The Daily Biotech Pulse: FDA Wants Omicron-Targeted COVID-19 Boosters, Provention Bio Clears Hits Hurdle For Diabetes Prevention Drug, Oxford Biomedica, AstraZeneca Strike Vaccine Pact

Zinger Key Points
  • After futility news for Zyesami, the company shifted focus on NRX-101 for bipolar depression with suicidality
  • The new deal would facilitate potential future manufacturing opportunities for AstraZeneca's COVID-19 shot

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

Stocks In Focus

FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.

The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the vaccine composition to create a two-component (bivalent) booster vaccine.

Genmab Plans To File US Application For Epcoritamab In Blood Cancer Setting

Genmab A/S GMAB plans to submit a marketing application to the FDA for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for relapsed/refractory large B-cell lymphoma, in 2H of 2022.

The planned submission is supported by results from the large b-cell lymphoma cohort of the pivotal EPCORE NHL-1 open-label, multicenter trial.

FDA Extends Decision Date For Provention Bio's Lead Product Candidate 

The FDA has extended the review period by three months for Provention Bio Inc's PRVB marketing application for teplizumab to November 17.

Teplizumab is under review for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals.

The company was also informed that if no major deficiencies are identified during the review period, the FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirements or commitment requests by Oct. 17.

Akebia Terminates Vadadustat Agreement With Otsuka

Akebia Therapeutics Inc AKBA has terminated the U.S. and ex-U.S. vadadustat agreement with Otsuka Pharmaceutical Co Ltd OTSKY.

As part of the termination, Otsuka has agreed to pay Akebia a settlement fee of $55 million.

Akebia is to assume responsibility for regulatory review processes previously led by Otsuka.

Shares are up 37.4% at 49 cents during the premarket session.

Oxford Biomedica Inks 3-Year Deal To Make AstraZeneca's COVID-19 Vaccine

Oxford Biomedica plc OXBDF signed a new, three-year agreement to potentially make AstraZeneca Plc's AZN COVID-19 vaccine beyond 2022.

Under the expanded deal, AstraZeneca will have access to Oxford Biomedica's Oxbox manufacturing facility to produce its shot on an as-needed basis beyond 2022.

Oxford Biomedica expects to recognize aggregate revenues of approximately 30 million pounds ($36 million) from AstraZeneca in the current financial year.

Also Read: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates.

FDA Rejects NRx Pharma's Emergency Use Request For Aviptadil For COVID-19

The FDA has declined to issue an Emergency Use Authorization for NRx Pharmaceuticals Inc's NRXP Zyesami (aviptadil) for a subgroup of patients who also received Gilead Sciences Inc's GILD remdesivir in addition to Zyesami.

NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.

We will evaluate the options for Zyesami in COVID-19 respiratory failure and other lung disorders once we receive the full data set from the National Institutes of Health," said Robert Besthof, interim CEO.

Shares are slipping 4.83% to 57 cents during the premarket session.

Endo Posts Disappointing Data From Frozen Shoulder Trial

Endo International plc ENDP has announced topline results from its Phase 2 study of collagenase clostridium histolyticum (CCH) in participants with adhesive capsulitis of the shoulder (frozen shoulder).

While participants receiving up to three doses of CCH showed some improvement in the change from baseline in the shoulder pathology composite score, the difference compared to those study participants receiving placebo was not statistically significant.

Shares are down 7.67% at 43 cents during the premarket session.

Nektar Names New Chief Finance Executive

Nektar Therapeutics NKTR has promoted Jillian Thomsen to senior vice president and CFO. 

Thomsen has served as SVP, finance and chief accounting officer of Nektar since 2008.

Gil Labrucherie, the company's current chief operating officer and chief financial officer, will be departing to pursue another opportunity at a private biotechnology company.


X4 Pharmaceuticals Inc XFOR has agreed to sell an aggregate of 50.9 million and warrants to purchase an aggregate of 50.9 shares in private investment in public equity financing for gross proceeds of approximately $55 million.

Posted In: CoronavirusCovid-19COVID-19 VaccineBiotechLarge CapNewsPenny StocksHealth CareFinancingOfferingsSmall CapFDAManagementGeneral

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