The Daily Biotech Pulse: FDA Orphan Drug Tag for Neurocrine Candidates, Editas;  PRV sale of BridgeBio;  RMAT designation for the PolarityTE product

The Daily Biotech Pulse: FDA Orphan Drug Tag for Neurocrine Candidates, Editas; PRV sale of BridgeBio; RMAT designation for the PolarityTE product

Here’s a rundown of the major developments in the biotech space over the past 24 hours:

The Swiss drug regulatory authority has approved Moderna Inc MRNA COVID-19 vaccine for children aged 6 to 11.

The approval is for the two-dose series of the 50 micrograms per dose vaccine, Moderna added.

The stock was up 6.72% to $ 138.92 on Friday.

Neurocrine Huntington’s Candidate Secures FDA Orphan Drug Label

The FDA has granted orphan drug designation to Neurocrine Biosciences Inc NBIX valbenazine for Huntington’s disease (HD).

Treatment of HD-associated chorea falls within the scope of this orphan drug designation.

Valbenazine is a selective vesicular monoamine transporter 2 inhibitor, being studied as a once-daily treatment in adults with HD-associated chorea.

Editas Medicine Inc MODIFY EDIT-301, an investigational gene-editing drug for beta-thalassemia, has received FDA orphan drug designation.

The FDA has previously granted EDIT-301 pediatric rare disease designation for beta-thalassemia and sickle cell anemia.

EDIT-301 is being studied in a clinical trial in patients with severe sickle cell anemia. Editas plans to initiate a phase 1/2 study of EDIT-301 in patients with transfusion-dependent beta-thalassemia in 2022.

CSL Ltd‘S CSLLY $ 11.7 billion buyout of Vifor Pharma AG GNHAY will have to wait a few more months.

Although CSL previously planned to close the acquisition this June, the regulatory approval process is taking longer than expected. Some antitrust authorities have approved the transaction, but others remain pending, Vifor said in a statement.

LOTTE Corporation agreed to buy Bristol Myers Squibb Co BMY manufacturing facility in East Syracuse, New York.

The East Syracuse site will serve as the LOTTE Center for North America Operations for the development of new organic product contracts and the manufacturing organization of LOTTE in the United States

The companies expect to complete the transaction by the second half of 2022.

Terms of the deal were not disclosed.

Statera Biopharmaceutical EPISODE intends to enter into a non-binding term sheet for a strategic partnership with Lay Sciences Inc to license worldwide manufacturing rights for certain Lay Sciences IgY products containing avian antibodies as an active ingredient.

Lay Sciences would receive an upfront payment including capital and cash and also have the potential to earn royalties and milestones associated with the development of IgY in upper respiratory and gastrointestinal indications.

Specific terms of the agreement were not disclosed.

Shares were up 19.4% to 27 cents during the pre-market session.

BridgeBio Pharma Inc BBIO agreed to sell its Rare Pediatric Disease Priority Review Coupon for $ 110 million to an unknown buyer.

BridgeBio received the voucher when its affiliate, Origin Biosciences Inc., received approval for Nulibry (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with type A molybdenum cofactor deficiency.

BridgeBio amended its existing senior secured line of credit, extending the two-year interest-only period and principal repayment until November 17, 2026.

Lantheus Holdings Inc LNTH dosed the first patient in a phase 2 study evaluating NM-01 for its potential to identify patients who will respond to checkpoint inhibitor therapies.

NM-01 is a technetium 99m SPECT imaging agent used to evaluate PD-L1 expression in cancer cells.

The shares are up 7.67% to $ 64.17 during the pre-market session.

The FDA has granted the Advanced Regenerative Medicine Therapy (RMAT) designation. PolarityTE Inc PTE SkinTE under the company’s open IND.

The RMAT designation is a dedicated program designed to accelerate drug development and review processes for promising regenerative medicine products.

Shares were up 42.9% to 21 cents during the pre-market session.

On the radar

I earn

The list of earnings presented is not complete. Click here to access Benzinga’s earnings calendar for the full schedule.

PLx Pharma Inc PLXP: Before the market opens.

Better Therapeutics Inc BTTX: Before the market opens.

Biofrontera Inc BFRI: Before the market opens.

ProPhase Labs Inc PRPH: Before the market opens.

Longeveron Inc LGVN: Before the market opens.

EQRx Inc EQRX: Before the market opens.

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