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Benzinga's Daily Biotech Pulse: EDAP Device Gets FDA Nod, Ampliphi Presents Positive Data, Agile To Cut Jobs

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Stocks hitting 52-week highs on June 7)

  • Baxter International Inc (NYSE: BAX)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
  • Boston Scientific Corporation (NYSE: BSX)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • Genomic Health, Inc. (NASDAQ: GHDX)
  • Globus Medical Inc (NYSE: GMED)
  • Krystal Biotech Inc (NASDAQ: KRYS)
  • Laboratory Corp. of America Holdings (NYSE: LH)
  • ResMed Inc. (NYSE: RMD)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)

Down In The Dumps

(Stocks hitting 52-week lows on June 7)

  • Achieve Life Sciences Inc (NASDAQ: ACHV)
  • Evelo Biosciences Inc (NASDAQ: EVLO)
  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT)
  • Reshape Lifesciences Inc (NASDAQ: RSLS)
  • Scpharmaceuticals Inc (NASDAQ: SCPH)
  • TrovaGene (NASDAQ: TROV)

Stocks In Focus FDA Approves EDAP's Device For Ablation of Prostate Tissue

Edap Tms SA (ADR) (NASDAQ: EDAP) said the FDA has given 510(k) clearance for its Focal One device for the ablation of prostate tissue.

The stock jumped 39.37 percent to $3.08 after hours.

Trovagene Prices Common Stock Offering

Trovagene said it has priced its 18 million common stock offering at $1 per share and accompanying common stock warrant. The company expects to close the offering on June 12.

Valeant Loses Patent Suit On Antifiungal Drug

Argentum Pharma announced that the U.S. patent office has ruled that Valeant Pharmaceuticals Intl Inc (NYSE: VRX)'s patent for its antifungal drug Jiublia is unpatentable for obviousness.

Roche's Rituxan Wins FDA Approval For Pemphigus Vulgaris

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Genentech unit announced that the FDA has approved its Rituxan for treating moderate-to-severe pemphigus vulgaris – a condition characterized by progressive painful blistering of the skin and mucous membranes. With this, Rituxan has now been approved for treating four autoimmune disease.

Related Link: Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

Biopharmx Loss Narrows

Biopharmx Corp (NYSE: BPMX) reported a narrower loss of 2 cents per share for its Q1 compared to a loss of 8 cents per share last year. As of April 30, the company had cash and cash equivalents of $10.9 million.

Ampliphi's Bacteriophage Therapy Found Safe, Well Tolerated

Ampliphi Biosciences Corp (NYSE: APHB) released abstract of a late-breaker poster presentation on intravenously administered AB-SA01, its investigational bacteriophage drug candidate, it is to make at the American Society for Microbiology Microbe 2018 annual meeting at 11-1 p.m. ET on June 8.

View more earnings on IBB

The abstract showed that AB-SA01 was well tolerated in patients, with no treatment-related adverse outcomes, while bacterial elimination was demonstrated in three out of four patients.

Agile to Cut Workforce By 30 Percent

Agile Therapeutics Inc (NASDAQ: AGRX), a women's healthcare company, announced corporate updates, including submission of formal dispute resolution request with the FDA regarding Twirla, its lead product candidate.

The company also said it will eliminate workforce by 30 percent and also cut down expenses, allowing existing cash to fund operations in Q2.

Ironwood Gets Orphan Drug Status For Sickle Cell Disease Drug

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that the FDA has granted orphan drug designation to olinciguate – codenamed IW-1701 – for treating patients with sickle cell disease.

The status is given to treat rare disorders affecting fewer than 200,000 people in the U.S., and bestows privileges including seven-year market exclusivity upon FDA approval, PDUF waivers and tax credits for qualified clinical trials.

Exact Sciences Announces Note Offering

EXACT Sciences Corporation (NASDAQ: EXAS) announced that it would offer $150 million in aggregate principal amount of 1 percent convertible senior notes due 2025 in a registered public offering.

On The Radar

Cidara Therapeutics Inc (NASDAQ: CDTX) is scheduled to present Phase 2 data (already released in March) for Rezafungin, code named CD101 IV, for treating Candidema at the American Society of Microbiology 2018 meeting.

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