IMMU Continues Ascent, IDXG On Fire, REGN’s Kevzara Disappoints In COVID-19 Trial, BLFS On Watch

Today’s Daily Dose brings you news about BioLife Solutions’ preliminary second-quarter revenue estimate; Immunomedics’ immediate catalyst; Interpace Biosciences’ stock price spike; MEI Pharma discontinuing Pracinostat trial in AML patients due to lack of efficacy and disappointing outcome from Regeneron/Sanofi’s study evaluating Kevzara in COVID-19 patients.

Read on…

1. BioLife’s Q2 Revenue Defies Covid-19 Impact

Shares of BioLife Solutions Inc. (BLFS) were up over 12% in Thursday’s trading, following better-than-expected revenue estimates for the second quarter of 2020.

The Company has announced preliminary revenue for the second quarter of 2020 of $9.6 million to $9.8 million, representing 43% to 46% growth over the same quarter in 2019. Wall Street analysts are expecting revenue of $8.52 million for the quarter.

BLFS closed Thursday’s trading at $17.98, up 12.09%.

2. Immunomedics To Provide Clinical Update On Monday

Immunomedics Inc. (IMMU) is all set to provide a clinical update on Monday, July 6, 2020, at 8:00 a.m. Eastern Time.

The Company’s lead product is TRODELVY (sacituzumab govitecan-hziy), which received accelerated FDA approval as recently as April, for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies.

Continued approval depends upon verification of clinical benefit in phase III confirmatory trial of Trodelvy in third-line mTNBC, dubbed ASCENT. The topline data readout from the ASCENT study is expected around mid-2020.

A phase III study of Trodelvy in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer, known as TROPiCS-02, is underway.

Trodelvy is also being tested in a phase II trial in stage IV urothelial cancer after failure of a platinum-based regimen and/or anti-PD-1/PD-L1-based therapies, dubbed TROPHY U-01.

IMMU touched a new 52-week high of $37.69 in intraday trading before closing at $37.54, up 1.71%. In after-hours, the stock was up 3.89% at $39.00.

3. Interpace Biosciences On Fire

Interpace Biosciences Inc. (IDXG) has developed COVIANT, a qualitative blood test for the detection of IgG antibodies against SARS-CoV-2 in human plasma and serum.

According to the Company website, the test has not been reviewed by the FDA but its availability and performance have been determined to be appropriate with Emergency Use Authorization approval granted to the kit manufacturer, EUROIMMUN US, Mountain Lakes.

Historically, the Company has been providing molecular diagnostics, bioinformatics, and pathology services for evaluation of the risk of cancer. ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts and RespriDX that differentiates lung cancer of primary vs. metastatic origin are the Company’s four commercialized molecular tests. One test is also in clinical development and it goes by the name BarreGEN for Barrett’s Esophagus.

COVIANT, the serology antibody ELISA testing for COVID-19, was developed in response to customer interest.

IDXG closed Thursday’s trading at $6.14, up 39.23%. In after-hours, the stock was up another 11.07% at $6.82.

4. MEIP/Helsinn Pull The Plug On Pracinostat Trial In AML Patients

Shares of MEI Pharma Inc. (MEIP) tumbled on Thursday after the Company’s decision to discontinue the ongoing phase III study of Pracinostat in combination with chemotherapy drug Vidaza (azacitidine) in patients with Acute Myeloid Leukemia who are unfit to receive standard intensive chemotherapy.

In August 2016, MEI Pharma licensed Pracinostat to Helsinn, a Swiss pharmaceutical group, in Acute Myeloid Leukemia and other indications, including MDS.

The decision to discontinue the trial was based on the Independent Data Monitoring Committee’s interim futility analysis that has demonstrated the study was unlikely to meet the primary endpoint of overall survival compared to the control group.

However, patients currently enrolled in other Pracinostat studies will continue treatment, noted the companies.

MEIP closed Thursday’s trading at $3.49, down 18.27%.

5. Regeneron/Sanofi’s Arthritis Drug Kevzara Disappoints In COVID-19 Trial

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) on Thursday announced that their U.S. phase III trial of arthritis drug Kevzara 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo). Moreover, adverse events were experienced by 80% of COVID-19 patients treated with Kevzara and 77% of placebo patients.

Based on the disappointing outcome, the U.S.-based trial of Kevzara in COVID-19 patients has been stopped.

A separate phase II/III trial led by Sanofi outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The companies expect to report the results of this trial outside of the U.S. this quarter (Q3, 2020).

Kevzara is an approved drug for rheumatoid arthritis and it is being tested for repurposing to treat COVID-19 based on data from a single-arm study in China suggesting that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19. Kevzara is also an interleukin-6 (IL-6) receptor antagonist.

REGN closed Thursday’s trading at $622.45, up 2.18%. In after-hours, the stock was down 1.54% at $611.

6. Stocks That Moved On No News

MTBC Inc. (MTBC) closed Thursday’s trading at $9.55, up 12.88%.

Applied Genetic Technologies Corp. (AGTC) closed Thursday’s trading at $6.43, up 10.29%.

Rocket Pharmaceuticals Inc. (RCKT) closed Thursday’s trading at $22.55, up 10%.

Liminal BioSciences Inc. (LMNL) closed Thursday’s trading at $16.75, down 26.50%.

Qualigen Therapeutics, Inc. (QLGN) closed Thursday’s trading at $4.10, down 10.28%.

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