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

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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)

  • Agenus Inc (NASDAQ: AGEN)(announced FDA clearance of its IND for evaluating its allogeneic iNKT therapy as a COVID-19 treatment option)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)(moved on a positive readout for a rival ulcerative colitis drug from Bristol-Myers Squibb Co (NYSE: BMY))
  • argenx SE – ADR (NASDAQ: ARGX)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)
  • Cardiff Oncology Inc (NASDAQ: CRDF)
  • Fortress Biotech (NASDAQ: FBIO)
  • Imara Inc (NASDAQ: IMRA)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • ORIC Pharmaceuticals Inc (NASDAQ: ORIC)
  • Protara Therapeutics Inc (NASDAQ: TARA)
  • Qiagen NV (NYSE: QGEN)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Tenax Therapeutics Inc (NASDAQ: TENX)( announced a positive Phase 3 readout)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX)
  • Unity Biotechnology Inc (NASDAQ: UBX)
  • Vermillion, Inc. (NASDAQ: VRML)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)(announced FDA acceptance of its BLA for Danyelza for the treatment of patients with relapsed/refractory high-risk neuroblastoma)

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

FSD Pharma Inc (NASDAQ: HUGE) said the FDA has given it permission to submit an IND for the use of its FSD-201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. The company said it's focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

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

partner AGC Biologics said Novavax, Inc. (NASDAQ: NVAX) has selected it for manufacturing Matrix-M, the adjuvant component of the latter's SARS-CoV-2 vaccine candidate, NVX-CoV2373, which enhances the immune response and stimulate high levels of neutralizing antibodies. AGC said it will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax' capacity to deliver doses in 2020 and 2021.

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

Eli Lilly And Co (NYSE: LLY) announced long-term data on Olumiant in patients with moderate to severe rheumatoid arthritis is to be presented at the at the European League Against Rheumatism, or EULAR, 2020 E-Congress. The study, according to the company, found that among patients with an inadequate response to methotrexate, or MTX, from drug initiation up to three years, 52% of patients initially treated with Olumiant (+MTX) were in a state of low disease activity at week 24 and this rate was maintained through week 148. The company also shared updated integrated safety analysis of Olumiant in the treatment of RA in patients treated up to 8.4 years, which showed no new safety signals.

Replimune Group Inc (NASDAQ: REPL) announced new interim data from the study of patients with melanoma and non-melanoma skin cancers treated with RP1 combined with Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo, which showed the investigational asset continued to provide strong support for its lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD-1 refractory melanoma.

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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