Gilead Sciences GILD announced that its first-in-class Trop-2-directed antibody-drug conjugate, Trodelvy (sacituzumab govitecan-hziy), has been granted a second Breakthrough Therapy designation by the FDA for a lung cancer indication. The indicated population includes adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.
Gilead’s Trodelvy is currently approved for second-line or later metastatic triple-negative breast cancer (TNBC) patients in more than 50 countries and for certain patients with pre-treated HR+/HER2- metastatic breast cancer (MBC) in more than 40 countries, including the United States. The first Breakthrough Therapy designation was granted to Trodelvy for the TNBC indication in the United States.
Benefits of the FDA’s Breakthrough Therapy Designation Grant
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on an important clinical measure. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
In the past three months, shares of Gilead have gained 10.6% against the industry’s 10.8% decline.
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The FDA's decision is based on promising results from the global phase II TROPiCS-03 study in patients with ES-SCLC. Per the data readout, Trodelvy showed encouraging antitumor activity as a second-line treatment in both platinum-resistant and platinum-sensitive cases, with a safety profile consistent with previous studies. These findings support further research, and Gilead plans to launch a late-stage study to evaluate the drug in this patient group.
Lung cancer is the second most common cancer in the United States and the leading cause of cancer-related deaths. About 15% of lung cancer cases are SCLC, with nearly 70% of these diagnosed at an extensive stage, where the cancer has spread to both lungs or other parts of the body. Patients with ES-SCLC who do not respond to first-line treatments often face a poor prognosis with limited treatment options. This highlights a critical need for new, more effective therapies to improve survival and slow disease progression.
Please note that Gilead is currently evaluating Trodelvy alone or in combination with other agents, across late-stage studies, for various cancer types, comprising certain other TNBC and HR+/HER2- breast cancer groups, as well as tumors with high Trop-2 expression. These include SCLC, where the drug showed promise in the TROPiCS-03 study, and first-line metastatic non-small cell lung cancer, demonstrated in the EVOKE-02 study. Additionally, Trodelvy is being studied for potential use in head and neck cancer and gynecological cancers.
GILD Signs Collaboration Agreement With Terray Therapeutics
In a separate press release, Gilead announced that it has entered into a strategic collaboration with Terray Therapeutics, an AI-powered biotech, to discover and develop novel, small molecule therapies across multiple targets.
Per the terms of the agreement, Terray will use its proprietary tNova platform to discover and develop small molecule compounds for targets selected by Gilead. If Gilead exercises its exclusive option to license the compounds, the company will assume responsibility for further development and commercialization.
In consideration of the above arrangement, Gilead is liable to pay Terray an undisclosed upfront amount. Terray is also eligible to receive milestone payments for preclinical, clinical and sales achievements from Gilead, along with tiered royalties on net sales of GILD’s products resulting from the collaboration.
Gilead includes acquired IPR&D expenses in its GAAP and non-GAAP financial measures. This deal is expected to reduce Gilead’s 2024 GAAP and non-GAAP EPS by about 1 cent.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
GILD’s Zacks Rank & Other Stocks to Consider
Gilead currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, 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, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 7.8%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In the past three months, CTMX stock has lost 3.4%.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 23.6%.
SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
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