The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Readouts And IPOs

Biotech stocks came made upward moves last week after a rangebound period. 

Among big pharma companies, Merck & Co., Inc. MRK was a standout gainer, notching up 52-week highs in successive sessions, partly due to the ongoing momentum of its cancer immunotherapy Keytruda.

Stocks also reacted to several independent clinical trial readouts as well as conference presentations. Melinta Therapeutics Inc MLNT was a strong performer, trebling on the news of the FDA accepting its sNDA for Baxdela to treat community-acquired pneumonia.

The following are key catalysts in the unfolding week.

Conferences

• BMO Capital 2019 Prescriptions for Success Healthcare Conference: June 25 in New York City.
• Parent Project Muscular Dystrophy 2019 Annual Conference: June 26-30 in Orlando, Florida.
• Cure SMA Annual Conference: June 28-July 1 in Anaheim, California. 

PDUFA Dates

The FDA is set to rule Sunday, June 23 on AMAG Pharmaceuticals, Inc. AMAG's NDA for Vyleesi, a novel melanocortin 4 receptor agonist under evaluation for restoring a natural sexual desire in premenopausal women with hypoactive sexual desire disorder.

Amag acquired the license to the investigational compound from Palatin Technologies, Inc. PTN.

Acer Therapeutics Inc ACER awaits the FDA verdict on its NDA for Edsivo, which is being evaluated for the treatment of vascular Ehlers-Danlos syndrome in patients with a confirmed type III collagen (COL3A1) mutation. The PDUFA date is set for Tuesday, June 25.

The FDA will announce on Wednesday, June 26, its decision Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN's sNDA for Dupixent to be used as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.

The FDA will also rule on Alexion Pharmaceuticals, Inc. ALXN's BLA for Soliris to be used in patients with neuromyelitis optica spectrum disorder. The decision is due Friday, June 28.

Pfizer Inc. PFE's PF-06439535, a biosimilar to Roche Holdings AG Basel ADR RHHBY's Avastin, is pending before the FDA for approval.

Clinical Trial Readouts

Navidea Biopharmaceuticals Inc NAVB is scheduled to present Phase 1/2 data for its NAV3-31 in rheumatoid arthritis.

Ascendis Pharma A/S ASND will release Phase 3 fliGHt data for its TransCon hGH, which is being evaluated for growth hormone deficiency in children.

Pfizer will present Phase 1b data for its PF-06939926 in Duchenne muscular dystrophy at the Parent Project Muscular Dystrophy 2019 annual conference on Friday.

Scholar Rock Holding Corp SRRK is due to release final Phase 1 data for its spinal muscular atrophy drug candidate SRK-015 at the Cure SMA Annual Conference on Friday.

IPOs

Adaptive Biotechnologies, which translates the scale and precision of people's adaptive immune systems into products to help diagnose, treat and monitor disease, is set to offer 4.9 million shares in an IPO to be priced between $19 and $22. The company seeks to list its shares on the NYSE under the ticker symbol "ADPT."

BridgeBio Pharma plans to offer 15 million shares in an IPO, with an estimated price range of $14-$16. The biotech, which focuses on therapies for genetic diseases and cancers, seeks to list its shares on the Nasdaq under the ticker symbol "BBIO."

G Medical Innovations Holding, a medical device company, has filed for a 1.43-million share IPO to be priced at $10.50. The shares are to be listed on the Nasdaq under the ticker symbol "GMVD."

Karuna Therapeutics, which develops therapies for schizophrenia and other central nervous system disorders, proposes to offer 4.375 million shares in an IPO, with an estimated price range of $15-$17. The company has applied to list its shares on the Nasdaq under the ticker symbol "KRTX."

Morphic Holding has filed to offer 5 million shares in an IPO to be priced between $14 and $16. The biotech, which develops small-molecule integrin inhibitors for chronic diseases, seeks to list its shares on the Nasdaq under the ticker symbol "MORF."