Xeris Pharma launches Gvoke HypoPen for hypoglycemia in the U.S.

Xeris Pharmaceuticals (NASDAQ:XERS) announces that Gvoke HypoPen (glucagon injection) is now available by prescription in the U.S. for the treatment of severe hypoglycemia in adults and children with diabetes ages 2 years and above.

Gvoke HypoPen is available in two doses: 0.5 mg/0.1 mL for children (who weigh less than 100 pounds) and 1 mg/0.2 mL for adolescents and adults (who weigh 100 pounds or greater).

For a limited time, eligible commercially-insured patients may pay $0 for a two-pack of Gvoke HypoPen by using the Gvoke copay savings card.

https://seekingalpha.com/news/3587660-xeris-pharma-launches-gvoke-hypopen-for-hypoglycemia-in-u-s

Blueprint Medicines files U.S. application for pralsetinib for thyroid cancer

Blueprint Medicines (NASDAQ:BPMC) has submitted a marketing application to the FDA seeking approval of RET inhibitor pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancers.

The filing was made under the agency’s Real-Time Oncology Review pilot program.

The company’s applications for RET-altered non-small cell lung cancer are currently under review in the U.S. and Europe.

https://seekingalpha.com/news/3587669-blueprint-medicines-files-u-s-application-for-pralsetinib-for-thyroid-cancer

ScPharma refiles Furoscix application in U.S.

July 1, 2020

Rebounding from the Complete Response Letter (CRL) it received in June 2018, scPharmaceuticals (NASDAQ:SCPH) has resubmitted its U.S. marketing application seeking approval of Furoscix (subcutaneous furosemide) for the treatment of congestion in heart failure patients.

The CRL cited the need for additional human factor studies and device modifications.

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

https://seekingalpha.com/news/3587677-scpharma-refiles-furoscix-application-in-u-s

Inovio down as two downgrades hit

Inovio (NASDAQ:INO) dropped 15% yesterday following positive results from its Phase 1 trial for Covid-19 DNA vaccine candidate INO-4800. The dip perhaps was to have been expected, with investors selling the news following the fast run higher in the stock leading up to the trial results.

“This preliminary data is likely to raise more questions,” says Stifel’s Stephen Willey, who is waiting for the full results to appear in a peer-reviewed journal before joining the bulls on the stock.

Roth’s Jonathan Aschoff, meanwhile, is “not encouraged” by the “very limited” data, and the absence of immune response details. “We are unimpressed that further preclinical work is required, rather than proceeding straight to later stage trials.” He downgrades to Sell from Neutral, continuing with an $11 price target, suggesting more than 50% downside.

The bulls at Maxim – noting a 700% run higher in the stock this year – downgrade to Hold from Buy.

https://seekingalpha.com/news/3587684-inovio-down-nearly-another-10-two-downgrades-hit

Rhythm Pharma nabs rare ped disease tag for obesity med

The FDA has granted Rare Pediatric Disease Designation to Rhythm Pharmaceuticals’ (NASDAQ:RYTM) setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.

POMC is an inherited disorder characterized by severe obesity due to overeating to satisfy chronic hunger.

LEPR is also characterized by severe obesity due to same urge to satisfy chronic hunger.

Rare Pediatric Disease Designation provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.

Setmelanotide activates a protein called melanocortin 4 receptor (MC4R) that plays a key role in controlling appetite.

https://seekingalpha.com/news/3587685-rhythm-pharma-nabs-rare-pediatric-disease-tag-for-setmelanotide-for-obesity-disorders

Qualigen to start selling COVID-19 antibody test mid-July

Qualigen Therapeutics (NASDAQ:QLGN) is up 46% premarket after submitting an official notification to the FDA to commence sales of its FastPack SARS-CoV-2 IgG test for COVID-19 antibodies in the U.S.

This test has already been submitted for Emergency Use Authorization (EUA) but the notification enables the company to commence sales even before the FDA considers or formally grants the emergency use nod.

Qualigen expects sales and shipments of the new test to begin in mid-July.

It is designed for use with the company’s new FastPack PRO System point-of-care diagnostic instruments.

https://seekingalpha.com/news/3587687-qualigen-to-start-selling-covidminus-19-antibody-test-mid-july

Geron set to nab Europe orphan drug tag for imetelstat for bone marrow disorder

The European Medicines Agency’s Committee for Orphan Medicinal Products has issued a positive opinion backing Orphan Drug status for Geron’s (NASDAQ:GERN) imetelstat for the treatment of myelodysplastic syndromes, a rare group of bone marrow failure disorders.

Among the benefits of Orphan Drug status in Europe is a 10-year period of market exclusivity for the indication, if approved.

https://seekingalpha.com/news/3587696-geron-poised-to-nab-orphan-drug-tag-in-europe-for-imetelstat-for-bone-marrow-disorder