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The Daily Biotech Pulse: Puma Biotech Earnings, Mersana Offering, Orphan Drug Designation For Ascendis

Shanthi Rexaline

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. 28)

  • Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)
  • Abbott Laboratories (NYSE: ABT)
  • Eli Lilly And Co (NYSE: LLY)
  • Horizon Pharma PLC (NASDAQ: HZNP)(announced positive Phase 3 results for teprotumumab, its treatment candidate for active thyroid eye disease)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Tcr2 Therapeutics Inc (NASDAQ: TCRR) (listed on Feb. 14)
  • Varian Medical Systems, Inc. (NYSE: VAR)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 28)

  • Achaogen Inc (NASDAQ: AKAO)
  • AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)
  • CytomX Therapeutics Inc (NASDAQ: CTMX) (reacted to Q4 results)
  • RA Medical Systems Inc (NYSE: RMED)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI) (reacted to Q4 results)
  • Novavax, Inc. (NASDAQ: NVAX)(reported negative trial results for its ResVax vaccine)
  • Seelos Therapeutics Inc (NASDAQ: SEEL)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)

Stock In Focus Mersana to Offer Shares to Fund Pipeline Development

Mersana Therapeutics Inc (NASDAQ: MRSN) intends to offer shares of its common stock in an underwritten public offering. All the shares are to be sold by the company.

Mersana said it intends to use the net proceeds to fund clinical development of XMT-1536, to progress its next ADC product candidate into Phase 1 trial, to progress its early platform development, among other things.
The stock slumped 19.96 percent to $4.41 in after-hours trading.

See Also: Major Shareholders Team To Scuttle Bristol-Myers Squibb's B Celgene Buyout: What's Next?

Ascendis' Dwarfism Drug Gets Orphan Drug Designation

Ascendis Pharma A/S (NASDAQ: ASND) said the FDA has granted Orphan Drug Designation to its TransCon CNP, a long-acting prodrug of C-type natriurectic peptide, in development for children with achondroplasia.

Achondroplasia is the most common form of dwarfism, resulting in severe skeletal complications and comorbidities. There are no FDA-approved therapies for this indication.

TG Therapeutics Announces Common Stock Offering, Loan Facility

TG Therapeutics Inc (NASDAQ: TGTX) announced a common stock offering, and also a debt financing agreement for up to $60 million with Hercules Capital.

The company said it intends to use the proceeds of the public offering and the debt facility to fund the development of ublituximab and umbralisib, for R&D and for general corporate purposes.

View more earnings on XBI

Earlier Thursday, the company reported positive results for a Phase 2b clinical trial, evaluating its umbralisib in patients with treatment-resistant non-Hodgkin lymphoma.

The stock slipped 5.59 percent to $6.42 in after-hours trading.

Earnings

Puma Biotechnology Inc (NASDAQ: PBYI) reported fourth-quarter revenues of $71.1 million compared to $21.6 million last year, with the bulk of the revenues coming from Nerlynx, which is its first commercial product indicated to treat early-stage HER2-positive breast cancer following adjuvant trrastuzumab-based therapy. The non-GAAP net loss per narrowed from $1.03 to 32 cents.

The stock jumped 21.18 percent to $33.70 in after-hours trading.

Bio-Rad Laboratories, Inc. Class A (NYSE: BIO)'s fourth quarter revenues slipped 0.6 percent year-over-year to $617.5 million, in line with the consensus estimate. On a non-GAAP basis, the company reported EPS of $2.13, higher than $1.90 in the year-ago period.

For 2019, the company forecasts currency-neutral revenue growth of 4-5 percent and non-GAAP operating margin of 12.5-13 percent.

The stock rallied 7.05 percent to $2.90 in after-hours trading.

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