While America continues to warm up to President-elect Donald Trump, investors should be exuberant, as major U.S. indices have staged a strong rally to new all-time highs. Since Donald Trump was confirmed the winner of the U.S. presidential election on November 9th, the Dow Jones Industrial Average has soared 1,167 points or 6.37%, the S&P 500 has risen 93 points or 4.37%, and the Nasdaq has rallied 187 points or 3.60%. The unusually robust rally over the past month continues to show very little signs of running out of steam. With plans to help ease regulations and jumpstart American economic expansion, here are four biotechnology companies that could continue to thrive under the new administration:
BioVie Inc (OTC Markets: BIVI)
BioVie’s lead asset, BIV-201, received orphan drug designation by the FDA in September and just recently submitted its investigational new drug application (IND) on November 29th. The drug is intended to treat refractory ascites die to liver cirrhosis. BIV-201 targets ascites formation at its “mechanistic source,” by blocking the activation of neuro-hormonal signals, and it thereby alleviates portal hypertension and corrects splanchnic vasodilation. Two studies in Italy and Australia have indicated the potential for BIV-201’s approach to reduce ascites without causing serious side effects.
Ascites is the most common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity. Currently, no drugs have been approved by the FDA to specifically treat ascites, thus a critical unmet medical need exists.
BIV-201 is unique in that it enables patients to be treated for Ascites in an outpatient setting. As public health advocates are embracing drugs with strong clinical data from other countries, BioVie may be set to gain with their data from Europe and Australia to advance in the regulatory pathway. In addition, the company has created a platform technology that will target other related liver diseases, including NASH, HRS, and EVB. In summary, the company has many short term inflection points that should create enormous value for shareholders.
In addition, BioVie announced that it has appointed Mr. James Lang as an independent member of the Board of Directors, on December 7, 2016. Mr. Lang has an extensive history of success within the healthcare and biotechnology industries. Formerly the CEO of Decision Resources Group, Mr. Lang help turn the company around and was able to achieve “robust revenue and profit growth.” In addition, the new independent BioVie board member has extensive history running and investing other healthcare companies, such as: Strategic Decisions Group, Boston Heart Diagnotics, and AlphaImpactRx. Overall, the appointment of Mr. Lang is a major victory for BioVie.
Anavex Life Science Corp. (NASDAQ: AVXL)
Anavex’s lead drug, Anavex 2-73, an oral compound, is being evaluated for the treatment of Alzheimer’s and Parkinson’s disease. Anavex 2-73 is an agonist of the intracellular sigma-1 chaperone protein. Demonstrated in many tissues and located at main contacts between mitochondria and the endoplasmic reticulum, the sigma-1 receptor forms heterodimers with many other membrane receptors, and thus is able to influence multiple cellular pathways and physiological processes.
Anavex just announced data on a Phase 2 forty-one-week treatment of Anavex 2-73 for patients with mild-to-moderate Alzheimer’s disease. Patients treated with oral dose of Anavex 2-73 at week forty-one showed a continued stabilization of both cognitive (MMSE) and functional (ADCS-ADL) measures. Another promising result from the trial was that Anavex 2-73 was well tolerated with no patients discontinuing treatments due to adverse events.
NorthWest Biotherapeutics, Inc (NASDAQ: NWBO)
Nothwest Bio is a company that is devoted to developing original cutting-edge vaccines to treat solid tumor cancers more effectively than current treatments and without the side effects of chemotherapy. The Company is developing its platform technology DCVax that uses activated dendritic cells designed to educate the immune system to attack cancers.
Northwest Bio is currently in a phase 3 trial in patients with newly diagnosed Glioblastoma multiforme. Glioblastoma is an orphan disease and is the most aggressive and dangerous form of brain cancer. Northwest Bio is also conducting phase 1/2 trials on patients with inoperable solid tumors. Currently, the FDA placed a clinical hold on Northwest Bio’s 348 patient phase 3 trial on patients with Glioblastoma. As Northwest Bio has been in contact with the FDA for a while to lift the clinical hold that may change very quickly under President Trump who wants to cut bureaucracy and red tape at the FDA.
Galena Biopharma Inc (NASDAQ: GALE)
Galena’s lead drug, GALE-401, a controlled release formulation of anagrelide, is being evaluated for the treatment of myeloproliferative neoplasms. Anagrelide has been approved in the U.S. and Europe for treating high platelets counts in patients with bone marrow disorders. GALE-401’s controlled release version of anagrelide is made to dissolve more slowly than currently marketed versions of this drug.
By slowing the release of the drug into the blood could help to lower side effects and have a better safety profile for patients.
Galena has shown in multiple Phase 1 studies in which 86 healthy subjects received GALE-401 have shown that the drug exhibits the desired pharmacokinetic profile. In Galenas Phase 2 trial, GALE-401 demonstrated a potentially faster onset of action, consistent efficacy, and an indication of improved tolerability compared to the immediate release version of anagrelid. Galena is expected to begin a phase 3 in Q2 of 2017.