BPTH On Steady Path, CGIX On Watch, GLPG/GILD Scrap IPF Drug, REGN’s Libtayo Gets FDA Nod

Today’s Daily Dose brings you news about Bio-Path’s patented DNAbilize platform technology, Cancer Genetics’ stock offering, Galapagos/Gilead scrapping Ziritaxestat and FDA approving the expanded approval of Regeneron’s Libtayo.

Read on…

1. Bio-Path On A Steady Path

Bio-Path Holdings Inc. (BPTH) has been granted the third U.S. patent, expanding the protection of its DNAbilize platform technology that helps to deliver DNA therapeutics directly to cancer cells.

In addition, the company is expected to be issued a patent related to its lead product candidate, Prexigebersen, in combination with either a cytidine analogue, such as decitabine, or the Bcr-Abl tyrosine kinase inhibitors dasatinib and nilotinib, on February 23, 2021.

Prexigebersen is in a Phase 2 study for blood cancers and Prexigebersen-A, a drug product modification of Prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors.

BPTH closed Wednesday’s trading at $11.77, up 126.35%.

2. Cancer Genetics On Watch

Cancer Genetics Inc. (CGIX) has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise approximately $17.5 million through the issuance of 2.78 million shares of its common stock at a purchase price of $6.30 each.

The closing of the offering is expected to occur on or about February 16, 2021.

CGIX closed Wednesday’s trading at $8.60, up 49.05%.

3. Galapagos/ Gilead Scrap Development of Ziritaxestat

Shares of Galapagos NV (GLPG) touched a new 52-week low on Wednesday, on news of the phase III clinical studies with the investigational autotaxin inhibitor Ziritaxestat in patients with idiopathic pulmonary fibrosis, dubbed ISABELA, being halted based on the recommendations of the Independent Data Monitoring Committee.

The ISABELA Phase 3 program consists of two identically designed trials, ISABELA 1 & 2, aiming to enroll 1,500 idiopathic pulmonary fibrosis patients combined. The study participants were randomized to receive either 200mg or 600mg Ziritaxestat once daily or placebo.

Ziritaxestat was discovered by Galapagos and Gilead in-licensed ex-European rights to the compound in July 2019 and commenced sharing the Phase 3 development costs.

The independent Data Monitoring Committee, which reviewed unblinded data, concluded that Ziritaxestat’s benefit-risk profile no longer supported continuing the studies.

All clinical trials with Ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued, the companies noted.

GLPG slumped to a new 52-week low of $89 in intraday trading, before closing at $89.90, down 17.76%.

4. FDA Approves Expanded Label of Regeneron’s Libtayo

The FDA has approved Regeneron Pharmaceuticals Inc. (REGN) and Sanofi’s Libtayo for patients with advanced basal cell carcinoma.

The drug has been granted full approval for patients with locally advanced basal cell carcinoma and accelerated approval for patients with metastatic BCC.

Libtayo is currently under Priority Review by the FDA for advanced non-small cell lung cancer with “more than or equal to 50%” PD-L1 expression, with a decision expected on February 28, 2021.

The drug received its first FDA approval in 2018 for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

In the U.S., Libtayo recorded sales of $74.1 million in the fourth quarter of 2020, compared to $60.5 million in the year-ago period.

REGN closed Wednesday’s trading at $491.22, up 0.11%.

5. Stocks That Gained/Lost the Most in the Day

Anchiano Therapeutics Ltd. (ANCN) closed Wednesday’s (Feb.10, 2021) trading at $7.96, up 187.36%.

Zynerba Pharmaceuticals, Inc. (ZYNE) closed at $8.76, up 47.10%.

111, Inc. (YI) closed at $26.07, up 43.24%.

Panbela Therapeutics Inc. (PBLA) closed at $6.02, down 26.59%.

Enlivex Therapeutics Ltd. (ENLV) closed at $19.18, down 20.08%.

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