Analyst action, Jan. 31

AdaptHealth (NASDAQ:AHCO) initiated with Buy rating and $17 (31% upside) price target at Stifel.

DURECT (NASDAQ:DRRX) initiated with Buy rating and $5 (158% upside) price target at B. Riley FBR. Shares up 6% premarket.

InMed Pharmaceuticals (IN CN) initiated with Buy rating and C$1.50 (341% upside) price target at Maxim Group (OTCQX:IMLFF).

Neptune Wellness Solutions (NEPT CN) initiated with Market Perform rating and C$3.75 (14% upside) (NASDAQ:NEPT).

Phreesia (NYSE:PHR) initiated with Overweight rating and $36 (15% upside) price target at KeyBanc.

Arena Pharmaceuticals (NASDAQ:ARNA) upgraded to Overweight with a $58 (32% upside) price target at JPMorgan. Shares up 2% premarket.

United Therapeutics (NASDAQ:UTHR) upgraded to Overweight with a $120 (25% upside) price target at JPMorgan.

Amgen (NASDAQ:AMGN) downgraded to Underperform with a $185 (18% downside risk) price target at Baird on soft 2020 guidance. Shares down 3% premarket.

Global Blood Therapeutics (NASDAQ:GBT) downgraded to Hold with a $75 (10% upside) price target at SunTrust Robinson Humphrey.

Intra-Cellular Therapies (NASDAQ:ITCI) downgraded to Neutral with a $26 (13% upside) price target at JPMorgan. Shares down 9% premarket.

ResMed (NYSE:RMD) downgraded to Neutral at UBS after FQ2 results.

Rubius Therapeutics (NASDAQ:RUBY) downgraded to Neutral with a $9 (17% upside) price target at JPMorgan. Shares down 5% premarket.

https://seekingalpha.com/news/3536846-baird-downgrades-amgen-on-soft-guidance-in-premarket-analyst-action

Merck withdraws Keytruda application in Europe for esophageal cancer

Merck (NYSE:MRK) has withdrawn its marketing application in Europe seeking approval to use Keytruda (pembrolizumab) to treat cancer of the esophagus. The EMA determined that the data supporting the application were not sufficient to prove that treatment prolonged survival.
https://seekingalpha.com/news/3536882-merck-withdraws-keytruda-application-in-europe-for-esophageal-cancer

EMA accepts Seattle Genetics’ tucatinib application for HER2+ breast cancer

The European Medicines Agency (EMA) has accepted for review Seattle Genetics’ (SGEN +0.4%) marketing application seeking approval for tyrosine kinase inhibitor tucatinib, combined with HER2/neu receptor antagonist trastuzumab and chemo agent capecitabine, for adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least two prior lines of anti-HER2 therapy.

The company filed its application in the U.S. a month ago under the FDA’s Real-Time Oncology Review Pilot Program.

https://seekingalpha.com/news/3536908-ema-accepts-seattle-genetics-tucatinib-application-for-her2-breast-cancer

Reata Pharma up 11% on potential acquisition interest

Reata Pharmaceuticals (RETA +10.9%) is up out the gate on reports that Amgen (AMGN -3.9%) is mulling acquiring assets in the space.

Reata’s lead candidate is bardoxolone methyl, in late-stage development for a kidney disorder called Alport syndrome, connective tissue disease-pulmonary arterial hypertension and focal segmental glomerulosclerosis.

Another late-stage candidate is omaveloxolone for a degenerative neuromuscular disorder called Friedreich’s ataxia.

https://seekingalpha.com/news/3536894-reata-pharma-up-11-on-potential-acquisition-interest

Celgene withdraws enasidenib application in Europe

Bristol-Myers Squibb (NYSE:BMY) unit Celgene (NASDAQ:CELG) has withdrawn its marketing application in Europe for Idhifa (enasidenib) for the treatment of adults with acute myeloid leukemia (AML).

The company took action after determining that it could not fully address EMA objections. Specifically, the agency concluded that the data supporting the application were insufficient to prove efficacy.

https://seekingalpha.com/news/3536875-celgene-withdraws-enasidenib-application-in-europe

European advisory group backs expanded use of J&J’s Rezolsta

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending an expanded label for Johnson & Johnson (NYSE:JNJ) unit Janssen-Cilag International NV’s HIV med Rezolsta (darunavir/cobicistat) to now include adolescents as young as 12 years old (previously 18 years old) weighing at least 40 kg.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3536851-european-advisory-group-backs-expanded-use-of-j-and-js-rezolsta

European advisory group backs Pfizer’s crisaborole for atopic dermatitis

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Staquis (crisaborole) for the treatment of adults and pediatric patients at least two years old with mild or moderate atopic dermatitis with no more than 40% of body surface area affected.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3536796-european-advisory-group-backs-pfizers-crisaborole-for-atopic-dermatitis