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Biotech Companies May Be Primed For 2018; New Regulations, Fast Approval

Published 01/11/2018, 07:35 AM
Updated 07/09/2023, 06:31 AM


Biotech firms had a good year in 2017. The NASDAQ Biotechnology Index reported a 20% jump as of early December even after a 10% correction since October.

This year appears to hold more promise for the biotech sector with diminished risk of stringent regulations, particularly with the drug price rule that has significantly subsided. In addition, the Trump administration issued a policy initiative in July to accelerate the approval process for new drugs.

With the US Food and Drug Administration (FDA) now at the forefront of the administration’s price-cutting initiative, the agency has been tasked with speeding up the drug approval process. These moves may be considered highly favorable to the biotech sector and are expected to provide further activity.

One of the companies which may potentially benefit from these changes in policy, combined with the current U.S. opioid crisis, is Biocorrx Inc (OTC:BICX), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions. They recently announced that they have submitted their pre-Investigational New Drug (pre-IND) package to the FDA for the company's naltrexone implant, BICX102. BICX102 is the company's sustained release naltrexone implant for the treatment of opioid and alcohol use disorders.

The submitted pre-IND package provides the FDA with current information on BICX102, as well as the proposed development plan. The purpose of the meeting is to review the development plan and to seek the agency’s guidance on further development and commercialization of BICX102.

This pre-IND submission follows BioCorRx's recent announcement that the FDA has granted BioCorRx a Type-B pre-IND meeting that is scheduled for January 24, 2018. The National Institute on Drug Abuse (NIDA) has agreed to attend the pre-IND meeting with the FDA for BICX102. NIDA and National Institute on Alcohol Abuse and Alcoholism (NIAAA) have also received the documents which BioCorRx submitted to the FDA.

Brady Granier, CEO, president, and director of BioCorRx, commented, “We are pleased that BioCorRx will be starting out the New Year with a meeting with the FDA. The submission of the pre-IND package is a major step that BioCorRx has completed in its efforts to bring BICX102 to market. We thank all of our advisors and consultants for their tireless efforts in putting together a package that we feel will lead to a very productive meeting. We are pursuing the 505(b)(2) regulatory pathway, which we believe will be a more rapid and cost-effective route to approval. We are pleased that both NIDA and NIAAA are involved in this process and we look forward to the meeting with the FDA.”

Top Biotech Performers of 2017

Investors who are on the lookout for opportunities in the biotech sector need to take a quick peek into this year’s top performers. Here are the top three performing biotech sectors with market capitalization between $50 and $500 million that are traded on the NASDAQ and the TSX.

1. XOMA Corp (NASDAQ:XOMA)

This Berkeley, California-based company saw a 656.4% increase in its share prices in 2017. Xoma boasts of seeking “transactions where it could exchange cash or equity today for future milestones and royalties.”

Chief Executive Officer Jim Neal stated in the company’s third-quarter report that Xoma “is very well positioned to deliver sustained growth in the years ahead and create long-term value for shareholders" because of the more than two dozen partner-funded programs that have the potential to generate substantial additional milestone and royalty payments.

2. AVEO Pharmaceuticals Inc (NASDAQ:AVEO)

Based in Cambridge, Massachusetts, and founded by Ronald DePinho in 2018, AVEO is reporting a 443.52% rise and share price value this year.

The company is also expecting U.S. approval for its FOTIVDA (tivozanib) in the first quarter of 2018 after the completion of a study in subjects with refractory advanced renal cell carcinoma. FOTIVDA (tivozanib) is AVEO’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, and ficlatuzumab, the company’s humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway.

AVEO is confident it can fully explore its opportunities in the oncology segment of the biotech industry.

3. Viking Therapeutics Inc (NASDAQ:VKTX)

Headquartered in California, Viking Therapeutics stocks jumped 245.38 in 2017. Viking is devoted to developing therapies for the metabolic and endocrine disorder.

Viking Chief Executive Officer Brian Lian said the company is scheduled to announce the results of Phase 2 trial of the company’s novel SARM program VK5211 in patients recovering from hip fracture by year-end.

VK5211, Viking's lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety, and tolerability of VK5211 in patients recovering from hip fracture surgery.


DISCLOSURE: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I am receiving compensation from BioCorRx for the article.

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