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07.08.2018 03:28:16

Recheck Propels PTGX, Analysts Boost Price Target On ICPT, Watch Out For AMPE

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

1. Protagonist Therapeutics Inc. (PTGX)

Gained 58.63% to close Monday's (Aug 6) trading at $11.12.

News: An independent blinded re-analysis of the Company's phase II study of oral alpha-4-beta-7 integrin antagonist PTG-100 for the treatment of patients with ulcerative colitis, dubbed PROPEL, provides signals of clinical efficacy and support further development of PTG-100.

On March 26, 2018, the Company had announced that it is discontinuing the PROPEL study, following an interim analysis by an independent Data Monitoring Committee. The interim data revealed an unusually high placebo rate of clinical remission (24 percent, approximately four times higher than historical norms for similar UC studies) that led to a futility decision and discontinuation of the trial. The news sent the stock down 57% to $8.75 that day.

Now, the Company has identified human error in initial reads provided by contract research organization. If the re-read of endoscopy results had been utilized for the interim futility analysis, the trial would have continued.

Near-term Catalysts:

-- Meet with the FDA during the second half of 2018 to discuss next steps regarding the PROPEL study. -- Present the PROPEL data at a future medical conference.

2. Intercept Pharmaceuticals Inc (ICPT)

Gained 17.94% to close Monday's trading at $114.71.

News: Analysts have boosted the price target of the Company.

Wedbush has raised its price target on Intercept to $217 from $203, and has reiterated its rating of "Outperform". Goldman Sachs has lifted its price target on Intercept to $157 from $46 and has upgraded its rating for the shares to Buy from Sell.

Near-term Catalyst:

-- Report top line data from the phase III study of Obeticholic Acid in subjects with compensated cirrhosis due to Nonalcoholic Steatohepatitis, dubbed REGENERATE, in first half of 2019.

3. T2 Biosystems Inc. (TTOO)

Gained 13.81% to close Monday's trading at $6.10.

News: No news

Recent event:

-- On Aug.2, the Company reported financial results for the second quarter ended June 30, 2018.

Net loss narrowed to $12.32 million or $0.32 per share from $15.45 million or $0.50 per share in the year-ago quarter. Total revenue for the recent second quarter was $3.93 million compared to $956 thousand in the year-ago quarter.

Looking ahead to full year 2018, the total revenue is expected to be in the range of $10.5 million to $12.0 million. Analysts polled by Thomson Reuters have a consensus revenue estimate of $10.66 million for the quarter.

4. Otonomy Inc. (OTIC)

Gained 13.64% to close Monday's trading at $3.75.

News: The Company has signed a co-promotion agreement with Mission Pharmacal Co. to promote OTIPRIO for acute otitis externa. Financial terms for the multi-year agreement were not disclosed.

OTIPRIO, developed by Otonomy, is a sterile, preservative-free, otic suspension of 6% ciprofloxacin administered as a single-dose by a healthcare professional. It was approved by the FDA for acute otitis externa in March of this year.

The agreement entitles Otonomy to receive an annual co-promotion fee and reimbursement of a proportion of product support expenses, and retain a share of gross profits from the sale of OTIPRIO to Mission's accounts. Otonomy retains all commercial rights for other customer segments for acute otitis externa and use of OTIPRIO in all other indications including ongoing sales for use during pediatric ear tube surgery.

5. Ampio Pharmaceuticals Inc. (AMPE)

Gained 13.62% to close Monday's trading at $2.92.

News: The Company announced that it will update the preparation of the Biologics License Application for Ampion on August 7 at 4:30 pm.

Ampion is an intra-articular injection under development for the treatment of pain due to osteoarthritis of the knee.

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Otonomy Inc 0,07 -2,64% Otonomy Inc
Protagonist Therapeutics Inc 45,04 0,47% Protagonist Therapeutics Inc