SBBP Going Strong, ENDP Boosts Outlook, ALNA Awaits Phase 3 Data In 2H

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

1. Strongbridge Biopharma plc (SBBP)

Gained 31.11% to close Wednesday's (Aug.8) trading at $5.90.

News: The Company reported second quarter 2018 financial results and positive top-line clinical results from its phase III trial of RECORLEV in endogenous Cushing's syndrome, dubbed SONICS.

On a non-GAAP basis, net loss attributable to ordinary shareholders widened to $16.7 million or $0.36 per share from $12.2 million or $0.34 per share for the same period in 2017. The net revenues from sales of KEVEYIS were $4.3 million in the second quarter of 2018, a 187 percent increase compared to $1.5 million in the second quarter of 2017.

As for the SONICS study, it achieved statistical significance of its pre-specified primary endpoint, with 30 percent of patients achieving normalization of mean urinary free cortisol following six months of maintenance treatment with RECORLEV without a dose increase, the Company said.

Based on the SONICS study data, the Company is planning to discuss the potential for accelerated approval of RECORLEV with the FDA, and continue its discussions with regulators around the world.

2. Endo International plc (ENDP)

Gained 28.30% to close Wednesday's trading at $16.23.

News: The Company reported second-quarter 2018 financial results and raised its outlook for the year.

Adjusted income from continuing operations for the recent second quarter declined to $172 million or $0.76 per share from $207 million or $0.93 per share in the year-ago quarter. Revenues for the second quarter of 2018 were $715 million, an 18 percent decrease compared to second-quarter 2017 revenues of $876 million.

Looking ahead to 2018, the Company now expects adjusted diluted EPS from continuing operations to be between $2.50 and $2.60, up from its prior guidance range of $2.15 and $2.55.

The revenue for the year is now anticipated to be between $2.75 billion and $2.85 billion compared to the earlier guidance range of $2.6 billion to $2.8 billion.

Near-term Catalyst:

Top-line results from two phase III trials for collagenase clostridium histolyticum (CCH) for the treatment of cellulite are expected in Q4, 2018.

3. HTG Molecular Diagnostics Inc. (HTGM)

Gained 24.74% to close Wednesday's trading at $3.58.

News: The Company reported financial results for the second quarter ended June 30, 2018.

Net loss for the second quarter of 2018 narrowed to $4.1 million or $0.14 per share from $5.5 million or $0.60 per share in the same period in the prior year. Total revenue for the recent second quarter soared to $4.9 million from $1.76 million in the year-earlier quarter.

Looking ahead, the company reaffirmed its full year revenue guidance of $21.0 to $25.0 million. Revenue in 2017 was $14.8 million.

4. Innovate Biopharmaceuticals, Inc. (INNT)

Gained 23.79% to close Wednesday's trading at $5.62.

News: No news

Pipeline:

The lead drug candidate is Larazotide acetate (INN-202), which has successfully completed its phase 2b efficacy clinical trial for celiac disease. Also in the pipeline are INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).

Recent events:

On July 11, the Company made a SEC filing related to the proposal of disposition from time to time of up to 13.99 million shares of its common stock, up to an aggregate maximum amount of $175 million.

As part of the 2018 Russell indexes reconstitution, the Company was added as a member of the broad-market Russell 3000, 2000 and Microcap Indexes, effective June 25, 2018.

Near-term Catalysts:

-- The Company is slated to report second quarter 2018 financial results on Aug.20. -- Phase III registration clinical trials of Larazotide acetate for celiac disease are expected to begin later in 2018.

5. Allena Pharmaceuticals, Inc. (ALNA)

Gained 22.38% to close Wednesday's trading at $11.70.

News: No news

Pipeline:

The Company's drug candidates include Reloxiliase, also known as ALLN-177, under a phase III trial in patients with enteric hyperoxaluria, dubbed URIROX-1, and a Phase 2 basket trial in adolescents and adults with primary hyperoxaluria or enteric hyperoxaluria and hyperoxalemia, dubbed Study 206; ALLN-346, intended for patients with hyperuricemia and moderate to severe chronic kidney disease, under a preclinical program.

Near-term Catalysts:

-- Initiate the second, larger, planned phase III clinical trial of Reloxiliase in patients with enteric hyperoxaluria, dubbed URIROX-2, in the second half of 2018. -- The interim data from Study 206 is expected to be announced in the second half of 2018. -- The top line data from URIROX-1 is expected to be announced in the second half of 2019.