Melinta sees Q2 2019 net product sales of ~$13.8M

Melinta Therapeutics (NASDAQ:MLNT) has reported preliminary Q2 results and provided a corporate update.

The Company expects Q2 net product sales of ~$13.8M.

Expected cash and equivalents are ~$90M, and the Company is targeting to reduce FY 2019 operating expenses by ~$70M.

On July 10, The World Health Organization added Vabomere (meropenem and vaborbactam) to its Essential Medicines List.

The FDA recently accepted for priority review a sNDA for Baxdela (delafloxacin) seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia; PDUFA action date is October 24.

Melinta will announce its Q2 2019 financial results on August 7, at 8:30 a.m. ET.

Shares are up 7% premarket.

https://seekingalpha.com/news/3478019-melinta-sees-q2-2019-net-product-sales-13_8m-shares-plus-7-percent-premarket

Seattle Genetics files U.S. application for enfortumab vedotin for urothelial cancer

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce the filing of a U.S. marketing application seeking approval for antibody-drug conjugate enfortumab vedotin for the treatment of patients with locally advanced/metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received platinum-based chemo in the neoadjuvant/adjuvant, locally advanced or metastatic setting, a Breakthrough Therapy-tagged indication.

The companies are co-developing enfortumab vedotin under an original 2007 agreement, equally sharing global costs and profits.

https://seekingalpha.com/news/3478031-seattle-genetics-files-u-s-application-enfortumab-vedotin-urothelial-cancer

ScPharma up premarket on accelerated Furoscix timeline

Thinly traded nano cap scPharmaceuticals (NASDAQ:SCPH) is up 4% premarket on light volume in response to a more bullish timeline for the filing of a U.S. marketing application for lead candidate FUROSCIX for the treatment of congestion in heart failure patients.

Based on FDA feedback that no additional efficacy, safety or pharmacology studies are required, the company expects to file the NDA by mid-2020.

FUROSCIX is pH-neutral solution of a diuretic called furosemide that is administered via subcutaneous infusion by a wearable injector that is part of an integrated drug delivery system.

https://seekingalpha.com/news/3478048-scpharma-4-percent-premarket-accelerated-furoscix-timeline

Roche teams up with Skyhawk in oncology and neurology

Roche (OTCQX:RHHBY) unit Genentech will collaborate with privately held Skyhawk Therapeutics to discover and develop small molecule therapeutics in oncology and neurology based on the latter’s SykSTAR technology platform that targets the loss of RNA expression due to mis-splicing, a condition considered highly resistant to “drugging.”

Under the terms of the agreement, Genentech will have an exclusive global license to develop and commercialize candidates directed to multiple targets and will pay Skyhawk an upfront fee, milestones and royalties on net sales. Specific financial terms are not disclosed.

https://seekingalpha.com/news/3478062-roche-teams-skyhawk-oncology-neurology

LogicBio nabs rare pediatric disease tag for LB-001

Thinly traded micro cap LogicBio Therapeutics (LOGC +5.2%) is up on light volume in early trade on the heels of the FDA’s rare pediatric disease designation for gene-editing therapy LB-001 for methylmalonic acidemia, an inborn error of metabolism characterized by the buildup of methylmalonic acid in the blood due to the body’s inability to break down certain proteins and fats. It occurs once in 50K – 100K people.

Under the designation, the marketing application has priority review status and, if approved, the company will receive a priority review voucher that it can use for a subsequent filing or it can sell it to another party.

https://seekingalpha.com/news/3478096-logibio-nabs-rare-pediatric-disease-tag-lbminus-001-shares-5-percent

CNS Pharmaceuticals readies IPO

CNS Pharmaceuticals (CNSP) has filed a preliminary prospectus for a 2.125M-share IPO at $4 -5 per share, valuing the offering at $9.6M from the midpoint.

The Houston, TX-based preclinical-stage pharma company develops drugs to treat primary and metastatic brain and central nervous system (CNS) tumors based on intellectual property in-licensed from Houston Pharmaceuticals and owned pursuant to an agreement with Reata Pharmaceuticals (NASDAQ:RETA).

Lead candidate is anthracycline chemo agent Berubicin, in development for glioblastoma since it is capable of crossing the blood-brain barrier.

2019 Financials (Q1): Operating Expenses: $211.5K (-31.7%); Net Loss: ($211.5K) (+31.7%); Cash Burn: ($82.7K) (+68.0%).

https://seekingalpha.com/news/3478180-cns-pharmaceuticals-readies-ipo

Seattle Genetics up after hours on Q2 revenue beat

Seattle Genetics (NASDAQ:SGEN) Q2 results highlights:

Revenues: $218.4M (+28%); Adcetris sales: $159.0M (+30%).

Net loss: ($79.2M) (-204%).

2019 guidance: Total revenues: $805M – 855M from $790M – 840M; Adcetris sales: $610M – 640M (unch).

Shares are up 7% after hours.

https://seekingalpha.com/news/3478219-seattle-genetics-7-percent-hours-q2-revenue-beat