Palm Beach, FL –July 18, 2019 – Acute myeloid leukemia (AML) is a cancer that is rarely seen before age 45 with the average age of onset around 65. It is the most common of the four major types of leukemia. Without treatment, AML is often deadly within a few months. The search for better treatments has and will continue to spark research and is projected to continue to generate yearly increasing revenues for the industry. A report from Mordor Intelligence states: “The global acute myeloid leukemia market was valued at USD 701.6 million in 2018, and is estimated to be valued at USD 1,539.99 million in 2024, witnessing a CAGR of 14.0%. The key factors propelling the growth of this market are high Incidence and prevalence of acute myeloid leukemia, advancements in pharmacology and molecular biology to promote drug development, and increasing investments in R&D by the pharmaceutical companies. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Guardion Health Sciences, Inc. (NASDAQ: GHSI), AVROBIO, Inc. (NASDAQ: AVRO), Amneal Pharmaceuticals, Inc. (NYSE: AMRX), Abbott Laboratories (NYSE: ABT).
The American Cancer Society’s estimates for leukemia in the United States, for 2019, indicates that approximately 61,780 new cases of leukemia and 22,840 deaths from leukemia are expected to occur in the country. Among them, the number of new cases of acute myeloid leukemia (AML) will be around 21,450, from which most of the population will be adults. In terms of mortality, the society has estimated that there will be around 10,920 deaths due to AML, in the country. This statistic shows that there is a huge number of people that are prone to suffer from acute myeloid leukemia, which may directly impact the growth of the AML market in the United States.
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland. 3 patients were treated at dose level of 150 mg/m2 with no drug-related adverse events, including no signs of cardiotoxicity. The results for all 3 patients were reviewed by the Drug Safety Review Committee, which determined that the trial could progress to the next higher dose level of 180 mg/m2. To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported. One patient has completed treatment in the 120 mg/m2 (second) cohort in the Company’s parallel US clinical trial (the US trial started at a lower initial dose of 100 mg/m2).
“Recruitment in Poland continues to move rapidly,” commented Walter Klemp, Moleculin’s Chairman and CEO. “And, moving beyond the 150 mg/m2 dosing level is quite significant, as the prior developer of Annamycin was unable to dose beyond this level. We remain optimistic that new methods for reducing the onset of mucositis (the dose limiting toxicity for Annamycin in prior clinical trials) will allow us to safely increase dosing to 180 mg/m2 or potentially even higher.”
Mr. Klemp continued: “It’s also important to remind people that one of the advantages we believe Annamycin will offer is a lack of cardiotoxicity. We continue to see no evidence of cardiotoxicity in any of the patients treated thus far. We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union.” Read this and more news for MBRX at: https://financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Guardion Health Sciences, Inc. (NASDAQ: GHSI) recently announced that it has received a patent from the Patents Registry in Hong Kong (Hong Kong Patent No. HK1204758 titled “Apparatus for Use in the Measurement of Macular Pigment Optical Density and/or Lens Optical Density of an Eye”) for its proprietary medical device, the MapcatSF®. The MapcatSF® measures the macular pigment density in the human eye, thus facilitating treatment for several ocular conditions and diseases that affect a large number of patients.
Dr David Evans, Guardion’s Chief Science Officer, commenting on the granting of this patent by Hong Kong, stated, “The granting of this patent in Honk Kong represents an important step in Guardion’s process to expand into the large Asian markets, where evidenced-based eye care is of great interest to both physicians and consumers. Guardion’s proprietary technologies strengthen our position as we consider additional business opportunities across Asia.”
AVROBIO, Inc. (NASDAQ: AVRO), a Phase 2 clinical-stage gene therapy company, recently announced the pricing of an underwritten public offering of 6,500,000 shares of its common stock at a public offering price of $18.50 per share. Gross proceeds from the underwritten public offering totaled approximately $120.25 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to 975,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering are to be sold by the Company. The offering is expected to close on or about July 19, 2019, subject to customary closing conditions.
Morgan Stanley, Cowen and Wells Fargo Securities are acting as joint book-running managers for the offering, Guggenheim Securities is acting as lead manager, and Wedbush PacGrow and H.C. Wainwright & Co. are acting as co-managers.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) recently announced a comprehensive restructuring plan designed to reduce its cost base, further right size its organization and optimize its global manufacturing infrastructure.
“Recently we initiated an in depth, company-wide review of our organizational structures, operational budgets, current and future capital projects, and existing capability and infrastructure alignments,” said Rob Stewart, President and Chief Executive Officer of Amneal. “We undertook this review in response to the continuing industry challenges impacting our business, including ongoing pressure on our base generics business from the limited number of buyers and the greater than expected effect of additional competition on our key generic products. Additionally, while the value from our complex product pipeline is still expected to be realized, it continues to take longer to materialize than we expected.”
“As a result of this review we have decided to take immediate steps to re-align our business infrastructure and cost base in an effort to align our Company to better deal with the current business realities,” said Mr. Stewart. “These decisive actions represent a difficult but necessary step forward to position Amneal for future success.”
Abbott Laboratories (NYSE: ABT) recently announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.
The MitraClip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart’s ability to pump oxygenated blood more efficiently. To date, MitraClip has helped treat more than 80,000 people worldwide suffering from both primary and secondary MR and is supported by the industry’s most extensive body of clinical evidence, including the recent results of the landmark COAPT™Trial published in The New England Joirnal of Medicine in September 2018.
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