commercial capabilities,” said Ryan Watts, Ph.D., Denali’s Chief Executive Officer. “In the third quarter, we began a Phase 1b study of our potential first-in-class eIF2B activator, DNL343, in individuals with amyotrophic lateral sclerosis (ALS). Also in ALS, Sanofi has advanced our RIPK1 inhibitor, SAR443820 (DNL788), into Phase 2 development. In Parkinson’s disease (PD), we presented a progress update at Biogen’s R&D Day event on our LRRK2 inhibitor collaboration, highlighting data and activities to support late-stage development of BIIB122 (DNL151). In addition, our Transport Vehicle (TV)-enabled portfolio continues to move forward. Our Phase 1/2 study of DNL310 (ETV:IDS) for Hunter syndrome is now enrolling Cohort C, which is designed to further explore clinical endpoints in participants younger than four years of age. In parallel, we have begun activities to initiate a pivotal Phase 2/3 study of DNL310 for Hunter syndrome in the first half of 2022. Furthermore, we have started building out a clinical manufacturing facility to support our development plans and expansion of our TV platform programs.”

Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), recently provided a corporate update and announced financial results for the three and nine months ended September 30, 2021.

Our REL-1017 development program for the treatment of major depressive disorder remains on track, and we expect key data catalysts in each quarter of next year,” said Dr. Sergio Traversa, Relmada’s Chief Executive Officer. “We anticipate top-line results from our second human abuse potential study, this one assessing REL-1017 versus intravenous ketamine, in the first quarter, followed by top-line data from RELIANCE III, our ongoing monotherapy registrational Phase 3 study in the second quarter. We expect top-line results from RELIANCE I and RELIANCE II, our Phase 3 pivotal studies for adjunctive treatment, in the third and fourth quarters of 2022, respectively. Importantly, our robust R&D initiatives are supported by a strong balance sheet.”

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a leading biotech company developing psychedelic-inspired therapies, recently announced it has launched recruitment for a randomized placebo-controlled study evaluating the effects of daytime and evening administration of repeated low doses of LSD (the “LSD Study”).

Researchers will use digital measurement devices and software to measure the effects of microdoses of LSD on neuroplasticity markers such as BDNF plasma levels, as well as on various sleep measures, mood, cognitive performance, regulation of emotions, quality of life, and immune system response. The study will be conducted by Dr. Kim Kuypers of Maastricht University, a leading global authority on the use of low dose psychedelics.

“Research into the practice of taking repeated low doses of psychedelics starts with the basics, looking at whether there is a time of day that influences the impact of these treatments,” said Dr. Kuypers. “We are investigating whether the repeated intake of lower doses could lead to realignment of patterns of thinking that would enable individuals to access levels of self-awareness that can provide an enriched experience of life.”

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