FDA Snubs HRTX Again, ICPT Disappoints, KNSA Hits Right Notes, Is The Writing On The Wall For VRCA?

akero june30 lt

Today's Daily Dose brings you news about Akero's near-term catalyst; FDA denying approval to Heron's HTX-011 for the management of postoperative pain and Intercept's OCA for treatment of NASH; Kiniksa's RHAPSODY trial results, PDS Biotechnology's KOL meeting and regulatory update on Verrica's VP-102.

Read on…

1. Akero To Shed More Light On BALANCED Study

Akero Therapeutics Inc. (AKRO) is all set to discuss new efficacy and safety data, including biopsy results, from its phase IIa study of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis, dubbed BALANCED, on Tuesday, June 30, 2020, after-market hours.

On March 31, 2020, the Company announced that its BALANCED study met the primary endpoint with statistically significant absolute reductions in liver fat of 12-14% at week 12. The news sent the stock up as high as 30% that day to $22.39.

AKRO has traded in a range of $10.78 to $34.00 in the last 1 year. The stock closed Monday's trading at $22.89, down 2.60%. In after-hours, the stock was up 2.66% at $23.50.

2. FDA Says No To Heron's Investigational Non-opioid Again

Shares of Heron Therapeutics Inc. (HRTX) plunged more than 28% on Monday, following the FDA's decision not to approve the Company's investigational non-opioid HTX-011 for the management of postoperative pain again.

In its Complete Response Letter, the FDA has cited four non-clinical issues as the reasons for denying approval to HTX-011. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage, the Company noted.

HTX-011 was turned down by the FDA last April also on issues related to chemistry, manufacturing and controls, and non-clinical information.

HRTX closed Monday's trading at $14.26, down 28.08%. in after-hours, the stock was up 1.02% at $14.40.

3. Intercept's Obeticholic Acid Denied FDA Approval for Treating NASH

Shares of Intercept Pharmaceuticals Inc. (ICPT) touched a new 52-week low after the FDA refused to approve the Company's Obeticholic Acid for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).

In its Complete Response Letter, the U.S. regulatory agency indicated that the predicted benefit of Obeticholic Acid based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.

The FDA has sought additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and has recommended the continuation of the long-term outcomes phase of the study.

Non-alcoholic steatohepatitis, or NASH, refers to liver inflammation due to fat buildup in the liver and is said to affect 2 to 5 percent of Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD, which affects an estimated 10 to 20 percent of people in the U.S.

Currently, there is no FDA-approved drug for the treatment of NASH. Saroglitazar, developed by India's Zydus Cadila, which was greenlighted by the Drug Controller General of India, in March this year, is the world's first and only NASH treatment.

ICPT touched a new 52-week low of $44.51 in intraday trading on Monday before closing at $46.70, down 39.73%.

4. Kiniksa's RHAPSODY Hits Right Notes

Shares of Kiniksa Pharmaceuticals Ltd. (KNSA) touched a new 52-week high of $28.65, following positive results from its pivotal phase III trial of Rilonacept in recurrent pericarditis, dubbed RHAPSODY.

Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease that typically presents with chest pain and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion.

In the RHAPSODY trial, the primary efficacy endpoint of median time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant. There was a 96% reduction in the risk of recurrent pericarditis events in patients treated with Rilonacept. The trial also met major secondary efficacy endpoints.

Developed by Regeneron Pharmaceuticals Inc. (REGN), Rilonacept is approved by the FDA under the brand name ARCALYST for the treatment of Cryopyrin-associated periodic syndrome (CAPS), a rare hereditary inflammatory disorder. ARCALYST recorded annual sales of $14.5 million in 2019 and quarterly sales of $3 million in the first quarter of 2020.

Kiniksa licensed Rilonacept from Regeneron in 2017 for evaluation in certain diseases, including recurrent pericarditis.

Based on the phase III RHAPSODY data, Kiniksa plans to submit a supplemental Biologics License Application for Rilonacept in the indication of recurrent pericarditis with the FDA later this year.

KNSA touched a new 52-week high of $28.65 in intraday trading on Monday, before closing at $26.00, up 12.90%.

5. Will PRIMROSES Revitalize ObsEva?

ObsEva SA (OBSV) is all set to release results from its phase III trials of Linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids, dubbed PRIMROSE 1 and PRIMROSE 2, on Monday, July 6, 2020.

The Company reported positive 24-week data from the PRIMROSE 2 trial last December. The study met the primary efficacy endpoint of the reduction in heavy menstrual bleeding at 24 weeks.

The data that will be reported on Monday will include twelve-month results from the phase III PRIMROSE 2 trial and six-month primary endpoint data from the phase III PRIMROSE 1 trial.

OBSV closed Monday's trading at $5.19, down 9.11%.

6. PDS Biotechnology To Host KOL Meeting

PDS Biotechnology Corporation (PDSB) is all set to hold a Key Opinion Leader meeting to discuss the applications for the Company's Versamune platform in SARS-CoV-2 and other infectious disease vaccines on June 30, 2020.

The Company has two SARS-CoV-2 vaccine candidates PDS0203 and PDS0204 for the prevention of COVID-19, both under pre-clinical development.

PDSB closed Monday's trading at $2.60, up 60.49%.

7. Is the writing on the wall for Verrica's VP-102?

Verrica Pharmaceuticals Inc. (VRCA) fell more than 21% in extended trading on Monday, following a regulatory update on VP-102, its investigational topical therapy, under FDA review, proposed for the treatment of molluscum contagiosum.

Molluscum contagiosum is a common, highly contagious viral skin infection affecting an estimated 6 million people in the United States, primarily children. Currently, there are no FDA-approved treatments for this viral skin disease.

The FDA has notified the Company that its New Drug Application for VP-102 contains deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. However, this observation is not going to have a bearing on the final decision on VP-102.

The final decision on VP-102 is expected on July 13, 2020. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH.

VRCA closed Monday's trading at $14.07, down 0.85%. In after-hours, the stock plunged 21.89% to $10.99.

8. Stocks That Moved On No News

Genetic Technologies Limited (GENE) closed Monday's trading at $2.49, up 21.46%.

Pacira BioSciences Inc. (PCRX) closed Monday's trading at $52.02, up 17.99%.

Rite Aid Corporation (RAD) closed Monday's trading at $17.31, up 14.71%.

Cleveland BioLabs Inc. (CBLI) closed Monday's trading at $2.45, down 42.49%.

NGM Biopharmaceuticals Inc. (NGM) closed Monday's trading at $19.58, down 12.47%.

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