The Daily Biotech Pulse: Pfizer Reports Positive Ulcerative Colitis Study Data, Novavax COVID Shot Authorized For Adolescents In India, Argenx Stock Sale

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

Stocks In Focus

J&J's Janssen Unit Initiates Large-Scale Study of Psoriasis Drug In People of Color

Johnson & Johnson's JNJ Janssen unit announced the initiation of VISIBLE, a large-scale prospective clinical study dedicated to people of color living with moderate to severe plaque and/or scalp PsO.

The study will further evaluate the efficacy and safety of Tremfya in people of color to generate additional data and provide valuable information about disease burden and the psoriatic disease patient journey in this population.

MorphoSys, Incyte Announce Temporary Approval For Blood Cancer Combo Therapy In Switzerland

MorphoSys AG MOR and partner Incyte Corporation INCY announced that the Swiss agency for therapeutic products has granted temporary approval for Minjuvi, in combination with Bristol-Myers Squibb Company's BMY Revlimid, followed by Minjuvi monotherapy.

The regimen is meant for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma, after at least one prior line of systemic therapy including an anti-CD20 antibody, who are not eligible for autologous stem cell transplant. Incyte holds exclusive commercialization rights for Minjuvi in Switzerland.

Incyte shares were advancing 2.06% to $79.66 in premarket trading and MorphoSys was gaining 1.86% to $6.57.

Novavax's COVID Vaccine Authorized For Use In Adolescents In India

Novavax, Inc. NVAX and its partner the Serum Institute of India announced that the Drugs Controller General of India has granted emergency use authorization for Novavax' protein-based COVID-19 vaccine for adolescents, ages between 12 and 18 years, in India.
The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax and is the first protein-based vaccine authorized for use in this age group in India.

Novavax shares were up 0.43% to $84.16 in premarket trading.

Click here to access Benzinga's FDA Calendar

Pfizer Announces Positive Late-Stage Data For Ulcerative Colitis Treatment

Pfizer, Inc. PFE announced positive topline results from a Phase 3 study of etrasimod, which is being developed as a treatment option for moderately to severely active ulcerative colitis.

In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The safety profile was consistent with previous Phase 2 studies.

OraSure Appoints Board Member Nancy Gagliano As Interim CEO

OraSure Technologies, Inc. OSUR announced that its board has appointed Nancy Gagliano, to serve as interim chief executive officer, effective April 1. The company has previously communicated that Stephen Tang, its President and CEO, will be leaving the company as of March 31.

The company also noted the search for a permanent CEO is actively underway.

4D Pharma Announces Positive Data For Phase 1/2 Study of Combo Therapy In Treating Renal Cell Carcinoma

4D Pharma plc FDMT announced that in Part B of its signal finding Phase 1/2 study of MRx0518 in combination with Merck & Co., Inc.'s MRK Keytruda in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor, the renal cell carcinoma group has met its primary efficacy endpoint ahead of enrollment completion.

Earnings

Aptose Biosciences Inc. APTO (after the close)
Caladrius Biosciences, Inc. CLBS (after the close)

Offerings

Argenx SE ARGX, which announced Tuesday a positive late-stage readout for its rare neuromuscular disease treatment, said it has commenced a global offering of $500 million of ordinary shares.

The global offering will comprise an offering of ordinary shares represented by ADSs in the U.S. and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the U.K. Each of the ADSs represents the right to receive one ordinary share. The U.S. offering and the European private placement are expected to close simultaneously.

The stock was losing 2.27% to $310 in premarket trading.

On The Radar

Earnings

Vascular Biogenics Ltd. VBLT (before the market open)
Aptinyx Inc. APTX (after the close)
Navidea Biopharmaceuticals, Inc. NAVB (after the close)
Celcuity Inc. CELC (after the close)
Ra Medical Systems, Inc. RMED (after the close)