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LJPC, PTLA Disappoint, SBPH Waiting To ACHIEVE, Busy Months Ahead For TCON


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(RTTNews.com) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. La Jolla Pharmaceutical Co. (LJPC)

Lost 25.39% to close Thursday's (Aug 9) trading at $24.46.

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

Net loss for the recent second quarter was $52.8 million or $2.02 per share, wider than Wall Street's expectation of $1.91 loss per share. The net product sales of GIAPREZA in the second quarter of 2018 were $1.6 million while analysts expected sales of $2.5 million

Last December, GIAPREZA was approved by the FDA to increase blood pressure in adults with septic or other distributive shock. The drug was launched in the U.S. in March of this year.

Near-term Catalyst:

In June 2018, La Jolla announced that the Marketing Authorization Application for GIAPREZA was validated by the European Medicines Agency. If approved, GIAPREZA could be available for marketing in the European Union in the second half of 2019.

2. Portola Pharmaceuticals Inc. (PTLA)

Lost 18.32% to close Thursday's trading at $30.81.

News: The Company announced second quarter financial results, which were short of analysts' estimates.

The net loss for the recent second quarter was $106.2 million or $1.61 per share on total revenue of $4.0 million while analysts polled by Thomson Reuters expected a loss per share of $1.49 on revenue of $6.35 million.

Net loss was $69.7 million or $1.22 per share on revenue of $3.8 million for the second quarter of 2017.

Near-term Catalysts:


-- Submit Prior Approval Supplement (PAS) for Generation 2 Andexxa product by the end of August, positioning the Company for a broader commercial launch in early 2019, upon FDA approval.
-- On track to deliver additional data to European regulatory authorities in the fourth quarter, with potential for European approval of Andexanet alfa in the first half of 2019.
-- Ongoing discussion with the FDA on the potential regulatory pathway for Cerdulatinib.

3. Spring Bank Pharmaceuticals Inc. (SBPH)

Lost 12.77% to close Thursday's trading at $12.30.

News: The Company has priced an underwritten public offering of 3 million shares of its common stock at a public offering price of $12.50 each, for expected gross proceeds of $37.5 million.

The offering is expected to close on or about August 13, 2018, subject to customary closing conditions. The underwriters have a 30-day option to purchase up to an additional 450,000 shares of common stock.

Recent Event:

-- On August 2, the Company announced positive results from the third monotherapy cohort (100mg Inarigivir) of the ongoing ACHIEVE trial.

ACHIEVE is a phase 2a trial evaluating 4 monotherapy dosing regimens of Inarigivir, also known as SB 9200, namely, 25mg, 50mg, 100mg and 200mg, followed by Viread for the treatment of chronic hepatitis B virus (HBV).

The Company presented results from the 24-week trial of both the 25mg and 50mg cohorts of the ACHIEVE trial in March of this year.

Near-term Catalyst:

-- Top-line results from the fourth and final monotherapy cohort (200mg) of the ACHIEVE trial are expected to be announced by the end of 2018.

4. TRACON Pharmaceuticals Inc. (TCON)

Lost 12.24% to close Thursday's trading at $2.15.

News: The Company announced that interim analysis of its phase III trial of TRC105 for the treatment of angiosarcoma, dubbed TAPPAS, will be delayed until Q1 2019. Earlier, the interim analysis was expected to be conducted in the second half of 2018.

Near-term Catalysts:

-- Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected prior to the end of 2018. -- Announcement of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected prior to the end of 2018. -- Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in Q1 2019.

5. Calithera Biosciences Inc. ( CALA )

Lost 11.27% to close Thursday's trading at $4.52.

News: No news

Recent event:

On August 7, the Company announced its financial results for the second quarter ended June 30, 218.

Clinical Trials & Near-term Catalysts:

The lead drug candidate is CB-839, under phase II development in Renal Cell Carcinoma.


-- A phase II trial of CB-839 in combination with Cabometyx for the treatment of renal cell carcinoma, dubbed CANTATA, and a phase II trial of CB-839 in combination with Everolimus in late stage renal cell carcinoma patients, dubbed ENTRATA, are underway.
-- A phase II study of CB-839 in combination with Paclitaxel in patients with advanced triple negative breast cancer including patients of African ancestry and non-African ancestry is ongoing. In the Press Release issued on Aug 7, the Company has revealed that it does not plan to pursue further development of CB-839 plus Paclitaxel triple negative breast cancer at this point of time.
-- The phase II portion of phase I/II study of CB-839 in combination with Capecitabine in treatment refractory advanced colorectal cancer is ongoing.
-- Also in the pipeline is INCB001158, which is being evaluated in multiple phase I clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.
-- An investigational New Drug (IND) Application for CB-280 for the treatment of cystic fibrosis is expected to be filed with the FDA in the first half of 2019.
-- An IND for CB-708, an orally administered small molecule inhibitor of CD73, is planned in 2019.

Read the original article on RTTNews (http://www.rttnews.com/2925517/ljpc-ptla-disappoint-sbph-waiting-to-achieve-busy-months-ahead-for-tcon.aspx)


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This article appears in: Stocks , Politics
Referenced Symbols: CALA ,



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