Premarket Biotech Digest – $RDHL gets Orphan Drug designation, $MYL gets sued, $MCK completes acquisition
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RedHill Biopharma ($RDHL) stock perked up as the company announced receiving Orphan Drug designation from the FDA for its YELIVA drug, which is designed for treating cholangiocarcinoma. The designation will allow the company to have several benefits such as tax credits for qualified clinical testing and waiver of a prescription drug user fee (PDUFA fee) upon submission of a potential marketing application. If the drug is approved then a seven-year marketing exclusivity period for the treatment of cholangiocarcinoma will also be granted.
The company stock perked up over 4 percent in the pre-trading session. YELIVA is a Phase II-stage, proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities.
Cyclacel Pharmaceuticals Inc. ($CYCC) announced positive results for its pipeline candidate CYC065. The results showed that CYC065 significantly inhibited growth, triggered apoptosis and induced anaphase catastrophe in mouse and human lung cancer cells with known metastatic potential. CYC065 is a next-generation cyclin-dependent kinase (CDK) 2/9 inhibitor. The drug also significantly bated migration and invasion of lung cancer cells and affected distinctive pathways which are involved in DNA damage response, apoptosis etc.
The company stock jumped over 21 percent in its pre-trading session. Its one year now stands at 37 percent while its Year to Date gain is over 21 percent.
Mylan ($MYL) has been sued again with a new proposed class action lawsuit over the price of its EpiPen allergy treatment. The company has been in constant trouble since massively increasing the price of its EpiPen. The pricing of the treatment was raised to more than $600 for a two-pack of the device from less than $100 in 2007. The new case is believed to focus on the role of pharmacy benefit managers. This class action lawsuit will bring claims under the Racketeer Influenced and Corrupt Organizations Act.
Sorrento Therapeutics ($SRPE) stock slumped as it announced early-stage results on its anti-CEA CAR-T candidate. Six patients completed the study, half had stable disease with decreases in the size of liver lesions ranging from 6 to 28%. One patient out of six is still alive with no evidence of liver disease at almost 11 months of follow-up. Mean overall survival (OS) as of March 28 was 7.5 months and median OS was 6.9 months.
Bristol-Myers Squibb ($BMY) announced results from the Phase 3 CheckMate-143 study assessing Opdivo (nivolumab) in patients with first recurrence of glioblastoma multiforme. The study failed to meet its primary endpoint of improved overall survival (OS) over Roche's Avastin (bevacizumab) alone. The company will continue two additional studies assessing Opdivo in GBM, CheckMate-498 and CheckMate-548, as planned.
Amicus Therapeutics ($FOLD) announced that it has hit the enrollment target for its Phase 3 clinical trial ESSENCE. The trial aims to evaluate topical medicine SD-101 for the treatment of epidermolysis bullosa, a rare inherited disorder characterized by blistering or erosion of the skin. The company expects to present the top line data during the third quarter of this year. Amicus had acquired the rights to the product candidate through its 2015 acquisition of Scioderm.
McKesson Corporation ($MCK) announced that it has completed the previously announced acquisition of CoverMyMeds LLC, which offers electronic prior authorization solutions. The deal is said to be worth $1.1 billion. It is expected to boost McKesson’s technology offerings to pharmaceutical manufacturers, clinicians as well as to the payers.
Invitae ($NVTA) announced that it is partnering with Alnylam for providing genetic testing for hereditary ATTR amyloidosis, a rare inherited and life-threatening disorder. The service, called Alnylam Act, is aimed at encouraging early genetic testing to aid in the prompt diagnosis of the disease. The companies did not disclose the financial terms of the deal.
Retractable Technologies Inc. ($RVP) announced that its loss from operations was $3.2 million in 2015 compared to an operating loss of $3.6 million in 2016. The company said that its overall unit sales decreased 7 percent. The domestic sale accounted for 88.2 percent of its total revenues.
Impact on Share Price
Arbutus Biopharma Corp (ABUS)
Neutral -> Buy
$3.00 -> $6.00
Baxter International (BAX)
Market Perform -> Outperform
Jefferies Group LLC
Royal Bank of Canada
Needham & Company LLC
$46.00 -> $50.00
Royal Bank of Canada
$138.00 -> $157.00
Gainers (% price change) Last Trade Change Mkt Cap
Syneron Medical Ltd. ELOS 11.10 +0.55 (5.21%) 383.69M
Omeros Corporation OMER 15.80 +0.68 (4.50%) 669.80M
Molina Healthcare, Inc. MOH 47.32 +1.72 (3.77%) 2.69B
Incyte Corporation INCY 138.52 +4.85 (3.63%) 27.39B
Exactech, Inc. EXAC 26.05 +0.85 (3.37%) 363.17M
Losers (% price change)
Acorda Therapeutics Inc ACOR 18.40 -2.60 (-12.38%) 670.35M
United Therapeutics Corp. UTHR 123.96 -11.42 (-8.44%) 5.53B
Fluidigm Corporation FLDM 5.26 -0.43 (-7.56%) 154.45M
Keryx Biopharmaceuticals KERX 5.78 -0.38 (-6.17%) 628.44M
Valeant Pharmaceuticals VRX 10.47 -0.57 (-5.21%) 3.56B
Most Actives (dollar volume)
Bristol-Myers Squibb Co BMY 54.21 -0.17 (-0.31%) 87.73B
Johnson & Johnson JNJ 124.69 +0.14 (0.11%) 337.72B
Pfizer Inc. PFE 34.24 +0.03 (0.09%) 203.07B
UnitedHealth Group Inc UNH 165.59 +1.62 (0.99%) 158.74B
Gilead Sciences, Inc. GILD 67.10 -0.82 (-1.21%) 88.22B