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Here's a roundup of top developments in the biotech space over the last 24 hours:
The FDA has accepted Eisai Co Ltd (OTC:ESALY) and Biogen Inc's (NASDAQ:BIIB) marketing application seeking accelerated approval for lecanemab for mild cognitive impairment due to Alzheimer's disease.
Eisai's application, completed in early May, has been granted Priority Review, with a Prescription Drug User Fee Act action date of January 6, 2023.
The FDA has granted priority review for Genentech, a unit of Roche Holdings AG (OTC:RHHBY), marketing application for Lunsumio (mosunetuzumab) for relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
FL is the most common indolent (slow-growing) form of non-Hodgkin's lymphoma, a type of blood cancer.
The FDA is expected to decide on approving this cancer immunotherapy by December 29.
BiomX Inc (NYSE:PHGE) announced the voluntary delisting of its shares on the Tel Aviv Stock Exchange (TASE).
The delisting of BiomX's shares is expected to become effective in three months, on October 6. Following the delisting of BiomX's shares of common stock on the TASE, BiomX's shares will continue to be listed on the NYSE. All BiomX shares now traded on the TASE are expected to be transferred to the NYSE.
Boehringer Ingelheim, Evotec SE (NASDAQ:EVO), and bioMérieux have formed a joint venture to create the next generation of antimicrobials and diagnostics to fight Antimicrobial Resistance.
The resulting company, Aurobac Therapeutics SAS will be funded by Boehringer Ingelheim as the lead investor with €30 million and by Evotec and bioMérieux with €5 million each.
Kamada Ltd (NASDAQ:KMDA) has secured an $11.4 million agreement to supply Varizig to an undisclosed international organization operating principally in Latin America. The supply of the product is expected to occur from the fourth quarter of 2022 through the first half of 2023.
Varizig is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups.
The product is the sole FDA-approved IgG product for this indication.
The FDA has granted Rare Pediatric Disease Designation to Kazia Therapeutics Limited's (NASDAQ:KZIA) paxalisib for treating atypical rhabdoid/teratoid tumors, a rare and highly-aggressive childhood brain cancer.
The designation means that the sponsor may be entitled to receive a tradeable pediatric priority review voucher that commanded prices over $100 million.
Shares are trading 12.5% higher at $4.70 during the premarket trading.
Also Read: Why Jim Cramer Says 'You Should Just Take Every Penny' And Buy Disney
The FDA has granted Fast Track designation to InflaRx N.V.'s (NASDAQ:IFRX) vilobelimab for ulcerative pyoderma gangrenosum. This rare condition causes large, painful sores (ulcers) to develop on the skin.
The Fast Track tag follows the recently reported orphan drug designation by the FDA and EMA.
Shares are up 12.7% at $1.60 during the premarket trading session.
Applied Molecular Transport Inc (NASDAQ:AMTI) Topline data results from its Phase 2 MARKET combination trial of AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe ulcerative colitis.
Sarepta Therapeutics Inc (NASDAQ:SRPT): New functional data across multiple studies from the SRP-9001 program for Duchenne muscular dystrophy.
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