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OPK Up 36% In 5 Days, SLDB Sparkles, CERS Abuzz, ARWR Expects Data In Nov.

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

1. OPKO Health Inc. (OPK)

Gained 29.19% to close Wednesday's (May 9) trading at $4.16.

News: The Company reported better-than-expected financial results for the first quarter ended March 31, 2018.

Net loss was $43.1 million or $0.08 per share on consolidated revenue of $254.9 million in the first quarter of 2018. Analysts polled by Thomson Reuters were expecting a loss of $0.13 per share and revenue of $236.9 million.

The Company had incurred a loss of $34.5 million or $0.06 per share on consolidated revenue of $266.4 million or the comparable period of 2017.

2. Solid Biosciences Inc. (SLDB)

Gained 16.77% to close Wednesday's trading at $20.12.

News: No news

Clinical Trials:

The Company's lead product candidate is SGT-001 for the treatment of Duchenne muscular dystrophy (DMD), which is under phase I/II study, dubbed IGNITE DMD.

Recent events:

-- Last November, the FDA had imposed a partial clinical hold on the higher-dose group in the IGNITE DMD study, and had sought answers to manufacturing-related questions. The response submitted by the Company related to previously-announced partial clinical hold has been considered satisfactory.
-- On January 30, 2018, the Company made its debut on the Nasdaq Global Select Market, offering its shares at a price of $16.00 each.
-- The IGNITE DMD was placed on clinical hold by the FDA on March 14, 2018, after 1 patient showed a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation.

3. Axovant Sciences Ltd. (AXON)

Gained 16.67% to close Wednesday's trading at $1.33.

News: No news

Recent events:

-- On February 12, 2018, the Company announced changes to management team and Board of Directors.

The Company's CEO David Hung, President and COO Marion McCourt, and directors Kate Falberg, Tony Vernon, and Patrick Machado have resigned. Pavan Cheruvu has been appointed CEO, while Roger Jeffs, former President and co-CEO of United Therapeutics, and George Bickerstaff, former CFO of Novartis Pharma, have joined the Axovant board of directors.

-- On January 8, 2018, the Company announced that its phase II study of Intepirdine in patients with dementia with Lewy bodies, dubbed HEADWAY, and a pilot phase II study of Intepirdine in patients with dementia and gait impairment did not meet the trial goals. The news sent the stock down as much as 57% to $2.30 that day.

4. Arrowhead Pharmaceuticals Inc. (ARWR)

Gained 16.13% to close Wednesday's trading at $9.00.

News: The Company announced financial results for its fiscal 2018 second quarter ended March 31, 2018, and provided an update on its business.

Clinical Trials & Near-term Catalysts:

-- Dosing is underway in a phase 1 single- and multiple-ascending dose study evaluating ARO-AAT on serum alpha-1 antitrypsin levels in healthy adult volunteers.
-- Dosing is ongoing in a phase 1/2 study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.
-- Data from one or both the above programs are expected in November of this year.

Piper Jaffray analyst Edward Tenthoff has upped his price target on Arrowhead Pharma to $11 from $5.50, and maintains his Overweight rating.

5. Bellicum Pharmaceuticals Inc. (BLCM)

Gained 15.60% to close Wednesday's trading at $7.93.

News: The Company reported financial results for the first quarter ended March 31, 2018, and provided an update on recent developments.

Clinical Trials & Near-term Catalysts:

-- The Company is now working with U.S. clinical sites to resume patient recruitment in the U.S. Studies of BPX-501.

BPX-501 is under multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

On January 31, 2018, the FDA had imposed clinical hold on the Company's U.S. studies of BPX-501 due to three cases of encephalopathy deemed as possibly related to the drug candidate. The clinical hold was lifted on April 12, 2018.

The BPX-501 E.U. registration trial in malignant and nonmalignant pediatric patients undergoing haploidentical hematopoietic stem cell transplant has completed enrollment - with top line data expected at the end of 2018.

Enrollment is ongoing in phase I clinical trials of three CAR-T and TCR programs namely, BPX-601, BPX-701, and CaspaCIDe-enabled CD19 CAR-T. The preliminary findings from all three studies are expected to be reported at medical meetings later this year.

Cash position:

Bellicum, which ended March 31, 2018 with cash of $88.0 million, raised $69.0 million in a public offering last month. The cash on hand is expected to be sufficient to meet the Company's operating requirements through the end of 2019.

6. Cerus Corp. (CERS)

Gained 14.99% to close Wednesday's trading at $6.29.

News: The Company reported narrower-than-expected loss for the first quarter ended March 31, 2018, and raised its full year guidance for product revenue.

Net loss for the first quarter of 2018 was $13.9 million or $0.11 per share on product revenue of $13.6 million. Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.12 per share on revenue of $14.26 million.

The net loss was $18.6 million or $0.18 per share on product revenue of $7.0 million during the first quarter of 2017.

Looking ahead, the Company has boosted its full year product revenue guidance range for 2018 to $53 million to $55 million from its prior forecast of $51 million to $53 million.

by RTTNews Staff Writer

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