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AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
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AbbVie (ABBV - Free Report) announced that it has submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its investigational antibody-drug conjugate (ADC) telisotuzumab vedotin (Teliso-V) for previously treated EGFR wild type non-squamous non-small cell lung (NSCLC) cancer in adult patients with c-Met overexpression.
Currently, there are no FDA-approved therapies for treating c-Met overexpressing NSCLC.
If approved, Teliso-V will become the first-in-class therapy for the given indication.
Year to date, shares of AbbVie have rallied 25.7% compared with the industry‘s 20.2% rise.
Image Source: Zacks Investment Research
BLA Based on ABBV's LUMINOSITY Study
The above BLA, which seeks an accelerated nod for Teliso-V in c-Met overexpressing NSCLC, was based on data from the phase II LUMINOSITY study.
Data from the study showed that study participants treated with Teliso V achieved an overall response rate (ORR) of 35% across c-Met high patients and 23% across c-Met intermediate patients.
Per management, c-Met overexpression is found in 25% of advanced EGFR wild-type NSCLC patients and is also associated with a poor prognosis for these patients.
More Updates on ABBV's c-Met ADC – Teliso-V
Teliso-V has been developed by AbbVie to target the c-Met protein, which is overexpressed in many solid tumors, including NSCLC.
The company is also evaluating Teliso-V as a monotherapy in the phase III confirmatory study called TeliMET NSCLC-01 in patients with previously treated c-Met overexpressing EGFR wild-type NSCLC. Enrollment in the study is currently ongoing.
Teliso-V is a key part of AbbVie’s oncology pipeline. The company has another promising cancer candidate, ABBV-383, a BCMA CD3 bispecific, which is being evaluated in a phase III study for treating relapsed/refractory multiple myeloma. Several regulatory updates and key data readouts are expected in the next 12 months.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 6.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 42.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 44.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
AbbVie (ABBV - Free Report) announced that it has submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its investigational antibody-drug conjugate (ADC) telisotuzumab vedotin (Teliso-V) for previously treated EGFR wild type non-squamous non-small cell lung (NSCLC) cancer in adult patients with c-Met overexpression.
Currently, there are no FDA-approved therapies for treating c-Met overexpressing NSCLC.
If approved, Teliso-V will become the first-in-class therapy for the given indication.
Year to date, shares of AbbVie have rallied 25.7% compared with the industry‘s 20.2% rise.
Image Source: Zacks Investment Research
BLA Based on ABBV's LUMINOSITY Study
The above BLA, which seeks an accelerated nod for Teliso-V in c-Met overexpressing NSCLC, was based on data from the phase II LUMINOSITY study.
The company announced encouraging top-line data from the phase II LUMINOSITY study last November.
Data from the study showed that study participants treated with Teliso V achieved an overall response rate (ORR) of 35% across c-Met high patients and 23% across c-Met intermediate patients.
Per management, c-Met overexpression is found in 25% of advanced EGFR wild-type NSCLC patients and is also associated with a poor prognosis for these patients.
More Updates on ABBV's c-Met ADC – Teliso-V
Teliso-V has been developed by AbbVie to target the c-Met protein, which is overexpressed in many solid tumors, including NSCLC.
The company is also evaluating Teliso-V as a monotherapy in the phase III confirmatory study called TeliMET NSCLC-01 in patients with previously treated c-Met overexpressing EGFR wild-type NSCLC. Enrollment in the study is currently ongoing.
Teliso-V is a key part of AbbVie’s oncology pipeline. The company has another promising cancer candidate, ABBV-383, a BCMA CD3 bispecific, which is being evaluated in a phase III study for treating relapsed/refractory multiple myeloma. Several regulatory updates and key data readouts are expected in the next 12 months.
ABBV's Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 6.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 42.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 44.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.