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Monday, July 6, 2020

Immunomedics antibody-drug conjugate succeeds in late-stage breast cancer study

Immunomedics (NASDAQ:IMMU) announces positive results from a Phase 3 clinical trial, ASCENT, evaluating antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in patients with relapsed/refractory triple-negative breast cancer (TNBC).
The study met the primary endpoint demonstrating a statistically significant improvement in progression-free survival (PFS) versus chemo at year 3. Specifically, median PFS in the treatment group was 5.6 months compared to 1.7 months in the chemo group (p<0.0001).
The trial also met the key secondary endpoints of overall survival and objective response rate.
The FDA approved Trodelvy in April for previously treated metastatic TNBC. The aim of ASCENT was to validate the safety and efficacy of the ADC that supported accelerated approval.

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ANI Pharma acquires fluconazole tablets for $3M

ANI Pharmaceuticals (NASDAQ:ANIP) has acquired Fluconazole Tablets USP, 50mg, 100mg, 150mg, and 200mg from an unnamed private company for $3M.
The U.S. market for the candidiasis med is ~$40M.

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Roche comes up empty in effort to block Amgen’s Avastin biosimilar

Roche (OTCQX:RHHBY) has come up empty in its appeal of a court ruling allowing Amgen (AMGN +0.9%) to sell Mvasi (bevacizumab-awwb), an Avastin biosimilar, in the U.S.
It also struck out in its attempt to block the latter’s Kanjinti (trastuzumab-anns), a Herceptin biosimilar.

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Neovasc reports Q2 preliminary revenue

Neovasc (NASDAQ:NVCN) +0.8% reports Q2 preliminary revenue of ~$295,000 down from $440,420K due to a reduction in reducer procedures that began in mid-March and persisted through early June.
Despite a marked slowdown in the number of implants and related revenue from the reducer amid COVID-19, the Company has seen a significant recovery culminating in the record highest monthly number of implants during June.
Neovasc will report financial results for the quarter ended June 30, 2020 after the market close on August 6, 2020.
Source: Press Release

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ISM Service jumps back into expansion zone

June ISM Non-Manufacturing Index: 57.1 vs. 50.1 consensus, 45.4 prior.
Business activity 66.0 vs 41.0.
New Orders 61.6 vs 41.9.
Employment 43.1 vs 31.8.
Prices 62.4 vs. 55.6

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Becton, Dickinson launches COVID-19 rapid test in U.S.

The FDA has granted emergency use authorization for Becton, Dickinson and Company’s (BDX +1.6%) rapid point-of-care test for the detection of the SARS-CoV-2 virus. The assay, performed on the BD Veritor Plus System, generates results in 15 minutes, enabling healthcare professionals to take action (if positive) while the patient is still onsite.
In clinical studies, the test showed 84% sensitivity (correctly identifying true positives) and 100% specificity (correctly identifying true negatives).
Market launch is underway. It expects to file for 510(k) clearance at a later date. It plans to ramp up production to 2M tests per week by the end of September.
Selected COVID-19 rapid test competitors: Abbott (ABT +1.5%), Roche (OTCQX:RHHBY +0.7%), Thermo Fisher Scientific (TMO +3.0%)

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Thermo Fisher leads rally in life science toolmakers

Thermo Fisher Scientific (TMO +3.6%) is up in early trade, albeit on below-average volume, after reporting that it expects Q2 sales above Wall Street views driven by strong demand for COVID-19 tests, products and services that contributed more than $1.4B in revenue during the quarter.
The bullish news has stocked buying in other life science toolmakers (albeit in lockstep with the broad market rally).
Selected tickers: Waters (WAT +1.1%), PerkinElmer (PKI +1.5%), Agilent (A +1.7%), Avantor (AVTR +3.2%), Danaher (DHR +2.0%)

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