Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
FDA Signs Off Marker Therapeutics Cell Therapy Study In Lymphoma Setting
The FDA cleared Marker Therapeutics Inc's (NASDAQ:MRKR) Investigational New Drug (IND) application for MT-601 for relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment.
MT-601 is a multi-tumor-associated antigen (multiTAA)-specific T cell product targeting six antigens.
In addition, the FDA has cleared Marker to initiate its study at a dose level of 200 million cells per infusion versus the dose range of 10-40 million cells per infusion used in the TACTAL study.
Shares are up 63.6% at 54 cents during the market trading session.
India-Based Pharma Companies In Race To Buy Athenex
Athenex Inc (NASDAQ:ATNX) shares climbed during the after-hours session as India's Intas Pharmaceuticals and Dr Reddy's Laboratories Ltd (NYSE:RDY) are reportedly in talks to acquire Athenex.
According to the Economic Times report, the deal could be valued at $200-250 million.
Athenex hired investment advisory firm Cowen Inc to run a formal process to find a buyer.
Shares are up 42% at 89 cents during the market trading session.
FDA Asks For Additional Study For Acadia's Pimavanserin In Alzheimer's-Associated Delusions
The FDA has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals Inc (NASDAQ:ACAD) regarding its supplemental marketing application for pimavanserin in hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).
The CRL recommended that Acadia conduct an additional trial in ADP.
Genmab, BioNTech Join Forces For Cancer Immunotherapy Candidates
Genmab A/S (NASDAQ:GMAB) and BioNTech SE (NASDAQ:BNTX) have expanded their global strategic collaboration to develop and commercialize novel cancer immunotherapies.
Under the expansion, Genmab and BioNTech will jointly work to research, develop, and commercialize novel monospecific antibody candidates for various cancer indications.
The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022.
Akebia's Anemia Drug Disappoints In Midstage COVID-19 Study
Akebia Therapeutics Inc (NASDAQ:AKBA) announced initial findings from an investigator-sponsored study evaluating vadadustat for Acute Respiratory Distress Syndrome (ARDS) with COVID-19 and hypoxemia.
Akebia said the drug failed the primary endpoint, as measured by the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS).
While the primary superiority threshold over placebo was 95%, researchers calculated a 94% probability that their drug was better than the placebo.
Shares are down 4.88% at 39 cents during the market session.
Kazia Posts Interim Data From Paxalisib Combo Study In Brain Metastases
Kazia Therapeutics Limited (NASDAQ:KZIA) announced the presentation of new data from an ongoing phase 1 trial of paxalisib in combination with radiotherapy for brain metastases.
Interim data from the first stage of the study reports that all nine evaluable patients experienced a complete or partial response, representing an overall response rate (ORR) of 100%.
The safety profile of paxalisib in combination was broadly consistent with monotherapy experience in other clinical trials. A maximum tolerated dose (MTD) of 45mg daily combined with radiotherapy was confirmed.
Shares are up 31.8% at $2.34 during the market session.
Neurocrine Stops Midstage Study In Essential Tremors
Tucked in its Q2 earning release, Neurocrine Biosciences Inc (NASDAQ:NBIX) said that in August, the Phase 2a study of NBI-827104 in essential tremor did not meet specified endpoints.
Based on the totality of data from the Phase 2a study, at this time, the company will not proceed further with the clinical development of NBI-827104 in essential tremors.
On The Radar
PDUFA Dates
Myovant Sciences Ltd (NYSE:MYOV) and Pfizer Inc (NYSE:PFE): Supplemental marketing application for Myfembree (Relugolix) for moderate to severe pain associated with endometriosis. The decision date is Aug. 6.
Earnings
Amneal Pharmaceuticals Inc (NASDAQ:AMRX): Before the market open.
Ocugen Inc (NASDAQ:OCGN): Before the market open.
Aldeyra Therapeutics Inc (NASDAQ:ALDX): Before the market open.
Celyad Oncology (NASDAQ:CYAD): Before the market open.
