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Bristol Myers (BMY) NSCLC Drug Application Gets EMA Validation
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Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (“EMA”) has validated its marketing authorization application (“MAA”) for the next-generation tyrosine kinase inhibitor (“TKI”) repotrectinib.
The MAA is seeking approval of the candidate for the treatment for ROS1 TKI-naïve and pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (“NSCLC”) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors.
The MAA was based on positive results from the registrational phase I/II TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positivesolid tumors). Data from these studies showed robust responses and durability in these patients.
The FDA approved the candidate as an oral therapy for NSCLC under the brand name Augtyro in November 2023.
The candidate was added to BMY’s portfolio with the acquisition of Turning Point Therapeutics in August 2022. The approval will add Augtyro to Bristol Myers’ growing and differentiated NSCLC portfolio, expanding the company’s presence in precision medicine.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 18.2% in the past six months against the industry's growth of 2.4%.
Image Source: Zacks Investment Research
The potential approval of additional new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
BMY is all set to acquire oncology-focused company Mirati Therapeutics for a total equity value of $5.8 billion.
The acquisition will add Mirati’s lung cancer drug Krazati (adagrasib) to BMY’s strong oncology portfolio. The FDA approved the drug in December 2022 for the treatment of adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
We remind investors that the lucrative NSCLC market is pretty crowded with top players like Merck’s (MRK - Free Report) Keytruda, among others.
NSCLC accounts for 85% of lung cancer diagnoses, which is the leading cause of death in the United States. The two main types of lung cancer are non-small cell and small cell.
In October 2023, Merck FDA’s approval for Keytruda for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. With this approval, Keytruda has six indications in NSCLC across both metastatic and earlier stages of NSCLC.
Entrada’s loss per share estimate for 2023 has narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.
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Bristol Myers (BMY) NSCLC Drug Application Gets EMA Validation
Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (“EMA”) has validated its marketing authorization application (“MAA”) for the next-generation tyrosine kinase inhibitor (“TKI”) repotrectinib.
The MAA is seeking approval of the candidate for the treatment for ROS1 TKI-naïve and pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (“NSCLC”) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors.
The MAA was based on positive results from the registrational phase I/II TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positivesolid tumors). Data from these studies showed robust responses and durability in these patients.
The FDA approved the candidate as an oral therapy for NSCLC under the brand name Augtyro in November 2023.
The candidate was added to BMY’s portfolio with the acquisition of Turning Point Therapeutics in August 2022. The approval will add Augtyro to Bristol Myers’ growing and differentiated NSCLC portfolio, expanding the company’s presence in precision medicine.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 18.2% in the past six months against the industry's growth of 2.4%.
Image Source: Zacks Investment Research
The potential approval of additional new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
BMY is all set to acquire oncology-focused company Mirati Therapeutics for a total equity value of $5.8 billion.
The acquisition will add Mirati’s lung cancer drug Krazati (adagrasib) to BMY’s strong oncology portfolio. The FDA approved the drug in December 2022 for the treatment of adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
We remind investors that the lucrative NSCLC market is pretty crowded with top players like Merck’s (MRK - Free Report) Keytruda, among others.
NSCLC accounts for 85% of lung cancer diagnoses, which is the leading cause of death in the United States. The two main types of lung cancer are non-small cell and small cell.
In October 2023, Merck FDA’s approval for Keytruda for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. With this approval, Keytruda has six indications in NSCLC across both metastatic and earlier stages of NSCLC.
Zacks Rank and A Stock to Consider
BMY currently has a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Entrada Therapeutics (TRDA - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2023 has narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.