Benzinga's Daily Biotech Pulse: Melinta, Ardelyx Pull Back On Offerings, Insys Awaits FDA Verdict

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 May 21)

• AstraZeneca plc (ADR) AZN (FDA approved its hyperkalaemia drug Lokelma)
• Atara Biotherapeutics Inc ATRA
• Bio-Rad Laboratories, Inc. BIO
• Boston Scientific Corporation BSX
• Haemonetics Corporation HAE
• Inspire Medical Systems Inc INSP
• Merit Medical Systems, Inc. MMSI
• T2 Biosystems Inc TTOO

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on May 21)

• Altimmune Inc ALT
• Calithera Biosciences Inc CALA
• Celgene Corporation CELG
• Edge Therapeutics Inc EDGE
• Immune Pharmaceuticals Inc IMNP
• Jounce Therapeutics Inc JNCE
• Mustang Bio Inc MBIO
• Stellar Biotechnologies Inc SBOT

Related Link: The Week Ahead In Biotech: PDUFA Dates, IPOs And More

Stocks In Focus

Amgen's Osteoporosis Drug Approved

Amgen, Inc. AMGN announced that the FDA approved its Prolia – chemically denosumab – to treat glucocorticoid-induced osteoporosis in men and women at high risk of fracture, or patients who have failed, or are intolerant to other available osteoporosis therapy.

The company said the approval is based on a late-stage study that showed patients who received Prolia had greater gains in bone mineral density relative to those who received active comparator.

Melinta Announces Stock Offering

Melinta Therapeutics, Inc. MLNT announced the commencement of a common stock offering to raise aggregate proceeds of $75 million. All the stocks sold in the offering are sold by the company.

Melinta slumped 8.9 percent to $6.65 after hours.

Ardelyx to Offer Common Stock, Inks Loan Agreement

Ardelyx Inc ARDX said it has commenced an offering of upto $50 million worth of shares, with all shares being offered by the company. Separately, the company said it has reached a loan agreement with Solar Capital and Bridge Bank to raise $50 million in loan.

The stock shed 8.85 percent to $5.15 after hours.

On The Radar

The FDA will announce its decision on Insys Therapeutics Inc INSY's NDA for buprenorphine to treat moderate-to-severe post-operative pain after bunionectomy.

Catalyst Biosciences Inc CBIO is set to present Phase 1/2 data for its hemophilia B treatment combo CB2679d/ISU304 at the World Federation of Hemophilia (WFH) World Congress.

BioMarin Pharmaceutical Inc. BMRN is scheduled to present Phase 2 data on its hemophilia B treatment candidate valoctocogene roxaparvovec at the WFH.