The Daily Biotech Pulse: Valneva's COVID-19 Vaccine Filing Accepted By EMA, Enanta's RSV Candidate Fails, Orphan Drug Tag For Mersana's Gastric Cancer Candidate

Zinger Key Points
  • The FDA has granted orphan drug designation to Mersana Therapeutics' XMT-2056 for the treatment of gastric cancer.
  • Adamis Pharmaceuticals has appointed David Marguglio, co-founder and chief business officer, as the president and CEO effective immediately.

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

Stocks In Focus

Enanta's RSV Candidate Fails In Low-Risk Patient Population 

Enanta Pharmaceuticals Inc's ENTA EDP-938 failed to reduce the total symptom score compared to placebo in healthy adults with community-acquired Respiratory Syncytial Virus (RSV). 

In this low-risk patient population, a statistically significant difference in the number of subjects achieving undetectable RSV RNA at the end of treatment at day five was observed.

Recruitment is ongoing in pediatric and hematopoietic cell transplant RSV patients. Enanta expects to initiate an additional Phase 2b study in a high-risk adult population by the end of 2022.

Shares moved 17.3% lower to $38 during after-hours trading.

Valneva's COVID-19 Vaccine Filing Accepted By EMA

The European Medicines Agency (EMA) has accepted Valneva SE's VALN marketing application seeking approval for its COVID-19 vaccine candidate, VLA2001. 

VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). 

If the CHMP accepts Valneva's conditional marketing authorization application, Valneva confirms it would expect to receive a positive CHMP opinion in June 2022.

Adamis Announces CEO Transition

Adamis Pharmaceuticals Corporation ADMP has appointed David Marguglio, co-founder and chief business officer, as the president and CEO effective immediately.

Dennis Carlo has retired as the president, CEO and director.

Marguglio will continue his director role. A search has commenced to identify an independent director to fill the vacancy resulting from Carlo's retirement.

Evotec, Almirall Ink Multitarget Dermatology Pact

Evotec SE EVO and Almirall SA LBTSF have collaborated to discover and develop novel therapeutics for severe skin diseases.

Evotec will be responsible for drug discovery and preclinical development. Almirall will lead the clinical development and marketing.

Under the agreement, Evotec receives an undisclosed upfront payment, research payments, and milestone-based payments of up to 230 million euros ($241 million) per program.

Mersana's Gastric Cancer Candidate Gets FDA Orphan Drug Tag

The FDA has granted orphan drug designation to Mersana Therapeutics Inc's MRSN XMT-2056, the company's lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer.

Mersana plans to initiate a Phase 1 trial of XMT-2056 in a range of HER2-expressing tumors in mid-2022.

Shares are up 10% at $3.62 during the premarket session.

Ocuphire's Night Blindness Candidate Shows Efficacy In Late-Stage Study

Ocuphire Pharma Inc OCUP announced topline results from the LYNX-1 Phase 3 trial of Nyxol for night (or dim light) vision disturbances, demonstrating efficacy.

"LYNX-1 represents our sixth consecutive positive data readout for Nyxol in several indications ... In alignment with our overall clinical priorities, and while we plan for a future LYNX trial as needed next year, we will focus on the pivotal trials for presbyopia and the NDA submission and pre-commercial activities for Nyxol in the reversal of mydriasis (RM)," said Mina Sooch, founder and CEO.

Insider Trading

Mersana Therapeutics Inc MRSN: Director Andrew Hack reported purchasing 350,000 shares at $3.25/share in a Form 4 filing.

Kodiak Sciences Inc KOD: Director Felix Baker reported purchasing 456,690 shares at $5.91/share in a Form 4 filing.

Clinical Readouts/Presentations

Chinook Therapeutics Inc KDNY: Three mini-oral presentations on the BION-1301 and atrasentan clinical programs at the ERA Congress 2022.

Ultragenyx Pharmaceutical Inc RARE: Sustained efficacy and safety from Phase 1/2 trial of DTX401 at week 52 and up to three years in glycogen storage disease Type Ia, at the American Society of Gene & Cell Therapy Annual Meeting.

Mustang Bio Inc MBIO: Interim results from Phase 1/2 study of lentiviral gene therapy in X-Linked Severe Combined Immune Deficiency at the American Society of Gene & Cell Therapy Annual Meeting.

Voyager Therapeutics Inc VYGR: New preclinical data on a family of AAV9-derived TRACER capsids demonstrating cross-species central nervous system transduction at the American Society of Gene and Cell Therapy Annual Meeting.

Rocket Pharmaceuticals Inc RCKT: Topline safety and efficacy data from phase 2 trial of RP-L201 in severe Leukocyte Adhesion Deficiency-I at the American Society of Gene and Cell Therapy Annual Meeting.

On The Radar

Earnings

Thermogenesis Holdings Inc THMO: Before the market open.

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