Novavax, Inc. NVAX, Orphazyme A/S ORPH and Avenue Therapeutics, Inc. ATXI are among the biggest movers among biopharma stocks Monday.
Novavax Finally Releases Phase 3 COVID-19 Results: After a protracted delay, Gaithersburg, Maryland-based Novavax reported preliminary results showing its coronavirus candidate NVX-CoV2371 met the primary endpoint of the Phase 3 PREVENT trial in the U.S. and Mexico.
The investigational vaccine demonstrated 100% protection against moderate and severe disease not involving variants of concern or variants of interest.
Against variants of concern and variants of interest, the efficacy was 93.2%. In high-risk populations, defined as over 65 or under 65 years with certain comorbidities or having circumstances with frequent COVID-19 exposure, the efficacy was 91%.
Overall efficacy was 90.4%, meeting the primary endpoint.
The company said it intends to file for regulatory authorizations in the third quarter upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls requirements.
Upon regulatory approvals, Novavax said it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.
NVAX Price Action: Novavax shares were down 0.13% at $209.40 at last check Monday.
Orphazyme's Volatile Ride Continues: Danish biopharma Orphazyme, which has seen frenzied promotion by retail traders, remains volatile ahead of a key binary event this week.
Shares of the company were rallying Monday after it shed over 55% Friday to end the session at $9.33. On Thursday, the stock saw irrational exuberance, as it shot up to an intraday high of $77 compared to the $5.23 at which it closed the previous session.
In a statement released Friday, the company said it is not aware of any material change in its clinical development programs, financial condition or results of operations that would explain such price volatility or trading volume.
Come Thursday, the company will have a make-or-break catalyst in the form of a PDUFA decision date for its Arimocolmol for the treatment of Niemann-Pick Disease Type C, a rare, progressive neurodegenerative disease.
Arimocolmol has been developed by CytRx Corporation CYTR and licensed to Orphazyme.
Orphazyme shares were jumping 15.65% to $10.79 at last check Monday.
Avenue's Non-Opioid Pain Drug Falters At FDA: Avenue said it has received a second complete response letter from FDA regarding its new drug application seeking approval for intravenous tramadol.
The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population, the company said.
Avenue said it disagrees with the FDA's interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
The original NDA for the treatment candidate was shot down with a CRL in October 2020 on the grounds that it is not safe for the intended patient population.
Avenue shares were slumping 40.14% to $2.52 at last check.
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