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ZSAN Explodes, TTPH On Radar, APLS Catches Eyes, CERC Hits A High


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

1. Zosano Pharma Corp. (ZSAN)

Gained 71.05% to close Monday's (Feb.26) trading at $7.68.

News: No news

Recent event:

-- A 1-for-20 reverse stock split was implemented on January 26, 2018.

Clinical Trials & Near-term Catalysts:

The lead drug candidate is M207 for the treatment of migraine. A long-term safety study of M207 is underway.

-- The Company expects to enroll 100 patients by the end of Q1, 2018, and 250 patients by Q2, 2018. -- 6-month safety data from the trial is expected in Q4, 2018. -- 12-month safety data from the trial is expected in Q1, 2019. -- NDA filing for M207 for the treatment of migraine is expected by the end of 2019.

2. Tetraphase Pharmaceuticals Inc. (TTPH)

Gained 30.45% to close Monday's trading at $2.87.

News: No news

Recent event:

-- On February 20, 2018, the Company entered into an exclusive licensing agreement with Everest Medicines Limited to develop and commercialize Eravacycline in mainland China, Taiwan, Hong Kong, Macau, South Korea, and Singapore.

Eravacycline is an investigational drug for the treatment of complicated intra-abdominal infections (cIAI) and other serious infections, including those caused by multidrug-resistant (MDR) pathogens.

Near-term Catalysts:

-- A New Drug Application for Eravacycline in the treatment of complicated intra-abdominal infections was submitted to the FDA last month. Eravacycline is also under review by the European Medicines Agency for the treatment of complicated intra-abdominal infections.

3. Mesoblast Limited (MESO)

Gained 17.93% to close Monday's trading at $7.30.

News: No news

Recent event:

-- On February 22, 2018, the Company announced that its phase III trial of allogeneic mesenchymal stem cell product candidate MSC-100-IV in children with steroid refractory acute Graft versus Host Disease successfully met the primary endpoint.

There are currently no products approved in the United States for treatment of steroid-refractory aGVHD. Full results from the ongoing trial are scheduled to be reported in the second quarter of this year.

4. Apellis Pharmaceuticals Inc. (APLS)

Gained 17.39% to close Monday's trading at $19.17.

News: No news

Recent event:

The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.

Clinical Trials & Near-term Catalysts:

-- APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. -- APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris. -- A phase III program of APL-2 for the treatment of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) is planned to begin in the second half of 2018.

5. OpGen Inc. (OPGN)

Gained 17.19% to close Monday's trading at $2.25.

The Company's products and services are designed to enable the rapid identification of hospital patients who are colonized or infected with life-threatening, multi-drug resistant organisms.

News: No news

Recent events:


-- On February 1, 2018, the Company announced the commercial availability of its Acuitas AMR Gene Panel u5.47 test, developed to detect the most common bacterial causes of cUTI directly from urine (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis) and isolated colonies. Additionally, the gene panel detects 47 gene targets that convey resistance to antibiotics.
-- On February 7, 2018, the Company announced the closing of $12 million public offering.
-- On February 13, 2018, the Company entered into a global supply agreement to use Thermo Fisher Scientific's real-time PCR technology in its Acuitas AMR Gene Panel Tests.

Near-term Catalyst:

The Company is slated to report Q4, 2017 financial results in the last week of March.

6. TransEnterix Inc. (TRXC)

Gained 16.57% to close Monday's trading at $1.97. The stock has gained nearly 41% in the last 5 trading days.

TransEnterix is a medical device company. It is focused on the commercialization of Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal surgery and laparoscopic gynecologic surgery. The Company has sought FDA clearance for the Senhance System to include laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery in the indicated list of covered procedures.

The Company expects to achieve FDA clearance for the expanded indications by mid-year 2018.

Upcoming event:

-- The Company is slated to release fourth quarter and fiscal year 2017 financial and operating results after the market closes on Tuesday, March 6, 2018.

7. Compugen Ltd. (CGEN)

Gained 16.18% to close Monday's trading at $3.95.

News: No news

Recent event:

-- On February 21, 2018, Company reported financial results for the fourth quarter and full year ended December 31, 2017.

The net loss for the fourth quarter of 2017 was $9.3 million, or $0.18 per share on nil revenue. This compared with a net loss of $8.5 million, or $0.17 per share and revenue of $53 thousand in the comparable period of 2016.

Near-term Catalysts:

-- File IND application for COM701 towards the end of Q1, 2018. COM701 may be tested in the indications of lung, ovary, breast, endometrial, kidney, and head & neck cancers. -- Initiate phase I study of COM701 in 2018.

Another product candidate is CGEN-15001T mAb, which is being developed in collaboration with Bayer. This compound is currently in IND-enabling studies.

8. Achillion Pharmaceuticals Inc. ( ACHN )

Gained 15.40% to close Monday's trading at $3.41.

News: The European Medicines Agency Committee for Orphan Medicinal Products has issued a positive opinion on ACH-4471 for orphan status in the European Union for the treatment of C3 glomerulopathy (C3G).

ACH-4471 is in phase 2 studies in C3 glomerulopathy. The compound is also being tested in a phase II study for paroxysmal nocturnal hemoglobinuria (PNH).

Near-term Catalysts:


-- Completion of a phase II 14-day study in patients with C3G or immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), with interim data targeted for third quarter 2018.
-- Initiation of a 6-month double-blind, placebo-controlled therapeutic study in patients with C3G with data available in 2019.
-- Initiation of a 12-month, open-label study in patients with C3G with interim data targeted for fourth quarter 2018.
-- Interim data from phase II study of ACH-4471 for the treatment of PNH targeted for fourth quarter 2018.

9. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 13.10% to close Monday's trading at $6.56.

News: No news

Pipeline:

In 2016, Arrowhead had to discontinue development of prior generation drugs, ARC-520, ARC-521, and ARC-AAT, which moved the Company from a clinical-stage company with two Phase 2 candidates and one Phase 1 candidate, to a preclinical-stage company overnight.

The current compounds in the Company's pipeline include ARO-AAT for the treatment of alpha-1 antitrypsin deficiency liver disease; ARO-HBV for the treatment of chronic hepatitis B virus infection, and ARO-APOC3, ARO-ANG3 for the treatment of hypertriglyceridemia, ARO-Lung for an undisclosed indication; ARO-HIF2 for renal cell carcinoma; ARO-F12 for Thrombosis/Hereditary Angioedema; ARO-LPA, partnered with Amgen, for cardiovascular disease and ARO-AMG, partnered with Amgen, for cardiovascular disease.

Recent events:

-- On February 15, 2018, the Company received regulatory clearance from the New Zealand Medicines and Medical Devices Safety Authority to begin phase 1/2 study of ARO-HBV for the treatment of Hepatitis B. -- On February 22, 2018, the Company received regulatory clearance from the New Zealand Medicines and Medical Devices Safety Authority to begin phase I study of ARO-AAT for the treatment of Alpha-1 Liver disease.

10. Cerecor Inc. (CERC)

Gained 12.50% to close Monday's trading at $4.95.

News: No news

Recent events:

-- On Feb.12, 2018, the Company agreed to acquire Avadel Pharmaceuticals' pediatric products including Karbinal ER, AcipHex Sprinkle, Cefaclor for Oral Suspension, and Flexichamber. The transaction, which is slated to close before February 28, 2018, is expected to be immediately accretive to revenue and earnings. -- Last November, the Company acquired TRx Pharmaceuticals, LLC, including subsidiary Zylera Pharmaceuticals LLC and its franchise of commercial medications led by Poly-Vi-Flor and Tri-Vi-Flor.

Near-term Catalyst:

The Company is slated to report Q4, 2017 financial results in the 2nd week of March.


Read the original article on RTTNews (http://www.rttnews.com/2866679/zsan-explodes-ttph-on-radar-apls-catches-eyes-cerc-hits-a-high.aspx)


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


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