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Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech stocks that hit 52-week highs Nov. 13.)
(Biotech stocks that hit 52-week lows on Nov. 13.)
Eli Lilly And Co (NYSE:LLY) and Boehringer Ingelheim said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 against the approval of their empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes.
"We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process," the companies said.
See also: Biotech Stock On The Radar: Alkermes At A Crossroads
Pfenex Inc (NYSE:PFNX) said its CFO Susan Knudson has resigned effective Wednesday, citing personal reasons. Knudson will support during the transition period until Feb. 1, 2020, the company said.
Updating on the minutes it received following the pre-NDA meetings with the FDA regarding migraine treatment Qtrypta, Zosano Pharma Corp (NASDAQ:ZSAN) said it believes the information included in its planned NDA will be sufficient for the FDA to file the NDA for substantive review.
The company had two meetings with the FDA: a face-to-face meeting held in September to discuss the non-clinical and clinical portions of the program and a second pre-NDA meeting to discuss chemistry control and manufacturing.
The company expects to file the NDA in December.
The stock rallied 10.34% to $2.24 in pre-market trading.
Fulgent Genetics Inc (NASDAQ:FLGT) said it has priced its previously announced underwritten public offering of 2.325 million shares at $11.25 each. The company expects to raise gross proceeds of about $26.2 million from the offering. The offering is expected to close Nov. 18.
The stock fell 12.46% to $11.94 in after-hours trading.
Kadmon Holdings Inc (NYSE:KDMN) announced a public offering of shares of its common stock. The company expects to use the proceeds primarily to fund the clinical development of its lead product candidates and R&D.
The stock was down 1.69% at $3.50 in Thursday's premarket session.
Phio Pharmaceuticals Corp (NASDAQ:PHIO) said it has commenced a proposed public offering of shares. All the shares earmarked for the offering are to be sold by the company.
The company said it plans to use the net proceeds to fund the development of its oncology programs, for R&D activities and general working capital needs.
The stock was down 24.7% at 20 cents in Thursday's premarket session.
Lipocine Inc (NASDAQ:LPCN), which recently faced a FDA rejection of its lead male sex hormone deficiency drug, said it has launched a public offering of units consisting of shares of its common stock and warrants to purchase its common stock.
The stock was falling 29.87% to 48 cents in the premarket session.
Edap Tms SA (NASDAQ:EDAP) said its third-quarter revenue climbed 26.7% year-over-year to $11.3 million. The company reversed from a loss of $800,000 in the third quarter of 2018 to a profit of $900,000. The bottom-line results were below expectations.
The stock was down 8.75% at $4.38 in premarket trading.
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC)'s third-quarter net loss narrowed from 18 cents per share in 2018 to 11 cents per share in 2019. Analysts had estimated a loss of 16 cents per share.
As of Sept. 30, the company has cash and cash equivalents of $13 million.
The stock was up 13.39% at 42 cents in the premarket session.
FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss Amarin Corporation plc (NASDAQ:AMRN)'s sNDA for Vascepa for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease.
The briefing document released Monday ahead of the panel vote showed deliberations in line with expectations.
Jaguar Health Inc (NASDAQ:JAGX) and Roche Holdings AG Basel ADR (OTC:RHHBY) are scheduled to release updated Phase 2 data for mytesi in cancer-related diarrhea.
2019 Connective Tissue Oncology Society Annual Meeting Presentations
Deciphera Pharmaceuticals Inc (NASDAQ:DCPH): initial Phase 1 data for DCC-3014 in solid tumors
Related Link: The Week Ahead In Biotech: Adcom Test For Amarin's Fish Oil Pill, Agile Awaits FDA Verdict
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