The Daily Biotech Pulse: Mixed Filgotinib Readout For Gilead-Galapagos, Akorn To File For Chapter 11, D-Day For Aquestive

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs on May 20.)

• ADC Therapeutics SA ADCT (went public May 15)
• Allogene Therapeutics Inc ALLO
• Ascendis Pharma A/S ASND (announced first-quarter results)
• Altimmune Inc ALT
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• Cue Biopharma Inc CUE (reacted to first-quarter results)
• Evoke Pharma Inc EVOK (announced FDA's conditional approval for the brand name Gimoti for its nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis)
• GENMAB A/S/S ADR GMAB
• I-Mab ADR IMAB
• Immunomedics, Inc. IMMU
• Intellia Therapeutics Inc NTLA
• Novo Nordisk A/S NVO
• PDL BioPharma Inc PDLI
• Pulmatrix Inc PULM
• Qiagen NV QGEN
• Soleno Therapeutics Inc SLNO
• Surface Oncology Inc SURF - announced an oncology partnership with Merck & Co., Inc. MRK
• VBI Vaccines Inc VBIV
• Zentalis Pharmaceuticals Inc ZNTL (announced $20-million Series A financing to establish a Chinese joint venture)

Down In The Dumps

(Biotech stocks that hit 52-week lows on May 20.)

• Genfit SA GNFT
• RA Medical Systems Inc RMED (priced its 22.22-million-share common stock offering at 45 cents per share)

Stocks In Focus

Gilead-Galapagos Drug Produces Mixed Results In Ulcerative Colitis Study

Gilead Sciences, Inc. GILD and GALAPAGOS NV/S ADR 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 Reports Positive Results For Midstage Study Of Osteoporosis Drug

Entera Bio Ltd 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. 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's NASH Drug Found Safe Enough To Advance Testing To Fourth Dose Level In Early Stage Study

Hepion Pharmaceuticals Inc 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 To Acquire New Clinical Packaging Facility In Japan

Catalent Inc 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 Pharma To Join S&P 500 Index

West Pharmaceutical Services Inc. WST said its shares have been selected to join the S&P 500 Index effective after the close of trading Thursday.

Synlogic Terminates Inflammatory Bowel Disease Drug Development Deal With AbbVie

Synlogic Inc SYBX announced the termination of its collaboration with AbbVie Inc 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 To File For Chapter 11 Bankruptcy

Akorn, Inc. 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-Astellas Anemia Drug Accepted For Regulatory Review In Europe

FibroGen Inc FGEN and ASTELLAS PHARMA/ADR 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.

Offerings

Flexion Therapeutics Inc 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 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 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

PDUFA Dates

The FDA is due to rule on Aquestive Therapeutics Inc's 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.

Earnings

• Medtronic PLC MDT (before the market open)
• PAVmed Inc PAVM (after the close)
• Xenon Pharmaceuticals Inc XENE (after the close)

Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan Stanley