Reaching Regulatory Milestones in Biotech

LAS VEGAS, November 9, 2017 /PRNewswire/ --

Estimating and understanding the value of a biotech company is less about calculating current worth of assets and future cash flows, but more about making less out of more between major finance advancements. The complexity of the current regulatory system in regard to biotech products and new developments can be difficult for the public to understand. It can also create challenges for small and mid-sized business who are navigating the regulatory process to test the safety and effectiveness of their products. We've broken down four major milestones in the biotechnology regulatory process to help the public, and investors alike, understand which companies are successfully piloting the regulatory process.

Four major regulatory milestone categories:
FDA approval decision: an absolute stock mover, once the FDA approves or rejects an application the stock is guaranteed to move either up or down. Tracking FDA approvals across biotech will guide you to the small to mid-size companies with the most potential whereas rejections usually cause stock prices to plummet.
Clinical trial results: the next, and often longest, step after FDA approval. This category is important as it will determine whether or not the drug or therapy is effective or not. It is not a sure fire stock mover the same way as category one but crucial as a good time to invest if the results are favorable.
Several types of regulatory filings, the most common being IND filings and trial starts: this category is important as it represents important events in the operation of a company.
Business development activity: this is important to value creation but can be an extremely impervious process. Many companies claim to be entering a partnership, or that a partnership is right around the corner, but often to not solidify these partnerships. Be sure to identify which companies are truly entering the process of licensing agreements and partnerships, not just claiming to.
The milestones listed are not always in the same order, so it's critical to know which companies are where in the process as it will define whether or not their stocks will move in the near future. A few companies to keep an eye on include: Propanc Biopharma, Inc. (OTC: PPCB), Kura Oncology, Inc. (NASDAQ: KURA), Verastem, Inc. (NASDAQ: VSTM), Stemline Therapeutics, Inc. (NASDAQ: STML) and Juno Therapeutics Inc. (NASDAQ: JUNO).

Propanc Biopharma, Inc. (OTCQB: PPCB)
Market Cap: $616,550, current share price: $.095
PPCB is leading the way in cancer research as a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancer. The Company has exciting news regarding their lead product, PRP, a solution for once daily intravenous administration of a combination of two proenzymes trypsinogen and chymotrypsinogen. The Company announced at the end of October they have submitted a request for Orphan Drug Designation (ODD) for PRP to the FDA. The proposed orphan drug indication for PRP is the treatment of ovarian cancer. This is their second ODD request, with the FDA granting ODD status for PRP for the treatment of pancreatic cancer. Keep a look out for PPCB as they move through stage one, a sure thing to move their stocks in the right direction.

Kura Oncology, Inc. (NASDAQ: KURA)
Market Cap: $394.55M, current share price: $14.25
KURA, similar to PPCB, is a biopharmaceutical company focused on the development of precision medicines for oncology. Earlier this month, KURA announced it will be presenting four different abstracts on their lead product, tipifarnib, at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition. This will be held December 9^th through the 12^th in Atlanta. These presentations can be extremely informative on where the Company is in the regulatory process and what milestones they've reached. 

Stemline Therapeutics, Inc. (NASDAQ: STML)
Market Cap: $329.9M, current share price: $13.05
STML is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. The company earlier this month announced that SL-401, a novel therapeutic directed to CD123, is going to be featured in multiple presentations at the 2017 American Society of Hematology. Over the last couple weeks the company's stock has increased by approximately $2 per share, likely because of the company's most recent press release. 

Verastem, Inc. (NASDAQ: VSTM)
Market Cap: $134.05M, current share price: $3.38
VSTM is a clinical stage biopharmaceutical company also focuses on discovering and developing drugs to improve outcomes for patients with cancer. Earlier this month the Company announced that it intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). They expect to submit in Q1 of 2018.

Juno Therapeutics Inc. (NASDAQ: JUNO)
Market Cap: $729.654M, current share price: $5.62
JUNO is a Company that specializes in cellular immunotherapies to treat cancer. They confirmed 15 abstract presentations containing updated clinical and pre-clinical results from it and its collaborators will be presented at the ASH, the same conference KURA will have four presentations. You'll be able to find out where JUNO is in category two of the regulatory milestones throughout their presentations.

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