Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week highs on March 27)
- Baxter International Inc BAX
- Catalyst Pharmaceuticals Inc CPRX
- Constellation Pharmaceuticals Inc CNST
- Novartis AG NVS(announced FDA approval for a new drug for a more severe form of multiple sclerosis)
Down In The Dumps
(Biotech stocks hitting 52-week lows on March 27)
- Achaogen Inc AKAO
- Adamas Pharmaceuticals Inc ADMS
- Aerpio Pharmaceuticals Inc ARPO
- Fennec Pharmaceuticals Inc FENC
- ImmuCell Corporation ICCC(announced pricing of common stock offering)
- KemPharm Inc KMPH
- Moleculin Biotech Inc MBRX (priced its common stock offering)
- Neovasc Inc NVCN
- RA Medical Systems Inc RMED
Stock In Focus
Blueprint To Expedite Clinical Programs And Offer $300M Worth Of Shares
Blueprint Medicines Corp BPMC said it plans to expedite development of avapritinib, BLU-667 and BLU-782 following recent clinical progress and interactions with regulatory authorities. Separately, the company said it has commenced an underwritten public offering of $300 million shares, with all the shares to be offered by the company.
The stock fell 3.04 percent to $77.45 in after-hours trading.
Akari's Eye Inflammation Drug Found Effective Over Longer Duration
Online abstract of updated Phase 1/2 data for Akari Therapeutics PLC AKTX's Coversin for eye surface inflammatory disease, to be presented at the 2019 annual meeting of the Association for Research in Vision and Ophthalmology, or ARVO, showed that Coversin, dosed topically once a day, maintained the same anti-inflammatory efficacy over 12 days. The ARVO is scheduled to be held between April 28 and May 2.
Presentation done at ARVO in 2018 showed equivalence with the gold standards, topical corticosteroids and cyclosporin, over a 4-day treatment period.
The company also said it will present a poster at ARVO showing Coversin's effect in a preclinical model of autoimmune uveitis, a back of the eye orphan disease with significant unmet need.
The stock rallied 4.99 percent to $3.79 in after-hours trading.
ACADIA Announces Publication of Positive Phase 2 Data For Neurlogical Disorder Drug
ACADIA Pharmaceuticals Inc. ACAD and partner Neuren Pharma, along with the Rettsyndrome.org, announced that positive Phase 2 results from a study that evaluated trofinetide in females with Rett syndrome has been published in Neurology, the medical journal of the American Academy of Neurology.
The study that evaluated 82 females with Rett syndrome aged between 5 and 15 years in a double-blind, placebo-controlled study showed that the highest dose, 200 mg/kg twice daily, achieved statistically significant improvement compared to placebo on three of five syndrome-specific efficacy measures.
There is no FDA-approved therapy for the Rett syndrome, which is a condition that leads to severe neurological impairments.
The stock advanced 2.90 percent to $26.99 in after-hours trading.
See Also: 6 Gene Therapy M&A Targets On The Radar
Amarin Adds To Regular Session Gains
Amarin Corporation plc AMRN gained in the regular session Wednesday after the American Diabetes Association included the company's Vascepa to its 2019 Standards of Care list for the reduction of cardiovascular risk in diabetic patients with atherosclerotic CV disease or other risk factors who have elevated triglycerides and are currently on statin therapy with controlled "bad" cholesterol.
The inclusion will make it easier for Vascepa to be included in the payers' formularies.
After rallying 3.14 percent, the shares rose 5.42 percent to $19.06 in after-hours trading.
HTG Molecular Announces Availability of New Gene Expression Analysis Panel
HTG Molecular Diagnostics Inc HTGM announced the release of a new HTG EdgeSeq Mouse mRNA Tumor Response Panel, in the U.S. and Europe. The new panel is used in mouse oncology models to identify and quantify expression of genes and gene pathways from a variety of sample types.
"The HTG EdgeSeq Mouse mRNA Tumor Response Panel is designed to measure over 1,600 mouse mRNA targets in one RNA extraction-free assay," the company said.
The stock rose 2.41 percent to $2.55 in after-hours trading.
Eyepoint To Offer Shares
Eyepoint Pharmaceuticals Inc EYPT intends to offer shares of its common stock in an underwritten public offering. All shares are to be sold by the company. The company said it intends to use the net proceeds to fund the commercialization of Dexycu and Yutiq, among other things.
The stock retreated 9.50 percent to $2 in after-hours trading.
Cyclacel Pharmaceuticals Inc CYCC reported fourth-quarter revenues of $0.2 million compared to nil revenues a year ago. The company's net loss per share narrowed from $1.95 to 62 cents.
As of Dec. 31, 2018, the company had cash and cash equivalents totaling $17.5 million, not including $4.1 million in net proceeds from a common stock sales agreement.
The stock fell 4.11 percent to 86 cents in after-hours trading.
On The Radar
- Vascular Biogenics Ltd VBLT (before the market open)
- Tricida TCDA (before the market open)
- Rubius Therapeutics Inc RUBY (before the market open)
- Unum Therapeutics Inc UMRX
- Tricida Inc TCDA (before the market open)
- Achaogen Inc AKAO (after the market close)
- Biocept Inc BIOC (after the market close)
- NovaBay Pharmaceuticals, Inc. NBY (after the market close)
- Vermillion, Inc. VRML (after the market close)
- Capricor Therapeutics Inc CAPR (after the market close)
Precision Biosciences, a genome editing biotech, has priced its initial public offering of 7.9 million shares at $16, within the estimated price range of $15-$17. The shares of the company will be listed on the Nasdaq under the ticker symbol DTIL.
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