Benzinga's Daily Biotech Pulse: Insmed Presents Data, Pfenex Pulls Back On Offering, Oncolytics Listing

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 22)

• ArQule, Inc. ARQL
• AstraZeneca plc (ADR) AZN
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Momenta Pharmaceuticals, Inc. MNTA
• Recro Pharma Inc REPH
• Tecogen Inc TGEN
• Xencor Inc XNCR

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on May 22)

• Cellectar Biosciences Inc CLRB
• Nemaura Medical Inc NMRD (due to present at the UBS Healthcare Conference On Wednesday)

Stocks In Focus

Insmed Announces Results of Therapy For Bacterial Lung Disease

Insmed Incorporated INSM announced that preliminary data from a Phase 3 trial evaluating its amikacine liposome inhalation suspension, or ALIS, and guideline-based therapy, or GBT, for treating non-tuberculous mycobacterial lung disease showed that 30 percent of patients receiving ALIS met culture conversion criteria.

"The global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical significance," the company said.

The data was presented at the American Thoracic Society 2018 International Conference.

See Also: Celgene Forges Oncology Partnership With Germany's Evotec

Oncolytics Applies for Nasdaq Listing

Oncolytics Biotech, Inc. (USA) ONCYF, which is developing reolysin, an intravenously delivered immune-oncolytic virus turning cold tumors hot, announced it has applied for Nasdaq listing, and also consolidation of its outstanding common shares.

The consolidation is likely to shrink its outstanding shares from 142.40 million to 14.99 million.

Zimmer Secures Marketing Approval For Spinal Implant

Zimmer Biomet Holdings Inc ZBH said it has received 510(k) clearance from the FDA for its Zyston Strut Open Titanium Interbody Spacer System manufactured with a 3D printing process.

Pfenex Announces Common Stock Offering

Pfenex Inc PFNX announced a common stock offering to fund expenses related to obtaining regulatory approval, commercialization and launch of its PF708.

The stock slipped 8.7 percent to $6.30 after hours.

Ardelyx Prices Offering

Ardelyx Inc ARDX announced it has priced its offering of 12.50 million shares at $4 per share. The company divulged details of two ways of fund raising after the close Monday.

After closing down 19.47 percent in Tuesday's session, the stock shed an incremental 2.2 percent to $4.45.

FDA Tidbits

The FDA sent out warning letters to three marketeers of kratom products, namely Front Range Kratom, Kratom Sport and Revibe for illegal sales of unapproved kratom-containing drug products, falsely claiming that these help in treating opioid addiction and withdrawal. Kratom is a plant growing naturally in countries such as Thailand, Malaysia, Indonesia, and New Guinea. The FDA's exception to the product is that it is also addictive.

Separately, FDA Commissioner Scott Gottlieb issued a statement emphasizing the need to keep away from sun exposure in a bid to avoid skin cancer. The communication also highlighted the deleterious effects of pills and capsules sold as dietary supplements with false claims of protection from harms that come with sun exposure.