04-07-2024 02:30 PM | Source: Accord Fintech
Alembic Pharma shines on getting USFDA`s tentative approval for Ivosidenib Tablets

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Alembic Pharmaceuticals is currently trading at Rs. 988.80, up by 38.80 points or 4.08% from its previous closing of Rs. 950.00 on the BSE.

The scrip opened at Rs. 970.00 and has touched a high and low of Rs. 990.00 and Rs. 955.10 respectively. So far 6489 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1093.05 on 21-Feb-2024 and a 52 week low of Rs. 635.00 on 05-Jul-2023.

Last one week high and low of the scrip stood at Rs. 990.00 and Rs. 871.00 respectively. The current market cap of the company is Rs. 19228.79 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 19.84% and 10.54% respectively.

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier). 

Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) Newly Diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy (b) Adult patients with Relapsed or refractory AML (c) Adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated. 

Ivosidenib Tablets, 250 mg have an estimated market size of $114 million for twelve months ending March 2024 according to IQVIA. The company has a cumulative total of 207 ANDA approvals (179 final approvals and 28 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.