Zai Lab Limited’s ( ZLAB Quick Quote ZLAB - Free Report) shares were up more than 11% on Aug 30, as its pipeline candidate, repotrectinib, obtained Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for treating patients with advanced solid tumors that have an NTRK gene fusion, who have progressed following treatment with tyrosine kinase inhibitors (TKIs).
The designation expedites the development and review of drugs for severe or life-threatening conditions for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over currently available treatment options.
The benefits include priority communications and guidance from the CDE to promote and expedite the drug development process.
ZLAB has an exclusive license agreement with Turning Point (acquired by Bristol Myers Squibb) to develop and commercialize repotrectinib in Greater China.
Zai Lab’s shares have lost 13.7% year to date compared with the
industry's 11.8% decline. Image Source: Zacks Investment Research
The Breakthrough Therapy tag is based on the global phase I/II TRIDENT-1 studywhere repotrectinib demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients.
Repotrectinib is a next-generation TKI that specifically targets ROS1 and NTRK oncogenic drivers implicated in advanced solid tumors, including non-small cell lung cancer (NSCLC).
In the United States, repotrectinib has already received three Breakthrough Therapy Designations from the FDA for various indications related to ROS1-positive metastatic NSCLC and advanced solid tumors with NTRK gene fusions.
In June 2023, the NMPA in China accepted a new drug application (NDA) seeking approval for repotrectinib to treat adult patients with locally advanced or metastatic ROS1-positive NSCLC. A similar NDA was also accepted by the FDA in the United States for the same indication in May 2023.
Zacks Rank & Stocks to Consider
Zai Lab currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are
ANI Pharmaceuticals ( ANIP Quick Quote ANIP - Free Report) , Annovis Bio ( ANVS Quick Quote ANVS - Free Report) and Corcept Therapeutics ( CORT Quick Quote CORT - 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 .
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 60.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 7.9% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 61.8% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.