Key FDA Approvals Paramount Catalyst for Biotech Run Heading Into November

Tuesday, October 31, 2017 Education News
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PALM BEACH, Florida, October 31, 2017 /PRNewswire/ --


has approved 34 drugs to date in 2017 after approving 22 novel drugs last year. Many biotech and pharma companies have dealt with the drug development process being lengthy and time-consuming along with requiring the utilization of a lot of funds and
resources while key drug development events including trial data and regulatory updates are of great importance and could act as major catalysts going forward. Active Biotech stocks are in position to close an already strong 2017 with a bang as the FDA gets set to approve additional drugs heading into next month. Notable biotech leaders in the headlines include: Citius Pharmaceuticals Inc. (NASDAQ: CTXR), MannKind Corporation (NASDAQ: MNKD), Akari Therapeutics Plc (NASDAQ: AKTX), Endocyte Inc. (NASDAQ: ECYT) and Adamas Pharmaceuticals Inc. (NASDAQ: ADMS)

Citius Pharmaceuticals, Inc.  (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received official notice from the U. S. Food and Drug Administration ("FDA") that the investigational program for Mino-Lok™ is designated "Fast Track". Mino-Lok is a catheter lock solution that has entered phase 3 trials for an adjunctive treatment for catheter related blood stream infection ("CRBSI"). Fast Track is a designation by the FDA of an investigational drug to expedite review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.  Read this and more news for Citius Pharmaceuticals at

A drug that receives Fast Track designation is eligible for the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;

• More frequent written correspondence from FDA about the design of the clinical trials;

• Priority review to shorten the FDA review process for a new drug from ten months to six months; and,

• Rolling Review, which means Citius can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. 

There are currently no approved therapies to salvage infected central venous catheters ("CVCs"), a potential $750 million sector in the US alone.  CRBSIs are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities. Citius is currently starting up sites for a phase 3 trial of Mino-Lok in the United States.  Mr. Myron Holubiak, Chief Executive Officer of Citius, commented "We are extremely pleased to receive Fast Track designation from the FDA. The agency has been very supportive and helpful in developing the trial design for Mino-Lok as salvage therapy for infected CVCs in CRBSI.  We look forward to our continuing collaboration in developing Mino-Lok."

In additional biotech/pharma developments around the markets: 

MannKind Corporation (NASDAQ: MNKD) closed up slightly on Monday at $3.43 trading over 4.2 Million shares by the market close and was also up slightly in afterhours trading. MannKind Corporation and BIOMM SA announced last week the submission of a registration dossier to ANVISA, seeking the approval of Afrezza® (insulin human) inhalation powder in Brazil. The registration dossier includes recently updated prescribing information for Afrezza, incorporating new clinical data describing the rapid time-action profile of Afrezza. "We are excited to file our first international application for approval of Afrezza in Brazil, which is in the top ten countries with the highest diabetes rates in the world according to the World Health Organization," said Michael Castagna, Chief Executive Officer of MannKind Corporation. 

Akari Therapeutics Plc (NASDAQ: AKTX) closed up over 7% on Monday at $4.64 by the market close. Akari Therapeutics, Plc, a clinical-stage biopharmaceutical company, focuses on the development and commercialization of therapeutics to treat rare and orphan autoimmune and inflammatory diseases. Its lead drug candidate is Coversin, a second-generation complement inhibitor that is in Phase II clinical trial for the treatment of autoimmune and inflammatory diseases, including paroxysmal nocturnal hemoglobinuria, guillain barré syndrome, and atypical hemolytic uremic syndrome.

Endocyte Inc. (NASDAQ: ECYT) closed up over 2% on Monday at $4.62 by the market close. The company announced it will host a conference call on Monday, Nov. 6th, at 4:30 p.m. EST to discuss its third quarter financial results and provide an operational update. Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company's website at or by dialing (877)845-0711 (U.S./Canada) or (760)298-5081 (International). The webcast will be recorded and available on the Company's website for 90 days following the call.

Adamas Pharmaceuticals Inc. (NASDAQ: ADMS) closed up over 21% on Monday at $23.61 trading over 5.2 million shares by the market close. Last week, the company announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Drug Products (OOPD) has recognized by letter to the company the seven-years of orphan drug exclusivity for GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. On August 24, 2017, GOCOVRI was approved by the FDA and earned orphan drug exclusivity that will continue through August 24, 2024. Based upon the FDA's letter, we expect GOCOVRI's orphan drug exclusivity to be additionally recognized in a future update of the Orange Book. Adamas will receive $65 million in funding from HealthCare Royalty Partners with such update, as part of the $100 million royalty-backed note the company signed in May 2017.

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