The Daily Biotech Pulse: Regulatory Delay For Novartis' Multiple Sclerosis Drug, FSD Gets Nod For COVID-19 Study

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 2)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 2)

  • Exagen Inc (NASDAQ:XGN)

Stocks In Focus

Novartis Announces 3-Month Extension In Regulatory Review Period For Multiple Sclerosis Drug

Novartis AG (NYSE:NVS) announced the receipt of a notification from the FDA, extending the review of its sNDA for ofatumumab for patients with relapsing multiple sclerosis. The company said the regulatory action would happen in September.

The company said it will continue to work with the FDA to complete the review as soon as possible. It also said additional regulatory filings are underway and that European approval of ofatumumab is expected in the second quarter of 2021.

FSD Pharma Gets FDA Nod For Initiating Proof-of-concept Study Of COVID-19 Treatment Candidate

In pre-market trading, the stock was galloping 129.03% to $7.10.

Novavax Partners With AGC Biologics to Manufacture Adjuvant Component of Coronavirus Vaccine

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

Anika's CFO to Quit Following a Transition Period

Anika Therapeutics Inc (NASDAQ:ANIK) said its CFO Sylvia Cheung communicated her decision to relinquish office, effective August 21, 2020. The company said it has initiated a search to identify a successor.

AnPac Bio Names New CFO

AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ:ANPC) announced the appointment of Jinqiu Tang as CFO of the company, effective June 1, succeeding Yu Zhang, who stepped down, effective May 31.

Offerings

Evofem Biosciences, Inc. (NASDAQ:EVFM) said it has priced its underwritten public offering of 28.50 million shares at $3.50 per share, for raising gross proceeds of $100 million. All the shares are being offered by the company. The company expects the offering to close on or about June 5.

In pre-market trading, Evofem shares were slipping 12.66% to $4.07.

EULAR 2020 Congress Presentations

On The Radar

Clinical Readouts

Kiniksa Pharmaceuticals Ltd (NASDAQ:KNSA) will present at the EULAR, 2020 E-Congress Phase 1 data for mavrilimumab in COVID-19 treatment.

IPOs

San Francisco, California-based Pliant Therapeutics, Inc. priced its upsized initial public offering of 9-million share offering at $16, the upper bound of the estimated range of $14-$16. The clinical stage biopharma focused on discovering and developing novel therapies for the treatment of fibrosis said its shares will be listed on the Nasdaq under the ticker symbol PLRX.

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