Biotech Sector Volatile Ahead of Trump Announcement

LAS VEGAS, May 15, 2018 /PRNewswire/ --

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After attacking pharmaceutical companies and the cost of medicines for more than a year, President Donald Trump will release his plans to combat drug pricing on Friday.

The near-term implications for biotechnology and pharmaceutical stocks remain murky on Wall Street. Cowen analysts said in a research note Thursday they expect Trump's speech will "be relatively benign, with more drastic proposals coming at a later date or not at all." Wells Fargo & Co.'s David Maris, meanwhile, has cautioned that calls for lower prices and greater transparency have "never been louder. Included in today's commentary is: Endonovo Therapeutics, Inc. (QTC: ENDV), Eli Lilly and Company (NYSE: LLY), ARMO BioSciences, Inc. (NASDAQ: ARMO), vTv Therapeutics, Inc. (NASDAQ: VTVT), Dynavax Technologies Corporation (NASDAQ: DVAX).

Trump's prolific tweets sank drug maker stocks in January 2017 when he accused the companies of "getting away with murder" with their pricing. Health and Human Services Secretary Alex Azar said last week that Trump's plan will be based on the 2019 budget proposal, but go "further, much further" in attacking high list prices and out-of-pocket costs. Investor fears deepened when Food and Drug Administration Commissioner Scott Gottlieb suggested the government could re-examine the safe harbor that drug rebates have under federal anti-kickback laws.

Ahead of this major announcement, the biotech sector has had some large announcements this week.

Some biotechs having major announcements this week include: Endonovo Therapeutics, Inc. (QTCQB: ENDV), Eli Lilly and Company (NYSE: LLY), ARMO BioSciences, Inc. (NASDAQ: ARMO), vTv Therapeutics, Inc. (NASDAQ: VTVT), Dynavax Technologies Corporation (NASDAQ: DVAX)

Endonovo Therapeutics, Inc. (OTCQB: ENDV)

Market Cap: 13.48M, current share price: $.04 

Endonovo Therapeutics, Inc. (OTCQB: ENDV), a commercial-stage developer of Electroceutical™ Therapies, just announced a distribution agreement with Plagens Medical Consultants for the distribution of  SofPulse™, its non-invasive Electroceutical™ Therapy for post-operative pain relief and reduction of swelling.

SofPulse™ is the Company's FDA-Cleared Electroceutical™ System for the palliative treatment of post-operative pain and edema in superficial soft tissues. SofPulse™ is an easy-to-place, non-invasive device delivering targeted MicroCurrent Therapy (tMCT) to enhance post-surgical recovery. tMCT is an innovative process using proprietary technology to reduce pain and swelling. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse™ has been used effectively and studied extensively in soft tissue post-operative management. The low levels of microcurrent are completely safe and, in fact, are 1000 times lower than those emitted by a mobile phone.

The Company's Electroceutical™ Therapy has been evaluated in 5 randomized, double-blind controlled clinical trials demonstrating:

• 300% decrease in mean pain scores at 5 hours post-surgery;
• 2.2-fold reduction in narcotic use post-surgery in active users; and
• 275% lower mean IL-1 beta (inflammatory biomarker) in the wound exudates of active users following surgery
  

Endonovo's non-invasive pain relief therapy, SofPulse®, represents a low-cost, drug free solution to the over use of opioids following surgical procedures. Non-invasive electrotherapies, such as Endonovo's SofPulse®, are believed to modulate pain signaling through activation of peripheral endogenous opioids and opioid receptors; making these non-pharmacological devices an extremely safe and economical alternative to prescription painkillers.

Eli Lilly and Company (NYSE: LLY)

Market Cap: $81.79B, current share price: $80.17 

ARMO BioSciences, Inc. (NASDAQ: ARMO)

Market Cap: $1.5B, current share price: $49.68 

Eli Lilly and Company (LLY) and ARMO BioSciences, Inc. (ARMO) just announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction. ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors.

The acquisition will bolster Lilly's immuno-oncology program through the addition of ARMO's lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Pegilodecakin is currently being studied in a Phase 3 clinical trial in pancreatic cancer, as well as earlier-Phase trials in lung and renal cell cancer, melanoma and other solid tumor types. ARMO also has a number of other immuno-oncology product candidates in various stages of pre-clinical development.

vTv Therapeutics, Inc. (NASDAQ: VTVT)

Market Cap: $72.70M, current share price: $2.25 

vTv Therapeutics Inc. (VTVT) today announced that based on post-hoc analyses of the data from Part A of the Company's Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer's disease, despite not meeting co-primary endpoints, identified a subpopulation that showed statistically significant benefit (unadjusted for multiple, post hoc comparisons) from azeliragon relative to placebo on ADAS-cog. The identified subpopulation consisted of participants with peak azeliragon blood plasma concentration of less than 7.5 ng/mL. Based on the subpopulation data analyses from the Part A study and the prior azeliragon trials, the company will submit a revised Statistical Analysis Plan (SAP) to the Food and Drug Administration for the Part B Study that pre-specifies a target population for the primary study analysis and expects to report Part B topline efficacy results based on 12 month data in June 2018

Dynavax Technologies Corporation (NASDAQ: DVAX)

Market Cap: $1.10B, current share price: $17.90 

Dynavax Technologies Corp. (DVAX) on Tuesday reported a loss of $39 million in its first quarter.  On a per-share basis, the Berkeley, California-based company said it had a loss of 63 cents.  The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 51 cents per share.  The biopharmaceutical company posted revenue of $165,000 in the period.  Dynavax Technologies shares have decreased 11 percent since the beginning of the year. The stock has more than tripled in the last 12 months.

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