The Daily Biotech Pulse: FDA Adcomm Backing For Novavax's COVID-19 Shot, New Data On Moderna's Omicron Vaccine, DBV Tech's Encouraging Peanut Allergy Trial Data

Zinger Key Points
  • Moderna has announced new clinical data on its omicron-containing bivalent COVID-19 booster candidate.
  • A 50 µg booster dose of mRNA-1273.214 met all pre-specified endpoints.

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

Stocks In Focus

FDA Advisors Back Novavax's COVID-19 Vaccine 

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of Novavax Inc's NVAX COVID-19 vaccine (NVX-CoV2373).

The committee voted 21-0, with one abstention recommending FDA Emergency Use Authorization for the COVID-19 vaccine 18 years and over.

Shares closed 21.5% higher at $57.77 on Tuesday.

Moderna's Updated COVID-19 Shot Boosts Omicron Protection

Moderna Inc MRNA has announced new clinical data on its omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.214, containing mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern. 

A 50 µg booster dose of mRNA-1273.214 met all pre-specified endpoints, including superior neutralizing antibody response against the omicron variant one month after administration compared to the original mRNA-1273 vaccine.

DBV Technologies Shares Jump On Positive Data From Peanut Allergy Trial In Toddlers

DBV Technologies SA's DBVT pivotal Phase 3 EPITOPE trial of Viaskin Peanut 250 µg for peanut-allergic toddlers ages 1 to 3 years met its primary endpoint

Viaskin Peanut demonstrated a statistically significant treatment effect, with 67% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months compared to 33.5% of subjects in the placebo arm.

DBV continues a productive dialogue with the FDA on the Phase 3 VITESSE trial protocol of the modified Viaskin Peanut patch in peanut-allergic children ages four years and older.

Shares are up 15% at $1.53 during the premarket trading session.

Eledon's Tegoprubart Secures FDA Orphan Drug Status To Prevent Transplant Rejection

The FDA has designated Orphan Drug status to Eledon Pharmaceuticals Inc's ELDN tegoprubart to prevent allograft rejection in pancreatic islet cell transplantation.

The product has already received an Orphan Drug tag for amyotrophic lateral sclerosis.

FDA Approves Dupixent As First Biologic For Kids Under 5 For Atopic Dermatitis

The FDA has approved Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY Dupixent (dupilumab) for children ages six months to 5 years with moderate-to-severe atopic dermatitis.

The approval covers patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 

Europe Approves Roche's Bispecific Antibody Lunsumio For Relapsed Follicular Lymphoma

The European Commission has granted conditional marketing authorization for Roche HoldingsAG's RHHBY Lunsumio (mosunetuzumab) for relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. 

Lunsumio is an off-the-shelf therapy readily available, so people do not have to wait to start treatment.

Immunocore's Eye Cancer Treatment Approved In Additional Three Countries

The regulatory agencies in the U.K., Australia, and Canada have approved Immunocore Holdings plc's IMCR Kimmtrak (tebentafusp) for unresectable or metastatic uveal melanoma (eye cancer).

The approval follows recent authorizations from the FDA and the European Commission.

BioCryst's Rare Disease Candidate Fast-Tracked In US 

The FDA has granted Fast Track Designation to BioCryst Pharmaceuticals Inc's BCRX BCX9250 to prevent heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP).

FOP is an ultra-rare genetic disorder characterized by the irregular formation of bone outside the normal skeleton.

Apellis' Pegcetacoplan Gets FDA Orphan Drug Tag For Rare Kidney Disease

The FDA has granted Orphan Drug Status to Apellis Pharmaceuticals Inc's APLS pegcetacoplan for immune complex-membranoproliferative glomerulonephritis (IC-MPGN).

In MPGN, the immune system attacks the kidneys' healthy cells, damaging the glomeruli.

MediciNova Posts Promising Data From COVID-19 Treatment Candidate

MediciNova Inc MNOV says the Phase 2 trial of MN-166 (ibudilast) in hospitalized COVID-19 patients demonstrated significant improvements compared to placebo for all four clinical endpoints analyzed. 

The trial achieved statistical significance for one of the co-primary endpoints, the proportion of subjects free of respiratory failure. 

The trial also achieved statistical significance for the proportion of subjects discharged from the hospital.

Shares are up 11.91% at $2.63 during the premarket session.

Offerings

Eiger BioPharmaceuticals Inc EIGR has entered into a term loan agreement with Innovatus Capital Partners LLC for up to $75 million and a stock purchase agreement for Innovatus to purchase $5 million of shares.

The loan facility and stock sale provide for refinancing the company's existing debt and supporting Eiger's late-stage pipeline development and commercialization.

On The Radar

Adcomm Meeting

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review Moderna Inc's MRNA COVID-19 vaccine emergency use authorization for younger age groups. 

Posted In: CoronavirusCovid-19vaccineBiotechNewsPenny StocksHealth CareFinancingOfferingsSmall CapFDAGeneral

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