The Daily Biotech Pulse: Exelixis Q4 Results, FDA Panel Greenlights J&J's Depression Drug, MacroGenics Prices Offering

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 ABT
• Amphastar Pharmaceuticals Inc AMPH
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Boston Scientific Corporation BSX
• Edwards Lifesciences Corp EW(CASM) for $100 million)
• Masimo Corporation MASI
• Mirati Therapeutics Inc MRTX

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 12)

• CELLECT BIOTECH/S ADR APOP
• Collegium Pharmaceutical Inc COLL
• Organogenesis Holdings Inc ORGO
• Scpharmaceuticals Inc SCPH

Stock In Focus

Exelixis Q4 Exceeds Expectations

Exelixis, Inc. 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 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 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 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.

See Also: Gilead Analysts React To Failed NASH Trial: Citigroup, Wells Fargo Downgrade Biotech

Moderna Reports Positive Early-Stage Results For Respiratory Infection Vaccine

Moderna Inc 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 MTFB's NDA for Iclaprim to acute bacterial skin and skin structure infections, or ABSSSI.

Earnings

Ironwood Pharmaceuticals, Inc. IRWD Q4 EPS $(0.10) Beats $(0.15) Estimate, Sales $130.69M Beat $98.47M Estimate
Natus Medical Inc BABY Q4 Adj. EPS $0.43 Misses $0.49 Estimate, Sales $141M Beat $136.65M Estimate
Vanda Pharmaceuticals Inc. VNDA (after the market close)
Urovant Sciences Ltd UROV (after the market close)