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

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 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 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 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 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 ACOR is due to release Phase 2 data for its primary sclerosing cholangitis treatment option BTT1023.

GALAPAGOS NV/S ADR 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) NVO will release Phase 2 data for its Concizumab that is being evaluated as a treatment option for hemophilia A.

Cytokinetics, Inc. 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 ENTX is due to release Phase 2 pharmacokinetic/pharmacodynamic data for EB612 that is being evaluated for hypoparathyroidism.

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

Soligenix, Inc. 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 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 PRNB