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The Week Ahead In Biotech: Spotlight On Gilead, BioMarin FDA Decisions, IPOs

Shanthi Rexaline
·3 min read

Biotech stocks came under pressure in the week ended Aug. 14 amid mixed earnings news flow from the sector. FDA decisions scheduled for the week also produced adverse outcomes. Eagle Pharmaceuticals Inc (NASDAQ: EGRX) and Fennec Pharmaceuticals Inc (NASDAQ: FENC) received complete response letters for their respective regulatory applications, while a decision on Eton Pharmaceuticals Inc's (NASDAQ: ETON) eye inflammation drug hadn't come by the Aug. 10 decision date.

The week, however, saw a signing spree by coronavirus vaccine developers, which stitched up manufacturing as well as supply deals.

Here are the key catalysts for the unfolding week.

Conferences

Virtual Keystone Symposia: Advances in Cancer Immunotherapy: Aug. 17-19

PDUFA Dates

Gilead Sciences, Inc. (NASDAQ: GILD) and licensing partner GALAPAGOS NV/S ADR (NASDAQ: GLPG) await FDA decision on the NDA for filgotinib in moderate-to-severe rheumatoid arthritis. (estimated date of Wednesday, Aug. 19, assuming priority review)

The FDA is set to rule on BioMarin Pharmaceutical Inc.'s (NASDAQ: BMRN) BLA for valoctocogene roxaparvovec, its investigational AAV5 gene therapy for treating adults with hemophilia A. (Friday)

Tricida Inc (NASDAQ: TCDA) has a Aug. 22 PDUFA date for the NDA for its TRC 101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. With FDA's communication to the company in mid-July, stating that it has identified deficiencies in the application, it is less likely the investigational drug is approved by the D-day. (Saturday)

See also: Genoskin Offers Live Skin Models To Bridge Animal, Human Testing: 'The Market Opportunity Is Huge'

View more earnings on IBB

Earnings

Monday

Milestone Scientific Inc. (NYSE: MLSS) (before the market open)
China Biologic Products Holdings Inc (NASDAQ: CBPO) (after the close)
Precipio Inc (NASDAQ: PRPO) (after the close)

Tuesday

ADC Therapeutics SA (NYSE: ADCT) (before the market open)
PAVmed Inc (NASDAQ: PAVM) (after the close)
Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the close)

IPOs

La Jolla, California-based InhibRx, a clinical-stage biotechnology company with a pipeline of novel biologic therapeutic candidates, with particular focus on oncology, has filed with the SEC to offer 6 million shares of its common stock at an estimated price range of $16-$18. The company said in the filing it has applied to list its shares on the Nasdaq under the ticker symbol INBX.

Harmony Biosciences Holdings Inc, a Plymouth, Pennsylvania-based commercial-stage pharmaceutical company focused on innovative therapies for patients living with rare neurological disorders, has filed with the SEC to offer 4.651 million shares of its common stock. The estimated price range for the offering is $20-$23. The company has applied for listing its shares on the Nasdaq under the ticker symbol HRMY.

IPO Quiet Period Expiry

Nurix Therapeutics Inc (NASDAQ: NRIX)
iTeos Therapeutics Inc (NASDAQ: ITOS)
Inozyme Pharma Inc (NASDAQ: INZY)
Annexon Inc (NASDAQ: ANNX)

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

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