The Daily Biotech Pulse: Zafgen Won't File IND For Metabolic Disorder Drug, Positive Results For Akebia's Anemia Drug

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 March 11)

  • Biohaven Pharmaceutical Holding Co Ltd BHVN
  • Cardiovascular Systems Inc CSII
  • Elanco Animal Health Inc ELAN LLY
  • Chiasma Inc CHMA
  • Fulgent Genetics Inc FLGT
  • Ionis Pharmaceuticals Inc IONS
  • Osiris Therapeutics, Inc. OSIR
  • Uniqure NV QURE

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 11)

  • Achaogen Inc AKAO
  • Amneal Pharmaceuticals Inc AMRX
  • Gritstone Oncology Inc GRTS
  • Harpoon Therapeutics Inc HARP
  • Iterum Therapeutics PLC ITRM
  • Soligenix, Inc. SNGX

Stock In Focus

Zafgen Ditches Plan for Filing IND For Rare Metabolic Disorder Drug

Zafgen Inc ZFGN said it has planned to suspend to file an investigational new drug application, or IND, for its ZGN-1258, which it's evaluating for rare metabolic disorders including Prader-Willi syndrome. The decision was based on an unexpected recent finding showing degeneration and other anomalies in rat muscle tissue to different degrees in both vehicle and dose arms of the studies.

The company also reported a narrower loss of 39 cents per share for the fourth quarter compared to a loss of 48 cents per share in the year-ago period. Analysts had expected a loss of 44 cents per share.

The stock slumped 24.13 percent to $3.49 in after-hours.

Akebia Reports Positive Results For Anemia Drug In Japanese Kidney Disease Patients

Akebia Therapeutics Inc AKBA reported positive results for the two Phase 3 studies evaluating its vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor in Japanese subjects with anemia due to chronic kidney disease, or CKD. The company said the study was conducted on behalf of its Japanese partner Mitsubishi Tanabe Pharma Corporation, or MTPC.

The company said MTPC will submit a Japanese NDA in 2019.

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

Earnings

Oxford Immunotec Global PLC OXFD reported fourth-quarter revenues of $15.4 million, up 22 percent year-over-year. Net income per share climbed from 33 cents to $5.23. For 2019, the company expects revenues of $69 million to $72 million compared to the consensus estimate of $69.85 million.

The stock rallied 13.53 percent to $18.80 in after-hours trading.

Kala Pharmaceuticals Inc KALA reported a wider loss of 76 cents per share compared to a loss of 46 cents per share last year. Analysts estimated a narrower loss of 52 cents per share.

Updating on its clinical program, the company said the PDUFA action date for its KPI-121 0.25 percent for the temporary relief of signs and symptoms of dry eye disease is Aug. 15, and that it expects top-line data from the STRIDE 3 trial evaluating KPI-121 0.25 percent in the fourth quarter.

The stock plunged 10.56 percent to $7.71 in after-hours trading.

Pfenex Inc PFNX reported an 81 percent drop in its fourth-quarter revenues to $3.4 million, as the year-ago quarter benefited from significant development achievements and milestones related to the Jazz Pharmaceuticals PLC JAZZ collaboration. The company reversed to a loss of 22 cents per share compared to a profit of 23 cents per share.

The stock dropped 8.90 percent to $4.30 in after-hours trading.

ENDRA Life Sciences Inc NDRA said its full-year 2018 revenues declined from $351,622 to $6,174. The net loss widened to $2.16 from $1.95.

The stock jumped 17.89 percent to $2.24 in after-hours trading.

On The Radar

Earnings

  • Brainstorm Cell Therapeutics Inc BCLI (before the market open)
  • Corbus Pharmaceuticals Holdings Inc CRBP (before the market open)
  • Synlogic Inc SYBX (before the market open)
  • Pieris Pharmaceuticals Inc PIRS (before the market open)
  • Aratana Therapeutics Inc PETX (after the market close)
  • Clearside Biomedical Inc CLSD (after the market close)
  • Verastem Inc VSTM (after the market close)
  • Inovio Pharmaceuticals Inc INO (after the market close)
  • Protagonist Therapeutics Inc PTGX (after the market close)
  • Amphastar Pharmaceuticals Inc AMPH
  • Cara Therapeutics Inc CARA
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