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Wednesday, December 11, 2019

BioCryst submits NDA for BCX7353

BioCryst Pharmaceuticals (NASDAQ:BCRX) has submitted a new drug application (NDA) to the FDA for approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

Analyst action, Dec. 11

AdaptHealth (NASDAQ:AHCO) initiated with Outperform rating and $13 (30% upside) price target at SVB Leerink.
Cyclo Therapeutics (OTCQB:CTDH) initiated with Buy rating and $1.25 (400% upside) price target at ThinkEquity.
CryoLife (NYSE:CRY) upgraded to Buy at Needham. Shares up 2% premarket.
Acadia Healthcare (NASDAQ:ACHC) downgraded to Equal Weight with a $35 (9% upside) price target at Wells Fargo.
Cigna (NYSE:CI) downgraded to Underweight with a $181 (6% downside risk) price target at Wells Fargo.
Correvio Pharma (NASDAQ:CORV) downgraded to Sell at Bloom Burton & Co. Shares down 59% premarket after negative FDA advisory committee vote on Brinavess for AF.
DENTSPLY SIRONA (NASDAQ:XRAY) downgraded to Neutral with a $65 (13% upside) price target at JPMorgan. Shares down 2% premarket.
Encompass Health (NYSE:EHC) downgraded to Underweight with a $68 (5% downside risk) price target at Wells Fargo.
GenMark Diagnostics (NASDAQ:GNMK) downgraded to Neutral with a $7 (25% upside) price target at JPMorgan.
Iterum Therapeutics (NASDAQ:ITRM) downgraded to Market Perform with a $4 (18% downside risk) price target at SVB Leerink. Shares down 47% premarket after failed Phase 3 study of sulopenem.
Lexicon Pharmaceuticals (NASDAQ:LXRX) downgraded to Hold at Gabelli & Co. Shares down 2% premarket.
Surmodics (NASDAQ:SRDX) downgraded to Hold at Needham. Shares down 2% premarket.
Walgreens Boots Alliance (NASDAQ:WBA) downgraded to Equal Weight with a $61 (4% upside) price target at Wells Fargo. Shares down 1% premarket.
WellCare Health Plans (NYSE:WCG) downgraded to Equal Weight with a $342 (7% upside) price target at Wells Fargo.

Viela Bio initiates mid-stage VIB4920 study

Viela Bio (NASDAQ:VIEdoses the first patient in its Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome.
Sjögren’s syndrome is a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.
The primary endpoints of the 174-subject study are the changes from baseline at day 169 in two scales called EULAR and ESSPRI.
The estimated primary completion date of the trial is November 1, 2021.

STAAR Surgical closing in on launch of implantable lens study

STAAR Surgical (NASDAQ:STAAannounces that the FDA has signed off on its planned study evaluating its EVO/EVO+ VISIAN Implantable Collamer Lens for myopia and its EVO/EVO+ Toric Implantable Collamer Lens for myopia with astigmatism.
The trial should launch next quarter.

Proteostasis to initiate personalized CF study in Europe

Proteostasis Therapeutics (NASDAQ:PTIannounces positive, initial ex-vivo results of its proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulators, PTI-801, PTI-808, and PTI-428, in individuals with cystic fibrosis (CF) who are ineligible for the current standard of care due to their genotype.
The data are part of a pan-European strategic initiative, known as HIT-CF (Human Individualized Therapy of CF), which seeks to accelerate the development of personalized therapies for CF patients, for whom no currently approved CFTR modulator therapy is indicated.
HIT-CF collects tissue samples and develops organoids, or miniaturized organs, that are genetically identical to the patient donor, and share the same micro-anatomy as the organ from which they were derived.
Thus far, rectal organoids from over 300 subjects have been collected for functional profiling and of those, 65 have been tested for response to PTI’s investigational drugs.
Early results support the initiation of enrollment of responding subjects into HIT-CF’s clinical trial known as “CHOICES” (Crossover trial based on Human Organoid Individual response in CF – Efficacy Study), which is designed to evaluate the translation of organoid ex-vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride.
CHOICES should launch in mid-2020 with initial data expected by year-end.
Results from the HIT-CF project to date will be presented at the Keystone Symposia on Tissue Organoids taking place on January 19-23, 2020 in Vancouver, BC, Canada.
Shares up 17% premarket.

Qiagen down 1% premarket on lack of Siemens interest

Reuters reports that Siemens Healthineers has no interest in acquiring diagnostics outfit QIAGEN N.V. (NYSE:QGEN). In an interview, CEO Bernd Montag said “we are not looking for profitable niches, but for solutions for the large problems in the health sector.”
Last month, shares jumped on unconfirmed reports that Thermo Fisher Scientific was mulling a bid.
Shares are down 1% premarket on light volume.

Correvio to explore strategic alternatives after Ad Com snub

Correvio Pharma (NASDAQ:CORV) plans to explore strategic alternatives after yesterday’s negative vote from an FDA advisory committee on its application for Brinavess for the rapid conversion of recent onset atrial fibrillation in adults.
The Company is also taking steps to reduce operating costs outside the core European commercial business.
Shares down 57% premarket on robust volume.