Benzinga's Daily Biotech Pulse: ASCO Abstracts, Fibrocell, Ispen And More

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 ABAX ZTS
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Endocyte, Inc. ECYT
• GW Pharmaceuticals PLC- ADR 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 HAE
• ICU Medical, Incorporated ICUI
• Ligand Pharmaceuticals Inc. LGND
• Momenta Pharmaceuticals, Inc. MNTA
• Neurocrine Biosciences, Inc. NBIX(Baird reiterated its Outperform rating on the shares)
• Rocket Pharmaceuticals Inc RCKT
• SurModics, Inc. SRDX

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on May 16)

• Anthera Pharmaceuticals Inc ANTH
• aTyr Pharma Inc LIFE
• BIOLASE Inc BIOL
• CELYAD SA/ADR CYAD(announced global offering of shares)
• Cesca Therapeutics Inc KOOL (Priced its $5.5 million common-stock offering
• ENDRA Life Sciences Inc NDRA (announced FQ1 results after the close, Tuesday)
• Obalon Therapeutics Inc OBLN
• OHR Pharmaceutical Inc OHRP
• Unity Biotechnology Inc UBX

Stocks In Focus

ASCO Abstract Submissions

Loxo Oncology Inc 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. 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 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. 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 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. 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 ALBO
• Taro Pharmaceutical Industries Ltd. TARO
• Vascular Biogenics Ltd VBLT

Other Events

Novartis AG (ADR) NVS and Amgen, Inc. AMGN await FDA verdict on the BLA for their migraine treatment Aimovig (Erenumab).

Audentes Therapeutics Inc 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 RXII is set to present Phase 2 data for its dermal scarring treatment RXI-109-1501.

FDA Tidbits

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.