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 Feb. 12)
- Abbott Laboratories (NYSE: ABT)
- Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)
- Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)
- Boston Scientific Corporation (NYSE: BSX)
- Edwards Lifesciences Corp (NYSE: EW)(CASM) for $100 million)
- Masimo Corporation (NASDAQ: MASI)
- Mirati Therapeutics Inc (NASDAQ: MRTX)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Feb. 12)
- CELLECT BIOTECH/S ADR (NASDAQ: APOP)
- Collegium Pharmaceutical Inc (NASDAQ: COLL)
- Organogenesis Holdings Inc (NASDAQ: ORGO)
- Scpharmaceuticals Inc (NASDAQ: SCPH)
Stock In Focus Exelixis Q4 Exceeds Expectations
Exelixis, Inc. (NASDAQ: EXEL) reported fourth-quarter non-GAAP EPS of 37 cents per share. Total revenues climbed from $120.1 million to $228.6 million, helped by strong Cabozantinib franchise net revenues, which climbed 84 percent year-over-year to $176.2 million. The results beat consensus estimates, which called for EPS of 24 cents on revenues of $188.76 million.
The stock rallied 7.38 percent to $23.28 in after-hours trading.
MacroGenics Price Of Common Stock Offering At A Discount
MacroGenics Inc (NASDAQ: MGNX) priced its public offering of 5.50 million shares at $20 per share. The company expects total proceeds from the offering of $110 million.
The stock slipped 1.62 percent to $20.65 in after-hours trading.
Vistagen Q3 Loss Wider Than Expected
Vistagen Therapeutics Inc (NASDAQ: VTGN), which has an investigational depression drug in its pipeline, reported a third-quarter loss of 24 cents per share compared to a loss of 25 cents per share a year ago. Analysts estimated a narrower loss of 22 cents per share.
The stock declined 3.41 percent to $1.70 in after-hours trading.
FDA Panel OKs J&J's Treatment-Resistant Depression Drug
Johnson & Johnson (NYSE: JNJ)'s Janssen unit said a joint meeting of FDA's Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of the benefit-risk profile of Esketamine nasal spray for adults with treatment-resistant depression, with 14 giving a thumbs up, 2 against and 1 member abstaining.
The PDUFA date for the pipeline asset is set for March 4.
Moderna Reports Positive Early-Stage Results For Respiratory Infection Vaccine
Moderna Inc (NASDAQ: MRNA) announced positive topline results from the first planned interim analysis of safety and immunogenicity from a Phase 1 study of mRNA-1653 in healthy adults.
mRNA is being evaluated as a prophylactic vaccine against t human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3), two viruses that cause respiratory infections, and is a combo vaccine that consists of two direct mRNA sequences encoding the fusion proteins of hMPV and PIV3 formulated in Moderna's proprietary lipid nanoparticle technology.
The interim results showed a single vaccination boosted serum neutralization titers against hMPV and PIV3, and that the magnitude of the boost was similar at all dose levels tested. The study also showed a single vaccination was sufficient to achieve a plateau in neutralizing antibodies in pre-exposed population. It was also found to be safe and generally well tolerated.
On The Radar PDUFA Date
The FDA is set to rule on MOTIF BIO PLC/S ADR (NASDAQ: MTFB)'s NDA for Iclaprim to acute bacterial skin and skin structure infections, or ABSSSI.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) Q4 EPS $(0.10) Beats $(0.15) Estimate, Sales $130.69M Beat $98.47M Estimate
Natus Medical Inc (NASDAQ: BABY) Q4 Adj. EPS $0.43 Misses $0.49 Estimate, Sales $141M Beat $136.65M Estimate
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
Urovant Sciences Ltd (NASDAQ: UROV) (after the market close)
See more from Benzinga
- The Daily Biotech Pulse: NASH Disappointment For Gilead, Xeris To Offer Shares
- FDA Panel Reviews Johnson & Johnson's Treatment-Resistant Depression Candidate: What To Expect
- The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials
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