IMMU Soars, MLND Leaves Investors Starved, VIR, GSK To Develop COVID-19 Drugs
Today’s Daily Dose brings you news about Co-Diagnostics securing FDA’s Emergency Use Authorization for its SARS-CoV-2 diagnostic test; Immunomedics’ ASCENT study; Millendo’s disappointing Prader-Willi syndrome data; Menlo’s failed Serlopitant trials; Mesoblast jumping into the COVID-19 drug development bandwagon and Vir Biotechnology’s collaboration with GlaxoSmithKline to research and develop solutions for coronaviruses, including SARS-CoV-2.
Co-Diagnostics Inc.’s (CODX) Logix Smart Coronavirus COVID-19 Test has been granted Emergency Use Authorization by the FDA to be used for the diagnosis of SARS-CoV-2.
The Company’s Logix Smart Coronavirus COVID-19 Test uses the Company’s patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus.
The Logix Smart Coronavirus COVID-19 Test received the European CE Mark in February of this year.
The Company has been witnessing a surge in both domestic and international demand for its novel coronavirus detection kits, leading to increased product shipments.
Commenting on the Emergency Use Authorization, Dwight Egan, CEO of Co-Diagnostics, said, “We believe that this authorization confirms the quality and performance of our COVID-19 test and that it is a significant step in opening more doors and helping this test to reach an even wider audience”.
CODX closed Monday’s trading at $10.31, up 25.73%.
Shares of Immunomedics Inc. (IMMU) skyrocketed on Monday after the Company announced that its ASCENT study will be halted due to compelling evidence of efficacy on the recommendation by the independent Data Safety Monitoring Committee.
The ASCENT study is a phase III confirmatory study evaluating Sacituzumab Govitecan in patients with refractory/relapsed triple-negative breast cancer. The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.
Last January, the FDA had refused to approve Sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior treatments due to issues related to Chemistry, Manufacturing and Control matters. A biologics license application resubmission seeking accelerated approval of Sacituzumab govitecan for the same indication is under FDA review, with a decision expected on June 2, 2020.
IMMU closed Monday’s trading at $18.78, up 99.79%. In after-hours, the stock was up another 3.33% to $19.41.
Shares of Millendo Therapeutics Inc. (MLND) plunged 70 percent on Monday after the Company announced that it is discontinuing the development of Livoletide as a potential treatment for Prader-Willi syndrome due to disappointing results from its pivotal Phase 2b ZEPHYR study.
Prader-Willi syndrome is a rare and complex genetic disorder characterized by an insatiable appetite which often results in obesity and type 2 diabetes.
The ZEPHYR study showed that treatment with Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) compared to placebo.
MLND closed Monday’s trading at $1.45, down 70.10%.
Menlo Therapeutics Inc.’s (MNLO) two phase III clinical trials evaluating the safety and efficacy of once-daily oral Serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN) have failed to achieve their goals.
The two studies, dubbed MTI-105 and MTI-106, have not met their respective primary endpoint of demonstrating a statistically significant reduction in pruritus in patients treated with Serlopitant compared to placebo based upon a 4-point improvement responder analysis, according to the Company.
MNLO closed Monday’s trading at $1.40, down 45.95%.
Mesoblast Limited (MESO) has received FDA clearance to evaluate intravenous infusions of its allogeneic mesenchymal stem cell product candidate Remestemcel-L as a treatment for patients with acute respiratory distress syndrome caused by COVID-19.
Remestemcel-L is being developed by the Company for various inflammatory conditions, and the safety and therapeutic effects of this product candidate have been evaluated in over 1,100 patients in various clinical trials.
MESO closed Monday’s trading at $6.16, up 46.67%.
Vir Biotechnology Inc. (VIR) has entered into a collaboration with GlaxoSmithKline plc (GSK) to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
The companies will initially focus on accelerating the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832 that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live virus-cellular assays.
Subject to regulatory review, Vir and GSK plan to advance the compounds directly into a phase II clinical trial within the next three to five months.
Under terms of the collaboration, GSK will make an equity investment in Vir of $250 million, priced at $37.73, a 10% premium to the closing share price on Friday, March 27, 2020.
Vir also has a collaboration with Alnylam Pharmaceuticals Inc. (ALNY) for the development and commercialization of RNAi therapeutics for SARS-CoV-2. Last month, Vir signed a letter of intent to collaborate with Biogen on the manufacturing of antibodies to potentially treat COVID-19.
VIR closed Monday’s trading at $36.70, up 26.55%.
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