Biotech and big pharma stocks have been a tear of late causing the SPDR S&P Biotech ETF (XBI) to edge towards annual highs. The biotech ETF has already outperformed the broader market year to date, rising 30 percent in the period from March 13th. Particularly active in the biotech sector is the development of anti-cancer drug candidates and other pre-clinical advancements in the race to develop the next cancer-fighting niche within the industry. Riding the biotech boom, are these pharma and biotech companies. Active stocks to keep a close eye include: Moleculin Biotech Inc. (NASDAQ: MBRX), Cerulean Pharma Inc. (NASDAQ: CERU), Celsion Corporation (NASDAQ: CLSN), Array BioPharma Inc. (NASDAQ: ARRY), Impax Laboratories, Inc. (NASDAQ: IPXL)
Moleculin Biotech, Inc. (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has appointed Dr. Lidia Gil of Poznan University of Medical Sciences in Poznan, Poland to be the lead European Principal Investigator (PI) for its upcoming planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML). Read this and more news for Moleculin Biotech at http://www.marketnewsupdates.com/news/mbrx.html
The Company announced on June 15, 2017 that it was expanding its engagement with its CRO, Theradex Systems, Inc., to include clinical sites in Poland in order to increase access to AML patients. "Dr. Gil is a highly-respected hematologist-oncologist in Poland," commented Walter Klemp, Chairman and CEO of Moleculin, "And we are honored to have her leading the European element of our upcoming clinical trial for Annamycin, which would commence only if our IND is permitted."
Dr. Robert Shepard, Moleculin's Chief Medical Officer added, "Dr. Gill is a dedicated investigator in AML and will bring significant expertise in the area as well as her potential to accelerate enrollment and the completion of our trial."
In other big pharma and biotech performers and developments in the markets of note:
Cerulean Pharma Inc. (NASDAQ: CERU) closed up big on Wednesday over 140% at $1.13 trading over 32 Million shares by the market close. Cerulean Pharma Inc. (CERU) and Daré Bioscience, Inc. yesterday announced that Daré Founder and CEO Sabrina Martucci Johnson mailed the following letter to Cerulean stockholders of record at the close of business on June 9, 2017 outlining the Daré value proposition and requesting they vote FOR all of the management proposals at the upcoming special meeting of stockholders to be held on July 19, 2017. Read it at https://finance.yahoo.com/news/dar-bioscience-distributes-letter-cerulean-123000507.html
Celsion Corporation (NASDAQ: CLSN) closed up over 19% on Wednesday at $2.42 trading over 11.6 Million shares by the market close. Celsion Corporation yesterday provided an update on its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's IL-12 gene-mediated immunotherapy, with neoadjuvant chemotherapy for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer followed by interval debulking surgery. Enrollment Complete in the OVATION Study. The last patient in the 4th dose cohort has completed their GEN-1 treatment which allows for a safety evaluation by the Company's Data Safety Monitoring Board (DSMB) in mid-July. The Company recently announced the latest clinical findings from the OVATION Study in a poster presentation at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting. The presentation summarized clinical findings and translational data from all fourteen patients treated in the trial to-date.
Array BioPharma Inc. (NASDAQ: ARRY) closed up Wednesday at $8.99 trading over 3.8 Million shares by the market close. Array BioPharma also yesterday announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.
In after market hours news from yesterday:
Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Focalin XR® (dexmethylphenidate hydrochloride) extended-release capsules CII, 25 and 35 mg. Impax has immediately initiated commercialization activities. This approval and launch of the 25 and 35 mg strengths complements the Company's commercialized generic portfolio of Focalin XR products, which also includes strengths of 5, 10, 15, 20 and 30 mg capsules. According to IMS Health, dexmethylphenidate hydrochloride extended-release capsules, 25 and 35 mg, had U.S. brand and generic sales of approximately $93 million for the 12 months ending May 2017.
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