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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 on May 20.)
(Biotech stocks that hit 52-week lows on May 20.)
Gilead Sciences, Inc. (NASDAQ:GILD) and GALAPAGOS NV/S ADR (NASDAQ:GLPG) announced top-line results from the Phase 2b/3 trial evaluating the efficacy and safety of filgotinib in adult patients with moderately to severely active ulcerative colitis showing mixed results.
The topline data showed that filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at week 10 and maintaining clinical remission at week 58 in a significantly higher proportion of patients compared with placebo, while the 100mg dose did not achieve statistically significant clinical remission at week 10.
Gilead shares were down 1.07% at $73.10 in Thursday's premarket session, while Galapagos shares were down 5.98% at $208.04.
Entera Bio Ltd (NASDAQ:ENTX) announced interim limited biomarker data from the ongoing Phase 2 clinical trial of EB613 in osteoporosis patients, with the study demonstrating statistically significant effects on the P1NP biomarker after one month of treatment as compared to placebo, and meaningful increases at months two and three as compared to placebo with the highest EB613 dose of 1.5mg.
Based on the favorable safety profile for patients on EB613 in the ongoing Phase 2 study, the company said it intends to evaluate additional doses greater than 1.5mg to advance into a potential Phase 3 study, if appropriate.
The company reported first-quarter results, posting revenue of $42,000 solely from R&D services provided to Amgen, Inc. (NASDAQ:AMGN) versus no revenue in the year-ago quarter. The loss per share narrowed from 26 cents to 16 cents.
The stock was down 12.28% at $2.50 in the premarket session.
Hepion Pharmaceuticals Inc (NASDAQ:HEPA) announced the advancement to the fourth dose level in its ongoing Phase 1b multiple ascending dose study of CRV431.
The open-label MAD study is designed to assess the safety, tolerability and pharmacokinetics of CRV431 administered orally to healthy volunteers once daily for 28 days.
With the study having assessed the 75mg, 150mg and 225mg doses, the Clinical Trial Management team has reviewed the 225mg cohort data and determined this dosing level to be safe and well-tolerated, authorizing advancement to the next dosing level of 300mg daily for 28 days.
The stock was up 7.07% at $1.97 premarket.
See also: The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows
Catalent Inc (NYSE:CTLT), a CDMO, announced a deal to acquire a clinical packaging facility in Minakuchi, located in the Shiga prefecture of Japan, from Teva-Takeda Pharmaceuticals. This purchase will establish a new clinical GMP manufacturing and distribution hub to support clinical studies. The deal is expected to close July 1. The companies did not disclose the financial terms of the deal.
West Pharmaceutical Services Inc. (NYSE:WST) said its shares have been selected to join the S&P 500 Index effective after the close of trading Thursday.
Synlogic Inc (NASDAQ:SYBX) announced the termination of its collaboration with AbbVie Inc (NYSE:ABBV) for the development of synthetic biotic medicines for the potential treatment of inflammatory bowel disease.Upon termination, Synlogic regains all rights to develop these and new IBD Synthetic Biotic medicines for all effectors targeting IBD.
Akorn, Inc. (NASDAQ:AKRX) said it and its U.S. subsidiaries filed for Chapter 11 bankruptcy protection to execute an in-court sale of its business while addressing litigation-related overhangs and best positioning the business for long-term success under new ownership.
In connection with the filing, the company said it has executed a restructuring support agreement with lenders representing more than 80% of its secured debt that will collectively serve as a "stalking horse" bidder in the company's sale process and provide additional liquidity to fund the company's business operations during this process.
The stock was plunging 26.08% at 21 cents in the premarket session.
FibroGen Inc (NASDAQ:FGEN) and ASTELLAS PHARMA/ADR (OTC:ALPMY) said the marketing authorization application for roxadustat for the treatment of anemia in adult patients with chronic kidney disease has been accepted by the European Medicines Agency for regulatory review.
Flexion Therapeutics Inc (NASDAQ:FLXN) said it has commenced an underwritten public offering of $75 million in shares of its common stock.
The stock was slipping 5.68% at $10.30 in the premarket session.
Boston Scientific Corporation (NYSE:BSX) said it has commenced concurrent offerings of $750 million in shares of its common stock and $750 million of shares of its Series A Mandatory Convertible Preferred Stock.
The stock was down 3.17% at $36 premarket.
Scpharmaceuticals Inc (NASDAQ:SCPH) priced an underwritten public offering of 5.78 million shares at $8.65 each to raise gross proceeds of $50 million. All the shares are being offered by the company. The offering is expected to close May 26.
In premarket trading, Scpharmaceuticals shares were down 16.81% at $9.01.
On The Radar
The FDA is due to rule on Aquestive Therapeutics Inc's (NASDAQ:AQST) NDA for apomorphine sublingual film (APL-130277), which is being evaluated for treating off episodes in Parkinson's disease patients. APL-130277 is being developed by Sunovion Pharmaceuticals, a subsidiary of Sumitomo Dainippon Pharma, and it is being evaluated in partnership with Aquestive.
Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan Stanley
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