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Biotech Stock Roundup: DICE Gains on LLY Buyout, MRSN Down on Update & More
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It was a busy week for the biotech sector. Mergers and acquisitions are back in the sector with the recent string of buyouts. Key regulatory and pipeline updates from bigwigs like GSK plc (GSK - Free Report) were in the spotlight during the week.
Recap of the Week’s Most Important Stories:
DICE Up on LLY Buyout: Shares of clinical-stage biopharmaceutical company DICE Therapeutics, Inc. surged on Jun 20 after pharma giant Eli Lilly (LLY - Free Report) announced a definite agreement to acquire the former for $48 per share or $2.4 billion. The transaction is expected to be completed by the third quarter. The offer price of $48 represented a premium of 41% to DICE’s closing price of $33.85 on Jun 16.
DICE utilizes its proprietary DELSCAPE technology platform to develop new oral therapies targeting chronic diseases in immunology. The company is evaluating two oral IL-17 inhibitors, DC-806 and DC-853, in separate clinical studies targeting psoriasis and other chronic diseases in immunology. Investors are upbeat about DICE’s prospects as an acquisition by a big pharma giant like Lilly would allow the company to accelerate the development of its pipeline with the help of LLY’s strong cash position. The deal will also give DICE access to Lilly’s strong supply chain and network distribution, which will help the commercialization of the candidates upon approval.
Arcellx Down on Regulatory Update: Shares of Arcellx, Inc. (ACLX - Free Report) were down after the company announced that the FDA placed a clinical hold on its iMMagine-1 program. This phase II, open-label, multicenter clinical trial is designed to evaluate the lead program CART-ddBCMA for treating adult patients with relapsed or refractory multiple myeloma (rrMM). CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy utilizing the company's novel BCMA-targeting binding domain. The primary objective of this study is to evaluate the overall response rate over 24 months. In addition to safety, secondary endpoints include depth of disease response, duration of response and overall survival over a 24-month period.
The hold was placed on Jun 16 after a patient died. Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. Nevertheless, the regulatory body has given Arcellx clearance to continue dosing patients who have undergone lymphodepletion.
Mersana Down on Clinical Hold on Study: Shares of clinical-stage biopharmaceutical company, Mersana Therapeutics, Inc. (MRSN - Free Report) , were down after the FDA issued a partial clinical hold pausing new patient enrollment in UP-NEXT and UPGRADE-A, evaluating lead product candidate, upifitamab rilsodotin (UpRi), in platinum-sensitive ovarian cancer.
The partial clinical hold was placed after Mersana submitted an aggregate safety report of all patients dosed with UpRi (approximately 560 patients) evaluating bleeding events. As noted in FDA guidance, aggregate analyses generally become more informative as a drug progresses through development and accumulates data. Mersana’s recent assessment determined that serious bleeding events occur at a higher rate than background, even though data on the background rate of bleeding in platinum-resistant ovarian cancer are limited. Most bleeding cases in this aggregate safety analysis were low-grade, but five (<1%) Grade 5 (fatal) bleeding events were observed among the approximately 560 patients dosed to date. The causes of bleeding events remain under investigation.
Mersana is currently awaiting the FDA’s written correspondence regarding the partial clinical hold, as the regulatory body is expected to request a comprehensive assessment of UpRi safety data, inclusive of bleeding events. Mersana’s ongoing clinical trial of UpRi in platinum-resistant ovarian cancer, UPLIFT, completed enrollment in October 2022. The company plans to submit the safety and efficacy data from this study once available.
Updates From GlaxoSmithKline: GSK plc (GSK - Free Report) announced that the FDA has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The new target action date is Sep 16, 2023. In August 2022, the FDA accepted the NDA for momelotinib seeking approval of the candidate for treating myelofibrosis patients with anemia and set a target action date of Jun 16, 2023. The NDA is based on the results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints. The candidate was added to GSK’s pipeline with the acquisition of Sierra Oncology, Inc in July 2022.
GSK also announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination. Data showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions.
The Nasdaq Biotechnology Index has lost 0.08% in the past four trading sessions. Among the biotech giants, Moderna has lost 3.95% during the period. Over the past six months, shares of MRNA have declined 42.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: KDNY Up on NVS Buyout, BIIB & Eisais AD Drug Update & More).
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What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: DICE Gains on LLY Buyout, MRSN Down on Update & More
It was a busy week for the biotech sector. Mergers and acquisitions are back in the sector with the recent string of buyouts. Key regulatory and pipeline updates from bigwigs like GSK plc (GSK - Free Report) were in the spotlight during the week.
Recap of the Week’s Most Important Stories:
DICE Up on LLY Buyout: Shares of clinical-stage biopharmaceutical company DICE Therapeutics, Inc. surged on Jun 20 after pharma giant Eli Lilly (LLY - Free Report) announced a definite agreement to acquire the former for $48 per share or $2.4 billion. The transaction is expected to be completed by the third quarter. The offer price of $48 represented a premium of 41% to DICE’s closing price of $33.85 on Jun 16.
DICE utilizes its proprietary DELSCAPE technology platform to develop new oral therapies targeting chronic diseases in immunology. The company is evaluating two oral IL-17 inhibitors, DC-806 and DC-853, in separate clinical studies targeting psoriasis and other chronic diseases in immunology. Investors are upbeat about DICE’s prospects as an acquisition by a big pharma giant like Lilly would allow the company to accelerate the development of its pipeline with the help of LLY’s strong cash position. The deal will also give DICE access to Lilly’s strong supply chain and network distribution, which will help the commercialization of the candidates upon approval.
Arcellx Down on Regulatory Update: Shares of Arcellx, Inc. (ACLX - Free Report) were down after the company announced that the FDA placed a clinical hold on its iMMagine-1 program. This phase II, open-label, multicenter clinical trial is designed to evaluate the lead program CART-ddBCMA for treating adult patients with relapsed or refractory multiple myeloma (rrMM). CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy utilizing the company's novel BCMA-targeting binding domain. The primary objective of this study is to evaluate the overall response rate over 24 months. In addition to safety, secondary endpoints include depth of disease response, duration of response and overall survival over a 24-month period.
The hold was placed on Jun 16 after a patient died. Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. Nevertheless, the regulatory body has given Arcellx clearance to continue dosing patients who have undergone lymphodepletion.
Mersana Down on Clinical Hold on Study: Shares of clinical-stage biopharmaceutical company, Mersana Therapeutics, Inc. (MRSN - Free Report) , were down after the FDA issued a partial clinical hold pausing new patient enrollment in UP-NEXT and UPGRADE-A, evaluating lead product candidate, upifitamab rilsodotin (UpRi), in platinum-sensitive ovarian cancer.
The partial clinical hold was placed after Mersana submitted an aggregate safety report of all patients dosed with UpRi (approximately 560 patients) evaluating bleeding events. As noted in FDA guidance, aggregate analyses generally become more informative as a drug progresses through development and accumulates data. Mersana’s recent assessment determined that serious bleeding events occur at a higher rate than background, even though data on the background rate of bleeding in platinum-resistant ovarian cancer are limited. Most bleeding cases in this aggregate safety analysis were low-grade, but five (<1%) Grade 5 (fatal) bleeding events were observed among the approximately 560 patients dosed to date. The causes of bleeding events remain under investigation.
Mersana is currently awaiting the FDA’s written correspondence regarding the partial clinical hold, as the regulatory body is expected to request a comprehensive assessment of UpRi safety data, inclusive of bleeding events. Mersana’s ongoing clinical trial of UpRi in platinum-resistant ovarian cancer, UPLIFT, completed enrollment in October 2022. The company plans to submit the safety and efficacy data from this study once available.
Updates From GlaxoSmithKline: GSK plc (GSK - Free Report) announced that the FDA has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The new target action date is Sep 16, 2023. In August 2022, the FDA accepted the NDA for momelotinib seeking approval of the candidate for treating myelofibrosis patients with anemia and set a target action date of Jun 16, 2023. The NDA is based on the results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints. The candidate was added to GSK’s pipeline with the acquisition of Sierra Oncology, Inc in July 2022.
GSK also announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination. Data showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions.
GSK currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
The Nasdaq Biotechnology Index has lost 0.08% in the past four trading sessions. Among the biotech giants, Moderna has lost 3.95% during the period. Over the past six months, shares of MRNA have declined 42.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: KDNY Up on NVS Buyout, BIIB & Eisais AD Drug Update & More).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.