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 Nov. 19)
- 89bio Inc ETNB (IPOed Nov. 11)
- Allergan plc AGN(announced publication of Phase 3 study results of migraine drug candidate)
- Agenus Inc AGEN
- Alnylam Pharmaceuticals, Inc. ALNY
- Antares Pharma Inc ATRS(announced a collaboration agreement with Idorsia Pharma for developing a drug-device combo for heart attack)
- Ardelyx Inc ARDX
- Arrowhead Pharmaceuticals Inc ARWR
- Arvinas Inc ARVN
- Axsome Therapeutics Inc AXSM
- Beigene Ltd BGNE
- Bio-Rad Laboratories, Inc. Class A BIO
- Cabaletta Bio Inc CABA
- CNS Pharmaceuticals Inc CNSP(IPOed Nov. 8)
- Crispr Therapeutics AG CRSP( announced positive Phase 1/2 results for gene-editing investigational therapy)
- DexCom, Inc. DXCM
- Dicerna Pharmaceuticals Inc DRNA
- Edwards Lifesciences Corp EW
- Eidos Therapeutics Inc EIDX
- Galera Therapeutics Inc GRTX(IPOed Nov. 7)
- Globus Medical Inc GMED
- Halozyme Therapeutics, Inc. HALO
- Karuna Therapeutics Inc KRTX
- Krystal Biotech Inc KRYS
- The Medicines Company MDCO ( reacted to buyout rumors)
- Seattle Genetics, Inc. SGEN
- Vertex Pharmaceuticals Incorporated VRTX(reacted to positive results for gene-editing program it is co-developing with CRISPR)
- XBiotech Inc XBIT
- XOMA Corp XOMA
Down In The Dumps
(Biotech stocks hitting 52-week lows on Nov. 19)
- Acorda Therapeutics Inc ACOR
- Aethlon Medical, Inc. AEMD
- Altimmune Inc ALT
- Auris Medical Holding Ltd EARS
- Cancer Genetics Inc CGIX
- ENDRA Life Sciences Inc NDRA
- Five Prime Therapeutics Inc FPRX
- Guardion Health Sciences Inc GHSI
- Invivo Therapeutics Holdings Corp NVIV
- Jaguar Health Inc JAGX
- Novavax, Inc. NVAX
- Ocugen Inc OCGN
- Pluristem Therapeutics Inc. PSTI
- Plus Therapeutics Inc PSTV
- Ritter Pharmaceuticals Inc RTTR
- Salarius Pharmaceuticals Inc SLRX
- Seneca Biopharma Inc SNCA
- Tetraphase Pharmaceuticals Inc TTPH
- Unum Therapeutics Inc UMRX
See Also: Analyst: Peak Sales Potential Of Amarin's Vascepa Underappreciated
Stocks In Focus
Endo's Cellulite Treatment Candidate Accepted For Review
Endo International PLC ENDP said the FDA has accepted for review its original BLA for collagenase clostridium histolyticum for the treatment of cellulite in the buttocks. The PDUFA action date has been set for July 6, 2020.
The stock gained 5.62% to $4.70 in after-hours trading.
Akcea, Ionis Announce Consummation of Antisense Therapy Licensing Deal With Pfizer
Akcea Therapeutics Inc AKCA, which is majority owned by Ionis Pharmaceuticals Inc IONS, and Ionis announced the closing of the exclusive licensing agreement with Pfizer Inc. PFE with regard to their investigational antisense therapy AKCEA-ANGPTL3-LRx.
AKCEA-ANGPTL3-LRx is being developed to treat patients with certain cardiovascular and metabolic diseases. The agreement provides for Akcea and Ionis receiving an upfront license fee of $250 million, which is to be split between the companies. Akcea also said it will settle its $125 million obligation to Ionis in Akcea common stock.
Akcea shares added 0.94% to $19.26 in after-hours trading.
Diffusion's Add-On Cancer Drug Increased Survival In Glioblastoma Patients
Diffusion Pharmaceuticals Inc DFFN announced results of the dose-escalation lead-in portion of its Phase 3 study of Trans Sodium Crocetinate, or TSC, along with standard-of-care, which showed increased survival in inoperable glioblastoma patients.
The stock jumped 35.52% to 30 cents in after-hours trading.
Novo Nordisk Reaffirms Its Long-term Financial Targets
Novo Nordisk A/S NVO said in the wake of its Capital Markets Day that it is on track to meet its current long-term financial targets of achieving average operating profit growth of 5%, cash-to-earnings ratio of 85% and operating profit after tax over net operating assets of 80%.
Merck KGaA's Lung Cancer Drug Gets Orphan Drug Designation In Japan
MERCK KGAA/S ADR MKKGY said the Japanese Ministry of Health, Labor and Welfare has granted orphan drug designation for its tepotinib, its investigational therapy to treat patients with non-small cell lung cancer harboring MET gene mutations.
Offerings
Organogenesis Holdings Inc ORGO said it's offering 9 million shares in an underwritten follow-on offering.
The stock slipped 8.92% to $7.25 in after-hours trading.
Axonics Modulation Technologies Inc AXNX has commenced a proposed public offering of $110 million shares of its common stock. Of the proposed offering, $100 million shares are to be offered by Axonics and $10 million by selling shareholders. The company expects to use the net proceeds to support the commercial launch of r-SNM System in the U.S., Europe and Canada and to fund R&D, among other things.
The stock fell 2.78% to $22.35 in after-hours trading.
CRISPR said it has commenced an underwritten public offering of 4.25 million shares.
The stock declined 5.78% to $64.50 in after-hours trading.
Analyst Actions
CytomX Therapeutics Inc CTMX shares reacted to Guggenheim's initiation of the shares at Buy.
The stock rose 3.67% to $5.37 in after-hours trading.
Amarin Corporation plc AMRN shares were initiated at an Underperform by Oppenheimer analyst Leland Gershell. The firm has a price target of $7 for the shares, suggesting 70% downside.
The stock fell 4.40% to $21.73 in after-hours trading.
On The Radar
Clinical Trial Readouts
Ideaya Biosciences Inc IDYA is due to present at the Society for Melanoma Research 2019 Congress, Phase 1 data for IDE196 in solid tumors.
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