The Daily Biotech Pulse: FDA Committee Backs Moderna Shot For 5-17 Years, 180 Life Sciences Stock Plunges, Pfizer's Posts Disappointing Paxlovid Data

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

Stocks In Focus

Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

An updated analysis from 1,153 patients showed a non-significant 51% relative risk reduction. 

Pfizer said it would halt enrollment in the EPIC-SR trial in standard-risk patients as the study revealed the treatment was ineffective in reducing symptoms in that group.

FDA Committee Backs Moderna's COVID-19 Shot For Kids, Adolescents: Report

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine received unanimous backing from the FDA's committee of independent immunization experts for children ages 6 through 17.

MorphoSys, Enters Equity Participation and License Agreements With HIBio

As per the agreements, HIBio obtains exclusive rights to develop and commercialize felzartamab and MOR210 across all indications worldwide, except Greater China for felzartamab and Greater China and South Korea for MOR210.

MorphoSys will receive a 15% equity stake in HIBio, and up to $1 billion in milestone payments across programs, plus double-digit royalties on net sales. MorphoSys receives an upfront payment of $15 million for MOR210.

MOR shares are up 9.65% at $5.00 during the premarket session.

180 Life Sciences Stock Plunges On UK, FDA Feedback On Early-Stage Dupuytren's Disease Therapy

The FDA indicated that the proposed outcome measures of nodule hardness and nodule size are not clinical outcomes.

Shares are down 38.7% at 82 cents during the premarket session.

Omega Files To Start Human Trial For Lead Candidate In Liver Cancer

The company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance.

Also See: Why Gilead Is Cheapest Large-Cap Biotech Despite Some Not So Favorable Acquisitions

Kymera Starts Dosing In Early-Stage Solid Tumor, Blood Cancer Trials

The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T-cell lymphomas and leukemia.

The KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma.

Clinical Readouts/Presentations

Akero Therapeutics Inc (NASDAQ:AKRO): Present at Keystone Symposium on Efruxifermin as a therapy for nonalcoholic steatohepatitis.

Offerings

On The Radar

FDA Meeting

Stock Split

Calithera Biosciences Inc (NASDAQ:CALA) filed to effect a 1-for-20 reverse stock split, effective as of 5:00 p.m. ET Tuesday.

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