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

Protagonist Therapeutics Inc (PTGX) announced topline results from the Phase 2 IDEAL study of PN-943 in moderate-to-severe ulcerative colitis patients.

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 FDA has approved Gilead Sciences Inc's (GILD) supplemental marketing application for Veklury (remdesivir) for pediatric COVID-19 patients older than 28 days.

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 In Blood Cancer Settings

The FDA has signed off and removed the clinical hold for a cryopreserved formulation of Gamida Cell Ltd's (GMDA) GDA-201, an off-the-shelf cell therapy candidate for follicular and diffuse large B cell lymphomas. 

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

Valneva SE (VALN) and Pfizer Inc (PFE) have reported Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. 

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 (MRKR)  has entered into a services agreement with Wilson Wolf Manufacturing Corporation. 

The agreement includes an $8-million upfront cash payment by Wilson Wolf to Marker in exchange for services relating to Marker's expertise in manufacturing cell therapies. 

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

Nektar Therapeutics (NKTR) announced a new strategic plan to prioritize key research and development efforts and cut 70% of its workforce, including several changes to its executive team. 

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.