As we step into the new year, the spotlight is firmly on biotech firms as they await significant FDA decisions slated for January.
In the year 2024, the FDA gave the green light to 50 novel drugs, equaling the number from 2021 and ranking it as the fourth-highest year for approvals. The peak record for novel drug approvals was set in 2018 with 59, followed by 55 in 2023 and 53 in 2020.
**Atara Biotherapeutics Inc. (ATRA)**
Atara Biotherapeutics is anticipating an FDA decision on its T-cell immunotherapy, Tab-cel, by January 15, 2025. Tab-cel is proposed as a standalone treatment for both adult and pediatric patients aged two and above who have Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) and have undergone at least one prior therapy. If approved, Tab-cel would become the first sanctioned therapy for EBV+ PTLD in the United States. It is already approved in the European Union, the United Kingdom, and Switzerland under the brand name Ebvallo for similar indications.
The company enhanced its global partnership with Pierre Fabre Laboratories last November to further the development, manufacturing, and commercialization of Tab-cel in the U.S. and other markets. The initial agreement in October 2021 aimed to commercialize Tab-cel for EBV-positive cancers across Europe, the Middle East, Africa, and other emerging regions. Atara’s stock closed at $13.31, marking a 0.23% increase as of December 31, 2024.
**Biogen Inc. (BIIB)**
Biogen is awaiting the FDA’s verdict on January 25, 2025, regarding a monthly intravenous maintenance dose of Leqembi for treating Alzheimer's disease. Initially launched in January 2023, Leqembi is targeted at patients with mild cognitive impairment or mild dementia due to early Alzheimer's. The current dosage involves administering 10 mg/kg intravenously every two weeks to eligible patients, with confirmed Amyloid beta pathology before treatment initiation. The proposed regimen aims to maintain therapeutic levels through monthly infusions after the biweekly initiation phase. Eisai Co., Ltd. leads the drug’s global development and regulatory submissions, while both Eisai and Biogen share marketing responsibilities, with Eisai making the final decisions. Biogen’s shares rose 1.82% to $152.92 on the latest trading day.
**AstraZeneca plc (AZN)**
The FDA is poised to make a decision on Datopotamab Deruxtecan by January 29, 2025. This drug is intended for patients with previously treated metastatic HR-positive, HER2-negative breast cancer, which represents 73% of metastatic breast cancer cases. Datopotamab Deruxtecan, a TROP2-directed DXd antibody-drug conjugate, was developed by Daiichi Sankyo and AstraZeneca. TROP2 is prevalent in HR-positive, HER2-negative breast cancer and is linked to aggressive tumor growth and poor prognosis. Clinical trials have shown that Datopotamab Deruxtecan significantly improved progression-free survival (PFS) compared to chemotherapy in patients who had undergone prior endocrine-based and systemic therapies. AstraZeneca’s stock fell slightly by 0.08%, closing at $65.52.
**Vertex Pharmaceuticals Inc. (VRTX)**
Vertex Pharmaceuticals is set to receive an FDA decision on its investigational oral drug, Suzetrigine, on January 30, 2025. Suzetrigine, a selective NaV1.8 pain signal inhibitor, is proposed for the treatment of moderate-to-severe acute pain—a condition affecting over 80 million individuals annually in the U.S. and typically lasting less than three months. If approved, Suzetrigine would be the first new class of acute pain medication in over two decades. According to GlobalData, Suzetrigine's sales could peak at $1.4 billion by 2030. Vertex’s stock price increased by 0.84%, closing at $402.70.
**Axsome Therapeutics (AXSM)**
Axsome Therapeutics Inc. (AXSM) has taken a proactive step to obtain FDA approval for its drug AXS-07, aimed at the acute treatment of migraines, with a decision anticipated by January 31, 2025.
AXS-07 is a combination of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan. It is purported to function by inhibiting the release of Calcitonin gene-related peptide (CGRP), counteracting CGRP-induced vasodilation, and preventing neuroinflammation, the transmission of pain signals, and central sensitization.
The FDA previously declined approval for AXS-07 in May 2022, citing issues related to the chemistry, manufacturing, and controls (CMC) of the drug and its manufacturing processes.
In response to the regulatory agency's concerns, Axsome Therapeutics resubmitted the New Drug Application (NDA) for AXS-07 intended for the acute treatment of migraines in August 2024. As mentioned, a verdict is expected by the end of January 2025.
The company projects that, upon approval, AXS-07 has the potential to generate peak sales ranging from $500 million to $1 billion.
On Tuesday, AXSM shares concluded trading at $84.61, reflecting a slight decrease of 0.20%.
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