The Daily Biotech Pulse: Vanda Q4 Results, Inovio Debt Offering, Caladrius Diabetes Drug Flunks Mid-Stage Trial

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. 13)

• Abbott Laboratories ABT
• Ionis Pharmaceuticals Inc IONS
• Varian Medical Systems, Inc. VAR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 13)

• Organogenesis Holdings Inc ORGO
• Xeris Pharmaceuticals Inc XERS

Stock In Focus

Vanda Q4 Results Trump Estimates

Vanda Pharmaceuticals Inc. VNDA reported fourth-quarter revenues of $53.041 million compared to $44.276 million in the year-ago period. The company reversed to a profit of 19 cents per share from a loss of 4 cents per share a year ago. Analysts expected a profit of 1 cent per share on revenues of $51.7 million.

For 2019, the company expects net product sales of $215 million to $225 million, while the consensus estimate calls for revenues of $246.66 million.

The stock rose 4.78 percent to $19.30 in after-hours trading.

Inovio To Offer $65M Worth Of Debt

Inovio Pharmaceuticals Inc INO intends to offer $65 million aggregate principal amount of convertible senior notes due 2024 in a private offering to qualified institutional buyers. The company expects to use the net proceeds for meeting clinical trial expenses, R&D expenses, general & administrative expenses, among other things.

The stock slumped 15.38 percent to $3.96 in after-hours trading.

Caladrius' Diabetes Drug Fails In A Mid-stage Trial

Caladrius Biosciences Inc CLBS announced top-line results from the Sanford Project: T-Rex Study, a Phase 2a clinical trial that evaluates its CLBS03 as a treatment for recent-onset type 1 diabetes in adolescents. Initial analysis of 1-year follow-up data of the 110 subjects evaluated showed that there was no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo. However, it was well tolerated at the two doses tested in the study.

The stock plunged 22.86 percent to $4.10 in after-hours trading.

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

FDA Approves Novartis' Drug To Treat Liver Fluke Infestation

Novartis AG NVS said the FDA approved its Egaten for the treatment of fascioliasis in patients six years of age and older. Fascioliasis, commonly known as liver fluke infestation, is a tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection, the company said.

ImmuCell Q4 Loss Widens

ImmuCell Corporation ICCC reported a decline in its fourth-quarter product sales from $3.133 million last year to $2.937 million. The net loss per share widened from 4 cents to 19 cents.

The stock rallied 15.53 percent to $9 in after-hours trading.

Xeris Prices Common Stock Offering

Xeris priced its public offering of 5.88 million shares at $10 per share. The company expects to mobilize gross proceeds of $58.8 million from the offering. The offering is expected to close Feb. 19.

The stock fell 2.09 percent to $10.32 in after-hours trading.

On The Radar

Earnings

Zoetis Inc ZTS Q4 EPS $0.79 Beats $0.77 Estimate, Sales $1.6B Beat $1.52B Estimate
Alkermes Plc ALKS Q4 EPS $0.34 Up From $0.31 YoY, Sales $315.8M Beat $255.09M Estimate
Prothena Corporation PLC PRTA (after the market close)
Acorda Therapeutics Inc ACOR (after the market close)

Clinical Trial Results

Veru Inc VERU is scheduled to make a poster presentation of Phase 2 data of its hot flashes treatment candidate Zuclomiphene citrate at the ASCO GU Cancers Symposium.

Pfizer Inc. PFE will present a poster on Phase 3 data for Xtandi, its metastatic hormone-sensitive prostate cancer candidate, at the ASCO GU Cancers Symposium.

Tyme Technologies Inc TYME is due to present updated Phase 2 data for SM-88, its prostate cancer candidate, at the ASCO GU Cancers Symposium.

IPO

TCR2 Therapeutics said it has priced its initial public offering, or IPO, of 5 million shares at $15, within the estimated price range of $14-$16. The shares of the immuno-oncology biotech will begin to trade on the Nasdaq under the ticker symbol TCRR.