Regeneron’s Ebola virus approval and other news: the quality of biopharmaceuticals (NASDAQ: REGN) | Instant News


Regeneron announces FDA approval of Ebola virus treatment REGN-EB3

Regeneron Pharmaceutical Company (Nasdaq:rain) Reported The U.S. Food and Drug Administration (FDA) has approved Inmazeb to treat infections caused by the Zaire Ebola virus in adult and pediatric patients (including newborns of mothers who have tested positive). Inmazeb is a combination of atoltivimab, maftivimab and odesivimab-ebgn. The company has used the same technology used to develop the COVID-19 antibody portfolio to develop this drug.

The company’s PALM test data is used to determine the safety and effectiveness of Inmazeb. This randomized, multi-center, controlled trial was launched in Congo (DRC) in 2018 and involved 681 patients. George D. Yancopoulos of Regeneron said: “We have invested in VelociSuite for decades.® Rapid response technology, the dedication of world-class scientists, and the brave contributions of healthcare providers and patients, as well as the outstanding cooperation between leading international health organizations and governments, together contributed to this important moment. “

The PALM trial was jointly sponsored by the World Health Organization, the National Institute of Biomedical Research and the National Institutes of Health. Because the pre-conducted interim analysis showed that the drug was superior to ZMapp and Remdesivir in terms of mortality, the trial ended prematurely.

At least 10% of Inmazeb patients experienced adverse reactions, including rapid heartbeat, rapid breathing, and rapid fever. Among these adverse events, Inmazeb had a higher frequency of chills compared with ZMapp.

July 2020, Regeneron Announce A new agreement with the Biomedical Advanced Research and Development Authority (BARDA). According to the agreement, BARDA agreed to REGN-EB3 as part of HHS’s goal of establishing a national response to public health emergencies. BARDA works under the auspices of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. The company will now deliver the agreed-upon amount of the drug within six years.

Regeneron worked with WHO, the US FDA and other global organizations to develop Inmazeb under a sympathetic use agreement. The drug has been included in the four-arm PALM trial. The company provides Inmazeb for free in DRC through the MEURI protocol to achieve sympathy.

Inmazeb was previously called REGN-EB3 and has been developed using the company’s VelocImmune® Platform and related VelociSuite® technology. The drug works by binding to a different, non-overlapping epitope on the Zaire Ebola virus glycoprotein. It neutralizes Ebola virus by preventing the Ebola virus from infecting patients and/or recruiting other immune cells to target the infected cells and then remove them from the body. Inmazeb is administered as a single, weight-based intravenous infusion.

Analyst: The candidate Ebola virus will not bring revenue to the company because it is an orphan disease and about 20,000 people need treatment.of market It is worth 56 million U.S. dollars in 2020. According to the sympathetic use agreement of the government agency, the money has been put into development. Regeneron has a market value of $63.11 billion, and its closing price as of October 16, 2020 is $599.74. The company’s debt is US$2.22 billion and its cash balance is US$3.14 billion. Institutions hold more than 88% of Regeneron’s shares, while public shareholding is less than 7%. There will be 2.05 million short-term equity available for payment in the next two days.

Investment papers: The stock has shown a sharp upward trend in recent years, but there is still a lot of room for growth. The company also has many catalysts, including COVID-19 handling, which may promote the development of the stock.

Pluristem won the second group of studies in chronic graft versus host disease research

Pluristem Therapeutics Inc. (Nasdaq:PSTI) Announce Obtain permission from the safety committee to continue its phase I/II research by starting to recruit second generations. The study will evaluate the ability of PLX-PAD cells to treat steroid-refractory chronic graft-versus-host disease.

The preliminary data and previous preclinical data of cohort I of the phase I/II study have demonstrated the potential of PLX-PAD cells in treating cGvHD patients and alleviating symptoms. Yaky Yanay, CEO and President of Pluristem said: “Pluristem is committed to contributing to the well-being and quality of life of patients. cGvHD is a sign that we believe there is an urgent need to enhance the current life-threatening conditions. Bone marrow transplantation. “

The first group included six patients. These participants injected 150 million cells twice every other week. During the three-month follow-up, temporary safety data showed that the PLX-PAD battery is safe. In addition, no side effects related to the treatment have been reported. Efficacy data indicate that four-sixths of patients report improved symptoms. This improvement resulted in a decrease in the severity of cGvHD, and the required steroid doses for some patients were significantly reduced.

This data is the basis for starting to join Cohort II. The cohort will recruit 14 patients. These patients will be injected with 450 million cells.

Pluristem Therapeutics is a regenerative medicine company. It is mainly engaged in the development of new placenta-based cell therapy product candidates. It is believed that the company’s PLX cell product candidates can function by releasing a series of therapeutic proteins in response to ischemia, inflammation, muscle trauma, radiation damage and hematological diseases.

analysis: Pluristem’s cGvHD candidates are being resolved market In 2016, it was US$360 million, and in 2021 it was US$510 million. It is estimated that it will reach US$640 million in 2026, with a compound annual growth rate of 6%. There are many participants in the more advanced stages of development in the market. Candidates can serve the company to prove the effectiveness of its platform for many diseases that can be solved. As of October 16, 2020, the company’s market capitalization was $279.2 million and the stock price was $10.68. The price is close to a 52-week high, and there will be more than 6% short interest to cover in the next two days. The public holds more than 60% of the shares, and insiders hold nearly 30% of the shares. The company’s cash balance was 45.78 million U.S. dollars, debt was 1.58 million U.S. dollars, and the cash consumption of the previous fiscal year (as of June 2020) was 29.5 million U.S. dollars.

Investment papers: The good news is expected to become a good catalyst for the stock price. The company also has a strong development channel to support its stock price rise.

AnaptysBio announces positive data for Imsidolimab Phase 3 trial

AnaptysBio, Inc. (ANAB) Announced the positive benefit data from the interim analysis of the phase 2 clinical trial of imsidolimab. The trial aims to evaluate the drug candidate’s role in the treatment of moderate to severe generalized pustular psoriasis (a chronic, life-threatening, rare inflammatory disease with no approved treatment).

The GALLOP trial recruited 8 patients with a baseline mean based on the modified Japanese Association of Dermatology Severity Index total score of 9. Paul F. Lizzul, Chief Medical Officer of AnaptysBio: “We look forward to working with regulatory agencies to advance imsidolimab to Phase 3, and in doing so, provide potential therapeutic interventions for patients with unmet medical needs.”

The primary endpoint of the trial is to improve the CGI scale on day 29. Six of the eight patients achieved this goal. The remaining two patients withdrew from the trial before day 29 and were therefore considered to have not met the main goal. On the 8th day, the mJDA-SI score decreased by an average of 29%, and on the 29th day, it decreased by an average of 54%. Genotype testing showed that the homozygous wild-type IL-36RN, CARD14 and AP1S3 alleles of all eight patients indicated that the candidate drug is widely applicable to pustular diseases regardless of genetic factors.

analysis: AnaptysBio imsidolimab market is expected achieve It will reach 13.1 billion USD by 2025, with a compound annual growth rate of 7.3%. As of October 16, 2020, the company’s market capitalization was $654.7 million, and the stock price was $24.08, which is the median price between $10 and $39.48 in 52 weeks. Within 16 days, you will have nearly 25% short equity, or 4.5 million shares. Institutions hold more than 68%, hedge funds hold more than 23%, and private equity/venture investment companies hold 7.45%. Insiders hold less than 2% of the shares and there is no visible public shareholding. The company’s cash balance was US$378.8 million, compared to US$16.1 million in cash consumption in the previous fiscal year. Wall Street’s target for the company is neutral, with a target price of $21.57, which is lower than the current price.

Investment papers: The stock’s current trading price is well below its 52-week low. The company is also working in various other studies, including ECLIPSE for chronic rhinosinusitis with nasal polyps.

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