Posts tagged Phase 3 study
Arbutus licensee Alnylam posts positive Phase 3 results

Arbutus Biopharma’s (NASDAQ:ABUS) lipid nanoparticle (LNP) licensee, Alnylam Pharmaceuticals (NASDAQ:ALNY), announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints.

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Theratechnologies partner files ibalizumab BLA

Theratechnologies’ (TSX:TH) partner, TaiMed Biologics of Taiwan, completed the submission of a biologics license application (BLA) to the FDA for ibalizumab for the treatment of multidrug-resistant human immunodeficiency virus-1 (MDR HIV-1).

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HCW starts OSE Immunotherapeutics at buy

H.C. Wainwright initiated coverage of OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) with a “buy” rating and a 12-month price target of €12.00. The stock closed at €6.25 on March 6.

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Ladenburg starts Albireo Pharma at buy

Ladenburg Thalmann initiated coverage of Albireo Pharma (NASDAQ:ALBO) with a “buy” rating and $40 price target. The stock closed at $20.28 on Feb. 15.

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HCW starts Histogenics at buy

H.C. Wainwright initiated coverage of Histogenics (NASDAQ:HSGX) with a “buy” rating and price target of $3.50, saying the company has an innovative product with significant market potential. The stock closed at $1.58 on Dec. 16.

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HCW starts Proteon Therapeutics at buy

H.C. Wainwright has initiated coverage of Proteon Therapeutics (NASDAQ:PRTO) with a ‘buy” rating and $18 price target. The stock closed at $8.75 on Wednesday.

Proteon is developing a novel therapy to help prolong vascular access patency for dialysis patients. The company’s lead product, vonapanitase, is a recombinant human elastase used during vascular surgery.

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WB drops coverage of OncoGenex

William Blair dropped coverage of OncoGenex (NASDAQ:OGXI) after the company announced that the AFFINITY study did not meet the primary endpoint. The stock closed at 90 cents on Monday.

“We note that AFFINITY is the key study of the lead asset, custirsen, as a chemotherapy companion in the second-line chemo setting in metastatic castration resistant prostate cancer,” writes analyst Katherine Xu. 

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Maxim cuts Omeros price target to $19

Maxim Group lowered its price target for Omeros (NASDAQ:OMER) to $19 from $30, citing a higher risk value from its three valuation models. The stock closed at $13.38 on Tuesday.

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Maxim cuts Sucampo Pharma price target to $17

Maxim Group lowered its price target for Sucampo Pharmaceuticals (NASDAQ:SCMP) to $17 from $26, citing a combination of the market environment and an assessment of the catalysts and risks. The stock was quoted at $11.89 at afternoon trading on Monday.

Analyst Jason Kolbert writes that he expects Sucampo’s stock to be driven by the quarterly sales progress associated with Amitiza, integration progress with RJ Ueno (Japan), and future product acquisitions.

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Maxim cuts Stellar Biotechnologies price target to $7

Maxim Group lowered its price target for Stellar Biotechnologies (NASDAQ:SBOT) to $7 from $17, citing market environment, catalysts related to clients for Stellar’s Keyhole Limpet Hemocyanin (KLH) protein, revisions to timelines for KLH revenues, and other related assumptions.

Shares of Stellar were quoted at $3.14 in afternoon trading on Monday.

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Dipexium, Tandem Diabetes make Feltl Best Ideas list

Dipexium Pharmaceuticals (NASDAQ:DPRX) and Tandem Diabetes (NASDAQ:TNDM) have made Feltl & Co.’s Best Ideas list for the second half this year.

Analyst Ben Haynor writes that top-line data for Dipexium’s two Phase 3 studies should be released in the next six-to-10 weeks, “which we believe will be positive,” based on trials conducted by Magainin Pharmaceuticals in the late 1990s and the design of Dipexium’s studies, which compare Locilex versus placebo cream.

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Braeburn presents Probuphine data at CPDD meeting

Closely-held Braeburn Pharmaceuticals has presented data from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the annual scientific meeting of The College on Problems of Drug Dependence (CPDD).

The FDA recently approved Probuphine, which was developed by its partner, Titan Pharmaceuticals (NASDAQ:TTNP), on May 26.

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Roth adjusts DelMar Pharma price target to $12

Roth Capital Partners has adjusted its price target for DelMar Pharmaceuticals (OTCQX:DMPID) to $12 from $3 after the company’s 1-for-4 reverse stock split. The stock closed at $5.41 on Friday.

Analyst Joseph Pantginis writes that the company’s net equity and operating funds are now sufficient to meet the goal of up listing to a senior exchange, either NASDAQ or NYSE-MKT, shortly.

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Roth ups Celator Pharma price target to $26

Roth Capital Partners has raised its price target for Celator Pharmaceuticals (NASDAQ:CPXX) to $26 from $22, after the company’s Vyxeos drug candidate received breakthrough therapy designation from the FDA. The stock closed at $15.07 on Wednesday

“This is an important next step for Vyxeos on the path to what we believe is likely approval,” writes analyst Joseph Pantginis.

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Leerink downgrades Sarepta to under perform

Leerink has downgraded Sarepta Therapeutics (NASDAQ:SRPT) to “under perform” and slashed its price target to $5 from $13. The stock closed at $17.92 on Monday.

Sarpeta has been a confounding stock for which to forecast each twist and turn, but now going into the PDUFA of May 26, 2016, we believe investors have the most information yet available to ascertain investability in Sarepta,” writes analyst Joseph Schwartz.

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HCW starts BioPharmX at buy

H.C. Wainwright has initiated coverage of BioPharmX (NYSE MKT:BPMX) with a “buy” rating and $3 price target. The stock closed at 99 cents on Wednesday.

BioPharmX’s lead product is Violet for the treatment of fibrocystic breast condition (FBC). It was launched in early 2015 and is currently sold over-the-counter in over 7,500 pharmacies in the U.S.

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