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  • Positive Orbit Study Results Propel Mereo (MREO) Shares After-Hours

    Positive Orbit Study Results Propel Mereo (MREO) Shares After-Hours

    During extended trading session, Mereo BioPharma Group plc (NASDAQ: MREO) observed a favorable trend in its share prices following the announcement of fresh results from orbit studies. MREO stock rose 13.37% to $3.99 on US stock charts, following a 1.44% increase to close at $3.52 during the regular session.

    Positive Results From the Phase 2 Orbit Study

    Mereo (MREO) announced positive 14-month results from the Phase 2 section of the ongoing Phase 2/3 Orbit study, which is being conducted in collaboration with Ultragenyx Pharmaceutical. Results showed that therapy with setrusumab substantially reduced the incidence of fractures in those with osteogenesis imperfecta (OI) after at least 14 months of follow-up.

    Furthermore, by month 12, there had been significant and long-lasting gains in the lumbar spine bone mineral density (BMD) due to setrusumab therapy, with no symptoms of plateauing. The previously reported significant reduction in the annualized fracture rate for patients treated for a minimum of 6 months was maintained in those treated for at least 14 months.

    Consistent Efficacy And Safety Profile

    The results indicate that setrusumab is achieving the anticipated effects, safely decreasing fracture incidence and enhancing BMD in OI patients. The anti-sclerostin antibody remains effective even after a year, with patients continuing to show measurable gains, suggesting a prolonged response over the long term.

    The consistent and significant improvements in BMD and Z-scores across all studied OI sub-types indicate that new, stronger bone is being formed, leading to a substantial reduction in fractures across different age groups and OI types.

    Mereo BioPharma is eager to possibly provide this novel medication to more OI patients, since the Phase 3 Orbit and Cosmic investigations are now completely recruited. As of the data cut-off date, no treatment-related serious adverse events were observed.

    The reported adverse events were in line with those seen in the Asteroid study, with infusion-related reactions and headaches being the most common. No hypersensitivity reactions to setrusumab were observed.

    Mereo BioPharma’s ongoing commitment to improving outcomes for OI patients is reflected in these promising results, paving the way for further advancements in treatment options.

  • Mereo BioPharma group PLC (MREO) Soars Premarket Prior to ASTRAEUS Study Conference Call

    The oncology and rare disease-focused biopharmaceutical company, Mereo BioPharma group PLC (MREO)’s stock is soaring in today’s premarket, May 9, 2022. At the time of writing, shares of the company were up by 14.72% and were trading at a price of $0.6679 apiece. This upsurge came after the stock registered a new 52-week low in Friday’s session which had it valued at $0.5822 at the close.

    Source: Duke Today

    On Friday, MREO said that it will be hosting a conference call today, May 9, at 10.30 a.m. Eastern Time to review data from its ASTRAEUS study. The company has been conducting the Phase 2 Study of Alvelestat in Alpha-1 Antitrypsin Deficiency-associated (AATD) Emphysema. The top-line clinical data from the study will be discussed today. Alvelestat had recently received Orphan Drug Designation for the treatment of AATD.

    What’s going on with MREO?

    Last week, MREO majorly traded in the red with continuous losses for over three days. No news from the company seems to have sparked the sell-off. Thus, the possible reasons for the sell-off which led to a new low in the stock are social media discussions and stock sentiment. Therefore, the external factors had the stock plunge down to a new low on Friday. This downfall ultimately gave way to a rebound in today’s premarket session.

    With top-line data from its trial scheduled for today, investors are buying the latest dip before the conference call is held. This also suggests a possible positive outlook of investors towards MREO’s today’s conference call. It seems given the Orphan Drug Designation of the candidate for the disease, investors are expecting the top-line data of the study to be positive. However, only a little more patience and time will tell how the drug candidate performed in the study.

    Market Overview

    Lately, the market has been in a frenzy with blows from all sides whether it is the economic situation or political. The Russian-Ukraine crisis while giving rise to geopolitical instability also sparked an economical crisis amid the ongoing supply chain disruptions, inflationary pressure, rising interest, and whatnot. The market was only beginning to recover from the woes of the pandemic when a new crisis emerged. However, amid the ongoing crisis healthcare sector and stock have been doing somewhat better as it is deemed to be a defensive sector.

    Conclusion

    Currently, the stock is trading in the green as investors are buying its recent dip. While the latest sell-off that ended in the stock plunging to a new low is one reason for the current rebound in MREO, its upcoming top-line data discussion is also a reason for investors to buy the dip.

  • Here’s why the Mereo BioPharma Group PLC (MREO) Stock Gained Momentum in the Pre Market

    Mereo BioPharma Group PLC (MREO) is leading oncology and rare diseases-related biopharmaceutical company. The main product candidate of the company is etigilimab (OMP-313M32) for the prevention of tumors. Another lead product of the company used for the prevention of late-line ovarian cancer is navicixizumab. The two rare diseases candidates of MREO include alvelestat (prevent Alpha-1 antitrypsin deficiency or AATD) and setrusumab (prevent osteogenesis imperfecta).

    The price of MREO stock on December 22, 2021, was $1.61 with a slight decline of 2.42%. On December 23, 2021, at the last check in the pre-market, the stock price showed an increase of 0.62%.

    Events and Happenings

    On December 22, 2021, MREO and The University of Alabama at Birmingham reported top-line results from Phase 1b/2 trials evaluating alvelestat, an innovative and orally active Neutrophil Elastase suppressor in severely infected COVID-19 patients. On December 13, 2021, MREO reported that it presented the data from the preliminary patients in a sponsored clinical study of alvelestat after hematopoietic stem cell transplantation. The results were presented at the 63rd Annual Meeting of the American Society of Hematology.

    On November 30, 2021, MREO announced positive results in terms of the product efficacy, safety, and biomarker data on patients from Phase 2 clinical trials of anti-TIGIT antibody, etigilimab, in amalgamation with nivolumab. On November 09, 2021, MREO reported that top management of the company presented at two investor conferences i.e., Jefferies London Healthcare Conference on November 17 and 33rd Annual Piper Sandler Virtual Healthcare Conference on November 22.

    On October 26, 2021, MREO reported that FDA had awarded Orphan Drug Designation to alvelestat for the prevention of AATD. On October 13, 2021, MREO, OIFE, and OIF reported the conclusion of patient enrollment in the data gathering to study the effect of Osteogenesis Imperfecta (OI) had on patients and families. The survey concluded with up to 2200 patient responses and the study will be helpful in diagnosis and treatment. The findings will be published in 2022.

    On October 01, 2021, MREO and Ultragenyx Pharmaceutical announced that the findings from Phase 2 trials on secondary endpoint of setrusumab were presented at the 2021 Annual Meeting of the American Society for Bone and Mineral Research.

    Key Financials

    On November 8, 2021, MREO reported the six-month financial outcomes ended on June 30, 2021. Some of the key highlights are as follows

    Revenue

    The revenue collected for the six-month period was £36 million.

    Basic and Diluted Loss

    Basic profit per share for the six-month period 2021 was £0.02 (with nil diluted profit) against the basic and diluted loss per share for the same period prior year was £1.05.

    Total Assets

    The total assets of the company for six months in 2021 were £144 million.

    Conclusion

    As the company announced the positive findings from the recent clinical trials of the product, the stock price began to surge phenomenally. The analysts are suggesting the aforementioned increase to be the result of the company’s strong and investor-friendly strategies and collaborations.

  • Mereo BioPharma Group plc (MREO) stock increased to 6.42% in aftermarket – What’s going on?

    Mereo BioPharma Group plc (MREO) stock increased to 6.42% in aftermarket – What’s going on?

    Mereo BioPharma Group plc (MREO) experienced an increase of 6.42% in the aftermarket. However, the last trading session closed at $2.18 with a decrease of 3.11%.

    Completion of the IMPACT Survey enrollment

    On 13th October 2021, MREO announced enrolment in the biggest worldwide data collection regarding the effect of OI on individuals with Osteogenesis Imperfecta (OI). The IMPACT Survey received approximately 2200 individual answers from 65 countries over the course of three months. The survey results will assist future joint efforts aimed at improving OI diagnosis, treatment, and care. It will also prompt assessment and availability of possible novel therapies.

    The findings of a comprehensive literature review conducted by MREO were presented at the American Society for Bone. MREO, Ultragenyx (partners in the development of setrusumab for the treatment of OI), and the OI community, coordinated by the umbrella organizations OIFE and OIF, collaborated closely to make the IMPACT Survey a reality.

    Phase 2b ASTEROID Study of UX143 Data by MREO

    MREO and Ultragenyx Presented Data from the Phase 2b ASTEROID Study of UX143 (setrusumab) in Osteogenesis Imperfecta on 1st October 2021. Studies in the Phase 2b ASTEROID trial previously revealed that a daily dosage has a meaningful bone-building impact in elderly patients. This impact was assessed by comparing areal bone mineral density (BMD) at the lumbar spine to baseline. Moreover, treatment with UX143 resulted in a dose-dependent rise in P1NP serum levels.

    In addition, UX143 is a completely human monoclonal antibody that inhibits sclerostin. It is a protein that suppresses the activity of bone-forming cells by acting on a critical bone-signaling route. Moreover, the objective of inhibiting sclerostin’s inhibitory actions is to promote new bone formation, collagen synthesis, and bone mineral density and strength. Lastly, Sclerostin inhibition also lowers excessive bone resorption, improving bone density even further.

    Appointment of Pierre Jacquet to Board of Directors

    MREO announced the appointment of Pierre Jacquet to the board of directors on 20th September 2021. Dr. Jacquet is Vice Chairman and Managing Director of L.E.K. Consulting’s Healthcare practice. Moreover, he has held a number of leadership positions, including Global Head, Healthcare Practice, and Global Leadership Team. Dr. Jacquet studied as a surgical resident at the University of Liège in Belgium and served as a Fellow at the Washington Cancer Institute.