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ACER Already Up 61% This Month, CTXR Recoups Some Losses, Time To Check CKPT

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

1. Citius Pharmaceuticals Inc. (CTXR)

Gained 48.25% to close Thursday's (Aug 9) trading at $1.69. The stock had touched an all-time low of $1.12 yesterday (Aug 8).

News: The Company announced the pricing of $10 million underwritten offering priced at-the-market.

Each share of Common Stock is being sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $1.275 per share and accompanying common warrant. The common warrants will be exercisable immediately at an exercise price of $1.15 per share and will expire five years from the date of issuance. The offering is expected to close on or about August 13, 2018.

Pipeline:

A phase III trial of Mino-Lok Therapy in combination with systemic antibiotics in the treatment of catheter-related bloodstream infections enrolled the first patient as recently as February of this year. This trial is planned to enroll 700 patients in 50 participating institutions, all located in the U.S. There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.

Also in the pipeline is CITI-001 (Halo-Lido) to treat hemorrhoids, which has successfully completed a phase IIa study.

2. Checkpoint Therapeutics Inc. (CKPT)

Gained 27.82% to close Thursday's trading at $3.17.

News: No news

Recent event:

On Aug 7, the Company announced financial results and recent corporate highlights for the second quarter ended June 30, 2018.

Net loss attributable to common stockholders for the recent second quarter was $6.6 million or $0.23 per share, compared to a net loss of $6.4 million or $0.28 per share, for the second quarter of 2017.

Pipeline:

The Company's clinical drug candidates include CK-301, under phase I testing, for treatment of patients with non small cell lung cancer (NSCLC) and other solid tumors, and CK-101, under Phase 1/2 clinical trial for the treatment of patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC.

Near-term Catalysts:

--Initial expansion cohort data from phase I portion of the Phase 1/2 clinical trial of CK-101 in NSCLC EGFR mutation-positive NSCLC are expected in the coming week.
-- Initial data from expansion cohort of phase I study of CK-301 in NSCLC and other solid tumors expected around year-end.
-- Initiate the first registration trials for CK-301 and CK-101 in 2019.

3. Idera Pharmaceuticals Inc. (IDRA)

Gained 26.91% to close Thursday's trading at $7.31.

News: No news

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.

Near-term Catalysts:

-- Complete enrollment of a phase I/II trial of Tilsotolimod in combination with Ipilimumab in patients with PD-1 refractory melanoma, dubbed ILLUMINATE-204, by year end 2018.

ILLUMINATE-204 is a phase I/II trial of Tilsotolimod in combination with Ipilimumab or Pembrolizumab in patients with PD-1 refractory melanoma.

-- Data update following completion of ILLUMINATE-204 Pembrolizumab combination Phase 1 component of the trial.
-- Data from a phase I study of Tilsotolimod in patients with refractory solid tumors, dubbed ILLUMINATE-101.
-- Complete enrollment in ILLUMINATE-204 with top line data in mid-2019.

4. Novavax Inc. (NVAX)

Gained 21.49% to close Thursday's trading at $1.47.

News: The Company announced second-quarter financial results and provided an update on its vaccine programs namely ResVax and NanoFlu.

The net loss for the recent second quarter was $44.5 million or $0.12 per share compared to a net loss of $44.5 million or $0.16 per share for the second quarter of 2017.

Revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017, driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million.

Near-term Catalysts:

-- Final efficacy results from phase III trial of ResVax to protect infants from respiratory syncytial virus disease, dubbed Prepare, are expected to be reported in the first quarter of 2019.
-- The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.
-- Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019. The FDA has already acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.

5. Acer Therapeutics Inc. (ACER)

Gained 16.12% to close Thursday's trading at $29.82.

News: No news

Recent event:

On August 3, the Company announced the closing of its previously announced underwritten public offering of 2.55 million shares of its common stock, including the underwriters' full exercise of their option to purchase additional shares, at a public offering price of $18.00 per share. The gross proceeds from this offering were about $46.0 million.

Pipeline:

The lead candidate is EDSIVO for treatment of vascular Ehlers-Danlos syndrome. Also in the pipeline is ACER-001 for treatment of Urea Cycle Disorders (UCD) and Maple Syrup Urine Disease. ACER-001 is a taste-masked, immediate release formulation of sodium phenylbutyrate (marketed as Buphenyl).

Near-term Catalyst:

Submit EDSIVO NDA for Ehlers-Danlos syndrome in early fourth quarter of this year.

Ehlers-Danlos syndrome (EDS) is a group of hereditary disorders of connective tissue.

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