The Daily Biotech Pulse: Poseida's Phase 1 Study Placed On Clinical Hold, Orphan Drug Designation For Krystal Biotech, Tiziana's Patent Award

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 17)

• Catalent Inc CTLT
• CureVac N.V. CVAC (follow-on buying after a 250% advance on its debut Friday)
• Fortress Biotech FBIO
• Inari Medical Inc NARI
• Inozyme Pharma Inc INZY
• iTeos Therapeutics Inc ITOS
• Kura Oncology Inc KURA
• Merit Medical Systems, Inc. MMSI
• Mesoblast limited MESO
• Mirati Therapeutics Inc MRTX
• Natera Inc NTRA
• Nurix Therapeutics Inc NRIX
• Pacific Biosciences of California Inc PACB
• Pacira Biosciences Inc PCRX
• PDL BioPharma Inc PDLI
• Principia Biopharma Inc PRNB - announced a deal to be bought by Sanofi SA SNY for $3.7 billion
• Qiagen NV QGEN
• Shockwave Medical Inc SWAV
• Silk Road Medical Inc SILK
• Syros Pharmaceuticals Inc SYRS
• TFF Pharmaceuticals Inc TFFP
• Vaxcyte Inc PCVX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 17)

• Burning Rock Biotech Ltd BNR
• Eyepoint Pharmaceuticals Inc EYPT
• NanoVibronix Inc NAOV
• Polypid Ltd PYPD
• Unity Biotechnology Inc UBX (reacted to a failed midstage study of lead asset in painful osteoporosis of knee)

Stocks In Focus

Krystal's Cystic Fibrosis Drug Lands Orphan Drug Designation

Krystal Biotech Inc KRYS said the FDA has granted orphan drug designation to KB407, which is in preclinical development for the treatment of cystic fibrosis.

"We are excited by the results of the in vitro data thus far, as presented at ASGCT earlier this year, and we look forward to sharing in vivo animal data later this year," Suma Krishnan, the founder and COO of Krystal, said in a statement. 

The stock rose 4.89% to $47 in after-hours trading.

Poseida's Phase 1 Prostate Cancer Study Placed On Clinical Hold

Poseida Therapeutics, Inc. PSTX said the FDA has placed on clinical hold its Phase 1 trial for PSMA-101 in metastatic castrate-resistant prostate cancer. The clinical hold is due to the death of a patient who failed treatment with multiple anti-cancer agents and was treated with PPSMA-101 in late July.

The patient developed symptoms consistent with macrophage activation syndrome, a serious and potentially fatal overactivation of the immune system that has been associated with CAR-T therapies, but can have other causes such as infection and autoimmune disease. The patient also developed blurred vision, which was diagnosed as uveitis. The clinical investigator has assessed the serious adverse event as possibly related to P-PSMA-101 pending further investigation, the company said.

The stock was down 24.23% at $9.85 premarket Tuesday.

See also: The Week Ahead In Biotech: Spotlight On Gilead, BioMarin FDA Decisions, IPOs

Gilead Expands Cancer Drug Collaboration With Tango

Gilead Sciences, Inc. GILD and Tango Therapeutics announced an expansion to their 2018 strategic collaboration focused on innovative targeted immune evasion therapies for patients with cancer.

Under the expanded collaboration, Tango will continue to leverage its CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The number of targets covered will expand from five to 15. Gilead will have options to worldwide rights for programs directed at these targets over the next seven years.

The terms of the expanded agreement call for Gilead making a $125-million upfront payment to Tango and a $20-million equity investment. In addition, Gilead will have the right to option up to 15 programs over the seven-year collaboration for up to $410 million per program in opt-in, extension and milestone payments.

Tango will also be eligible to receive up to low double-digit tiered royalties on net sales.

Gilead shares were trading 0.48% higher at $69.48 premarket Tuesday.

Tiziana Granted Patent For Crohn's Disease Treatment

TIZIANA LF SCIE/S ADR TLSA said the U.S. Patent and Trademark Office has granted a patent for the use and methods of treatment of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies .

In premarket trading Tuesday, Tiziana shares were jumping 14.32% to $4.63.

Lilly, Innovent Expand Cancer Drug Licensing Agreement

Eli Lilly And Co LLY announced a global expansion of their strategic alliance for Tyvyt, an anti-PD-1 monoclonal antibody immuno-oncology medicine that was co-developed by Innovent and Lilly in China.

Under the terms of the expanded license agreement, Lilly will obtain an exclusive license for Tyvyt for geographies outside of China and plans to pursue registration of it in the U.S. and other markets.

In return, Innovent will receive an upfront payment of $200 million and will be eligible for up to $825 million in potential development and commercial milestones, as well as tiered double-digit royalties on net sales.

NovaBay Announces Availability Of Facial Sanitizer On Walmart.com

NovaBay Pharmaceuticals, Inc. NBY announced the launch of Avenova on Walmart Inc's WMT online store, increasing the availability of its unique facial sanitizer, which is confirmed through independent laboratory testing to kill the SARS-CoV-2 virus on hard surfaces.

Avenova is FDA-cleared, non-toxic and gentle enough for daily use on the sensitive skin around the eyes, nose and mouth, according to the company. 

In premarket trading Tuesday, NovaBay shares were soaring 33.33% to $1.28.

Vanda Reports Positive Interim Late-Stage Readout For COVID-19 Study

Vanda Pharmaceuticals Inc. VNDA said an interim analysis of the Phase 3 ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia improved sooner when treated with tradipitant as compared to placebo.

This finding was based on a preliminary analysis of the first 60 patients enrolled in the ODYSSEY study of tradipitant in COVID-19 pneumonia.

In premarket trading Tuesday, the stock was rallying 11.59% to $13. 

Earnings

Adamis Pharmaceuticals Corp ADMP reported $8.6 million in revenue for the six months ended June 30, 2020, a year-over-year decline from $10.7 million. 

"The COVID-19 pandemic has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians' offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC's customers for certain of USC's products," the company said.

The stock was down 6.5% premarket at 88 cents. 

Offerings

Translate Bio Inc TBIO filed with the SEC regarding the sale from time to time of up to 4.884 million shares of its common stock by certain selling stockholders to which the shares were issued in a private placement. The company said it will not receive any proceeds from the sale of the shares.

The stock slid 3.47% to $15.32 in after-hours trading.

On The Radar

Earnings

• ADC Therapeutics SA ADCT (before the market open)
• PAVmed Inc PAVM (after the close)
• Supernus Pharmaceuticals Inc SUPN (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates