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The Daily Biotech Pulse: Positive Readouts From Adamas And Ironwood, Sesen Bio To Offer Shares, Stoke Therapeutics Debut

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The Daily Biotech Pulse: Positive Readouts From Adamas And Ironwood, Sesen Bio To Offer Shares, Stoke Therapeutics Debut

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 June 18)

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  • Abbott Laboratories (NYSE: ABT)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • Bicycle Therapeutics PLC (NASDAQ: BCYC)
  • Cardiovascular Systems Inc (NASDAQ: CSII)
  • Cortexyme Inc (NASDAQ: CRTX)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • Iovance Biotherapeutics Inc (NASDAQ: IOVA)
  • Merck & Co., Inc. (NYSE: MRK) (Keytruda received one more approval, this time for metastatic small cell lung cancer in patients who have been treated previously)
  • Novocure Ltd (NASDAQ: NVCR)
  • Repligen Corporation (NASDAQ: RGEN)
  • SAGE Therapeutics Inc (NASDAQ: SAGE)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
  • Zynex Inc. (NASDAQ: ZYXI)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech stocks hitting 52-week lows on June 18)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • BioNano Genomics Inc (NASDAQ: BNGO)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
  • Kezar Life Sciences Inc (NASDAQ: KZ)
  • Mediwound Ltd (NASDAQ: MDWD)
  • MEREO BIOPHARMA/ADR (NASDAQ: MREO)
  • Trinity Biotech plc (NASDAQ: TRIB)

Stocks In Focus

Adamas Parkinson's Drug Reduces Frequency And Duration of Daily Episodes of Dyskinesia and OFF

Adamas Pharmaceuticals Inc (NASDAQ: ADMS) announced retrospective data analysis from pooled Phase 3 study of its Gocovri extended release capsules, which showed that the drug reduced both the number and duration of troublesome dyskinesia and OFF episodes relative to placebo such that patients experienced approximately half as many transitions between troublesome dyskinesia and OFF at endpoint vs baseline.

Gocovri is approved by the FDA for treating dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

The stock rose 4.63% to $5.20 in after-hours trading.

Obseva Says Nolasiban Progressing Toward Phase 3 Trial

Following its recent end-of-the Phase 2 meeting with the FDA, Obseva SA (NASDAQ: OBSV) said the regulatory body provided clarification on a number of key development issues for its oral oxytocin receptor antagonist nolasiban. The company said it anticipates beginning its U.S. Phase 3 clinical trial in the fourth quarter of 2019 or early 2020.

Based on the meeting, ObsEva said it anticipates working with FDA regarding certain issues, including timing of randomization and number of previous IVF failures, and expects to submit the IMPLANT 3 trial protocol with an updated IND in the third quarter of 2019.

Ironwood-Allergan's Irritable Bowel Syndrome Drug Aces Late-Stage Trial

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced positive topline results from a Phase 3b study evaluating Linzess 290 mcg on multiple abdominal symptoms in adult patients with irritable bowel syndrome with constipation, or IBS-C.

"The trial met its primary multi-component endpoint and demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients compared to placebo," the companies said.

The study also met the secondary endpoints.

Ironwood shares climbed 4.26% to $11.99 in after-hours trading.

See Also: Stoke Therapeutics IPO: What You Need To Know

Offerings

Sesen Bio Inc (NASDAQ: SESN) intends to offer, subject to market conditions, shares of its common stock, and warrants to purchase common stock in an underwritten public offering. All the shares and warrants are to be sold by the company.

The company intends to use the net proceeds for regulatory submission of Vicinium for the treatment of high-risk non-muscle invasive bladder cancer, among other things.

The stock declined 20.11% to $1.47 in after-hours trading.

Genocea Biosciences Inc (NASDAQ: GNCA) commenced an underwritten public offering of 10 million shares of its common stock. All the shares are to be sold by the company.

The stock moved down 4.88% to $4.87 in after-hours trading.

Kura Oncology Inc (NASDAQ: KURA) priced its underwritten public offering of 5.9 million shares at $17 per share. The offering is expected to close June 21.

The stock fell 7.03% to $17.45 in after-hours trading.

Calithera Biosciences Inc (NASDAQ: CALA) priced its previously-announced underwritten public offering of 12.50 million shares at $4 per share to generate gross proceeds of $50 million. The offering is expected to close June 21.

The stock receded 5.27% to $4.49 in after-hours trading.

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) commenced an underwritten public offering of $300 million of its common shares, with all the shares to be sold by the company.

On The Radar

Clinical Trial Readouts

Affimed NV (NASDAQ: AFMD) will present updated Phase 1b/2a data for AFM13 in CD30-postive lymphoma at the International Conference On Malignant Lymphoma.

Beigene Ltd . (NASDAQ: BGNE) will present Phase 1b data for Zanubrutinib and Obinutuzumab in relapsed/refractory follicular lymphoma at the International Conference On Malignant Lymphoma.

IPO

Stoke Therapeutics, which develops RNA-targeted therapies for rare genetic disorders, priced its upsized initial public offering of 7.89 million shares at $18, above the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol STOK.

Posted-In: Biotech News Offerings FDA IPOs Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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