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AbbVie's Temab-A Gets Two FDA Breakthrough Therapy Tags in Cancer
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Key Takeaways
AbbVie's Temab-A earns two FDA Breakthrough Therapy designations for CRC and NSCLC.
Temab-A is being studied as a c-Met-directed ADC with a topoisomerase 1 inhibitor payload.
AbbVie is also evaluating Temab-A in head and neck, pancreatic, ovarian and other cancers.
AbbVie (ABBV - Free Report) announced that the FDA has granted two Breakthrough Therapy designations (BTDs) to its investigational next-generation antibody-drug conjugate (ADC), telisotuzumab adizutecan (Temab-A; ABBV-400), for two different types of cancer indications – colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
One BTD covers Temab-A in combination with bevacizumab for treating adults with refractory, metastatic CRC who were previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and, if indicated, anti-EGFR mAb therapy.
The second BTD is for Temab-A as a monotherapy for treating adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy.
The two new designations from the FDA mark the first BTDs for Temab-A.
ABBV’s Price Performance
Year to date, shares of AbbVie have rallied 21.6% compared with the industry’s increase of 11.7%.
Image Source: Zacks Investment Research
Both the above designations for Temab-A were based on data from the first-in-human M21-404 study. Temab-A is being evaluated as a c-Met-directed ADC with a topoisomerase 1 inhibitor payload across several advanced solid tumors, including CRC and NSCLC.
Besides CRC and NSCLC, AbbVie is evaluating Temab-A in other advanced solid tumors, including head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and ovarian cancer. The development program includes several phase III and phase II/III studies evaluating the drug as a monotherapy and in combination with other therapies.
AbbVie boasts a robust pipeline. The company recently announced positive top-line data from the phase III CERVINO study on etentamig for treating third-line-plus multiple myeloma. The study met both its primary goals, showing that treatment with etentamig significantly improved the objective response rate and progression-free survival compared with standard available therapies.
AbbVie is strengthening its portfolio of oncology medicines with the addition of ADCs, which are being considered a disruptive innovation in the pharmaceutical industry. ADCs will allow better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
AbbVie expects pivotal data readouts for some other key pipeline candidates, including Temab-A in metastatic CRC and lutikizumab in hidradenitis suppurativa. The company is also developing ABBV-706, an ADC for treating relapsed/refractory small-cell lung cancer, as well as some other candidates that are in early-stage development.
Over the past 60 days, estimates for Actuate Therapeutics’ 2026 loss per share have narrowed from 86 cents to 73 cents, while loss per share estimates for 2027 have declined from 78 cents to 59 cents during the same time. ACTU’s shares have plunged 88.2% year to date.
Actuate Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 8.21%.
Over the past 60 days, estimates for Bristol Myers’ 2026 earnings per share have risen from $6.81 to $6.91, while estimates for 2027 have increased from $6.42 to $6.46 during the same time. BMY’s shares have risen 15.6% year to date.
Bristol Myers’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 14.43%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have narrowed from $4.53 to $4.47, while loss per share estimates for 2027 have declined from $3.63 to $3.61 during the same time. CRSP’s shares have lost 0.1% year to date.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average negative surprise being 1.38%.
View the Zacks #1 Rank List
Image: Bigstock
AbbVie's Temab-A Gets Two FDA Breakthrough Therapy Tags in Cancer
Key Takeaways
AbbVie (ABBV - Free Report) announced that the FDA has granted two Breakthrough Therapy designations (BTDs) to its investigational next-generation antibody-drug conjugate (ADC), telisotuzumab adizutecan (Temab-A; ABBV-400), for two different types of cancer indications – colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
One BTD covers Temab-A in combination with bevacizumab for treating adults with refractory, metastatic CRC who were previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and, if indicated, anti-EGFR mAb therapy.
The second BTD is for Temab-A as a monotherapy for treating adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy.
The two new designations from the FDA mark the first BTDs for Temab-A.
ABBV’s Price Performance
Year to date, shares of AbbVie have rallied 21.6% compared with the industry’s increase of 11.7%.
Image Source: Zacks Investment Research
Both the above designations for Temab-A were based on data from the first-in-human M21-404 study. Temab-A is being evaluated as a c-Met-directed ADC with a topoisomerase 1 inhibitor payload across several advanced solid tumors, including CRC and NSCLC.
Besides CRC and NSCLC, AbbVie is evaluating Temab-A in other advanced solid tumors, including head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and ovarian cancer. The development program includes several phase III and phase II/III studies evaluating the drug as a monotherapy and in combination with other therapies.
Strong Pipeline Expands ABBV’s Growth Opportunities
AbbVie boasts a robust pipeline. The company recently announced positive top-line data from the phase III CERVINO study on etentamig for treating third-line-plus multiple myeloma. The study met both its primary goals, showing that treatment with etentamig significantly improved the objective response rate and progression-free survival compared with standard available therapies.
AbbVie is strengthening its portfolio of oncology medicines with the addition of ADCs, which are being considered a disruptive innovation in the pharmaceutical industry. ADCs will allow better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
AbbVie expects pivotal data readouts for some other key pipeline candidates, including Temab-A in metastatic CRC and lutikizumab in hidradenitis suppurativa. The company is also developing ABBV-706, an ADC for treating relapsed/refractory small-cell lung cancer, as well as some other candidates that are in early-stage development.
ABBV’s Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Actuate Therapeutics, Inc. (ACTU - Free Report) , Bristol Myers Squibb (BMY - Free Report) and CRISPR Therapeutics (CRSP - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Actuate Therapeutics’ 2026 loss per share have narrowed from 86 cents to 73 cents, while loss per share estimates for 2027 have declined from 78 cents to 59 cents during the same time. ACTU’s shares have plunged 88.2% year to date.
Actuate Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 8.21%.
Over the past 60 days, estimates for Bristol Myers’ 2026 earnings per share have risen from $6.81 to $6.91, while estimates for 2027 have increased from $6.42 to $6.46 during the same time. BMY’s shares have risen 15.6% year to date.
Bristol Myers’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 14.43%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have narrowed from $4.53 to $4.47, while loss per share estimates for 2027 have declined from $3.63 to $3.61 during the same time. CRSP’s shares have lost 0.1% year to date.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average negative surprise being 1.38%.