Athenex announced the launch of Levothyroxine Sodium for injection through its subsidiary Athenex Pharmaceutical Division, or APD. The APD product was brought to market in close cooperation with development partner, MAIA Pharmaceuticals. APD is focused on supplying the U.S. hospital market with specialty injectable products that address unmet or underserved hospital needs, including high-volume, niche and/or shortage products. The Levothyroxine Sodium for injection market in the United States exceeds $85M annually.
Wednesday, December 26, 2018
NeuroMetrix initiated at H.C. Wainwright
NeuroMetrix initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Andrew Fein initiated NeuroMetrix with a Buy rating and $5 price target, stating that he sees “plenty of room for the stock to appreciate” and believes that the recent launch of a new generation of Quell technology could facilitate market adoption given its smarter design, a 50% smaller size, and a better app. He also thinks the environment for addressing the opioid crisis, and a pressing need to limit opioid use while seeking alternative pain management options, bodes well for Quell uptake, Fein tells investors.
Goldman: only niche opportunity for Inbrija, keeps Acorda at Sell
After the FDA approved Therapeutics’ Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa, Goldman Sachs analyst Salveen Richter said he assumes annual pricing of $4,800, which he estimates will translate to about $550M in U.S. peak sales, lower than the company’s guidance of over $800M. His checks with key opinion leader doctors point to Inbrija being a niche drug, said Richter, who adds that sees limited optionality in its remaining pipeline assets, which are “still early or risky.” Richter maintains a Sell rating on Acorda shares with a $10 price target.
GenMark receives FDA 510 clearance for ePlex BCID-FP panel
GenMark announced that it has received FDA 510 market clearance from the FDA for its ePlex blood culture identification fungal pathogen, or BCID-FP, panel. This panel, together with the ePlex blood culture identification gram-positive, or BCID-GP, and gram-negative panels, were developed for the diagnosis and disease management of bloodstream infections, or BSI, that can lead to sepsis. The BCID-FP panel has the broadest coverage of fungal pathogens compared to other commercially available molecular panels and includes many resistant and emerging strains, including Candida auris. Fungal pathogens are a growing cause of BSI and are associated with some of the highest mortality rates.
https://thefly.com/landingPageNews.php?id=2841207
Stemline boxed warning shouldn’t deter use of Elzonris, says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju noted that the FDA approved Stemline’s Elzonris two months before the drug’s PDUFA date, which he sees as evidence of the FDA’s acknowledgement of the urgent need for blastic plasmacytoid dendritic cell neoplasm patients given this is the first drug approved in this indication. He also believes, based on his talks with knowledge leaders at the American Society of Hematology meeting, that the boxed warning given to Elzonris should not deter physicians from getting BPDCN patients on the drug, Selvaraju tells investors. He maintains a Buy rating and $38 price target on Stemline shares.
FDA accepts Acer Therapeutics’ NDA and priority review
Acer Therapeutics (NASDAQ:ACER) announces that the FDA has accepted for review Acer’s NDA for EDSIVO for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation.
The FDA also granted a priority review of the NDA and assigned a PDUFA target action date of June 25, 2019.
Priority Review shortens the review clock to six months from the standard 10 months.
FDA approves Merck, Sanofi pediatric vaccine
The FDA approves Vaxelis, a pediatric hexavalent combination vaccine developed as a JV between Sanofi (SNY +0.2%) and Merck (MRK +2%).
The vaccine is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in patients aged 6 weeks to 4 years.
The companies are working to maximize production to meet U.S. demand will a commercial launch happening no sooner than 2020.
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