CODX Explodes, AXON Completes Restructuring, No Time To Frown For EOLS

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

1. Co-Diagnostics Inc. (CODX)

Gained 118.52% to close Tuesday's (May 29) trading at $3.54.

News: No news

Recent events:

On April 5, 2018, Co-Diagnostics filed its initial Annual Report on Form 10-K as a public company. The Company went public on the NASDAQ on July 12, 2017, offering its shares at a price of $6.00 each.

Net loss for 2017 widened to $6.96 million or $0.63 per share from $1.93 million or $0.20 per share in 2016. Revenue for the year 2017 was $7,700, primarily licensing revenue, compared to zero revenue in full year 2016.

The Company ended the year with cash and equivalents of $3.5 million and zero long-term debt.

2. Axovant Sciences Ltd. (AXON)

Gained 23.65% to close Tuesday's trading at $1.49.

News: The Company announced that the organizational restructuring, initiated in February 2018, to simplify its organization, reduce costs, and streamline business processes in preparation for future business development activities, has been completed.

As part of restructuring, the Company has enhanced its capabilities in clinical research and business development, while reducing its internal headcount by approximately 43%.

The Company has also strengthened its management team by appointing Gavin Corcoran, as Executive Vice President of Research & Development, and Michael Hayden, as a senior scientific advisor to the company and Chairman of its newly established Scientific Advisory Board.

3. Savara Inc. (SVRA)

Gained 17.57% to close Tuesday's trading at $10.44.

News: Two case reports exploring the use of aerosolized granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of Mycobacterium abscessus (M. abscessus), in individuals living with cystic fibrosis lend credence to the scientific rationale for the treatment of NTM lung infection using inhaled GM-CSF.

The two case reports were initially published in the European Respiratory Journal (ERJ) by Mark E. Wylam, M.D., pulmonologist and critical-care specialist at the Mayo Clinic College of Medicine, and his coworkers.

A phase 2a clinical study of the Company's lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in subjects with persistent pulmonary NTM infection, dubbed OPTIMA, initiated in March of this year is underway.

Near-term Catalysts:

-- Patient enrollment in the OPTIMA study is on track to complete in Q3 2018. -- Top-line results of the OPTIMA study are expected in H1 2019. However, as OPTIMA is an open-label study, depending on enrollment and other factors, interim results from the study may be provided in 2018.

4. Sierra Oncology Inc. (SRRA)

Gained 17.08% to close Tuesday's trading at $2.81.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is SRA737. It is under two phase I trials - a phase I/II trial of SRA737 administered orally in subjects with advanced cancer (Solid Tumors or Non-Hodgkin's Lymphoma), and a phase I/II trial of oral SRA737 given in combination with Gemcitabine plus Cisplatin or Gemcitabine alone in subjects with advanced cancer (Advanced Solid Tumors).

In February of this year, the Company expanded the SRA737 monotherapy phase 1/2 trial to enroll CCNE1-driven ovarian cancer cohort. The preliminary data from the Monotherapy trial are anticipated in the fourth quarter of 2018.

The Company has also expanded its SRA737 phase 1/2 Low-Dose Gemcitabine combination trial into the cohort expansion phase II portion. An update from this trial is also expected in the fourth quarter of 2018.

5. Evolus Inc. (EOLS)

Gained 16.76% to close Tuesday's trading at $26.20.

News: The Company has appointed Lauren Silvernail as its Chief Financial Officer and Executive Vice President, Corporate Development.

Silvernail joins Evolus from Revance Therapeutics where she most recently served as Chief Financial Officer and Chief Business Officer. At Revance she successfully led multiple capital raises and executed a number of the company's pre-commercial strategies.

Recent event:

-- On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to FDA within 90 days.

-- The same day, i.e., on May 16, 2018, the Company also announced good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

6. Corvus Pharmaceuticals Inc. (CRVS)

Gained 9.93% to close Tuesday's trading at $12.62.

News: No news

Clinical Trials:

-- A phase 1/1b study of CPI-444 both as a single agent and in combination with Roche's Tecentriq in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC) is underway. -- A phase 1b/2 clinical trial of CPI-444 in combination with Tecentriq as second- or third-line therapy in patients with NSCLC who are resistant or refractory to prior anti-PD-(L)1 antibody therapy is ongoing. -- A Phase 1/1b clinical trial with CPI-006 as a single agent and in combination with CPI-444, and in combination with Merck's immuno-oncology drug, Keytruda in patients with advanced cancers initiated as recently as April of this year is ongoing.