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

Stocks In Focus

Protagonist's Ulcerative Colitis Study Disappoints With Higher Dose Of PN-943

While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved 27.5% clinical remission with a delta of 13% versus the placebo and a delta of 16% (p=0.04) in the bio-naïve group. 

In addition, the 150 mg BID data showed strong concordance across multiple parameters.

Shares are falling 32.7% at $12.66 during the premarket trading session.

Gilead's Remdesivir Becomes First Approved Treatment For Pediatric COVID-19 Patients

The approval covers patients weighing at least 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe infection.

Gamida Cell Shares Surge On FDA Nod For Cell Therapy Study In Blood Cancer Settings

Gamida Cell expects to initiate a Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.

GMDA shares are up 30.9% at $3.69 during the premarket session

Valneva, Pfizer Post Encouraging Data From Lyme Disease Vaccine Candidate

VLA15 was found to be more immunogenic than in adults with both two-dose and three-dose vaccination schedules tested.

No vaccine-related serious adverse events were observed.

Marker Therapeutics Inks Services Agreement With Wilson Wolf For $8M

Marker Therapeutics Inc (NASDAQ:MRKR) has entered into a services agreement with Wilson Wolf Manufacturing Corporation. 

Wilson Wolf has agreed to pay Marker an additional $1 million if the certain work, as defined in the services agreement, is completed within one year from the onset of the services agreement.

Shares are up 18% at $0.39 during premarket trading.

After Bristol Myers Cuts Ties, Nektar Enacts Cost Restructuring

After accounting for BEMPEG wind-down and restructuring costs, Nektar expects to end the year with approximately $440 million-$450 million in cash and investments. 

The company said it expects to take a charge of $150 million-$160 million, a substantial portion of which will be recorded in the second quarter. 

Shares are down 4.03% at $4.53 during the premarket session.

Ambrx Biopharma's ARX788 Selected For Phase 2 Adaptive Breast Cancer Trial

ARX788 will be evaluated as a monotherapy, combined with the PD-1 targeting checkpoint inhibitor cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting. 

Enrollment will start in May 2022.

Biocytogen Signs RenMab/RenLite Licensing Agreement With BeiGene

BGNE stock is up 0.1% at $162.96 in premarket trading.

VBL Biogenics Receives Fast Track Tag For Ovarian Cancer Gene Therapy

VBL recently completed patient enrollment of 409 patients in this global trial. In addition, the Independent Data Safety Monitoring Committee unanimously recommended continuing the trial as planned, following a review of unblinded data from 370 randomized patients.

Shares are up 11.7% at $1.62 during the premarket session Tuesday. 

Clinical Readouts/Presentations

Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT) 

Magenta Therapeutics Inc (NASDAQ:MGTA): Phase 2 Study of MGTA-145 + Plerixafor in hematopoietic stem cell mobilization for autologous stem cell transplant in multiple myeloma patients.

Offerings

Underwriters have an option to purchase up to 2 million additional shares.

Shares are down 4.59% at $17.86 during premarket trading.

On The Radar

Novartis AG (NYSE:NVS) Q1 Earnings.

Agile Therapeutics Inc's (NASDAQ:AGRX) 1-for-40 reverse stock split effective tomorrow.