The Daily Biotech Pulse: FDA Decision On Biogen Alzheimer's Drug Due In January, FDA Reviews Roche's Lymphoma Candidate, Rare Pediatric Tag For Kazia's Pediatric Brain Cancer Candidate

Zinger Key Points
  • Eisai will submit for complete approval of lecanemab to the FDA during FY22 ending March 2023.
  • Roche's blood cancer candidate is a fixed-duration treatment option with the potential to be administered in an outpatient setting

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

Stocks In Focus

Eisai - Biogen's Alzheimer's Candidate Under FDA Priority Review

The FDA has accepted Eisai Co Ltd ESALY and Biogen Inc's 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.

Genentech's Follicular Lymphoma Candidate Goes Under FDA Review

The FDA has granted priority review for Genentech, a unit of Roche Holdings AG 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 Voluntarily Delists From The Tel Aviv Stock Exchange

BiomX Inc 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, bioMérieux Launch Antimicrobial Resistance-Focused Joint Venture

Boehringer IngelheimEvotec SE 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 Secures $11.4M Procurement Pact For Chicken Pox Treatment

Kamada Ltd 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.

Kazia Therapeutics' Pediatric Brain Cancer Candidate Gets FDA Rare Pediatric Tag

The FDA has granted Rare Pediatric Disease Designation to Kazia Therapeutics Limited's 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 

InflaRx's Skin Disorder Candidate Fast-Tracked In US

The FDA has granted Fast Track designation to InflaRx N.V.'s 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.

On The Radar

Data Readout

Applied Molecular Transport Inc 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 SRPT: New functional data across multiple studies from the SRP-9001 program for Duchenne muscular dystrophy.

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