Posts tagged trial
RepliCel hair loss trial meets primary endpoints

RepliCel Life Sciences (OTCQB:REPCF; TSXV:RP; FRA:P6P2) has successfully completed its first-in-human clinical study of the company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

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Stifel ups Esperion price target to $45

Stifel raised its price target for Esperion Therapeutics (NASDAQ:ESPR) to $45 from $30. The stock closed at $29.33 on March 2.

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Avivagen undertakes human health proof of concept

Avivagen (TSX-V:VIV), with the help of the National Research Council of Canada (NRC), will undertake a project to establish proof of concept for a first human health application of its OxC-beta technology.

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Vital Therapies updates Phase 3 trial

Vital Therapies (NASDAQ:VTL) updated its Phase 3 trial, VTL-308, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis.

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BTIG starts Intra-Cellular Therapies at buy

BTIG launched coverage of Cellular Therapies (NASDAQ:ITCI) with a “buy” rating and $44 price target, saying there is considerable promise for the company’s antipsychotic, ITI-007, in multiple indications. The stock closed at $15.05 on Dec. 21.

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Leerink starts AC Immune at outperform

Leerink initiated coverage of AC Immune SA (NASDAQ:ACIU) with an “outperform” rating and $22 price target. The stock closed at $14.43 on Friday.

AC Immune is focused on developing novel medicines for neurodegenerative disorders. Its lead asset, crenezumab, which is partnered with Roche/Genentech, is a monoclonal antibody that binds multiple sub-types of beta-amyloid.

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Galectin completes enrollment in Phase 2b trial ahead of schedule

Galectin Therapeutics (NASDAQ:GALT) has completed enrollment one month early in its NASH-CX Phase 2b trial with 162 subjects with nonalcoholic steatohepatitis (NASH).

The Phase 2b study is testing the company’s GR-MD-02 drug candidate and is being conducted with a primary endpoint of hepatic venous pressure gradient, which the FDA may view as an acceptable surrogate for outcomes for registration trials in this patient population. Top-line results are expected in December 2017.

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HCW starts OncoMed Pharma at buy

H.C. Wainwright has launched coverage of OncoMed Pharmaceuticals (NASDAQ:OMED) with a “buy” rating and $20 price target. The stock closed at $11.87 on Wednesday.

“We believe OncoMed is entering a year of dramatic changes with upcoming opt-in decisions for its lead drug candidates expected from its three partners: Celgene, Bayer and GlaxoSmithKline,” writes analyst Shaunak Deepak.

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Roth starts Fate Therapeutics at buy

Roth Capital Partners has launched coverage of Fate Therapeutics (NASDAQ:FATE) with a “buy” rating and a target price of $8. The stock closed at $3.18 on Wednesday.

Analyst Mark Breidenbach writes that the company's lead asset, ProTmune, could address a serious unmet medical need in patients requiring hematopoietic transplants (HSCTs), and “we expect to see early clinical data by the end of 2016.”

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Roth ups Bionomics price target to A$2.50

Roth Capital Partners raised its price target for Bionomics (ASE:BNO; OTCQX:BNOEF) to (Australian) $2.50 from $1.50 after the company’s Phase 2 BNC210 trial met its primary and secondary endpoints in treating generalized anxiety disorder (GAD) in an acute setting. The stock closed at 27 cents on Tuesday.

Analyst Joseph Pantginis writes that there are two key takeaways from the study: brain systems involved with anxiety are being engaged effectively and the data significantly increase the partnering potential for BNC210. Merck (NYSE:MRK) has already signed two separate partnerships with Bionomics.

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Vital Therapies updates Phase 3 trial

In a corporate update, Vital Therapies (NASDAQ:VTL) reported that 14 subjects have been enrolled at sites in the U.S. and EU in VTL-308, the company's Phase 3 trial, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis.  

There are now 24 sites open for enrollment in the U.S and EU. The company expects to announce topline results in mid-2018.

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Wainwright starts Mirna Therapeutics at buy

H.C. Wainwright initiated coverage of Mirna Therapeutics (NASDAQ:MIRN) with a ‘buy” rating and $6 price target, saying the company’s promising microRNA technology “could be a gift to long-term investors.” The stock was quoted at $2.50 on Monday afternoon.

“We believe the current Mirna share price offers an attractive entry point for long-term investors, as the stock is trading well below the $73-million June cash position,” writes analyst Shaunak Deepak.

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HCW assumes coverage of Vical at buy

H.C. Wainwright analyst Shaunak Deepak assumed coverage of Vical (NASDAQ:VICL) with a “buy” rating and $12 price target. The stock was quoted at $4.39, up 3 cents, Tuesday afternoon.

“With a co-marketable asset in Phase 3 development that is fully funded by partner, Astellas, and a diversified clinical pipeline, we believe Vical should be trading above cash,” Mr. Deepak writes.

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HCW starts Rigel Pharma at buy

H.C. Wainwright initiated coverage of Rigel Pharmaceuticals (NASDAQ:RIGL) with a “buy” rating and $6 price target. The stock closed at $2.26 on Tuesday.

“We would be buyers of Rigel going into the August readout from the first Phase 3 trial for its Syk inhibitor, fostamatib, in immune thrombocytopenic pupura (ITP) based on compelling data from a Phase 2 trial,” writes analyst Shaunak Deepak.

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BTIG downgrades T2 Biosystems to sell

BTIG Research downgraded T2 Biosystems (NASDAQ:TTOO) to “sell” from “buy” and slashed its price target to $4 from $12. The stock closed at $7.61 on Thursday.

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Avivagen reports new livestock trials with OxC-beta

Avivagen (TSX-V:VIV) has provided results of four new trials of OxC-beta livestock as a feed additive for swine in the Philippines and Vietnam, and broiler poultry in the Philippines and Spain.

In a new trial with the National Institute of Animal Sciences for Vietnam, the use of OxC-beta significantly improved the major commercial parameters of average daily gain (ADG), final body weight (FBW), feed conversion ratio (FCR) and rates of diarrhea and mortality, compared with non-supplemented animals.

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Titan Pharma sensitivity analyses confirm efficacy of Probuphine

Titan Pharmaceuticals (NASDAQ: TTNP) is presenting data today from four post hoc sensitivity analyses of the final Phase 3 trial of Probuphine at a poster session during The College on Problems of Drug Dependence 78th Annual Meeting in Palm Springs.

Probuphine is a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence.

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ARIAD reports updated data in pivotal ALTA study

ARIAD Pharmaceuticals (NASDAQ:ARIA) has reported updated clinical data for brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy.

The data show that, of patients on the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54% achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival exceeded one year (12.9 months) in this post-crizotinib setting.

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