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 May 16)
- Abaxis Inc (NASDAQ: ABAX) (announced a deal to be bought by Zoetis Inc (NYSE: ZTS)
- Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
- Endocyte, Inc. (NASDAQ: ECYT)
- GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (announced publication of the results of a Phase 3 trial of its epidiolex for treating Lennox-Gastaut syndrome in the New England Journal of Medicine
- Haemonetics Corporation (NYSE: HAE)
- ICU Medical, Incorporated (NASDAQ: ICUI)
- Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
- Neurocrine Biosciences, Inc. (NASDAQ: NBIX)(Baird reiterated its Outperform rating on the shares)
- Rocket Pharmaceuticals Inc (NASDAQ: RCKT)
- SurModics, Inc. (NASDAQ: SRDX)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on May 16)
- Anthera Pharmaceuticals Inc (NASDAQ: ANTH)
- aTyr Pharma Inc (NASDAQ: LIFE)
- BIOLASE Inc (NASDAQ: BIOL)
- CELYAD SA/ADR (NASDAQ: CYAD)(announced global offering of shares)
- Cesca Therapeutics Inc (NASDAQ: KOOL) (Priced its $5.5 million common-stock offering
- ENDRA Life Sciences Inc (NASDAQ: NDRA) (announced FQ1 results after the close, Tuesday)
- Obalon Therapeutics Inc (NASDAQ: OBLN)
- OHR Pharmaceutical Inc (NASDAQ: OHRP)
- Unity Biotechnology Inc (NASDAQ: UBX)
Stocks In Focus
ASCO Abstract Submissions
Loxo Oncology Inc (NASDAQ: LOXO): The company published an abstract containing interim data from the Phase 1 trial for LOXO-292, its highly-selective RET inhibitor, for treating RET-altered cancers. The company also said the efficacy improved between the abstract cut-off date of Jan. 2018 and ASCO meeting cut-off date of April.
The stock soared 18.21 percent to $164.90 after hours.
Immunomedics, Inc. (NASDAQ: IMMU): The company announced that its lead investigational antibody-drug conjugate sacituzumab govitecan produced promising objective responses as a single agent in heavily pre-treated patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.
The stock rose 4.82 percent to $20.45 after hours.
Jounce Therapeutics Inc (NASDAQ: JNCE): Abstract of the Phase 1/2 ICONIC trial that evaluated JTX-2011 monotherapy as well as in combination with nivolumab showed that the company has met its target enrolment in its combination cohorts across four solid tumor types, namely gastric cancer, triple-negative breast cancer, head and neck squamous cell cancer and non-small cell lung cancer.
Preliminary data from the trial showed that the drug candidate was well-tolerated alone, as well as in combination with nivolumab, showing evidence of biologic activity and tumor reductions in heavily pre-treated patients, who have failed all available therapies.
The stock plummeted 25.58 percent to $13.15 after hours.
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP): The company announced clinical data showing that its controlled IL-12 platform elicited a sustained increase in killer T cells, with a good safety profile in patients with breast cancer and patients with brain cancer. The data was from two open-label trials that evaluated Ad-RTS-hlL-12 plus veledimex, a gene therapy.
The stock rose 2.66 percent to $4.63 after hours.
See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates
Fibrocell Announces Presentation at Dermatology Conference
Fibrocell Science Inc (NASDAQ: FCSC) said it will make an oral presentation of interim data from adult patients in the Phase 1 portion of the Phase 1/2 clinical trial of FCX-007 for treating recessive dystrophic epidermolysis bullosa at the7th International Investigative Dermatology meeting on May 19.
The stock rallied 8.62 percent to $0.65 after hours.
Exelixis' Partner Gets European Commission Approval for Renal Cancer Candidate
Exelixis, Inc. (NASDAQ: EXEL) said its partner Ispen secured the European Commission approval for its cabometyx as a first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma. Exelixis stands to get $50 million as milestone payment for the approval.
On The Radar
The following companies report earnings on Thursday:
- Albireo Pharma Inc (NASDAQ: ALBO)
- Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
- Vascular Biogenics Ltd (NASDAQ: VBLT)
Novartis AG (ADR) (NYSE: NVS) and Amgen, Inc. (NASDAQ: AMGN) await FDA verdict on the BLA for their migraine treatment Aimovig (Erenumab).
Audentes Therapeutics Inc (NASDAQ: BOLD) will present preliminary Phase 1/2 data on AT342 to treat Crigler-Najjar syndrome at the American Society of Gene & Cell Therapy. The syndrome is an inherited disorder that impairs bilirubin metabolism, leading to accumulation of it in blood. Bilirubin is formed when red blood cells are broken down.
RXi Pharmaceuticals Corp (NASDAQ: RXII) is set to present Phase 2 data for its dermal scarring treatment RXI-109-1501.
Following a priority review the FDA approved US WorldMeds' lucemyra for reducing opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. The company said the candidate will be made available in the U.S. by August.
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