Benzinga's Daily Biotech Pulse: Gemphire On Fire, Acceleron-Celgene Taste Success, AbbVie Ditches Galapagos

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 28)

  • Aerpio Pharmaceuticals Inc ARPO
  • Aptinyx Inc APTX
  • Ligand Pharmaceuticals Inc. LGND(HC Wainwright increased its price target for the shares from $182 to $239 and maintained its Buy rating.)
  • OptiNose Inc OPTN

Down In The Dumps

(Stocks hitting 52-week lows on June 28)

  • Advaxis, Inc. ADXS
  • Aralez Pharmaceuticals Inc ARLZ
  • Atossa Genetics Inc ATOS
  • Aytu Bioscience Inc AYTU
  • Bio-Path Holdings Inc BPTH
  • Citius Pharmaceuticals Inc CTXR
  • Curis, Inc. CRIS
  • Cytori Therapeutics Inc CYTX
  • Enzo Biochem, Inc. ENZ
  • Five Prime Therapeutics Inc FPRX
  • Flex Pharma Inc FLKS
  • Keryx Biopharmaceuticals KERXAKBA
  • MeiraGTx Holdings PLC MGTX
  • Nabriva Therapeutics PLC – ADR NBRV
  • Neon Therapeutics, Inc. NTGN(debuted on the Nasdaq on Wednesday)
  • Novartis AG (ADR) NVS
  • Recro Pharma Inc REPH
  • Rockwell Medical Inc RMTI
  • Soligenix, Inc. SNGX(priced its common stock offering)
  • Syndax Pharmaceuticals Inc SNDX
  • TrovaGene Inc TROV

Stocks In Focus

Gemphire's Hypertriglyceridemia Drug Produces Positive Results in Mid-stage Trial

Gemphire Therapeutics Inc GEMP said its gemcabene evaluated in a Phase 2b study dubbed INDIGO-1 for treating sever hypertriglyceridemia demonstrated statistically significant lowering of triglycerides. Secondary endpoints of statistically significant reductions in serum LDL cholesterol, non-HDL cholesterol, VLDL cholesterol, apoB, apoE, apoCIII, and SAA were also met.

The pipeline candidate also showed safety and tolerability, in combination with statins.

The company said INDIGO-1 results support its rationale for testing gemcabene as a treatment option for non-alcoholic fatty liver disease, or NAFLD, or non-alcoholic steatohepatitis, or NASH.

The stock skyrocketed 124.24 percent to $11.75 in after-hours trading.

Acceleron, Celgene Report Positive Results For Immature Blood Cells Drug

Acceleron Pharma Inc XLRN and Celgene Corporation CELG announced their luspatercept, which is evaluated in a Phase 3 study dubbed MEDALIST to treat patients with low-to intermediate risk myelodysplastic syndromes met the primary and key secondary endpoints.

The companies plan regulatory submission in the U.S. and Europe in the first-half of 2019.

Acceleron shares jumped 26.55 percent to $43 in after-hours trading, while Celgene added 1.6 percent to $77.89.

Vertex Gets Health Canada Approval For Cystic Fibrosis Drug

Vertex Pharmaceuticals Incorporated VRTX said Health Canada approved its Symdeko – a tezacaftor-ivacaftor combo – to treat underlying causes of cystic fibrosis in people aged 12 years and older, with certain mutations in the CFTR gene. Symdeko has been approved by the FDA in February.

The stock gained 7.06 percent to $158.01 in after-hours trading.

GALAPAGOS' CF Drug Found Safe and Effective; AbbVie Pulls Out From Triple Combo Study

GALAPAGOS NV/S ADR GLPG announced top line results of its first Phase 2 study dubbed PELICAN, which evaluated its investigational C2 corrector GLPG2737 for treating adult patients with cystic fibrosis, who are homozygous for the Class II F508del mutation.

The results showed that GLPG2737 was well tolerated, while the mean change from baseline in sweat chloride concentration compared to the placebo at day 28, the primary endpoint, was a significant decrease of 19.6 mmol/L.

However, the company said AbbVie Inc ABBV has opted out of the study dubbed FALCON, evaluating a second triple combo, with potentiator GLPG3067, C1 corrector GLPG2222, and C2 corrector GLPG2737.

"Galapagos is reviewing the future of its CF collaboration with AbbVie," the company said.

The stock fell 12.80 percent to $83.55 in after-hours trading.

Novartis to Present Positive Data On Migraine Drug At AHS

Novartis announced results of two open-label extension studies of its Aimovig to treat chronic and episodic migraine, which established the safety and efficacy of the pipeline candidate.

The data is to be presented 60th Annual Scientific Meeting of the American Headache Society in San Francisco

"Compared to a baseline of 18.1 average monthly migraine days, patients taking Aimovig 140mg and 70mg, respectively achieved a substantial reduction of average monthly migraine days to 10.5 and 8.5 days," the company said.

The candidate is being jointly commercialized by Novartis and Amgen, Inc. AMGN and was approved by the FDA in mid-May.

Precision Therapeutics to Acquire Helomics

Precision Therapeutics Inc AIPT announced a deal with Helomics Holding by buy the 75 percent it doesn't already own in Helomics. Precision Therapeutics said the deal will give it full access to Helomics' suite of Artificial Intelligence, or AI, precision diagnostic and integrated CRO capabilities.

The deal stipulates all Helomics shares Precision doesn't already own will be converted into the right to receive a proportionate share of 7.5 million shares of newly issued Precision stock.

The stock moved up 7.65 percent to $1.26 in after-hours trading.

On The Radar

Alder Biopharmaceuticals Inc ALDR is due to release Phase 3 results of its ALD403 that is being evaluated in a study dubbed PROMISE 2 for frequent episodic migraine. Updated 6-month data will be presented at the American Headache Society meeting.

Dermira Inc DERM awaits FDA ruling on its primary axillary hyperhidrosis treatment candidate glycopyrronium tosylate. The PDUFA action date is Saturday.

The FDA is set to decide on Alkermes Plc ALKS's schizophrenia drug candidate aripiprazole lauroxil nanocrystal dispersion by Saturday.

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