AbbVie ABBV 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.
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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, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, 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%.
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AbbVie Inc. (ABBV) : Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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