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

Zinger Key Points
  • MorphoSys AG and Human Immunology Biosciences established an equity participation agreement and license agreements.
  • Calithera Biosciences filed to effect a 1-for-20 reverse stock split, effective as of 5:00 p.m. ET Tuesday.

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

Pfizer Inc PFE shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid in patients at standard risk of developing severe COVID-19. 

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

Children ages 6 to 11 would receive smaller 50 microgram shots, while teens ages 12 to 17 would receive the same dosage as adults at 100 micrograms.

MorphoSys, Enters Equity Participation and License Agreements With HIBio

MorphoSys AG MOR and Human Immunology Biosciences, Inc (HIBio) established an equity participation agreement and license agreements.

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 U.K. agency says that 180 Life Sciences Corp's ATNF adalimumab study's primary endpoint of nodule hardness and the secondary endpoint of nodule size would require evidence to validate them as clinically meaningful surrogate endpoints.

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

Omega Therapeutics Inc OMGA has submitted an Investigational New Drug Application to the FDA for its lead product candidate, OTX-2002, for hepatocellular carcinoma.

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

Kymera Therapeutics Inc KYMR has recently dosed the first patients in separate Phase 1 trials evaluating KT-333 and KT-413. 

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 AKRO: Present at Keystone Symposium on Efruxifermin as a therapy for nonalcoholic steatohepatitis.

Offerings

VectivBio Holding AG VECT has priced a public offering of 5.715 million shares at $5.25 per share for aggregate gross proceeds of approximately $30 million.

Day One Biopharmaceuticals DAWN has priced its upsized public offering of 10 million shares at $15.00 per share, with gross proceeds of $150 million versus an earlier announcement of $125 million.

On The Radar

FDA Meeting

The outside experts will meet to consider the Moderna Inc MRNA COVID-19 shot for children under six years and Pfizer Inc PFE and BioNTech SE's BNTX COVID vaccine for children under 5 - and in both cases as young as six months.

Stock Split

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

Posted In: COVID-19 CoronavirusCOVID-19 VaccineBiotechLarge CapNewsPenny StocksHealth CareFinancingOfferingsContractsSmall CapFDAStock SplitMoversTrading IdeasGeneral

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