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The Daily Biotech Pulse: Third FDA Rejection For Verrica's Skin Disease Drug, Assembly Bio Terminates Hepatitis B Virus Pact, Consistency Data For Valneva's Chikungunya Vaccine

Here’s a roundup of top developments in the biotech space over the last 24 hours.

The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc’s VRCA marketing application for VP-102 for molluscum contagiosum.

The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services LLC, the contract manufacturing organization that manufactures Verrica’s bulk solution drug product. 

Shares are slipping 58.6% at $2.30 during the premarket session.

Privately-held Antios Therapeutics Inc’s ATI-2173 has been placed on FDA clinical hold following a safety report involving a patient who received a triple combination of vebicorvir, ATI-2173, and a nucleos(t)ide analog reverse transcriptase inhibitor for chronic hepatitis B virus infection.

Effective May 20, because of the clinical hold, Antios has terminated the clinical trial collaboration agreement with Assembly Biosciences Inc ASMB, announced in October 2021.

CureVac BV CVAC and myNEO., a Belgium-based immunotherapy company, have entered into a research and option agreement to identify specific antigens on tumor surfaces to develop novel mRNA immunotherapies. 

myNEO will leverage its biological datasets and its integrated machine learning and bioinformatics platform to identify and validate specific antigen targets predicted to elicit a strong immune response.

Related: The Week Ahead In Biotech: Verrica, Bristol-Myers Squibb FDA Decisions, Medtronic Earnings, Conference Presentations & More

Valneva SE VALN has completed the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. 

The final analysis included six-month follow-up data.

The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.

Crinetics Pharmaceuticals Inc CRNX announced results from the multiple ascending dose portion of the Phase 1 study of CRN04894 for Cushing’s disease, congenital adrenal hyperplasia, and other conditions of excess ACTH.

Results showed serum cortisol below normal levels and a marked reduction in 24-hour urine-free cortisol excretion in the presence of sustained, disease-like ACTH concentrations.

The FDA has granted Fast Track designation to Elevation Oncology Inc’s ELEV seribantumab for advanced solid tumors that harbor NRG1 gene fusions.

The FDA has accepted Phathom Pharmaceuticals Inc’s PHAT vonoprazan application for erosive esophagitis, relief of heartburn, and maintenance. 

The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.

Clinical Readouts/Presentations

BrainStorm Cell Therapeutics Inc BCLI: Use of cerebrospinal fluid biomarkers to interrogate multiple neuroinflammatory, neurodegenerative, and neuroprotection pathways in NurOwn’s Phase 3 ALS trial at the ALS Drug Development Summit.

Ironwood Pharmaceuticals Inc IRWD: New findings for IW-3300 for abdominopelvic visceral pain in patients with disorders of gut-brain interaction (DGBI) and related visceral pain disorders at the Digestive Disease Week.

Also See Benzinga’s Full FDA Calendar.


Chinook Therapeutics Inc KDNY has priced its underwritten public offering of 6.43 million shares at $14.00 per share

Chinook also offers pre-funded warrants to purchase up to 1.07 million shares at $13.99 per pre-funded warrant. 

The gross proceeds are expected to be $105 million.

Shares are down 7.35% at $14 during the premarket session.

Cutera Inc CUTR has priced $210 million 2.25% senior convertible notes due 2028 in a private placement. 

Cutera also granted the initial purchasers an option to purchase up to an additional $30 million notes. 

The company will use a portion of the net proceeds for the Notes Exchange and the remainder for general corporate purposes.

CureVac BV CVAC: Before Market Open.

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