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The biotech sector continues to be in focus with pipeline and regulatory updates. The development of vaccine for COVID-19 also continues to be in focus, particularly for the younger population.
Recap of the Week’s Most Important Stories:
Regeneron’s Libtayo Gets Positive CHMP Opinions for Additional Indications: Regeneron (REGN - Free Report) and partner Sanofi announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given positive opinions for oncology drug, Libtayo (cemiplimab), as monotherapy in two advanced cancers. The CHMP recommended the approval of the drug for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. The drug was recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
Libtayo is currently approved in the European Union (EU) and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma (CSCC).
Moderna’s COVID-19 Vaccine Study on Teens Meets Goals: Moderna, Inc. (MRNA - Free Report) announced that the phase II/III study of its COVID-19 vaccine, mRNA-1273, in adolescents met its primary immunogenicity endpoint. The study, TeenCOVE, enrolled more than 3,700 participants aged 12 to less than 18 years in the United States. The primary endpoint was non-inferior immunogenicity compared to the COVE study that evaluated the vaccine in adults. Data from the TeenCOVE study showed an efficacy of 100%, with no cases of COVID-19 after 14 days following administration of the second dose. A vaccine efficacy of 93% in seronegative participants was observed after 14 days of the first dose. The positive data from the study demonstrate successful bridging of immune responses to the adult vaccination. Moderna plans to submit data from the study to regulators globally in early June and request authorization for the vaccine.
Bristol Myers’ Opdivo Label Expansion: Bristol Myers (BMY - Free Report) announced that the FDA has approved another label expansion of its blockbuster immuno-oncology drug, Opdivo (nivolumab). Opdivo (injection for intravenous use) has been approved for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
Earlier, the company announced that the CHMP recommended approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for another indication. The combination has been recommended for approval for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
Eyenovia Surges on Positive Data: Shares of clinical-stage ophthalmic biopharmaceutical company, Eyenovia, Inc. (EYEN - Free Report) , surged after it announced that its VISION-1 study evaluating its proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. The VISION-1 study evaluated the safety and efficacy of Eyenovia’s 1% and 2% pilocarpine Micro-Array Print formulations versus placebo, all administered via the company’s proprietary Optejet dispenser. Results showed that a statistically significant proportion of subjects treated with a therapeutic dose of MicroLine showed a three-line or more improvement in distance corrected near visual acuity (DCNVA) versus placebo in low light conditions at two hours post-treatment. Preparations are underway for a second phase III registration study, VISION-2. The positive results from these studies will serve as the basis for a planned New Drug Application (NDA) submission to the FDA.
Omeros Declines on FDA Review Extension: Shares of commercial-stage biopharmaceutical company, Omeros Corporation (OMER - Free Report) , were down after it announced that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new target action date is Oct 17, 2021. The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request. The FDA has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 0.66% in the last five trading sessions. Among the biotech giants, Gilead lost 3.81% during the period. Over the past six months, shares of Alexion have surged 44.07%. (See the last biotech stock roundup here: Biotech Stock Roundup: AGEN, SRPT Surges & Other Pipeline Updates From BIIB, REGN).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Image: Bigstock
Biotech Stock Roundup: MRNA's Vaccine Update & Pipeline Updates From REGN, BMY
The biotech sector continues to be in focus with pipeline and regulatory updates. The development of vaccine for COVID-19 also continues to be in focus, particularly for the younger population.
Recap of the Week’s Most Important Stories:
Regeneron’s Libtayo Gets Positive CHMP Opinions for Additional Indications: Regeneron (REGN - Free Report) and partner Sanofi announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given positive opinions for oncology drug, Libtayo (cemiplimab), as monotherapy in two advanced cancers. The CHMP recommended the approval of the drug for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. The drug was recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
Libtayo is currently approved in the European Union (EU) and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma (CSCC).
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna’s COVID-19 Vaccine Study on Teens Meets Goals: Moderna, Inc. (MRNA - Free Report) announced that the phase II/III study of its COVID-19 vaccine, mRNA-1273, in adolescents met its primary immunogenicity endpoint. The study, TeenCOVE, enrolled more than 3,700 participants aged 12 to less than 18 years in the United States. The primary endpoint was non-inferior immunogenicity compared to the COVE study that evaluated the vaccine in adults. Data from the TeenCOVE study showed an efficacy of 100%, with no cases of COVID-19 after 14 days following administration of the second dose. A vaccine efficacy of 93% in seronegative participants was observed after 14 days of the first dose. The positive data from the study demonstrate successful bridging of immune responses to the adult vaccination. Moderna plans to submit data from the study to regulators globally in early June and request authorization for the vaccine.
Bristol Myers’ Opdivo Label Expansion: Bristol Myers (BMY - Free Report) announced that the FDA has approved another label expansion of its blockbuster immuno-oncology drug, Opdivo (nivolumab). Opdivo (injection for intravenous use) has been approved for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
Earlier, the company announced that the CHMP recommended approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for another indication. The combination has been recommended for approval for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
Eyenovia Surges on Positive Data: Shares of clinical-stage ophthalmic biopharmaceutical company, Eyenovia, Inc. (EYEN - Free Report) , surged after it announced that its VISION-1 study evaluating its proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. The VISION-1 study evaluated the safety and efficacy of Eyenovia’s 1% and 2% pilocarpine Micro-Array Print formulations versus placebo, all administered via the company’s proprietary Optejet dispenser. Results showed that a statistically significant proportion of subjects treated with a therapeutic dose of MicroLine showed a three-line or more improvement in distance corrected near visual acuity (DCNVA) versus placebo in low light conditions at two hours post-treatment. Preparations are underway for a second phase III registration study, VISION-2. The positive results from these studies will serve as the basis for a planned New Drug Application (NDA) submission to the FDA.
Omeros Declines on FDA Review Extension: Shares of commercial-stage biopharmaceutical company, Omeros Corporation (OMER - Free Report) , were down after it announced that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new target action date is Oct 17, 2021. The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request. The FDA has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 0.66% in the last five trading sessions. Among the biotech giants, Gilead lost 3.81% during the period. Over the past six months, shares of Alexion have surged 44.07%. (See the last biotech stock roundup here: Biotech Stock Roundup: AGEN, SRPT Surges & Other Pipeline Updates From BIIB, REGN).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Click here to download this report FREE >>