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 (NASDAQ: ETNB) (IPOed Nov. 11)
- Allergan plc (NYSE: AGN)(announced publication of Phase 3 study results of migraine drug candidate)
- Agenus Inc (NASDAQ: AGEN)
- Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
- Antares Pharma Inc (NASDAQ: ATRS)(announced a collaboration agreement with Idorsia Pharma for developing a drug-device combo for heart attack)
- Ardelyx Inc (NASDAQ: ARDX)
- Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
- Arvinas Inc (NASDAQ: ARVN)
- Axsome Therapeutics Inc (NASDAQ: AXSM)
- Beigene Ltd (NASDAQ: BGNE)
- Bio-Rad Laboratories, Inc. Class A (NYSE: BIO)
- Cabaletta Bio Inc (NASDAQ: CABA)
- CNS Pharmaceuticals Inc (NASDAQ: CNSP)(IPOed Nov. 8)
- Crispr Therapeutics AG (NASDAQ: CRSP)( announced positive Phase 1/2 results for gene-editing investigational therapy)
- DexCom, Inc. (NASDAQ: DXCM)
- Dicerna Pharmaceuticals Inc (NASDAQ: DRNA)
- Edwards Lifesciences Corp (NYSE: EW)
- Eidos Therapeutics Inc (NASDAQ: EIDX)
- Galera Therapeutics Inc (NASDAQ: GRTX)(IPOed Nov. 7)
- Globus Medical Inc (NYSE: GMED)
- Halozyme Therapeutics, Inc. (NASDAQ: HALO)
- Karuna Therapeutics Inc (NASDAQ: KRTX)
- Krystal Biotech Inc (NASDAQ: KRYS)
- The Medicines Company (NASDAQ: MDCO) ( reacted to buyout rumors)
- Seattle Genetics, Inc. (NASDAQ: SGEN)
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)(reacted to positive results for gene-editing program it is co-developing with CRISPR)
- XBiotech Inc (NASDAQ: XBIT)
- XOMA Corp (NASDAQ: XOMA)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Nov. 19)
- Acorda Therapeutics Inc (NASDAQ: ACOR)
- Aethlon Medical, Inc. (NASDAQ: AEMD)
- Altimmune Inc (NASDAQ: ALT)
- Auris Medical Holding Ltd (NASDAQ: EARS)
- Cancer Genetics Inc (NASDAQ: CGIX)
- ENDRA Life Sciences Inc (NASDAQ: NDRA)
- Five Prime Therapeutics Inc (NASDAQ: FPRX)
- Guardion Health Sciences Inc (NASDAQ: GHSI)
- Invivo Therapeutics Holdings Corp (NASDAQ: NVIV)
- Jaguar Health Inc (NASDAQ: JAGX)
- Novavax, Inc. (NASDAQ: NVAX)
- Ocugen Inc (NASDAQ: OCGN)
- Pluristem Therapeutics Inc. (NASDAQ: PSTI)
- Plus Therapeutics Inc (NASDAQ: PSTV)
- Ritter Pharmaceuticals Inc (NASDAQ: RTTR)
- Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
- Seneca Biopharma Inc (NASDAQ: SNCA)
- Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
- Unum Therapeutics Inc (NASDAQ: UMRX)
Stocks In Focus
Endo's Cellulite Treatment Candidate Accepted For Review
Endo International PLC (NASDAQ: 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 (NASDAQ: AKCA), which is majority owned by Ionis Pharmaceuticals Inc (NASDAQ: IONS), and Ionis announced the closing of the exclusive licensing agreement with Pfizer Inc. (NYSE: 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 (NASDAQ: 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 (NYSE: 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 (OTC: 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.
Organogenesis Holdings Inc (NASDAQ: 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 (NASDAQ: 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.
CytomX Therapeutics Inc (NASDAQ: CTMX) shares reacted to Guggenheim's initiation of the shares at Buy.
The stock rose 3.67% to $5.37 in after-hours trading.
The stock fell 4.40% to $21.73 in after-hours trading.
On The Radar
Clinical Trial Readouts
Ideaya Biosciences Inc (NASDAQ: IDYA) is due to present at the Society for Melanoma Research 2019 Congress, Phase 1 data for IDE196 in solid tumors.