XERS Up 36% This Month, EVFM On Fast Track, NDRA Hitting Right Notes

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. Xeris Pharmaceuticals Inc. (XERS)

Gained 18.24% to close Tuesday's (Aug 14) trading at $25.02.

Recent events:

On Aug 13, the Company announced financial results for the second quarter and provided corporate highlights.

Xeris has submitted the NDA for its lead product candidate, Glucagon Rescue Pen, for the treatment of severe hypoglycemia, a potentially life-threatening condition, in people with diabetes.

On June 21, 2018, the Company went public on the Nasdaq Global Select Market, offering its shares at a price of $15.00 each.

2. Idera Pharmaceuticals Inc. (IDRA)

Idera is a clinical-stage biopharmaceutical company focused on developing novel oligonucleotide therapeutics for oncology and rare diseases. Its lead drug candidate is Tilsotolimod.

Gained 15.16% to close Tuesday's trading at $8.51. The stock has gained 36% over the last two days.

News: The Company made a presentation at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018.

Recent events:

-- On August 3, the Company reported its financial and operational results for the second quarter ended June 30, 2018. -- On July 30, a one-for-eight reverse stock split of common stock was implemented.

Clinical Trials & Near-term Catalysts:

-- A phase III trial of intratumoral Tilsotolimod in combination with Ipilimumab versus Ipilimumab alone in patients with PD-1 refractory metastatic melanoma, dubbed ILLUMINATE 301, initiated in the first quarter of 2018, is underway. -- A two-arm Phase 1/2 study of Tilsotolimod in combination with either Yervoy or Keytruda for the treatment of patients with anti-PD-1 refractory metastatic melanoma, dubbed ILLUMINATE-204, is ongoing. Enrollment in the Yervoy combination arm is expected to be completed by year-end 2018. -- A phase 1b trial of intratumoral Tilsotolimod monotherapy in patients with refractory solid tumors is underway.

The Company also has three investigator sponsored trials namely,

-- A Phase 1/2 open label study of intratumoral Tilsotolimod in combination with intratumoral Yervoy and IV Opdivo in a protocol open to multiple tumor types including non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck and urothelial carcinoma. -- A phase II study of intratumoral Tilsotolimod in combination with IV Keytruda in patients with NSCLC. -- A Phase 2 placebo-controlled study of intradermal administration of Tilsotolimod in patients with T3/T4 primary melanoma scheduled to undergo a combined re-excision and sentinel node biopsy (SNB) procedure.

3. XOMA Corp. (XOMA)

Gained 14.58% to close Tuesday's trading at $18.55.

News: The Company made a presentation at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018.

Recent event:

On August 7, the Company announced second quarter 2018 financial results.

Net loss for the second quarter of 2018 was $1.9 million, compared to net income of $0.3 million for the second quarter of 2017. Total revenue in the recent second quarter declined to $2.25 million from $10.89 million in the year-earlier quarter. On June 30, 2018, XOMA had cash and cash equivalents of $38.7 million.

Upcoming event:

The Company is scheduled to make a presentation at:

-- 2018 Southern California Investor Conference on Thursday, August 23, 2018, at 10:30AM PT in Newport Beach, California.

4. ENDRA Life Sciences Inc. (NDRA)

ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS) system that will help clinicians to visualize tissue function, composition, and monitor a variety of therapeutic interventions at the point of care. The first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease.

Gained 13.33% to close Tuesday's trading at $2.55.

Near-term Catalyst:

The Company has completed TAEUS liver system and safety testing and is now awaiting Health Canada's investigational testing authorization (ITA) required to commence recruitment for the clinical study.

5. Adial Pharmaceuticals Inc. (ADIL)

Adial is a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder.

Gained 12.57% to close Tuesday's trading at $3.85.

News: No news

Clinical Trials & Near-term Catalyst:

The lead investigational new drug product is AD04, which has successfully completed a Phase 2b University of Virginia investigator sponsored clinical trial for the treatment of alcohol use disorder.

The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes.

Recent events:

-- On July 27, the Company's common stock and warrants began trading on The NASDAQ Capital Market under the ticker symbols "ADIL," and "ADILW," respectively. The offering comprised of 1.46 million units, priced at a public offering price of $5.00 per unit, with each unit consisting of one share of common stock and a five-year warrant to purchase one share of common stock at an exercise price of $6.25 per share. -- On July 31, the Company closed its IPO of units for gross proceeds of $7.32 million.

6. Evofem Biosciences Inc. (EVFM)

Evofem is a clinical-stage specialty biopharmaceutical company committed to improving the health and well-being of women.

Gained 11.74% to close Tuesday's trading at $2.38.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.

Data from the phase III clinical trial of Amphora for the prevention of pregnancy are now expected in late 2018, ahead of its earlier guidance of Q1, 2019. If all goes well as planned, resubmit Amphora NDA for contraception in the first half of 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.