We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Biotech Stock Roundup: ALXN, MRNA Up on Coronavirus Treatment Updates, & More
Read MoreHide Full Article
The spotlight in the biotech sector continues to be on companies developing treatments for coronavirus. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19 and updates from these companies continue to cheer investors as the pandemic is unlikely to die out soon. Meanwhile, other pipeline and regulatory updates too were in the news.
Recap of the Week’s Most Important Stories:
Alexion to Test Ultomiris for COVID-19: Alexion is the latest entrant in the bandwagon of companies repurposing their existing drugs for the treatment of coronavirus. The company recently announced that it will initiate a study to evaluate its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection. The initiation follows the FDA’s rapid review and acceptance of Alexion’s investigational new drug (IND) application for Ultomiris for severe COVID-19. The global phase III study will evaluate Ultomiris in a subset of adults with COVID-19, who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS). The study will begin in May and enroll approximately 270 patients across countries with high numbers of diagnosed cases. The study will evaluate the impact of Ultomiris, a biologic medicine, on the survival, the duration of mechanical ventilation and the hospital stay compared to best supportive care. Shares were up on the news.
Vaxart Announces Positive Data on COVID-19 Vaccine Program: Shares of Vaxart, Inc. (VXRT - Free Report) gained after obtaining positive pre-clinical results for its COVID-19 vaccine candidates, with several of the candidates generating immune responses in all tested animals after a single dose. Vaxart had initiated a program to develop a COVID-19 vaccine in January based on its VAAST oral vaccines platform. At present, it is evaluating multiple vaccine candidates in its preclinical models. Results from the first round of preclinical testing showed that all animals receiving one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination. Additionally, all vaccinated groups showed antibody responses, which were statistically significant compared to the untreated controls. Vaxart plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and breadth of the immune response.
Moderna Up on Grant for Coronavirus Vaccine: Moderna, Inc. (MRNA - Free Report) signed an agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), under which the agency has committed to pay up to $483 million to accelerate the development of its mRNA-based coronavirus vaccine candidate, mRNA-1273. The award will fund the development of the candidate to FDA licensure. Moderna’s mRNA-1273 is currently being evaluated in a phase I study, conducted by the National Institutes of Health. The company plans to start a phase II study this quarter, if safety data from phase I study supports. It is also planning to initiate the phase III stage as early as fourth-quarter 2020.
aTyr Pharma Surges on COVID-19 Pipeline Update: Shares of aTyr Pharma, Inc. (LIFE - Free Report) rose after the FDA accepted the IND application to evaluate its lead therapeutic candidate, ATYR1923, in a phase II study in COVID-19 patients with severe respiratory complications. The mid-stage study will be a randomized, double-blind, placebo-controlled study in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States. The study will evaluate the safety and preliminary efficacy of ATYR1923 in COVID-19 patients with severe respiratory distress.
Incyte Gets FDA Nod for Bile Duct Cancer DrugPemazyre: Incyte (INCY - Free Report) announced that the FDA has approved pemigatinib, a kinase inhibitor indicated for the treatment of adults with previously-treated, unresectable, locally-advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The candidate has been approved under the brand name, Pemazyre. The New Drug Application (NDA) for the drug was reviewed under the FDA’s Priority Review program. Pemazyre is the first and only FDA-approved treatment for this rare cancer that forms in the bile duct. It was approved under accelerated approval based on ORR and DOR. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory study.
Incyte also initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus standard-of-care (SoC) in patients aged 12 and above with COVID-19-associated cytokine storm. The study is sponsored by Incyte in the United States and Novartis outside of the country.
Gilead Announces Collaboration: Gilead Sciences, Inc. (GILD - Free Report) entered into a three-year cancer immunotherapy research collaboration with oNKo-innate to support the discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells. Per the terms of the agreement, oNKo-innate will receive an upfront payment and be eligible to receive milestone payments along with sales royalties across the immuno-oncology and cell therapy programs. In exchange, oNKo-innate will use genome-wide screening techniques and its proprietary technology platform to discover novel immune cell targets, which enhance NK cell anti-tumor immunity, and create NK cell therapies.
Exelixis Gains on RCC Study Update: Exelixis’ (EXEL - Free Report) shares gained after it announced that the phase III study evaluating Opdivo in combination with Cabometyx compared to sunitinib in previously-untreated advanced or metastatic renal cell carcinoma (RCC) met its primary endpoint of progression-free survival (PFS) at the final analysis. The study also achieved the secondary endpoints of overall survival (OS) at a pre-specified interim analysis and the objective response rate (ORR). Preliminary data also showed a favorable safety profile. Assuming approval, the combination of an immunotherapy and a tyrosine kinase inhibitor can become an important, new first-line option for patients with metastatic RCC.
Performance
The Nasdaq Biotechnology index gained 3.26% in the last five trading sessions. Among the biotech giants, Incyte gained 8.96% during this period. Over the past six months, shares of Regeneron have gained 82.71%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN & INCY Focus on Coronavirus Treatments, & More)
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19 along with earnings updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Biotech Stock Roundup: ALXN, MRNA Up on Coronavirus Treatment Updates, & More
The spotlight in the biotech sector continues to be on companies developing treatments for coronavirus. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19 and updates from these companies continue to cheer investors as the pandemic is unlikely to die out soon. Meanwhile, other pipeline and regulatory updates too were in the news.
Recap of the Week’s Most Important Stories:
Alexion to Test Ultomiris for COVID-19: Alexion is the latest entrant in the bandwagon of companies repurposing their existing drugs for the treatment of coronavirus. The company recently announced that it will initiate a study to evaluate its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection. The initiation follows the FDA’s rapid review and acceptance of Alexion’s investigational new drug (IND) application for Ultomiris for severe COVID-19. The global phase III study will evaluate Ultomiris in a subset of adults with COVID-19, who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS). The study will begin in May and enroll approximately 270 patients across countries with high numbers of diagnosed cases. The study will evaluate the impact of Ultomiris, a biologic medicine, on the survival, the duration of mechanical ventilation and the hospital stay compared to best supportive care. Shares were up on the news.
Vaxart Announces Positive Data on COVID-19 Vaccine Program: Shares of Vaxart, Inc. (VXRT - Free Report) gained after obtaining positive pre-clinical results for its COVID-19 vaccine candidates, with several of the candidates generating immune responses in all tested animals after a single dose. Vaxart had initiated a program to develop a COVID-19 vaccine in January based on its VAAST oral vaccines platform. At present, it is evaluating multiple vaccine candidates in its preclinical models. Results from the first round of preclinical testing showed that all animals receiving one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination. Additionally, all vaccinated groups showed antibody responses, which were statistically significant compared to the untreated controls. Vaxart plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and breadth of the immune response.
Moderna Up on Grant for Coronavirus Vaccine: Moderna, Inc. (MRNA - Free Report) signed an agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), under which the agency has committed to pay up to $483 million to accelerate the development of its mRNA-based coronavirus vaccine candidate, mRNA-1273. The award will fund the development of the candidate to FDA licensure. Moderna’s mRNA-1273 is currently being evaluated in a phase I study, conducted by the National Institutes of Health. The company plans to start a phase II study this quarter, if safety data from phase I study supports. It is also planning to initiate the phase III stage as early as fourth-quarter 2020.
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
aTyr Pharma Surges on COVID-19 Pipeline Update: Shares of aTyr Pharma, Inc. (LIFE - Free Report) rose after the FDA accepted the IND application to evaluate its lead therapeutic candidate, ATYR1923, in a phase II study in COVID-19 patients with severe respiratory complications. The mid-stage study will be a randomized, double-blind, placebo-controlled study in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States. The study will evaluate the safety and preliminary efficacy of ATYR1923 in COVID-19 patients with severe respiratory distress.
Incyte Gets FDA Nod for Bile Duct Cancer Drug Pemazyre: Incyte (INCY - Free Report) announced that the FDA has approved pemigatinib, a kinase inhibitor indicated for the treatment of adults with previously-treated, unresectable, locally-advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The candidate has been approved under the brand name, Pemazyre. The New Drug Application (NDA) for the drug was reviewed under the FDA’s Priority Review program. Pemazyre is the first and only FDA-approved treatment for this rare cancer that forms in the bile duct. It was approved under accelerated approval based on ORR and DOR. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory study.
Incyte also initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus standard-of-care (SoC) in patients aged 12 and above with COVID-19-associated cytokine storm. The study is sponsored by Incyte in the United States and Novartis outside of the country.
Gilead Announces Collaboration: Gilead Sciences, Inc. (GILD - Free Report) entered into a three-year cancer immunotherapy research collaboration with oNKo-innate to support the discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells. Per the terms of the agreement, oNKo-innate will receive an upfront payment and be eligible to receive milestone payments along with sales royalties across the immuno-oncology and cell therapy programs. In exchange, oNKo-innate will use genome-wide screening techniques and its proprietary technology platform to discover novel immune cell targets, which enhance NK cell anti-tumor immunity, and create NK cell therapies.
Exelixis Gains on RCC Study Update: Exelixis’ (EXEL - Free Report) shares gained after it announced that the phase III study evaluating Opdivo in combination with Cabometyx compared to sunitinib in previously-untreated advanced or metastatic renal cell carcinoma (RCC) met its primary endpoint of progression-free survival (PFS) at the final analysis. The study also achieved the secondary endpoints of overall survival (OS) at a pre-specified interim analysis and the objective response rate (ORR). Preliminary data also showed a favorable safety profile. Assuming approval, the combination of an immunotherapy and a tyrosine kinase inhibitor can become an important, new first-line option for patients with metastatic RCC.
Performance
The Nasdaq Biotechnology index gained 3.26% in the last five trading sessions. Among the biotech giants, Incyte gained 8.96% during this period. Over the past six months, shares of Regeneron have gained 82.71%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN & INCY Focus on Coronavirus Treatments, & More)
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19 along with earnings updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>