NEPT Hits A High, CLBS Up 118% In 2 Days, APEN Abuzz, Busy Days Ahead For TSRO

pharma june19

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

1. Xenetic Biosciences Inc. (XBIO)

Gained 50.31% to close Wednesday's (June 20) trading at $2.39.

News: No news

Clinical Trials & Near-term Catalysts:

A phase II clinical study of XBIO-101 for the treatment of progesterone resistant endometrial cancer is underway. Interim data from this trial is expected to be announced before the end of 2018.

The Company has an agreement with Baxalta Inc., Baxalta US Inc., and Baxalta GmbH - the wholly-owned subsidiaries of Shire plc (SHPG) - related to its PolyXen technology.
PolyXen technology is Xenetic's proprietary drug development platform.

2. Neptune Technologies & Bioressources Inc. (NEPT)

Gained 37.77% to close Wednesday's trading at $4.45. This is the second straight day of double-digit gain for the stock.

Recent event:

On June 19, 2018, the Company announced that it has entered into a multi-year agreement with Canopy Growth (WEED.TO) (CGC) to provide extracted cannabis products. The stock soared nearly 32% yesterday.

3. Caladrius Biosciences Inc. (CLBS)

Gained 30.71% to close Wednesday's trading at $8.64.

The Company has two technology platforms - T regulatory cells for immune modulation and CD34 cells for ischemic repair.

News: On June 19, the Company announced that its late-stage CD34+ cell therapy program for the treatment of refractory angina has been granted regenerative medicine advanced therapy ("RMAT") designation by the FDA. The news sent the stock more than 67% that day.

Clinical Trials & Near-term Catalysts:

-- A phase II clinical trial of CLBS03 as a treatment for recent-onset type 1 diabetes (T1D), dubbed T-Rex study, is underway. Top line data is expected in early 2019.
-- A phase II clinical trial with its proprietary CD34 cell therapy (CLBS12) for the treatment of no-option critical limb ischemia ("CLI") was initiated as recently as March of this year in Japan. The trial is designed to enroll 35 patients, with final results expected in mid-late 2019.
-- A phase I/II proof of concept study of CLBS14 in patients with coronary microvascular dysfunction and without obstructive coronary artery disease is ongoing. Results from this study are expected by the end of 2019.

4. aTyr Pharma Inc. (LIFE)

Gained 21.90% to close Wednesday's trading at $1.28.

News: No news

Recent events:

-- On May 14, 2018, the Company announced that it is implementing an immediate workforce reduction of approximately 30% as well as additional cost saving measures.

Clinical Trials & Near-term Catalysts:

-- A phase I clinical trial of ATYR1923 in healthy volunteers in Australia is ongoing. ATYR1923 is being developed for the treatment of interstitial lung diseases. Top-line results from this study are expected in 2Q 2018.
-- A phase II trial of ATYR1923 is planned for initiation in the fourth quarter of this year.


Gained 19.20% to close Wednesday's trading at $1.49.

News: On June 19, the Company announced the appointment of veteran senior dental industry executive, Todd Norbe and veteran senior finance executive Jess Roper to its Board of Directors, effective immediately.

Roper becomes chairman of the audit committee and replaces James Talevich, who resigned from the Board due to other commitments. The addition of Norbe increases the size of the Board to five directors.

Recent events:

-- On May 30, 2018, the Company regained compliance with Nasdaq minimum bid price requirement of $1.00 per share for continued listing on the Nasdaq Capital Market.
-- On May 10, 2018, the Company effected a 1-for-5 reverse stock split to raise the per share trading price of its common stock to continue its listing on the Nasdaq Capital Market.

6. Apollo Endosurgery Inc. (APEN)

Gained 18.21% to close Wednesday's trading at $6.62.

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures. The marketed products include OverStitch Endoscopic Suturing System, ORBERA Intragastric Balloon, and LAP-BAND Adjustable Gastric Banding System.

News: The Company has priced an underwritten public offering of 3.75 million shares of its common stock at a public offering price of $5.50 per share for gross proceeds of approximately $20.6 million.

The offering is expected to close on June 22, 2018.

Recent event:

-- On June 5, 2018, the Company presented results from Mayo Clinic's prospective open-label study demonstrating significant benefits of weight loss with the ORBERA Intragastric Balloon in patients with NASH and nonalcoholic fatty liver disease.

According to the Company, 65% of patients achieved resolution of NASH on biopsy; 80% of patients had a greater than or equal to 2 point improvement in NAFLD activity score; and 15% had tissue evidence indicating regression of fibrosis (scarring), despite the relatively short period of the study.

7. Tesaro Inc. (TSRO)

Gained 16.25% to close Wednesday's trading at $46.49.

News: No news

Near-term Catalysts:

-- Additional data from a phase 1 dose escalation and cohort expansion study of TSR-042 in patients with advanced solid tumors, dubbed GARNET, to be submitted to European Society for Medical Oncology (ESMO) in October and Society for Immunotherapy of Cancer (SITC) in November.
-- Initial data from a Phase 1 trial of TSR-022 in combination with TSR-042 in patients with advanced solid tumors to be submitted to SITC (November).
-- Phase 1 dose-escalation trial data of TSR-033, dubbed CITRINO, to be submitted to SITC (November).
-- Initial data from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor in patients with non-small cell lung cancer to be available in 2H 2018.
ZEJULA is approved in the U.S. and Europe for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

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