01.05.2018 02:52:34

HTBX Gains Momentum, DOVA Faces FDA In May, No Stopping CHEK, So Long STDY

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

1. Heat Biologics Inc. (HTBX)

Gained 87.72% to close Monday's (Apr.30) trading at $2.14.

News: No news

Near-term catalysts:

-- Receive $6.9 million in CPRIT (Cancer Prevention Research Institute of Texas) grant funds in Q3, 2018. -- Interim phase II Non Small Cell Lung Cancer data readout of HS-110 in Q4, 2018. -- IND filing for first ComPACT trial of HS-130 in NSCLC in Q4, 2018. -- Enroll first patient in ComPACT trial in Q4, 2018. -- PTX-35 IND filing in Q1, 2019. -- Enroll first patient in PTX-35 trial in Q1, 2019. -- Complete enrollment in Phase 2 NSCLC trial in Q2, 2019. -- Phase II NSCLC data readout in Q2, 2019. -- Interim ComPACT data readout in Q2, 2019. -- Interim PTX-35 data readout in Q3, 2019.

2. Steadymed Ltd. (STDY)

Gained 77.36% to close Monday's trading at $4.70.

News: The Company is all set to be acquired by United Therapeutics Corp. (UTHR) for $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialization of Trevyent. The transaction, including the $75 million in contingent consideration, is valued at $216 million.

If all goes well as planned, the transaction is expected to be completed in the third quarter of this year.

Steadymed is developing Trevyent for the treatment of Pulmonary Arterial Hypertension. On August 31, 2017, the FDA refused to even accept the Company's New Drug Application for Trevyent for the treatment of Pulmonary Arterial Hypertension. The resubmission of Trevyent NDA is expected to occur before the end of 2018.

3. Check Cap Ltd. (CHEK)

Gained 41.80% to close Monday's trading at $12.79.

News: No news

Check-Cap is a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer screening.

Recent events:

-- On January 10, 2018, the Company received CE Mark approval for the C-Scan system.

The C-Scan system, an ingestible capsule, offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures.

-- On March 12, 2018, the Company initiated an EU post approval study using its Advanced C-Scan system. -- On April 4, 2018, the Company implemented a 1-for-12 reverse stock split of its outstanding ordinary shares. -- On April 19, 2018, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2), which concerns minimum bid price listing requirements.

Near-term Catalyst:

-- The Company is expected to initiate the US pilot trial for advanced C-Scan Version in the second half of 2018.

4. Atossa Genetics Inc. (ATOS)

Gained 29.97% to close Monday's trading at $4.38.

News: The Company has received approval from the Swedish Medical Products Agency (MPA) to conduct a phase II Study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD.

Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.

5. Arsanis Inc. (ASNS)

Gained 15.05% to close Monday's trading at $20.03.

News: No news

Recent events:

-- On November 16, 2017, the Company went public on the NASDAQ Global Market, offering its shares at a price of $10 each. -- On April 4, 2018, the Company entered into an agreement under which BB100 LLC secured an exclusive, worldwide preclinical development license, and an option to a clinical development and commercialization license, to monoclonal antibodies (mAbs) targeting E. coli that were discovered by Arsanis in its ASN200 program.

Clinical Trials & Near-term catalysts:

-- The Company's investigational lead product candidate is ASN100, which is currently in a Phase 2 clinical trial for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients. -- Top line safety and efficacy results from the phase II study of ASN100 are expected in the second half of 2018.

6. Dova Pharmaceuticals Inc. (DOVA)

Gained 13.83% to close Monday's trading at $28.81.

News: No news

Near-term Catalyst:

-- The Company's New Drug Application for Avatrombopag is under Priority Review by the FDA, with a decision expected on May 21, 2018.

Avatrombopag is proposed for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure.

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