Analyst action, Dec. 12

Amyris (NASDAQ:AMRS) initiated with Outperform rating and $8 (147% upside) price target at Oppenheimer. Shares up 8% premarket.

Bausch Health Companies (NYSE:BHC) upgraded to Overweight with a C$50.04 (30% upside) price target at JPMorgan. Shares up 2% premarket in the U.S.

Globus Medical (NYSE:GMED) upgraded to Overweight with a $63 (11% upside) at Wells Fargo. Shares up 1% premarket.

Healthcare Realty Trust (NYSE:HR) upgraded to Buy at Citigroup.

MEDNAX (NYSE:MD) upgraded to Buy with a $33 (23% upside) price target at Stifel. Shares up 1% premarket.

Shockwave Medical (NASDAQ:SWAV) upgraded to Overweight with a $49 (17% upside) price target at Wells Fargo. Shares up 3% premarket.

Merit Medical Systems (NASDAQ:MMSI) downgraded to Underweight with a $26 (13% downside risk) price target at Baird. Shares down 4% premarket.

Miragen Therapeutics (NASDAQ:MGEN) downgraded to Neutral with a $1 (45% upside) price target at Baird. Shares down 19% premarket on change in strategy and downsizing.

West Pharmaceutical Services (NYSE:WST) downgraded to Underperform with a $135 (8% downside risk) at BofA Merrill Lynch.

https://seekingalpha.com/news/3525813-jpmorgan-likes-bausch-health-in-premarket-analyst-action

Puma Bio up on Nerlynx data in heavily pretreated breast cancer patients

Puma Biotechnology (NASDAQ:PBYI) is up 5% premarket on light volume in response to results from an ongoing open-label Phase 2 basket study, SUMMIT, evaluating Nerlynx (neratinib), combined with Roche’s Herceptin (trastuzumab) and AstraZeneca’s Faslodex (fulvestrant), in patients with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer. The data were presented at the San Antonio Breast Cancer Symposium.

28 HER+/HR+ patients who had received a median of four prior lines of therapy (range: 0-10) for their metastatic cancer received 240 mg of neratinib each day plus trastuzumab and fulvestrant.

In 17 evaluable patients the overall response rate (ORR) was 53% (=9/17), all partials, while one experienced stable cancer for at least 24 weeks implying a disease control rate of 59% (n=10/17). Median duration of response had not been reached at data cutoff. Median progression-free survival was 9.8 months.

No new safety signals were observed.

The FDA approved Nerlynx in July 2017 for early-stage HER+ breast cancer.

https://seekingalpha.com/news/3525792-puma-bio-up-5-premarket-on-nerlynx-data-in-heavily-pretreated-breast-cancer-patients

ATyr Pharma down on (lack of) safety data on lead candidate

Thinly traded nano cap aTyr Pharma (NASDAQ:LIFE) was down 17% premarket on increased volume, 65K shares, in reaction to its announcement of safety and tolerability results from a multiple-ascending dose Phase 1b/2a clinical trial evaluating lead candidate ATYR1923 in patients with pulmonary sarcoidosis (PS), a rare lung disorder caused by inflammation that can lead to pulmonary fibrosis (scarring in the lungs).

The company says ATYR1923, a fusion protein designed to downregulate the immune response to inflammatory disease states, was “generally safe and well-tolerated” in 15 PS patients but provides no specifics, only saying the results were consistent with a Phase 1 study in healthy volunteers. Adverse events were “mostly” mild or moderate.

CEO Sanjay Shukla, M.D., M.S. says the trial will now advance to the efficacy stage.

https://seekingalpha.com/news/3525823-atyr-pharma-down-17-premarket-on-lack-of-safety-data-on-lead-candidate

Provention Bio reaffirms PRV-031 application timeline

Provention Bio (NASDAQ:PRVB) perks up 5% premarket on modest volume in reaction to its announcement that it continues to expect to start its rolling U.S. marketing application in mid-2020 for lead candidate PRV-031 (teplizumab) for the prevention or delay of type 1 diabetes (T1D) in at-risk people. The filing should be completed by Q4 2020.

A recent meeting with the FDA clarified the required contents of the application.

Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.

https://seekingalpha.com/news/3525826-provention-bio-reaffirms-prvminus-031-application-timeline-shares-up-5-premarket

FDA OKs Amneal ANDA for EluRyng

Amneal Pharmaceuticals (NYSE:AMRX) is up 31% premarket on receiving Abbreviated New Drug Application (ANDA) approval from the FDA for EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of Merck’s NuvaRing.

According to IQVIA, NuvaRing U.S. annual sales for year ended October 31, 2019 were ~$976M.

https://seekingalpha.com/news/3525829-fda-oks-amneal-anda-for-eluryng-shares-up-31-premarket

FDA approves Elite Pharma and SunGen’s generic Adderall XR

Elite Pharmaceuticals (OTCQB:ELTP) has received FDA approval for a generic version of Shire’s Adderall XR, an extended-release mixed salt of a single entity Amphetamine product with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets.

The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder.

According to IQVIA, the branded product and its equivalents had total U.S. sales of $1.3B for year ended October 2019.

Generic Adderall XR is jointly owned and the second product of Elite and SunGen Pharma collaboration.

https://seekingalpha.com/news/3525834-fda-approves-elite-pharma-and-sungens-generic-adderall-xr

Grifols launches subcutaneously administered immunoglobulin

Grifols S.A. (OTCPK:GIKLY) launches Xembify (immune globulin subcutaneous human-klhw), its first 20% subcutaneous immunoglobulin therapy for the treatment of patients at least two-year-olds with primary immunodeficiency.

https://seekingalpha.com/news/3525875-grifols-launches-subcutaneously-administered-immunoglobulin