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Friday, June 1, 2018

Lannett gets FDA OK for generic of Levaquin


Lannett announced that it received approval from the FDA of its abbreviated new drug application, or ANDA, for Levofloxacin oral solution USP, 25 mg/mL, the therapeutic equivalent to the reference listed drug, Levaquin oral solution, 25 mg/mL, of Janssen Pharmaceuticals. For the 12 months ended April 2018, total U.S. sales of Levofloxacin oral solution USP, 25 mg/mL, was approximately $6M, according to IMS.

Humana started at buy by Citi


Humana coverage resumed with a Buy at Citi. Citi analyst Ralph Giacobbe resumed coverage of Humana with a Buy rating and $340 price target. The analyst continues to see the company as well positioned in an “attractive” Medicare Advantage end market that has “broad demographic/structural tailwinds.” This creates a solid long-term growth profile for Humana and makes the company a “coveted asset and providing valuation support in the least,” Giacobbe tells investors in a research note.

Endo target cut by Deutsche Bank


Deutsche lowers Endo target to $10, keeps Buy rating. Deutsche Bank analyst Gregg Gilbert says that while it is difficult to predict when sentiment on Endo International could improve, the potential exists for greater visibility on some key overhangs over the next year or so. The stock is down 20% year-to-date as U.S. generic market pressures, Vasostrict risk, potential legal liabilities and high leverage continue to weigh on the stock, Gilbert tells investors in a research note. The analyst lowered his price target for Endo to $10 from $12 but keeps a Buy rating on the name. He believes it will be important to see continued stabilization for the generics business and new generic approvals for the stock to work.

CytomX started at buy by SunTrust


CytomX Therapeutics initiated with a Buy at SunTrust. SunTrust analyst Peter Lawson initiated CytomX Therapeutics with a Buy rating and $38 price target. In a research note to investors, Lawson said he is “encouraged” by the biopharma validation of CytomX’s platform, while the company retains ownership of a major part of its pipeline, and believes ASCO and 2H data validates the CX-072 platform for safety and efficacy. Additionally, Lawson contends that 2H data for CX-2009 will validate the company’s strategy of targeting “undruggable” antigens, unlocking two components of CytomX’s valuation. Further, he believes three readouts in 2018 — updated CX-027 data at ASCO, initial Phase 1/2 data from CX-2009 in the second half of the year, and follow-on Phase 1/2 data from CX-072 in the second half — could be positive for the company.

Valeant target upped by Deutsche Bank


Deutsche still likes Valeant risk/reward, ups price target to $25. Deutsche Bank analyst Gregg Gilbert raised his price target for Valeant Pharmaceuticals to $25 from $23 after giving the company some additional credit for protecting the Xifaxan franchise. The analyst pushed out his generic cliff assumption to 2027 from 2026, which he notes still represents a potential “settlement” scenario with generic competition ahead of patent expiry. It is important to note there could be “significant upside to the theoretical valuation” if Xifaxan grows faster than anticipated, generic competition is delayed beyond 2027, and/or if Valeant is able to protect the franchise with new formulations and indications, Gilbert tells investors in a research note. He continues to like the risk/reward for the stock and keeps a Buy rating on the shares.

Merit Medical selloff overdone: Canaccord

Merit Medical selloff after CFO departure overdone, says Canaccord. Canaccord analyst Jason Mills said the selloff in Merit Medical due to the departure of its CFO is overdone. The analyst said the departure was a surprise to the company as well as Wall Street, leading him to believe its was a personal decision as opposed to something untoward about the company’s financials. Mills reiterated his Buy rating and $60 price target on Merit Medical shares.

Pfizer gets nod for cancer med biosimilar in Europe


Pfizer announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending marketing authorization for TRAZIMERA, a potential biosimilar to Herceptin, for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.