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The Daily Biotech Pulse: Syndax Lung Cancer Trial Disappoints, Gemphire To Trim Workforce, Opiant's Offering

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The Daily Biotech Pulse: Syndax Lung Cancer Trial Disappoints, Gemphire To Trim Workforce, Opiant's Offering
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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 Sept. 25)

  • Abbott Laboratories (NYSE: ABT)
  • Aldeyra Therapeutics Inc (NASDAQ: ALDX)
  • Amarin Corporation plc (NASDAQ: AMRN)(announced positive topline results for Vascepa capsules, a single-molecule prescription product consisting of omega-3 acid, in a study dubbed REDUCE-IT, that evaluated it in statin-treated patients with elevated cardiovascular risk)
  • Amgen, Inc. (NASDAQ: AMGN)
  • Boston Scientific Corporation (NYSE: BSX)(received FDA approval for its pre-market application to market Eluvia Drug-eluting Vascular Stent System for treating peripheral artery disease)
  • Chiasma Inc (NASDAQ: CHMA)
  • Edwards Lifesciences Corp (NYSE: EW)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Genomic Health, Inc. (NASDAQ: GHDX)
  • Medtronic PLC (NYSE: MDT)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Pfizer Inc. (NYSE: PFE)
  • OASMIA PHARMACE/ADR (NASDAQ: OASM)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 25)

  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
  • Arsanis Inc (NASDAQ: ASNS)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Eyenovia Inc (NASDAQ: EYEN)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • REALM THERAPEUTICS ADR (NASDAQ: RLM)
  • Vaccinex Inc (NASDAQ: VCNX)

Related Link: The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Stocks In Focus

Syndax Lung Cancer Drug's Objective Response Rate Fails to Meet Endpoint In a Mid-stage Trial

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) released updated results from its Phase 2 study dubbed ENCORE 601 that evaluated its Entinostat in combination with Merck's Keytruda for treating non-small cell lung cancer, or NSCLC, previously treated with both chemotherapy and PD-(L)1 therapy.

At the time of data cut-off, there were seven confirmed partial responses among the overall population of 72 efficacy-evaluable patients, for a 10 percent objective response rate, a median duration of response of 5.3 months, and a median progression free survival of 2.8 months, the company said. The results didn't meet the pre-specified ORR endpoint.

The stock slumped 17.01 percent to $6 in after-hours trading.

Novan Gets FDA Guidance On its Acne Treatment Candidate

Novan Inc (NASDAQ: NOVN) said it received the FDA meeting minutes from a Type C meeting it had with the agency in Q2, which it said is critical for advancement of its SB204 in acne vulgaris for the U.S. market.

The company said the FDA has suggested in the minutes two paths forward for the acne indication, confirming the need for an additional pivotal trial for moderate-to-severe acne, or as an alternative, additional preliminary trials for a severe-only patient population.

The stock rose 2.48 percent to $2.89 in after-hours trading.

Arena Reports Positive Results For Pipeline Candidate to Treat Abdominal Pain Associated With Crohn's Disease

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced positive Phase 2a results for its Olorinab in patients with abdominal pain associated with Crohn's disease. The candidate demonstrated statistically significant improvement in abdominal pain over eight weeks of treatment. It was also found to be safe and was generally well tolerated. The company said it intends to progress the Olorinab clinical program targeting gastrointestinal pain.

The stock rose 3.59 percent to $44.39 in after-hours trading.

Gemphire to Eliminate 33 Percent Jobs

Gemphire Therapeutics Inc (NASDAQ: GEMP) said its board has approved a workforce reduction plan in a bid to reduce costs and conserve cash following FDA's request for additional pre-clinical data in order to schedule an End-of-Phase 2 meeting for gemcabene in treating dyslipidemia indications. The reduction will involve five employees or about 33 percent of its workforce, including its CFO and Chief Medical Officer.

The stock plummeted 14.85 percent to $1.95 in after-hours trading.

Amgen's Blood Cancer Drug Approved In Japan

Amgen announced the Japanese Ministry of Health, Labor and Welfare granted marketing approval for its Blincyto for the treatment of refractory B-cell acute lymphoblastic leukemia. In Japan, Blincyto is developed by a joint venture between Amgen and Astellas Pharma.

Common Stock Offering

AnaptysBio Inc (NASDAQ: ANAB) said it intends to offer $200 million worth of its common stock in an underwritten public offering. All the shares are to be offered by the company. The company said it intends to use the net proceeds to fund R&D for its clinical development programs, including the planned clinical trials of etokimab and ANB019, as well for the ongoing pre-clinical discovery and research programs, and for working capital and other general corporate purposes.

The stock fell 1.91 percent to $100 in after-hours trading.

Opiant Pharmaceuticals Inc (NASDAQ: OPNT) announced its intention to sell shares of its common stock in an underwritten public offering, with all the shares to be sold by the company.

The stock slumped 12.76 percent to $18.60 in after-hours trading.

On The Radar

Clinical Trial Results

Loxo Oncology Inc (NASDAQ: LOXO) is due to present updated Phase 1 data for its LOXO-292 for treating RET-fusion NSCLC, medullary thyroid cancer and other tumors at the International Association of Study of Lung Cancer, 19th World Conference on Lung Cancer between 3:15 and 4:45 pm ET.

Novocure Ltd (NASDAQ: NVCR) will present final Phase 2 data for its tumor treating fields for treating mesothelioma.

Posted-In: Biotech News Offerings FDA Top Stories Trading Ideas Best of Benzinga

 

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