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The Week Ahead In Biotech: Conferences, Clinical Trial Results And IPOs

Shanthi Rexaline

As we step into the final quarter of 2018, biotech stocks have recorded double-digit gains for the year-to-date period.

Will the run up continue? Stay tuned to the following events of the upcoming week.

Conferences

  • 10th Annual Conference on Stem Cell and Regenerative Medicine – Oct. 8-9, in Zurich, Switzerland
  • 9th International Summit on Clinical Microbiology – Oct. 8-9, in Zurich
  • 3rd International Conference and Expo on Optometry & Vision Science – Oct. 8-9, in Edinburgh, Scotland
  • 2nd International Conference on Craniofacial Surgery – Oct. 8-9, in London
  • 3rd European Otolaryngology-ENT Surgery Conference – Oct. 8-10, in London
  • 3rd World Kidney Congress – Oct. 08-10, in Dubai, UAE
  • 5th International Conference on Gynecology and Obstetrics – Oct. 8-10, in Hilton Zurich Airport Zurich
  • The European Committee for Treatment and Research In Multiple Sclerosis, or ECTRIMS, 2018 Congress – Oct. 10-12, in Berlin, Germany.
  • 21st European Biotechnology Congress – Oct. 11-12, in Moscow, Russia
  • 36th World Cancer Conference – Oct. 11-13, in Zurich

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

Adcom Meeting Schedule

The Oncologic Drugs Advisory Committee will meet Oct. 10 to discuss Celltrion's BLA for CT-P10, a proposed biosimilar to Roche Holdings AG Basel ADR (OTC: RHHBY) unit Genentech, Inc.'s Rituxan, for treating CD20-positive, B-cell Non–Hodgkin's Lymphoma.

The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA will discuss Oct. 11 Trevena Inc (NASDAQ: TRVN)'s NDA for oliceridine 1 milligram/milliliter injection for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will evaluate safety, efficacy as well as benefit-risk considerations. Trevena shares have been trending up in recent sessions.

The Anesthetic and Analgesic Drug Products Advisory Committee will also review AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)'s NDA for sufentanil sublingual tablets for treating moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committee will look at risk-benefit considerations and also recommend approvability of the candidate. The Adcom meeting is scheduled for Oct. 12.

AcelRx's NDA was handed down a CRL in October 2017 following which a resubmission was made, with the new PDUFA date set for Nov. 3.

Clinical Trial Results

TG Therapeutics Inc (NASDAQ: TGTX) is scheduled to present final Phase 2a data for TG-1101, its treatment candidate for relapsing form of multiple sclerosis, at the ECTRIMS Congress on Oct. 11.

Pending Releases From Q3

Acorda Therapeutics Inc (NASDAQ: ACOR) is due to release Phase 2 data for its primary sclerosing cholangitis treatment option BTT1023.

GALAPAGOS NV/S ADR (NASDAQ: GLPG) is due to release Phase 2 data for its combo treatment GLPG 2451+2222+2737 for cystic fibrosis in homozygous F508del patients.

Novo Nordisk A/S (ADR) (NYSE: NVO) will release Phase 2 data for its Concizumab that is being evaluated as a treatment option for hemophilia A.

Cytokinetics, Inc. (NASDAQ: CYTK) will release interim analysis of Phase 1b data for its CK-2127107 for limited mobility. The company will also release results of a Phase 2 study of the same candidate for treating COPD.

Related Link: FDA Approves Paratek's Bacterial Pneumonia, Skin Infection Treatment

October Releases (with no specified date)

Entera Bio Ltd (NASDAQ: ENTX) is due to release Phase 2 pharmacokinetic/pharmacodynamic data for EB612 that is being evaluated for hypoparathyroidism.

Esperion Therapeutics Inc (NASDAQ: ESPR) will release Phase 3 data for its hypercholesterolemia treatment bempedoic acid.

Soligenix, Inc. (NASDAQ: SNGX) is set to release interim analysis of Phase 3 data for SGX301, its treatment candidate for cutaneous T-cell lymphoma.

Auris Medical Holding AG (NASDAQ: EARS) is scheduled to release Phase 1 data for its AM-125, which is being studied for vertigo.

IPOs

Allogene Therapeutics, which develops CAR T cell cancer therapies, is set to offer 16 million shares in an IPO, with the shares priced between $16 and $18. The company seeks to list the shares on the Nasdaq under the ticker symbol ALLO.

Equillium, a developer of monoclonal antibody therapies for aGVHD and cGVHD, will offer 4.67 million shares, with an estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol EQ.

Osmotica Pharma, which develops extended-release neurology and women's health drugs, is due to offer 8.3 million shares, priced between $14 and $16. The shares will be listed on the Nasdaq under the ticker symbol OSMT.

IPO Quiet Period Expiry

Principia Biopharma Inc (NASDAQ: PRNB)

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