The Week Ahead In Biotech: Conference Presentations, IPOs In The Mix

Biotech stocks found themselves among gains in the week ended Sept. 18, with conference presentations, IPO news flow and updates on coronavirus vaccine/antibody candidates catalyzing some strong moves.

A big-ticket M&A was announced at the start of the week. Gilead Sciences Inc. (NASDAQ: GILD agreed to buy Immunomedics Inc. (NASDAQ: IMMU), which has a commercial antibody drug conjugate in the market.

Three biopharma companies and a dialysis equipment maker debuted on Wall Street, with the former group raising combined gross proceeds of $522 million.

Here're the catalytic events for the unfolding week:

Conferences

  • 56th annual meeting of the European Association for the Study of Diabetes, or EASD: Sept. 21-25
  • 2020 American Academy of Neurology Science Highlights: Sept. 23-24
  • 14th annual Sickle Cell Disease Research and Educational Symposium and 43rd National Sickle Cell Disease Scientific Meeting (virtual event): Sept. 23-25

PDUFA Dates

The FDA could announce its decision on Bausch Health Companies Inc's BHC NDA for EM-100, which it had licensed from Eton Pharmaceuticals Inc ETON, for the treatment of allergic conjunctivitis. The regulatory agency had not ruled by the GDUFA date of Sept. 15. Eton announced in a Sept. 16 news release its partner Bausch has not received any communication by the decision date.

See Also: 7 Reasons Why A Coronavirus Vaccine May Not Work The Way You Hope

Clinical Readouts:

Pieris Pharmaceuticals Inc. PIRS is scheduled to present at the ESMO Congress, phase 1 dose-escalation data for PRS-343 monotherapy and combination with Roche Holdings AG's Basel ADR Common Stock RHHBY Tecentriq for treating HER2-positive tumors.

vTv Therapeutics Inc. VTVT will present at the EASD annual meeting additional positive clinical study results from the Phase 2 Simplici-T1 as adjunctive therapy for patients with Type 1 diabetes.

GlycoMimetics Inc. GLYC will present a poster on data from a post hoc analysis of the Phase 3 RESET trial that evaluated rivipansel as a treatment option for acute vaso-occlusion in sick cell disease patients requiring hospitalization for treatment.

Earnings

  • Centogene NV NASDAQ: CNTG (Tuesday before the market open)
  • Aytu Bioscience Inc NASDAQ: AYTU (Thursday, after the close)

IPOs

Woodcliff Lake, New Jersey-based Paxmedica Inc. has filed with the SEC for a 2.5-million share initial public offering, or IPO. It is a clinical stage biopharma, focusing on the development of anti-purinergic therapies for the treatment of neurodevelopmental disorders, including autism spectrum disorder, and Fragile X tremor-ataxia syndrome. The company expects the offering to be priced between $5.50 and $6.50. The company has applied for listing its shares on the Nasdaq under the ticker symbol PXMD.

Dallas-based Taysha Gene Therapies Inc. is planning to offer 6.579 million shares of its common stock at an estimated price range of $18-$20. The company, which is engaged in the development of AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system, has applied to list its shares on the Nasdaq under the ticker symbol TSHA.

IPO Quiet Period Expiry

  • Sun Biopharma Inc SNBP
  • PainReform Ltd PRFX
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