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Ligand Partner Melinta Therapeutics Submits NDA for Baxdela
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Ligand Pharmaceuticals Incorporated (LGND - Free Report) said its partner Melinta Therapeutics, a private pharma company, has submitted New Drug Applications (NDAs) to the FDA for its pipeline candidate Baxdela (delafloxacin) to treat serious bacterial infections.
Ligand Pharma and Melinta Therapeutics are looking to get the intravenous and oral versions of Baxdela (delafloxacin) approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The submission of the NDA led to a $1.5 million milestone payment to Ligand Pharma. After approval, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela along with $1.5 million approval milestone payment.
Ligand had partnered with Melinta Therapeutics to develop antibiotics for the treatment of serious bacterial infections. Baxdela (delafloxacin) belongs to the well-established quinolone class of antibiotics, which are currently used in one out of three hospital-treated infections.
The NDAs of Melinta are based on the results of two phase III studies. Baxdela met the primary endpoint of non-inferiority in reducing lesion size at the primary infection site at 48-to-72 hours to a combination regimen of vancomycin plus aztreonam in both the phase III studies
A regulatory decision from the FDA is expected by mid-year 2017.
Baxdela is also being evaluated for treatment of hospital-treated community-acquired bacterial pneumonia (CABP) and the companies plan to initiate studies in complicated urinary tract infections (cUTI).
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to a gain of 3 cents for 2017 over the last 60 days. The company has posted positive earnings surprises twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed 105% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 to $1.79 for 2017 over the last 60 days.
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Ligand Partner Melinta Therapeutics Submits NDA for Baxdela
Ligand Pharmaceuticals Incorporated (LGND - Free Report) said its partner Melinta Therapeutics, a private pharma company, has submitted New Drug Applications (NDAs) to the FDA for its pipeline candidate Baxdela (delafloxacin) to treat serious bacterial infections.
Ligand Pharma and Melinta Therapeutics are looking to get the intravenous and oral versions of Baxdela (delafloxacin) approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The submission of the NDA led to a $1.5 million milestone payment to Ligand Pharma. After approval, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela along with $1.5 million approval milestone payment.
LIGAND PHARMA-B Price
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Ligand had partnered with Melinta Therapeutics to develop antibiotics for the treatment of serious bacterial infections. Baxdela (delafloxacin) belongs to the well-established quinolone class of antibiotics, which are currently used in one out of three hospital-treated infections.
The NDAs of Melinta are based on the results of two phase III studies. Baxdela met the primary endpoint of non-inferiority in reducing lesion size at the primary infection site at 48-to-72 hours to a combination regimen of vancomycin plus aztreonam in both the phase III studies
A regulatory decision from the FDA is expected by mid-year 2017.
Baxdela is also being evaluated for treatment of hospital-treated community-acquired bacterial pneumonia (CABP) and the companies plan to initiate studies in complicated urinary tract infections (cUTI).
Zacks Rank & Key Picks
Ligand currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Axovant Sciences Ltd. (AXON - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to a gain of 3 cents for 2017 over the last 60 days. The company has posted positive earnings surprises twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed 105% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 to $1.79 for 2017 over the last 60 days.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>