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

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 (NYSE: ABT)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS)
  • Varian Medical Systems, Inc. (NYSE: VAR)

Down In The Dumps

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

  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Xeris Pharmaceuticals Inc (NASDAQ: XERS)

Stock In Focus

Vanda Q4 Results Trump Estimates

Vanda Pharmaceuticals Inc. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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


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

Clinical Trial Results

Veru Inc (NASDAQ: 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. (NYSE: 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 (NASDAQ: TYME) is due to present updated Phase 2 data for SM-88, its prostate cancer candidate, at the ASCO GU Cancers Symposium.


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.

Posted-In: Biotech News Offerings FDA Top Stories Trading Ideas Best of Benzinga


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