Premarket Biotech Digest – $AVRX receives FDA approval, $MYGN inks new deal, $MRK receives CRL
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Myriad Genetics Inc. ($MYGN) announced signing a development agreement with BeiGene ($BGNE), a Chinese biotech firm. Under the terms of the agreement, BieGene will have access to Myriad’s myChoice HRD and BRACAnalysis CDx companion diagnostic tests for supporting the clinical development of PARP inhibitor BGB-290. The companies did not disclose the financial terms of the agreement.
Myriad said that it expects the collaboration to help “integrate advanced genetic information into clinical practice and achieve better patient outcomes." The company lost over 50 percent of its value in the past 12 months. However, it is showing signs of recovery as the price gained 10 percent this year so far.
Trevena Inc. ($TRVN) stock jumped in its pre-market session as it announced the results from its two Phase 3 studies viz. APOLLO-1 and APOLLO-2. These studies are instituted for the purpose of assessing analgesic candidate OLINVO (oliceridine injection) for the management of moderate-to-severe acute pain in a hospital setting. Both studies met their primary efficacy endpoints compared to placebo but failed to consistently demonstrate statistically valid reductions in side effects compared to morphine (0.35 mg and 0.5 mg doses).
The company stock lost over 42 percent of its value in this year so far while its 12 months’ loss stand at over 59 percent.
Imprimis Pharmaceuticals ($IMMY) reported entering into a new deal with Richard Lindstrom, M.D., for exclusive global rights to Klarity, an ophthalmic topical solution and gel technology for the treatment of dry eye disease. Specific financial terms are not disclosed. The product is designed to protect and rehabilitate the ocular surface following ophthalmic surgery, contact lens wear or in patients with moderate-to-severe DED.
Spark Therapeutics ($ONCE) announced results from an ongoing Phase 1/2 clinical trial evaluating factor IX product SPK-9001. The study showed that based on patient histories prior to the study, annualized bleed rates (ABRs) were reduced 96% to a mean of 0.39 annual bleeds. Annual infusion rates (AIRs) were reduced 99% to an average of 0.98 annual infusions.
Avita Medical ($AVMXF) announced receiving the FDA approval for an increase in the number of patients who can be treated in the U.S. with the ReCell regenerative medical device under a compassionate use protocol. The FDA now allows treatment of up to 68 patients who have insufficient healthy skin for skin grafting treatment of their injury at 18 U.S. burns centers.
Merck ($MRK) announced that it has received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Applications. The company seeks to add cardiovascular outcomes data from the TECOS study to the labels of JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin HCl) and JANUMET XR (sitagliptin and metformin HCl extended-release). Merck said it is reviewing the letter and will discuss next step with the agency.
Janssen Pharmaceuticals ($JNJ) inked a new deal with PeptiDream. The collaboration will use PeptiDream's proprietary Peptide Discovery Platform System technology for identifying certain peptides against multiple metabolic and cardiovascular targets. Under the terms of the agreement, PeptiDream will received an upfront payment, research funding, milestones potentially valued at up to $1.1 billion.
Prometic Life Sciences ($PFSCF) announced that it has completed at deal regarding the supply of affinity resin that will be used for large-scale purification of a therapeutic protein product. The company did not disclose the name of the other party. The deal is expected to be worth $9.5 million. The delivery is expected to start in the second half of this year and continue throughout 2018.
Impact on Share Price
Alliqua Biomedical (ALQA)
Buy -> Buy
$2.50 -> $1.50
HSBC Holdings plc
AstraZeneca plc (AZN)
Hold -> Reduce
Jefferies Group LLC
Boston Scientific (BSX)
$26.00 -> $28.00
Cidara Therapeutics (CDTX)
Corbus Pharmaceuticals Holdings (CRBP)
ContraVir Pharmaceuticals (CTRV)
Jefferies Group LLC
Eiger Biopharmaceuticals (EIGR)
HSBC Holdings plc
Grifols SA, Barcelona (GRFS)
Hold -> Reduce
Gainers (% price change) Last Trade Change Mkt Cap
Fluidigm Corporation FLDM 5.24 +0.39 (8.04%) 149.36M
China Cord Blood Corp CO 7.30 +0.43 (6.26%) 574.02M
Akorn, Inc. AKRX 25.22 +1.26 (5.26%) 3.22B
Cerus Corporation CERS 4.27 +0.17 (4.15%) 432.86M
Clearfield Inc CLFD 15.50 +0.60 (4.03%) 212.65M
Losers (% price change)
Infinity Pharmaceuticals INFI 2.57 -0.23 (-8.21%) 116.68M
Synergy Pharmaceuticals SGYP 4.09 -0.23 (-5.32%) 881.92M
BioSpecifics Tech. Corp. BSTC 51.90 -2.82 (-5.15%) 372.50M
Clovis Oncology Inc CLVS 56.83 -2.82 (-4.73%) 2.47B
ImmunoGen, Inc. IMGN 3.24 -0.13 (-3.86%) 257.09M
Most Actives (dollar volume)
Gilead Sciences, Inc. GILD 66.48 +0.01 (0.02%) 86.24B
Pfizer Inc. PFE 34.11 -0.07 (-0.20%) 202.24B
Johnson & Johnson JNJ 125.05 +0.25 (0.20%) 339.32B
Amgen, Inc. AMGN 162.25 +0.01 (0.01%) 117.95B
UnitedHealth Group Inc UNH 165.34 -0.03 (-0.02%) 159.45B