Posts tagged clinical data
Mackie cuts Intellipharmaceutics to sell

Mackie Research Capital downgraded Intellipharmaceutics International (NASDAQ, TSX:IPCI) to “sell” from “speculative buy” and slashed its price target to $1 from $6 after a FDA advisory committee voted 22-1 against recommending approval of Rexista. The stock slumped $1.13 to close at $1.36 on July 27.

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Tetra readies Phase 3 pain relief trial of medical cannabis

Tetra Bio-Pharma (CSE:TBP; OTCQB:TBPMF) and subsidiary, PhytoPain Pharma, have submitted a report on the safety and pharmacokinetics of its PPP001 smokeable cannabis product to Health Canada.

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RepliCel in service partnerships for dermal injector

RepliCel Life Sciences (OTCQB:REPCF; TSX-V:RP; FRA:P6P2) has signed agreements with two European firms to get the company's commercial-grade RCI-02 dermal injector prototypes manufactured and tested.

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Cardiovascular Systems, Kindred on Feltl Top Idea list

Feltl’s Top Ideas list for 2017 includes Cardiovascular Systems (NASDAQ:CSII) and Kindred Biosciences (NASDAQ:KIN).

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Roth starts Global Blood Therapeutics at buy

Roth Capital Partners initiated coverage of Global Blood Therapeutics (NASDAQ:GBT) as a “Focus Pick” with a “buy” rating and price target of $47. The stock closed at $17.45 on Monday

“In our view, Global Blood Therapeutics represents an attractive investment opportunity because its lead product, GBT440, has the potential to improve the standard of care for patients who suffer from sickle cell anemia (SCA),” writes analyst Mark Breidenbach.

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Mackie starts Aurinia Pharma at speculative buy

Mackie Research launched coverage of Aurinia Pharmaceuticals (NASDAQ:AUPH) with a “speculative buy” recommendation and a 12-month target price of $8. The stock closed at $3.03 on Monday.

Aurinia is developing voclosporin as a first-line treatment for lupus nephritis (LN) and advancing the drug candidate into Phase 3 trials.

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Analysts start Obalon Therapeutics at buy

Analysts at Stifel and BTIG initiated coverage of Obalon Therapeutics (NASDAQ:OBLN) with “buy” ratings and price targets of $18 and $20, respectively. The stock closed at $13.80 on Friday.

“Obalon appears poised for dramatic top-line growth with its highly-differentiated intragastric balloon system, already FDA-approved to treat 30-to-40 body mass index range obese patients,” writes Rick Wise of Stifel.

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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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Analysts start Tactile Systems at buy, outperform

Analysts at BTIG Research, Piper Jaffray and William Blair initiated coverage of Tactile Systems Technology (NASDAQ:TCMD) with “buy,” “overweight” and “outperform” ratings, respectively.

Tactile makes pneumatic compression devices (PCD) to treat lymphedema, along with a chronic venous leg ulcer product. Tactile closed an IPO of 4,120,000 shares at $10 apiece earlier this month. The stock was changing hands at $12.98 at mid-day Monday.

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Roth reinitiates coverage of Pieris Pharma at buy

Roth Capital Partners reinitiated coverage of Pieris Pharmaceuticals (NASDAQ:PIRS) with a “buy” rating and $6 price target. The stock closed at $1.70 on Thursday.

“We believe the company’s anticalin platform has broad potential for the long term and that the multiple partners, broad pipeline and flexibility of the platform provide investors with the potential for multiple catalysts along with partner-based non-dilutive funding,” writes analyst Joseph Pantginis.

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Ocular Therapeutix gets complete response letter

Ocular Therapeutix (NASDAQ:OCUL) received a complete response letter (CRL) from the FDA about its NDA for DEXTENZA for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

Concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies remain open since the last response submitted by the company.

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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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Roth reinitiates coverage of Cempra at buy

Roth Capital Partners has reinitiated coverage of Cempra (NASDAQ:CEMP) with a “buy” rating and $37 price target. The stock closed at $19.48 on Monday.

With impressive pivotal studies on solithromycin (Solitaire-IV and Solitaire-Oral), we encourage investors to accumulate a position in Cempra as the company leverages its clinical data in treating community acquired bacterial pneumonia (CABP), including the increasing number of drug-resistant strains,” writes analyst Michael Higgins.

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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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