Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Kezar Life Sciences Reports Positive Interim Phase 2 Data For Lupus Nephritis Treatment Candidate
Kezar Life Sciences, Inc. KZR announced positive interim results from the Phase 2 portion of the MISSION clinical study evaluating KZR-616 in patients with active, proliferative lupus nephritis.
At the end of treatment period, three of the five patients achieved a 50% or greater reduction in urine protein to creatinine ratio, or UPCR, compared to baseline, thus meeting the primary efficacy endpoint of the study.
The stock was jumping 56.72% to $13.18 in premarket trading.
Amarin Announces Positive Data For Vascepa In Patients With Prior Peripheral Artery Disease
At the American Heart Association meeting, Amarin Corporation plc AMRN presented data on Vascepa in patients with prior peripheral artery disease at risk for major adverse cardiovascular events.
"These results strongly support the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction by physicians caring for their high-risk PAD patients," said Deepak Bhatt, principal investigator of the study.
Talis Taps Former Abbott Executive As CEO
Talis Biomedical Corporation TLIS announced the appointment of Brian Blaser to President, chief executive officer and Director, effective Dec. 1. Kim Popovits, currently serving as interim CEO, will resume her role as director on the board of Talis.
Blaser has more than 25 years of senior leadership experience in the in-vitro diagnostics industry, including 17 years at Abbott Laboratories ABT.
Separately, the company reported a narrower loss for the third quarter.
Talis shares were up 2.59% at $5.95 in premarket trading.
Pfizer Inks Deal With UN-Backed MPP To License Its Oral Antiviral COVID-19 Pill
Pfizer, Inc. PFE and the Medicines Patent Pool, a United Nations-backed public health organization, announced the signing of a voluntary license agreement for Pfizer's COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir.
The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.
Pfizer shares were down 1.21% at $49.05 in premarket trading.
Biogen Announces Retirement Of Alfred Sandrock As Head Of R&D
Biogen, Inc. BIIB said Alfred Sandrock, head of R&D will retire from the company effective December 31. A 23-year veteran of Biogen, Sandrock, 64, led the development of many of the most important and transformational therapies in neurological diseases, including Aduhelm.
Priya Singhal, head of Global Safety and Regulatory Sciences, also with oversight responsibility for Japan and China R&D, will assume Sandrock's duties on an interim basis until a permanent successor is identified.
The stock was moving down 1.35% to $268.14 in premarket trading.
Molecular Partners' Antiviral Treatment Candidate Fails To Meet Thresholds To Continue Phase 3 Study In Hospitalized COVID-19 Patients
Molecular Partners AG MOLN announced that a planned futility analysis of ensovibep in the ongoing ACTIV-3 clinical study has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting.
This global Phase 3 ACTIV-3 platform study is being conducted by the NIH. At the time of the analysis, 470 patients had been randomized in the ensovibep arm of the study. Ensovibep was observed to be generally safe and well-tolerated with reported side effects consistent with standard of care.
Molecular Partners and Novartis AG NASDAQ are collaborating on the development of ensovibep and are evaluating it in another global late-stage study, EMPATHY, which is designed to assess ensovibep's ability to rapidly reduce viral load and prevent worsening of symptoms and hospitalization of patients who are in the early stages of disease.
Topline interim data for the first 400 patients from the EMPATHY trial is expected in early 2022.
Molecular Partners shares were slumping 34.96% to $9.62 in premarket trading.
Earnings
ENDRA Life Sciences, Inc. NDRA reported a narrower loss of 6 cents per share in the third quarter of 2021 compared to a loss of 15 cents per share a year-ago.
The stock was slumping 12.03% to $1.17 in after-hours trading.
Offerings
Optinose, Inc. OPTN announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All shares of common stock to be sold in the offering will be sold by the company.
Separately, the company reported a 41% increase in third-quarter revenues and a narrower loss.
The stock was slipping 24.27% to $1.81 in premarket trading.
Apellis Pharmaceuticals, Inc. APLS announced that it has commenced an underwritten public offering of $300 million of its common stock. All of the shares are being offered by Apellis.
In premarket trading, the stock was seen moving down 3.73% to $40.51.
Click here to access Benzinga's FDA calendar.
On The Radar
Earnings
- NRx Pharmaceuticals, Inc. NRXP (before the market open)
- MediWound Ltd. MDWD (before the market open)
- PAVmed Inc. PAVM (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
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