Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week highs on Oct. 31)
- Allergan plc AGN
- Amgen, Inc. AMGN
- AstraZeneca plc AZN
- Bristol-Myers Squibb Co BMY( reported better-than-expected third-quarter results)
- Celgene Corporation CELG(third-quarter earnings came in ahead of estimates)
- Deciphera Pharmaceuticals Inc DCPH
- Dicerna Pharmaceuticals Inc DRNA (reacted to a licensing deal with Roche Holdings AG Basel ADR Common Stock RHHBY)
- Dova Pharmaceuticals Inc DOVA
- GENMAB A/S/S ADR GMAB
- GlaxoSmithKline plc GSK
- Oyster Point Pharma Inc OYST (IPOed Thursday)
- Rapt Therapeutics Inc RAPT (IPOed Thursday)
- Recro Pharma Inc REPH( received a written decision from the FDA granting its appeal of the CRL relating to the NDA seeking approval for intravenous meloxicam)
- Reata Pharmaceuticals Inc RETA
- ResMed Inc. RMD
- Vertex Pharmaceuticals Incorporated VRTX(reacted to third-quarter results)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on Oct. 31)
- AcelRx Pharmaceuticals Inc ACRX
- Acorda Therapeutics Inc ACOR
- Agios Pharmaceuticals Inc AGIO(reported below-consensus third-quarter earnings)
- Alimera Sciences Inc ALIM
- Aridis Pharmaceuticals Inc ARDS
- BioCryst Pharmaceuticals, Inc. BCRX
- Cerus Corporation CERS(reacted to third-quarter results)
- Cocrystal Pharma Inc COCP(announced common stock offering)
- Cyclerion Therapeutics Inc CYCN
- Hoth Therapeutics Inc HOTH
- Iterum Therapeutics PLC ITRM
- MacroGenics Inc MGNX
- Miragen Therapeutics Inc MGEN
- Mirum Pharmaceuticals Inc MIRM
- Neurometrix Inc NURO
- OpGen Inc OPGN
- Proteon Therapeutics Inc PRTO
- Rockwell Medical Inc RMTI
- Trevi Therapeutics Inc TRVI
Stocks In Focus
Amgen Takes Stake In Beigene To Expand Oncology Presence In China
Amgen announced a strategic collaboration with Beigene Ltd BGNE, which would expand its oncology presence in China. As part of the collaboration, Amgen will acquire a 20.5% stake in BeiGene for $2.7 billion in cash, with the purchase price translating to $174.85 per BeiGene ADS, a 36% premium to its 30-day volume-weighted average share price as of Oct. 30.
The agreement allows BeiGene to commercialize Amgen's Xgeva, Kyprolis and Blincyto in China, with both parties equally sharing profit and losses. It also provides for both companies advancing 20 of Amgen's oncology pipeline assets in China and globally. BeiGene will share global R&D costs and will contribute $1.25 billion to advance these medicines, while Amgen will pay royalties on the sales of these products outside of China, with the exception of AMG 510.
In pre-market trading, Beigene shares soared 25.05% to $172.99.
See Also: Agile Therapeutics Rallies After FDA Panel Backs Contraceptive Patch
Mallinickrodt Receives Australian Regulatory Nod For Its Graft Vs. Host Disease Treatment
Mallinckrodt PLC MNK said it has received Australian regulatory approval for extracorporeal administration with the Therakos cellex photopheresis system, or TCPS, which is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease in adults following allogenic hematopoietic stem cell transplantation.
Australia's Therapeutic Goods Administration also approved Uvadex in conjunction with the TCPS for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma that is unresponsive to other forms of treatment.
Paratek's Antibacterial Drug Produces Mixed Results In Exploratory Phase 2 Studies
Paratek Pharmaceuticals Inc PRTK announced top-line results from two exploratory Phase 2 studies of once-daily oral or IV dose of omadacycline in patients with two common forms of urinary tract infections, which showed comparable levels of clinical success to either nitrofurantoin or levofloxacin but microbiological responses were generally lower than the comparators.
The company said it has identified dose regimens that require additional investigation before determining any future development plans for these indications.
The stock slipped 3.73% to $2.97 in after-hours trading.
Ideaya Given The Go Ahead For Initiating Phase 2 Study Of Eye Cancer Drug
Following the receipt of the minutes of the end-of-Phase 1 meeting with the FDA, Ideaya Biosciences Inc IDYA said it plans to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE 196 monotherapy. The company expects the Phase 2 dose selection and the initiation of the registration enabling Phase 2 part of the Phase 1/2 trial to be done in the fourth quarter.
IDE196 is being evaluated for metastatic uveal melanoma.
The stock rose 1.74% to $5.77 in after-hours trading.
Earnings
CareDx Inc CDNA's third-quarter revenues jumped 60% year-over-year to $33.8 million, and it reversed to a profit of 2 cents per share on a non-GAAP basis from a loss of 1 cent per share. Analysts estimated a profit of 1 cent per share.
The company's full-year revenue guidance is indicated to come in below the consensus estimate.
The stock slumped 11.67% to $23.15 in pre-market trading.
bluebird bio Inc BLUE's third-quarter revenues declined from $11.5 in 2018 to $8.9 million in 2019. The net loss widened from $2.73 to $3.73. Analyst estimated a narrower loss of $3.52.
The stock moved down 2.16% to $79.25 in after-hours trading.
On The Radar
Earnings
AMAG Pharmaceuticals, Inc. AMAG (before the market open)
AbbVie Inc ABBV (before the market open)
ImmunoGen, Inc. IMGN (before the market open)
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