Market Overview

The Week Ahead In Biotech: Pfenex And Clinuvel On The Radar Ahead of FDA Decisions, 2 IPOs On Deck

Share:
The Week Ahead In Biotech: Pfenex And Clinuvel On The Radar Ahead of FDA Decisions, 2 IPOs On Deck

Notwithstanding the ESMO conference generating some huge moves in some stocks, last week turned out to be a muted one for biotechs.

A few FDA approvals came through, with Puma Biotechnology Inc (NASDAQ: PBYI) getting a label expansion for its breast cancer drug Nerlynx and Novartis AG (NYSE: NVS)'s Entresto, a combo therapy, given the go ahead for pediatric heart failure.

Invest in IPO shares before the stock hits the market with ClickIPO. Check it out here

Here are the key biotech catalysts for the unfolding week.

Conferences

  • European Huntington Association Conference: Oct. 4–6 in Bucharest, Romania
  • Experts Gather on Cardiovascular Disorders and Cardiology Research: Oct. 7-8 in Paris, France
  • 5th Annual Congress on Infectious Diseases: Oct. 7-8 in Frankfurt, Germany
  • 9th International Conference on Neurological Disorders & Stroke: Oct. 7-8 in Dublin, Ireland
  • Chardan 3rd Annual Genetic Medicines Conference: Oct. 7-8 in New York City
  • Jefferies Gene Therapy/Editing Summit: Oct. 8 in New York City
  • 37th World Cancer Conference: Oct. 9-10 in Dublin
  • 28th European Academy of Dermatology and Venereology, or EADV, Congress: Oct. 9-13, in Madrid, Spain
  • Ophthalmology Innovation Summit: Oct. 10 in San Francisco, California
  • American Academy of Ophthalmology, or AAO: Oct. 12-15, in San Francisco

Related Link: Sell-Side Positive On Johnson & Johnson's Unexpected Ohio Opioid Settlement

PDUFA Dates

The FDA is scheduled to rule on Pfenex Inc (NYSE: PFNX)'s PF708, a therapeutic equivalent of Eli Lilly And Co (NYSE: LLY)'s Forteo, which was approved in 2002 to treat osteoporosis in men and menopausal women, who are at high risk of having a fracture. The PDUFA date is set for Monday.

The regulatory body will issue its verdict Tuesday on Clinuvel Pharmaceuticals Ltd (OTC: CLVLY)'s NDA for Scenesse, which is being evaluated as a preventative treatment for phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria.

Clinical Trial Readouts

28th EADV Congress Presentations

Akari Therapeutics PLC (NASDAQ: AKTX) – Additional Phase 2 data for Coversin in bullous pemphigoid (Thursday)

Concert Pharmaceuticals Inc (NASDAQ: CNCE) – Phase 2 data for CTP-543 in alopecia areata (Saturday)

AAO 2019 Presentations

Adverum Biotechnologies Inc (NASDAQ: ADVM) – Additional Phase 1 data for ADVM-022 in wet age-related macular degeneration Friday)

Regenxbio Inc (NASDAQ: RGNX) – Phase 1/2a data for RGX-314 in wet age-related macular degeneration (Friday)

IPOs

BioNTech, a German biotech developing individualized monotherapies for cancer, is planning a 13.2-million share IPO, which is estimated to be priced between $18 and $20. The company proposes to list shares on the Nasdaq under the ticker symbol "BNTX."

Vir Biotechnology, a biotech developing immunologic therapies for infectious diseases, is seeking to list shares on the Nasdaq through an IPO of 7.14 million shares in the price range of $20 to $22 per share. Shares will be listed under the ticker symbol "VIR."

IPO Quiet Period Expiry

Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
SpringWorks Therapeutics Inc (NASDAQ: SWTX)
10X Genomics Inc (NASDAQ: TXG)

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

 

Related Articles (AKTX + ADVM)

View Comments and Join the Discussion!

How And Why Are Online Brokers Offering Commission-Free Trades?

Emergency Funds: How Much To Save And The Best Place To Save It