The Daily Biotech Pulse: Paratek Launches Antibiotic In US, Eli Lilly Earnings, Catabasis 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. 5)

• Amphastar Pharmaceuticals Inc AMPH
• Array Biopharma Inc ARRY (reported a narrower-than-expected loss for Q2)
• Axsome Therapeutics Inc AXSM
• Osiris Therapeutics, Inc. OSIR
• XBiotech Inc XBIT

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 5)

• BioNano Genomics Inc BNGO
• CELLECT BIOTECH/S ADR APOP (began collaboration with Washington University aimed at determining the safety and tolerability in a Phase 1/2 study using ApoGraft for bone marrow transplantations)

Stock In Focus

Paratek Commercially Launches its Recently Approved Antibiotic In The U.S.

Paratek Pharmaceuticals Inc PRTK announced the U.S. commercial launch of its recently approved Nuzyra for treating community-acquired pneumonia and acute skin and skin structure infections.

"We have created a solid foundation from which to launch NUZYRA including beginning to secure institutional access and building a world-class antibiotic sales force whose primary focus during this first year of launch will be directed towards physicians with a history of early adoption," said Michael Bigham, CEO of Paratek.

The stock rallied 7.73 percent to $7.25 in after-hours trading.

Vanda Sues FDA

Vanda Pharmaceuticals Inc. VNDA said it has filed a complaint against the FDA for lifting the partial clinical hold the agency had imposed on the company, prohibiting it from studying tradipitant, a promising new drug, in humans more than 12 weeks without conducting unnecessary and unethical animal studies.

The stock fell 4.23 percent to $24 in after-hours trading.

Offerings

Catabasis Pharmaceuticals Inc CATB intends to offer its common stock in an underwritten public offering. The company intends to use the net proceeds from the offering for clinical trials and other R&D activities, among others.

The stock slumped 15.37 percent to $5.12 in after-hours trading.

Aeglea Bio Therapeutics Inc AGLE priced its underwritten public offering of 3.75 million shares at $8 per share. The company expects gross proceeds of $60 million from the offering. The offering is expected to close on or about Feb. 8.

The stock declined 6.79 percent to $8.78 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates

Earnings

Vertex Pharmaceuticals Incorporated VRTX reported Q4 total revenues of $870.11 million, up from $651.63 million in the year-ago quarter. The non-GAAP EPS more than doubled from 61 cents to $1.30. Analysts, on average, estimated earnings of $1.06 per share on revenues of $819.12 million.

For FY19, the company expects total CF product revenues of $3.45 billion to $3.55 billion. Analysts expect total revenues of $3.55 billion.

The stock rose 3.02 percent to $192.50 in after-hours trading.

Myriad Genetics, Inc. MYGN reported fiscal-year 2018 second-quarter revenues of $216.8 million, up 15 percent year-over-year, and adjusted EPS came in at 38 cents, up 6 percent. The EPS trailed expectations but revenues were in line.

For Q3, the company expects non-GAAP EPS of 42-44 cents on revenues of $216 million to $218 million. The company guided fiscal year 2019 non-GAAP EPS to $1.70-$1.75 on revenues of $855 million to $865 million.

The stock moved down 3.66 percent to $26.85 in after-hours trading.

Neurocrine Biosciences, Inc. NBIX reported Q4 revenues of $131.5 million compared to $94.5 million in the year-ago quarter. The EPS for the quarter rose from 7 cents to 19 cents. The results exceeded estimates.

For 2019, the company expects revenue milestones under the AbbVie Inc ABBV agreement to be $20 million, contingent on the FDA accepting the NDA submission of elagolix for uterine fibroids. SG&A and R&D expenses are estimated at $550 million to $600 million.

The stock gained 0.63 percent to $88.25 in after-hours trading.

On The Radar

Clinical Trial Results

Avrobio Inc AVRO is scheduled to release update on Phase 1 study and two-year data for first patient treated with Fabry disease candidate AVR-RD-01 at the WORLDSymposium.

Abeona Therapeutics Inc ABEO will release Phase 1/2 safety and tolerability data for ABO-102, its treatment candidate for Sanfilippo syndrome type A, at the WORLDSymposium.

Earnings

Boston Scientific Corporation BSX Q4 Adj. EPS $0.39 Beats $0.37 Estimate, Sales $2.56B Inline
Eli Lilly And Co LLY Q4 EPS $1.33 Misses $1.34 Est, Sales $6.438B Beat $6.28B Est.
Regeneron Pharmaceuticals Inc REGN Q4 Adj. EPS $6.84 Beats $5.72 Estimate, Sales $1.93B Beat $1.71B Estimate
Enanta Pharmaceuticals Inc ENTA (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)