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The Daily Biotech Pulse: Regulatory Roadblock For Akcea-Ionis, Affimed's Alliance, FDA Nod For Tetraphase's Antibiotic

The Daily Biotech Pulse: Regulatory Roadblock For Akcea-Ionis, Affimed's Alliance, FDA Nod For Tetraphase's Antibiotic

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 Aug. 27)

  • Abbott Laboratories (NYSE: ABT)
  • Ascendis Pharma A/S (NASDAQ: ASND)
  • AtriCure Inc. (NASDAQ: ATRC)
  • Avanos Medical Inc (NYSE: AVNS)
  • Becton Dickinson and Co (NYSE: BDX)
  • Codexis, Inc. (NASDAQ: CDXS)
  • Eli Lilly And Co (NYSE: LLY)
  • Emergent Biosolutions Inc (NYSE: EBS)
  • Endocyte, Inc. (NASDAQ: ECYT)
  • Illumina, Inc. (NASDAQ: ILMN)
  • Inogen Inc (NASDAQ: INGN)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
  • ResMed Inc. (NYSE: RMD)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)
  • Verastem Inc (NASDAQ: VSTM)

Down In The Dumps

(Biotech Stocks hitting 52-week lows on Aug. 27)

Eidos Therapeutics Inc (NASDAQ: EIDX)(reacted to data released by Pfizer Inc. (NYSE: PFE) for its tafamidis)
Genprex Inc (NASDAQ: GNPX)
Pernix Therapeutics Holdings Inc (NASDAQ: PTX)(reacted to court ruling on a patent litigation)

Stocks In Focus

Akcea, Ionis Receive CRL For Drug to Treat Inability of Body to Digest Fats

Akcea Therapeutics Inc (NASDAQ: AKCA) and Ionis Pharmaceuticals Inc (NASDAQ: IONS) announced the FDA handed down a Complete Response Letter (CRL) for their Waylivra, chemically volanesorsen, which is being evaluated to treat familial chylomicronemia syndrome. FCS manifests itself as elevated triglycerides, and causes unpredictable and potentially fatal acute pancreatitis, chronic complications due to permanent organ damage.

Akcea and Ionis, which rallied in regular session Monday, slumped after hours, when Akcea plunged 24.49 percent to $25.01 and Ionis plummeted 12.44 percent to $44.02.

Osiris' Diabetic Foot Ulcer Treatment Meets Study Endpoints

Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced publication of a peer-reviewed manuscript that compared the efficacy of viable cryopreserved placental membrane, named Grafix, to Organogenesis' Dermagraft, a human fibroblast-derived dermal substitute in treating chronic diabetic foot ulcers.

The study, which was intended to compare clinical outcomes and product cost between the two, met its primary endpoint of Grafix not being inferior to Dermagraft.

The stock rallied 21.55 percent to $11 in after-hours trading.

Tetraphase Receives FDA Nod for Intra-Abdominal Infection Treatment

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) announced FDA approval for Eravacycline, a fully-synthetic fluorocycline, being developed for complicated intra-abdominal infections. The company said it expects to commercially launch the product in the fourth quarter of 2018.

The stock rallied 6.95 percent to $3.65 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Results

Affimed Strikes Cancer Therapy Partnership With Roche Unit

Affimed NV (NASDAQ: AFMD) said it has entered into a strategic collaboration agreement with Roche Holdings AG Basel ADR(OTC: RHHBY)'s Genentech to develop and commercialize novel NK cell engager-based immunotherapeutics to treat multiple cancers.

The agreement provides for Genentech paying Affimed $96 million in an initial upfront payment and other near-term committed funding. The latter is also eligible to receive up to an additional $5 billion in regulatory and commercial milestone payments as well as royalties on sales, over time.

Affimed skyrocketed 140.62 percent to $3.85 in after-hours trading.

Illumina Receives Chinese Regulatory Approval For Its In-vitro Diagnostic System

Illumina announced the China National Drug Administration approved its MiSeq Dx Sequencing System, which allows it to market the system to hospitals and medical institutions for in-vitro diagnostic testing throughout China.

Wright Medical Prices Equity Offering At a Discount

Wright Medical Group NV (NASDAQ: WMGI) announced it has priced its previously announced public offering of 18.25 million shares at $24.60 per share, a discount to Monday's closing price of $26.79.

The stock fell 5.15 percent to $25.40 in after-hours trading.

Ultragenyx' Lysosomal Storage Disorder Drug Now Approved in Europe

Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) said the European Commission has approved the Marketing Authorization Approval for its Mepsevii for treating non-neurological manifestations of Mucopolysaccharidosis VII. Mepsevii has already been approved by the FDA.

Editas Chief Medical Officer to Leave

Editas Medicine Inc (NASDAQ: EDIT) announced the departure of its Chief Medical Officer Gerald Cox at the end of the year.  The stock fell 2.47 percent to $30 in after-hours trading.

FDA Greenlights Shire's Edema Drug

Shire PLC (ADR) (NASDAQ: SHPG) announced FDA approval for its Takhzyro injection for prophylaxis to prevent attacks of hereditary angioedema, or HAE, in patients 12 years of age and older.

"HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body," Shire said.


Related Articles (TTPH + AKCA)

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