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Biotech Stock Roundup: GILD's Coronavirus Drug Update, NTLA-REGN Deal & More
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It was a busy week for the biotech sector with many updates from the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Meanwhile, as the pandemic spreads further, the spotlight in the biotech sector remains on companies developing treatments for coronavirus. Updates from these companies continue to cheer investors, raising hopes of a possible treatment soon. Other pipeline updates and collaboration deals also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Gilead Reports Mixed Data on Coronavirus Drug: Gilead (GILD - Free Report) reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia. The open-label phase III SIMPLE study evaluated five-day and 10-day courses of remdesivir plus standard of care as compared to standard of care alone in these patients. Data showed that patients in the five-day remdesivir treatment group were 65% more likely to have clinical improvement at day 11 compared with those in the standard of care group. However, the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care alone were favorable but did not attain statistical significance. Consequently, shares were down on the data.
Gilead also announced that it has entered into a 10-year partnership with clinical-stage, oncology-focused company, Arcus Biosciences, Inc. The companies will co-develop and co-commercialize current and future therapeutic product candidates in Arcus’ pipeline, which includes AB154, an investigational anti-TIGIT monoclonal antibody; AB928, an investigational A2aR/A2bR antagonist; and zimberelimab (AB122), an investigational anti-PD-1 monoclonal antibody. The agreement will also provide funding to support Arcus’ research and development programs.
Gilead’s company, Kite, also announced results from an interim analysis of ZUMA-5, a global, multicenter, single-arm, open-label phase II study evaluating Yescarta in adult patients with relapsed or refractory indolent (slow growing) non-Hodgkin lymphoma (NHL) after at least two prior lines of therapy. In the study, 93% of patients (n=96 evaluable for efficacy) responded, with 80% of patients achieving a complete response (CR) as assessed by an independent review committee after a single infusion of Yescarta. The data were presented in an oral session during the 2020 American Society of Clinical Oncology Annual Meeting held from May 29-31.
Intellia Gains on Collaboration With Regeneron: Shares of Intellia Therapeutics, Inc. (NTLA - Free Report) gained after it announced an expansion of its existing collaboration with Regeneron Pharmaceuticals (REGN - Free Report) . Per the terms, the companies will co-develop potential hemophilia A and B treatments using their jointly-owned targeted transgene insertion capabilities. Regeneron will gain rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets. The company will also get non-exclusive rights to independently develop and commercialize ex vivo gene-edited products. In exchange, Intellia will receive an upfront payment of $70 million. Regeneron will make an additional equity investment in Intellia of $30 million at $32.42 per share. Both companies had entered into a licensing and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development in 2016. Shares of Intellia surged on the news, as investors are positive that collaboration with Regeneron will accelerate the pipeline development efforts of the former.
Ironwood Down on Pipeline Setback: Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that the delayed-release formulation of its marketed drug, Linzess — MD-7246 — has failed to meet primary as well as secondary endpoints in a phase II study. The study was evaluating MD-7246 in patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). Data showed that MD-7246 failed to achieve statistically significant improvements in abdominal pain compared to placebo.
Based on the study data, Ironwood and its partner AbbVie are planning to discontinue the development of MD-7246. Ironwood had previously reported data from another phase II study evaluating the candidate in patients with IBS with constipation (IBS-C) in 2016. Data from the IBS-C study showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function.
Regeneron Presents New Data on Libtayo: Regeneron and partner Sanofi announced new, longer-term data for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma (CSCC) from a mid-stage study at ASCO. Results from the phase II study showed that 46% of patients experienced substantial tumor shrinkage following Libtayo treatment, with a median time to response of two months (interquartile range: two-four months) with up to three years of follow-up. Moreover, 16% of the patients saw their tumors disappear completely over time compared to previous analyses. Results demonstrated both longer durability and higher complete response (CR) rates than previously reported. In fact, 20% of patients have achieved a CR among those with metastatic disease, who had the longest available follow-up, an increase from 7% in the 2017 primary analysis. Median time to CR was 11 months (interquartile range: 7-15 months) in patients who achieved a CR in any group.
ARCA biopharma Surges on COVID-19 Program: Shares of ARCA biopharma, Inc. (ABIO - Free Report) surged after it announced a new development program to evaluate AB201 (rNAPc2), a potent, selective inhibitor of tissue factor (TF), as a potential treatment for COVID-19-associated coagulopathy (CAC) and the related inflammatory response. The company expects to file an Investigational New Drug (IND) application with the FDA in the third quarter and initiate late-stage clinical testing in the second half of this year.
PhaseBio Surges on FDA Nod for Coronavirus Study: PhaseBio Pharmaceuticals, Inc. surged after it announced that the FDA cleared its IND application for PB1046, a novel subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, as a treatment for hospitalized COVID-19 patients who stand at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS). The IND clearance from the regulatory body came under the Coronavirus Treatment Acceleration Program (CTAP). The company received the FDA authorization to begin the potentially pivotal clinical study — VANGARD — to evaluate PB1046 in the given patient population. The multi-center, randomized, double-blind VANGARD study will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients. The primary endpoint of the study will measure the days alive and free of respiratory failure. The company plans to begin dosing patients by June-end, with a target to report results late in the fourth quarter of 2020.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 2.67% in the last five trading sessions. Among the biotech giants, Regeneron gained 13.29% during this period. Over the past six months, shares of Regeneron have gained 68.72%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Stake Buyback, INO, NVAX's Coronavirus Updates & More).
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
Zacks Top 10 Stocks for 2020
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Biotech Stock Roundup: GILD's Coronavirus Drug Update, NTLA-REGN Deal & More
It was a busy week for the biotech sector with many updates from the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Meanwhile, as the pandemic spreads further, the spotlight in the biotech sector remains on companies developing treatments for coronavirus. Updates from these companies continue to cheer investors, raising hopes of a possible treatment soon. Other pipeline updates and collaboration deals also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Gilead Reports Mixed Data on Coronavirus Drug: Gilead (GILD - Free Report) reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia. The open-label phase III SIMPLE study evaluated five-day and 10-day courses of remdesivir plus standard of care as compared to standard of care alone in these patients. Data showed that patients in the five-day remdesivir treatment group were 65% more likely to have clinical improvement at day 11 compared with those in the standard of care group. However, the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care alone were favorable but did not attain statistical significance. Consequently, shares were down on the data.
Gilead also announced that it has entered into a 10-year partnership with clinical-stage, oncology-focused company, Arcus Biosciences, Inc. The companies will co-develop and co-commercialize current and future therapeutic product candidates in Arcus’ pipeline, which includes AB154, an investigational anti-TIGIT monoclonal antibody; AB928, an investigational A2aR/A2bR antagonist; and zimberelimab (AB122), an investigational anti-PD-1 monoclonal antibody. The agreement will also provide funding to support Arcus’ research and development programs.
Gilead’s company, Kite, also announced results from an interim analysis of ZUMA-5, a global, multicenter, single-arm, open-label phase II study evaluating Yescarta in adult patients with relapsed or refractory indolent (slow growing) non-Hodgkin lymphoma (NHL) after at least two prior lines of therapy. In the study, 93% of patients (n=96 evaluable for efficacy) responded, with 80% of patients achieving a complete response (CR) as assessed by an independent review committee after a single infusion of Yescarta. The data were presented in an oral session during the 2020 American Society of Clinical Oncology Annual Meeting held from May 29-31.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Intellia Gains on Collaboration With Regeneron: Shares of Intellia Therapeutics, Inc. (NTLA - Free Report) gained after it announced an expansion of its existing collaboration with Regeneron Pharmaceuticals (REGN - Free Report) . Per the terms, the companies will co-develop potential hemophilia A and B treatments using their jointly-owned targeted transgene insertion capabilities. Regeneron will gain rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets. The company will also get non-exclusive rights to independently develop and commercialize ex vivo gene-edited products. In exchange, Intellia will receive an upfront payment of $70 million. Regeneron will make an additional equity investment in Intellia of $30 million at $32.42 per share. Both companies had entered into a licensing and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development in 2016. Shares of Intellia surged on the news, as investors are positive that collaboration with Regeneron will accelerate the pipeline development efforts of the former.
Ironwood Down on Pipeline Setback: Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that the delayed-release formulation of its marketed drug, Linzess — MD-7246 — has failed to meet primary as well as secondary endpoints in a phase II study. The study was evaluating MD-7246 in patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). Data showed that MD-7246 failed to achieve statistically significant improvements in abdominal pain compared to placebo.
Based on the study data, Ironwood and its partner AbbVie are planning to discontinue the development of MD-7246. Ironwood had previously reported data from another phase II study evaluating the candidate in patients with IBS with constipation (IBS-C) in 2016. Data from the IBS-C study showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function.
Regeneron Presents New Data on Libtayo: Regeneron and partner Sanofi announced new, longer-term data for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma (CSCC) from a mid-stage study at ASCO. Results from the phase II study showed that 46% of patients experienced substantial tumor shrinkage following Libtayo treatment, with a median time to response of two months (interquartile range: two-four months) with up to three years of follow-up. Moreover, 16% of the patients saw their tumors disappear completely over time compared to previous analyses. Results demonstrated both longer durability and higher complete response (CR) rates than previously reported. In fact, 20% of patients have achieved a CR among those with metastatic disease, who had the longest available follow-up, an increase from 7% in the 2017 primary analysis. Median time to CR was 11 months (interquartile range: 7-15 months) in patients who achieved a CR in any group.
ARCA biopharma Surges on COVID-19 Program: Shares of ARCA biopharma, Inc. (ABIO - Free Report) surged after it announced a new development program to evaluate AB201 (rNAPc2), a potent, selective inhibitor of tissue factor (TF), as a potential treatment for COVID-19-associated coagulopathy (CAC) and the related inflammatory response. The company expects to file an Investigational New Drug (IND) application with the FDA in the third quarter and initiate late-stage clinical testing in the second half of this year.
PhaseBio Surges on FDA Nod for Coronavirus Study: PhaseBio Pharmaceuticals, Inc. surged after it announced that the FDA cleared its IND application for PB1046, a novel subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, as a treatment for hospitalized COVID-19 patients who stand at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS). The IND clearance from the regulatory body came under the Coronavirus Treatment Acceleration Program (CTAP). The company received the FDA authorization to begin the potentially pivotal clinical study — VANGARD — to evaluate PB1046 in the given patient population. The multi-center, randomized, double-blind VANGARD study will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients. The primary endpoint of the study will measure the days alive and free of respiratory failure. The company plans to begin dosing patients by June-end, with a target to report results late in the fourth quarter of 2020.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 2.67% in the last five trading sessions. Among the biotech giants, Regeneron gained 13.29% during this period. Over the past six months, shares of Regeneron have gained 68.72%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Stake Buyback, INO, NVAX's Coronavirus Updates & More).
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
Zacks Top 10 Stocks for 2020
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2020 today >>