Pacira BioSciences surges after Heron receives CRL

Heron Therapeutics is having a tough day after receiving a Complete Response Letter from the FDA for HTX-011 for management of post-operative pain.

That’s good news for Pacira BioSciences (PCRX +15.3%), and its opioid-free, extended release local anesthetic exparel. RBC late last week said any negative Heron surprise could mean big upside for the highly shorted Pacira.

https://seekingalpha.com/news/3586913-pacira-biosciences-surges-after-heron-receives-crl

FDA rejects Heron Therapeutics’ NDA for HTX-011 for postoperative pain

Heron Therapeutics (NASDAQ:HRTX) is down 11% premarkket in reaction to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its NDA for HTX-011 for the management of postoperative pain.

The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information.

The Agency did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.

The Company will request a Type A meeting to obtain agreement with the Agency and resubmit the application as quickly as possible.

https://seekingalpha.com/news/3586877-fda-rejects-heron-therapeutics-nda-for-htxminus-011-for-postoperative-pain

FDA clears Boston Scientific implantable arrhythmia detection device

Boston Scientific (NYSE:BSX) has received FDA 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke and syncope.

The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

The company will immediately begin a limited market release of the LUX-Dx ICM System in the U.S., with full launch commencing later this year.

https://seekingalpha.com/news/3586788-fda-clears-boston-scientific-implantable-arrhythmia-detection-device

Altimmune nabs $4.7M funding to initiate mid-stage T-COVID trial

Altimmune (NASDAQ:ALT) is up 30% premarket after securing a $4.7M award from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19.

Patient enrollment is expected to commence in coming weeks, with data readout anticipated in Q4.

If successful, the Company plans to initiate a Phase 2/3 trial of T-COVID early next year and commence discussions regarding a potential Emergency Use Authorization.

The T-COVID therapeutic program complements the Company’s novel single-dose COVID-19 vaccine candidate, AdCOVID, that utilizes intranasal vaccine technology and has the potential to prevent infection by activating multiple arms of the immune system.

https://seekingalpha.com/news/3586804-altimmune-nabs-4_7m-funding-to-initiate-mid-stage-t-covid-trial

FDA OKs Orthofix Firebird SI Fusion System for low back pain

Orthofix Medical (NASDAQ:OFIX) announces the FDA 510(k) clearance and the first patient implants of the FIREBIRD SI Fusion System.

Designed to compress and stabilize the sacroiliac joint (also called the SI joint) during fusion, the FIREBIRD SI Fusion System is the first 3D printed titanium bone screw to launch in the U.S. for treating SI joint dysfunction.

Sacroiliac joint fusion is an important treatment option to reduce pain through a minimally invasive procedure that can enable patients to return to better function and quality of life.

https://seekingalpha.com/news/3586832-fda-oks-orthofix-firebird-si-fusion-system-for-low-back-pain

Kiniksa’s rilonacept successful in pivotal heart inflammation study

Kiniksa Pharmaceuticals (NASDAQ:KNSA) announces positive results from a Phase 3 clinical trial, RHAPSODY, evaluating rilonacept in patients with recurrent pericarditis, inflammation of the pericardium, two layers of the sac-like tissue surrounding the heart.

The study met the primary endpoint, time to pericarditis recurrence at week 24, and all key secondary endpoints. Treatment with rilonacept, a subcutaneously administered recombinant fusion protein that blocks Interleukin-1α and Interleukin-1β signaling, resulted in 96% less risk in recurrent pericarditis events.

The company expects to file a supplemental marketing application in the U.S. later this year.

Rilonacept was discovered and developed by Regeneron Pharmaceuticals (NASDAQ:REGN) who markets the med under the brand name Arcalyst for a rare inflammatory disorder called cryopyrin-associated periodic syndromes (CAPS). Kiniksa in-licensed rights in 2017 for diseases believed to be mediated by both IL-1α and IL-1β, including recurrent pericarditis.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3586834-kiniksas-rilonacept-successful-in-pivotal-heart-inflammation-study

FDA nod on Rocket Pharma gene therapy for infantile malignant osteopetrosis

Rocket Pharmaceuticals (NASDAQ:RCKT) has received FDA clearance for its IND application for RP-L401, a lentiviral vector-based gene therapy for the treatment of Infantile Malignant Osteopetrosis, a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure.

The non-randomized, open-label Phase 1 clinical trial will enroll two pediatric patients, one month of age or older.

The trial is designed to assess safety and tolerability of RP-L401, as well as preliminary efficacy, including potential improvements in bone abnormalities/density, hematologic status and endocrine abnormalities.

https://seekingalpha.com/news/3586846-fda-signs-off-on-rocket-pharmas-gene-therapy-for-infantile-malignant-osteopetrosis