The FDA approved three novel drugs in March, bringing the total number of novel drug approvals this year to ten.
Now, let’s take a look at the biotech stocks with regulatory catalysts in April.
Merck & Co. Inc. (MRK)
The FDA decision on the expanded use of Merck & Co. Inc.’s (MRK) Vaxneuvance for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age is expected on April 1, 2022.
Vaxneuvance is already approved for the prevention of invasive pneumococcal disease in adults caused by 15 serotypes. This vaccine utilizes Ligand Pharmaceuticals Inc.’s (LGND) CRM197 vaccine carrier protein, which is produced using the patent-protected Pelican Expression Technology platform.
MRK closed Friday’s trading at $81.34, up 1.16%.
BioXcel Therapeutics Inc. (BTAI)
BioXcel Therapeutics Inc.’s (BTAI) BXCL501, proposed for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, is under FDA review, with a decision anticipated on April 5, 2022.
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of Dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms.
Agitation is a common and difficult to manage symptom in schizophrenia and bipolar disorders I and II. These two diseases affect an estimated 9 million persons in the United States, with more than 3 million experiencing agitation each year.
If approved, BXCL501 could rake in peak sales of $1 billion, according to analysts.
BTAI closed Friday’s trading at $21.96, up 0.46%.
Regeneron Pharmaceuticals Inc. (REGN)
The FDA decision on Regeneron Pharmaceuticals Inc.’s (REGN) REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals is expected on April 13, 2022.
In the U.S., REGEN-COV is currently authorized under an Emergency Use Authorization (EUA) to?treat people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain?post-exposure prophylaxis?settings.
REGN closed Friday’s trading at $680.03, up 0.04%.
Alnylam Pharmaceuticals Inc. (ALNY)
Alnylam Pharmaceuticals Inc’s (ALNY) investigational RNAi therapeutic Vutrisiran is at the FDA altar, with a decision expected on April 14, 2022.
Vutrisiran, administered subcutaneously, is proposed for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, which encompasses both hereditary ATTR (hATTR) amyloidosis and wild-type ATTR (wtATTR) amyloidosis.
The company already has one approved drug for hATTR amyloidosis in adults that goes by the name Onpattro.
Onpattro is administered via intravenous (IV) infusion once every 3 weeks while Vutrisiran is designed to be administered subcutaneously (SC) once every 3 months.
If approved, Vutrisiran could bring home peak sales of over $1 billion, according to analysts.
ALNY closed Friday’s trading at $163.81, up 0.07%.
TG Therapeutics Inc. (TGTX)
An FDA panel is scheduled to review TG Therapeutics Inc.’s (TGTX) Biologics License Application/supplemental New Drug Application for the combination of Ublituximab and Ukoniq, known as the U2 regimen, on April 22, 2022.
Ublituximab is an investigational anti-CD20 monoclonal antibody and Ukoniq is an approved phosphoinositide 3 (PI3) kinase delta inhibitor indicated for patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma.
The U2 regimen is proposed for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are the same disease. In CLL, cancer cells are found mostly in the blood and bone marrow while in SLL cancer cells are found mostly in the lymph nodes. (Source: National Cancer Institute).
TGTX closed Friday’s trading at $9.97, down 3.48%.
Bristol-Myers Squibb Company (BMY)
Bristol-Myers Squibb Co.’s (BMY) Mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, which is at the FDA altar, awaits the decision on April 28, 2022.
Mavacamten is proposed for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Hypertrophic cardiomyopathy, which is the most common inherited heart disease, is characterized by excessive contraction of the heart muscle and reduced ability of the left ventricle to fill – leading to the development of debilitating symptoms and cardiac dysfunction. It is estimated to affect one in every 500 people.
According to Evaluate Vantage, Mavacamten, if approved, could achieve peak sales of $1.7 billion in 2026.
BMY closed Friday’s trading at $73.28, up 1.20%.
Supernus Pharmaceuticals Inc. (SUPN)
The FDA decision date on the expanded use of Supernus Pharmaceuticals Inc.’s (SUPN) Qelbree in the treatment of attention-deficit/hyperactivity disorder in adults is set for April 29, 2022.
Attention-deficit/hyperactivity disorder or ADHD is one of the most common pediatric neurodevelopmental disorders. It is most commonly diagnosed in childhood and lasts far into adulthood.
Qelbree was approved in the U.S. for the treatment of pediatric patients with ADHD aged 6 to 17 last April. Launched in May 2021, the drug generated sales of $9.9 million last year.
SUPN closed Friday’s trading at $32.03, down 0.74%.
Axsome Therapeutics Inc. (AXSM)
Axsome Therapeutics Inc.’s (AXSM) AXS-07, developed for the acute treatment of migraine, is under FDA review, with a decision expected on April 30, 2022.
AXS-07 works by inhibiting Calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuroinflammation, pain signal transmission, and central sensitization.
Some of the FDA-approved drugs for the acute treatment of migraine include Eli Lilly’s Reyvow, Allergan’s Ubrelvy, and Biohaven’s Nurtec.
If approved, the drug could achieve peak U.S. sales of $500 million to $1 billion, according to the company.
AXSM closed Friday’s trading at $35.36, down 1.72%.
HUTCHMED (China) Limited (HCM)
The FDA decision on HUTCHMED (China) Ltd.’s (HCM) Surufatinib, proposed for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors, is expected on April 30, 2022.
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They are classified as pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors.
Surufatinib has a unique dual mechanism of action – inhibiting angiogenesis and promoting the body’s immune response against tumor cells.
In China, Surufatinib is marketed under the brand name Sulanda since January 2021 for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors.
The drug has the potential to achieve peak blockbuster sales, according to analysts.
Novartis’ Afinitor and Pfizer’s Sutent are approved in the U.S. for certain neuroendocrine tumors.
HCM closed Friday’s trading at $18.46, down 10.91%.
Coherus BioSciences Inc. (CHRS)
The FDA decision on Coherus BioSciences Inc.’s (CHRS) Toripalimab, developed for nasopharyngeal carcinoma, is anticipated on April 30, 2022.
Nasopharyngeal carcinoma is a rare tumor of the head and neck that originates in the nasopharynx. Currently, there are no FDA-approved immuno-oncology treatment options for this condition.
Toripalimab has received conditional approval for three indications in China where it is marketed as Tuoyi. The approved indications are metastatic urothelial carcinoma, unresectable or metastatic melanoma and recurrent or metastatic nasopharyngeal carcinoma.
The drug is developed Shanghai Junshi Bioscience Co., Ltd., and in January 2021, Coherus in-licensed rights to develop and commercialize Toripalimab in the United States and Canada.
CHRS closed Friday’s trading at $12.43, down 3.57%.
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