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Tuesday, December 17, 2019

Analyst action, Dec. 17

Amgen (NASDAQ:AMGN) resumed with Overweight rating and $280 (15% upside) price target at Morgan Stanley.
Hill-Rom Holdings (NYSE:HRC) upgraded to Overweight with a $138 (25% upside) price target at Morgan Stanley.
Johnson & Johnson (NYSE:JNJ) upgraded to Overweight with a $170 (20% upside) price target at Morgan Stanley. Shares up 1% premarket.
MedMen Enterprises (MMEN CN) upgraded to Market Perform at Cowen and Company.
Alexion Pharmaceuticals (NASDAQ:ALXN) downgraded to Equal Weight with a $128 (15% upside) price target at Morgan Stanley. Shares down 1% premarket.
Baxter International (NYSE:BAX) downgraded to Equal Weight with an $88 (5% upside) price target at Morgan Stanley. Shares down 1% premarket.
Galapagos NV (NASDAQ:GLPG) downgraded to Equal Weight at Morgan Stanley. Shares up 1% premarket.
Kala Pharmaceuticals (NASDAQ:KALA) downgraded to Neutral at BofA Merrill Lynch. Shares down 6% premarket.
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New additions to NASDAQ Biotechnology index

Axsome Therapeutics (NASDAQ:AXSM), Affimed N.V. (NASDAQ:AFMD), XBiotech (NASDAQ:XBIT) and ADMA Biologics (NASDAQ:ADMA) have been selected for addition to the NASDAQ Biotechnology Index, as part of the annual index evaluation.
All the Company’s additions will become effective prior to the market open on December 23, 2019.
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Adamas Pharma’s Gocovri meets endpoint in late-stage MS study

Adamas Pharmaceuticals (NASDAQ:ADMS) announces positive results from a Phase 3 clinical trial, INROADS, evaluating Gocovri (amantadine) (ADS-5102) in multiple sclerosis (MS) patients with walking impairment.
The study met the primary endpoint demonstrating a statistically significant improvement in response rate compared to placebo as determined by at least a 20% improvement in walking speed from baseline at week 12 in a Timed 25 Foot Walk. Specifically, patients receiving 274 mg of ADS-5102 each day showed a 21.1% response rate versus 11.3% for control (p=0.01). The response rate was 17.6% in the 137 mg dose arm but the separation from placebo was not statistically valid.
Neither dose sufficiently separated from placebo on the secondary walking measures.
On the safety front, the discontinuation rates in the 274 mg and 137 mg arms were 20.5% and 6.4%, respectively, compared to 3.8% in the control arm. The most common (>5%) treatment-related adverse events were peripheral edema, dry mouth, fall, constipation, urinary tract infection and insomnia.
The FDA approved Gocovri in August 2017 for Parkinson’s disease-related dyskinesia.
Shares, currently halted, will resume trading at 9:50 am ET.
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Adamas shares halted pending news

Nasdaq has suspended trading in Adamas Pharmaceuticals (NASDAQ:ADMS) pending the release of news.
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Proteostasis down 34% on mixed results in mid-stage cystic fibrosis study

Proteostasis Therapeutics (NASDAQ:PTI) slumps 34% premarket on robust volume on the heels of topline results from a Phase 2 clinical trial evaluating its CFTR modulator combinations in cystic fibrosis (CF) patients.
The study assessed dirocaftor (PTI-808) and posenacaftor (PTI-801) with or without nesolicaftor (PTI-428) in 28 F508del homozygous and 40 F508del heterozygous subjects.
On the plus side, homozygous patients receiving the triple combo (n=11) experienced a mean absolute 8% relative improvement in lung function compared to pooled placebo at day 28 (p<=0.01). The treatment effect on lung function and sweat chloride concentration was higher for the triplet therapy versus the doublet (dirocafter + posenacaftor) but specific values are not provided.
In the heterozygous group, the results were mixed. The mean relative change in lung function for the triplet therapy was not statistically significant, but the change in sweat chloride concentration was.
The company plans to launch a Phase 3 study, MORE, in homozygous CF patients in 2020.
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FDA OKs expanded use of Astellas and Pfizer’s Xtandi

Astellas Pharma (OTCPK:ALPMF) and development/commercialization partner Pfizer (NYSE:PFE) announce FDA approval of Xtandi (enzalutamide) for the treatment of men with metastatic castration-sensitive prostate cancer, a type of prostate cancer that affects ~40K Americans.
The androgen receptor inhibitor was approved in the U.S. in August 2012 for metastatic castration-resistant prostate cancer and in July 2018 for non-metastatic castration-resistant prostate cancer.
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Eiger Bio launches rolling submission of lonafarnib NDA for progeria

Eiger BioPharmaceuticals (NASDAQ:EIGR) initiates the rolling submission of its U.S. marketing application seeking approval of lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome (HGPS or progeria) and progeroid laminopathies.
Progeria is an ultra-rare and fatal disorder characterized by premature aging in children. Without treatment, sufferers usually die from heart disease at an average age of 14.5 years.
Lonafarnib, a farnesyltransferase inhibitor in-licensed from Merck, has Orphan Drug, Breakthrough Therapy and Rare Pediatric Disease Designation status for the indication.
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