AbbVie Inc. (NYSE:ABBV) shares are trending on Wednesday night.
FDA Fast-Tracks Temab-A in Two Major Cancers
Shares of the North Chicago-based biopharmaceutical company edged 0.44% higher to $272.56 in after-hours trading on Wednesday after the Food and Drug Administration granted two Breakthrough Therapy Designations (BTDs) to telisotuzumab adizutecan.
Telisotuzumab adizutecan is a next-generation antibody drug conjugate (ADC) that targets the c-Met protein, which is found at higher levels in many solid tumors. It combines a c-Met binding antibody with a topoisomerase 1 inhibitor as the drug payload. A cleavable linker connects the antibody and payload and is designed to limit the release of the payload throughout the body.
What The Two Designations Cover
The first BTD is for Temab-A plus bevacizumab in adults with refractory, metastatic colorectal cancer. The second is for monotherapy in EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer.
Both were primarily based on first-in-human study M21-404, AbbVie said.
Eleni Lagkadinou, AbbVie’s vice president of oncology early development, said, “These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors.”
What Investors Should Know
The company said the FDA’s BTD program is intended to expedite the development and review of investigational drugs with clinical evidence that may show substantial improvement over existing therapies.
Temab-A is investigational and has not been approved by global regulatory authorities.
AbbVie is also studying the drug in head and neck, gastroesophageal, pancreatic and ovarian cancers. These studies include several Phase 3 and Phase 2/3 trials.
Trading Metrics, Technical Analysis
AbbVie has a market capitalization of about $479.52 billion. Its stock has traded between a 52-week high of $274.94 and a 52-week low of $190.75.
ABBV has a Relative Strength Index (RSI) of 65.80.
On Wednesday, AbbVie experienced an elevated trading session, with volume reaching 6.08 million shares, 1.4 times above its average trading volume of 4.26 million.
Over the past 12 months, the stock has gained 16.55%.
Currently, ABBV is trading very close to its 52-week high.
Price Action: In the regular session, the biotech stock closed at $271.36, up 1.75%, according to Benzinga Pro data.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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