Canaccord analyst Dewey Steadman maintained a Buy rating and $25 price target on Paratek Pharmaceuticals following the release of the company's 10-K. In a research note to investors, Steadman says he is "encouraged" by the company's initial marketing efforts for Nuzyra and sees initial revenue guidance of $10M-$13M as achievable. As Nuzyra gains market acceptance over the coming quarters, Steadman says he likes the Paratek story and continues to see an attractive entry point for what could be one of the most compelling true antibacterial product launches in the past several years;
https://thefly.com/landingPageNews.php?id=2877677
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Tuesday, March 12, 2019
Neurocrine announces results from Phase II study evaluating NBI-74788
Neurocrine Biosciences announced positive interim results from a Phase II proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of NBI-74788, a proprietary corticotropin-releasing factor type 1, or CRF1, receptor antagonist, in adult patients with classic congenital adrenal hyperplasia (CAH). The results from this ongoing Phase II open-label study demonstrated a reduction of at least 50% from baseline in 17-hydroxyprogesterone, or 17-OHP, and adrenocorticotropic hormone, or ACTH, levels in more than 50% of CAH patients treated with NBI-74788 for 14 days. Meaningful reductions were also observed in other biomarkers, including androstenedione. NBI-74788 was shown to be well tolerated with no serious adverse events reported to date. The Company plans to meet with the FDA to discuss the registration program for NBI-74788 in adult and pediatric patients with CAH, a genetic disorder affecting the adrenal glands.
https://thefly.com/landingPageNews.php?id=2877741
https://thefly.com/landingPageNews.php?id=2877741
JPMorgan sees downside to WW revenue guidance and shares
JPMorgan analyst Christina Brathwaite continues to see risk to WW's 2019 revenue guidance, which she says "embeds trends improve significantly throughout the year." SimilarWeb data indicates that the company's daily active users in the U.S. remains weak with trends now down 39% year-over-year thus far quarter-to-date, which points to North America end of period subscribers down high-teens percent in Q1, Brathwaite tells investors in a research note. She points out that this is worse than the down low single-digit trend she's currently modeling. The analyst continues to see downside to WW shares and reiterates the stock as her top Focus List short idea. Brathwaite has an Underweight rating on the name with a $14 price target.
https://thefly.com/landingPageNews.php?id=2877815
https://thefly.com/landingPageNews.php?id=2877815
Krystal Biotech reports FY18 EPS (97c), consensus (92c)
Cash, cash equivalents and short-term investments totaled $111.8M on December 31, 2018. CEO Krish Krishnan said, "Our top four priorities in 2019 are to commence the pivotal study of KB103 following completion of the Phase 1/2 GEM-1 study, initiate a Phase 1/2 clinical study of our second rare disease therapy, KB105, file an IND on an additional pipeline product, yet to be disclosed and begin work on our second, larger cGMP facility in Pittsburgh, to fully serve the production needs of our pipeline products."
https://thefly.com/landingPageNews.php?id=2877759
https://thefly.com/landingPageNews.php?id=2877759
Amneal launched generic version of Exelon Patch
Amneal Pharmaceuticals announced that it has launched its generic version of Exelon Patch, or Rivastigmine Transdermal System, 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. The Company received FDA approval of its Rivastigmine Transdermal System in January 2019, and has received final approval on 10 Abbreviated New Drug Applications this year. According to IQVIA, U.S market annual sales for the 12 months ended January 2019 for Rivastigmine Transdermal System is estimated to be approximately $214M.
https://thefly.com/landingPageNews.php?id=2877800
https://thefly.com/landingPageNews.php?id=2877800
Lipocine data worse than January's disclosure, STAT's Feuerstein says
STAT's Adam Feuerstein said via Twitter, "Not that anyone trading cares, but today's $LPCN liver fat (NASH? NAFLD? Something else?) data are worse than the data previously disclosed in January. Also, wow, so many changes to endpoint definitions. Carry on...." Shares of Lipocine are up 34c, or 16%, to $2.52 in premarket trading.
https://thefly.com/landingPageNews.php?id=2877810
https://thefly.com/landingPageNews.php?id=2877810
Stealth Biotherapeutics initiated at Jefferies
Stealth Biotherapeutics initiated with a Hold at Jefferies. Jefferies analyst Maury Raycroft started Stealth Biotherapeutics with a Hold rating and $16 price target. Elamipretide has a unique mechanism that should help treat a range of severe diseases of the mitochondria and potentially the eye, Raycroft tells investors in a research note. However, he believes the stock rally post the initial public offering has reached a fair price.
https://thefly.com/landingPageNews.php?id=2877837
https://thefly.com/landingPageNews.php?id=2877837
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