Posts tagged PDUFA
CIBC-favored health care stocks for 2018

For 2018, CIBC World Markets is recommending investors hold a basket of healthcare stocks that include a combination of more speculative small and midcap companies with selected large caps.

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WB starts PTC Therapeutics at MP

William Blair initiated coverage of PTC Therapeutics (NASDAQ:PTCT) with a “market perform” rating, citing a possibly tough road ahead for approval of the company’s ataluren in the U.S. The stock closed at $17.72 on Aug. 22.

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FDA completes inspection of ibalizumab plant

Theratechnologies (TSX:TH) has been notified by its partner, TaiMed Biologics of Taiwan, that the FDA has completed the pre-license inspection of the WuXi Biologics facility, where Theratechnologies’ ibalizumab will be manufactured.

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FDA grants priority review to Theratechnologies’ ibalizumab

Theratechnologies (TSX:TH) has been notified by its partner, TaiMed Biologics, that the FDA has accepted for review the biologics license application for ibalizumab as a treatment for multidrug-resistant human immunodeficiency virus-1.

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HCW starts Antares Pharma at buy

H.C. Wainwright initiated coverage of Antares Pharma (NASDAQ:ATRS) with a “buy” rating and $5 price target. The stock closed at $3.01 on June 22.

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Stifel ups Aerie Pharma price target to $50

Stifel raised it price target for Aerie Pharmaceuticals (NASDAQ:AERI) to $50 from $40 after the company’s Roclatan eye drop hit all its endpoints with clinically meaningful results in a Phase 3 trial. The stock closed at $21.13 on Wednesday.

Analyst Annabel Samimy writes that the 90-day primary efficacy readout of the MERCURY-1 trial demonstrated statistically significant lowering of intraocular pressure (IOP) of Roclatan over its Rhopressa and latanoprost components.

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Maxim downgrades Radius Health to sell

Maxim Group downgraded Radius Health (NASDAQ:RDUS) to “sell” from “hold” with a $24 price target. The stock closed at $50.55 on Thursday.

“At the current valuation, we believe that Radius is back to an overvalued state,” writes analyst Jason McCarthy.

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Stifel downgrades Keryx to hold

Stifel downgraded Keryx Biopharmaceuticals (NASDAQ:KERX) to “hold” from “buy” and removed its price target after the company announced an imminent supply disruption with its Auryxia product. The stock closed at $4.72 on Monday.

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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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Ocular Therapeutix second Phase 3 trial unsuccessful

Ocular Therapeutix’s (NASDAQ:OCUL) results from its second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA, a bioresorbable intracanalicular depot, for the treatment of ocular itching associated with chronic allergic conjunctivitis failed to achieve statistical significance.

The single primary endpoint of the trial was the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points seven days following insertion of the depots and was not achieved.

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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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Stifel upgrades Exelixis to buy

Stifel has upgraded Exelixis (NASDAQ:EXEL) to “buy” from “hold” with a price target of $7. The stock closed at $4.05 on Friday.

Exelixis is developing small molecule therapies for the treatment of cancer and is focusing its development and commercialization efforts primarily on cabozantinib, an internally discovered inhibitor of multiple receptor tyrosine kinases.

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HHS ups buprenorphine prescribing to treat opioid addiction

In a speech today, President Obama announced that the Department of Health and Human Services (HHS) has issued a new proposed rule to increase the current patient limit for qualified physicians who prescribe buprenorphine to treat opioid addiction.

The proposed rule will increase the patient limit to 200 patients from 100 for physicians who have been trained and waivered for more than a year to prescribe buprenorphine.

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Titan’s Probuphine attracts more media attention

The New York Times has published an article about addiction medicines that includes a segment about Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction.

The article quotes Richard Rosenthal, medical director of addiction psychiatry at Mount Sinai Behavioral Health System in New York, who discusses how Probuphine solves three problems associated with opioid maintenance therapy.  The first is the chance of resale or accidental exposure to the pills. “Also, there’s the opportunity for non-adherence — people forget, or don’t take their dose, which leaves them vulnerable again,” he said.  “The other issue mentioned is that medicines have peaks and troughs. “People on various medications may have increased cravings during those troughs.”

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Knight to sublicense Titan Pharma’s Probuphine in Canada

Titan Pharmaceuticals’ (NASDAQ:TTNP) development and marketing partner, closely-held Braeburn Pharmaceuticals, and Knight Therapeutics (TSX:GUD) have entered into an agreement, giving Knight exclusive rights to commercialize Titan’s Probuphine in Canada.

Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, promoting patient compliance and retention, as well as helping to prevent accidental pediatric exposure.

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FDA adcom votes in favor of approving Titan’s Probuphine

The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

The committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.

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