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The Daily Biotech Pulse: Paratek Launches Antibiotic In US, Eli Lilly Earnings, Catabasis Offering

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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 (NASDAQ: AMPH)

  • Array Biopharma Inc (NASDAQ: ARRY) (reported a narrower-than-expected loss for Q2)

  • Axsome Therapeutics Inc (NASDAQ: AXSM)

  • Osiris Therapeutics, Inc. (NASDAQ: OSIR)

  • XBiotech Inc (NASDAQ: XBIT)

Down In The Dumps

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

  • BioNano Genomics Inc (NASDAQ: BNGO)

  • CELLECT BIOTECH/S ADR (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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.

View more earnings on IBB

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

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