Neurocrine misses primary endpoint in schizophrenia trial

  Neurocrine Biosciences (Nasdaq: NBIX) today announced that investigational drug luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in the Phase II INTERACT study in adults with negative symptoms of schizophrenia, as measured by the change from baseline on the PANSS NSFS at Day 84. Luvadaxistat met secondary endpoints of cognitive assessment, which merit further clinical evaluation. The adverse event profiles for luvadaxistat were consistent with previous trials. Takeda Pharmaceutical Company Limited ("Takeda") granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including luvadaxistat, in June 2020. The results from the Phase II INTERACT study are being evaluated to determine next steps for development activities.

"The Phase II INTERACT study was a well-designed and executed clinical study that resulted in a negative outcome for luvadaxistat on the primary endpoint assessing the change from baseline in negative symptoms of schizophrenia. We are, however, encouraged that secondary endpoints assessing cognitive performance within the trial were met and that treatment emergent adverse events reported were consistent with previous luvadaxistat studies," said Eiry W. Roberts, M.D., Chief Medical Officer of Neurocrine Biosciences. "The totality of the top-line data from this study therefore support further clinical evaluation of luvadaxistat. We plan to work with our partner Takeda as we move forward."

https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-top-line-results-from-phase-ii-interact-study-evaluating-luvadaxistat-nbi-1065844-for-the-treatment-of-negative-symptoms-and-cognitive-impairment-associated-with-schizophrenia-cias-301238086.html

Leerink, Oppenheimer, Morgan Stanley start Pharvaris at Buy, B of A at Neutral

 Targets $50, $48, $51, $41 respectively

https://finviz.com/quote.ashx?t=phvs

Applied DNA, Evvivax Initiate Phase I Trial of LinearDNA™ COVID Vax for Cats

 - Vaccine Candidate Previously Demonstrated Antibodies and T-cell Response in Mouse Models -

- Clinical Trial to Serve as Initial Validation of LinearDNA Platform in Large Mammals with Potential Advantages in Manufacturing, Storage, and Distribution over Other Vaccines -

https://www.biospace.com/article/releases/applied-dna-and-evvivax-initiate-phase-i-of-clinical-trial-to-evaluate-lineardna-covid-19-vaccine-candidate-for-feline-veterinary-market/

Eyenovia: FDA Accepts MydCombi Application

 Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet®.

“We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam,” said Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia.

https://www.businesswire.com/news/home/20210302005329/en/Eyenovia-Announces-FDA-Acceptance-of-the-MydCombi-NDA

Cerecor sees shares jump on COVID-19 readout, seeks EUA

 Cerecor, which has a market cap of less than $400 million and some small, low-key raises and pacts over the years, saw its shares bounce around 15% premarket this morning on new phase 2 data for its experimental COVID-19 drug.

The asset, a monoclonal antibody known as CERC-002, saw top-line data at the start of the year but now has more details. The test breaks down like this: It saw all patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome.

A total of 83 patients were randomized to get the standard of care at the sites plus either a single dose of 1,200 mg of CERC-002 or placebo subcutaneously; 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.

The trial hit this endpoint, which was the proportion of patients alive and free of respiratory failure over the 28-day study period, compared to placebo, though the p-value was very close, at 0.044, for the ITT population.

The drug performed best in patients over 60 (34 in total), though again, the statistical significance here was tight at a p-value of 0.042. The drug was tested alongside steroids and Gilead’s remdesivir.

At both the 28-day and the 60-day final time points, the biotech said “approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.” The company did not say whether it had tested the drug on newer variants of the SARS-CoV-02 virus, which could dampen the affect of mAbs.

Cerecor has asked the FDA for both breakthrough-therapy and fast-track tags for the med in COVID-19 and plans to meet with the FDA “to discuss the potential path” to an emergency use authorization and approval.

https://www.fiercebiotech.com/biotech/little-cerecor-sees-shares-jump-covid-readout-seeks-eua-though-margins-success-are-thin

Merck, Johnson & Johnson partner on COVID-19 vaccine manufacturing

 Merck & Co. is teaming up with rival Johnson & Johnson to help manufacture its recently-approved COVID-19 vaccine as the nation seeks to eliminate the virus in part through a mass inoculation effort. Two White House officials confirmed the partnership to Fox News.

Johnson & Johnson previously agreed to supply the U.S. with 100 million doses of its one-shot vaccine by June, but White House officials said the company had struggled with supply and material issues.

Last week, ahead of the FDA's emergency use authorization, Jeff Zients, White House COVID-19 coordinator, had said the Biden administration was working to further "accelerate the pace and timeframe" for which the company delivered the agreed-upon supply after learning that Johnson & Johnson had fallen behind in their production schedule. 

President Joe Biden is expected to formally announce the partnership between rivals Merck and Johnson & Johnson later Tuesday.

https://www.foxnews.com/health/merck-johnson-johnson-partner-on-covid-19-vaccine-manufacturing

Jefferies Downgrades FibroGen (FGEN) to Hold

 Analyst Michael Yee cuts from Buy.

https://www.streetinsider.com/Analyst+Comments/UPDATE%3A+Jefferies+Downgrades+FibroGen+%28FGEN%29+to+Hold/18060706.html