FDA OKs expanded use of Karyopharm’s selinexor

Under accelerated review status, the FDA has approved Karyopharm Therapeutics’ (KPTI +4.3%) Xpovio (selinexor) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

The agency OK’d the nuclear export inhibitor in July 2019 for multiple myeloma.

The company plans to file an application in Europe in 2021.

https://seekingalpha.com/news/3584990-fda-oks-expanded-use-of-karyopharms-selinexor

Mersana Therapeutics’ XMT-1592 shows positive action in early-stage study

Mersana Therapeutics (MRSN +4.8%) announces encouraging preclinical data on antibody-drug conjugate (ADC) XMT-1592. The results were presented virtually at the American Association for Cancer Research Annual Meeting.

In a non-small cell lung cancer (NSCLC) adenocarcinoma patient-derived xenograft model, XMT-1592 showed sustained tumor regressions.

Also, early-stage data on multiple Immunosynthen STING-agonist ADCs showed complete tumor regressions after a single dose, improved tolerability and immune memory.

The results also showed that the STING-agonist ADC was over 100-fold more potent with limited induction of systemic cytokines compared to intravenously administered unconjugated (free) agonist.

The company will select its first Immunosynthen STING-agonist ADC development candidate in H2.

https://seekingalpha.com/news/3584993-mersana-therapeutics-xmtminus-1592-shows-positive-action-in-early-stage-study

Five Prime Therapeutics (NASDAQ:FPRX) Upgraded by Wedbush to Outperform

Five Prime Therapeutics Upgraded by Wedbush on 6/22/2020. In a note to investors, the firm issued a new rating of Outperform. The analysts previously had rating of Neutral.
https://stockmarketdaily.co/2020/06/22/five-prime-therapeutics-nasdaqfprx-upgraded-by-wedbush-to-outperform/

SiNtx soars on upbeat data on its silicon nitride powder’s effect on COVID-19 virus

Shares of SiNtx Technologies Inc. SINT, 165.92% skyrocketed more than 4-fold (up 343%) in premarket trading Monday, after the original equipment manufacturer ceramics company said the SARS-CoV-2 virus which causes COVID-19 was “inactivated” when exposed to its sintered silicon nitride powder in a controlled laboratory study. Trading volume spiked to over 847,000 shares ahead of the open, already more than half full-day average of about 1.4 million shares. The company said it will share additional data soon, once the findings are published. SiNtx said it was conducting additional testing at independent laboratories to corroborate the results. “The antiviral data are consistent with the well-established anti-bacterial properties of SINTX’s silicon nitride, and with previously reported effectiveness against several single-strand RNA viruses,” said Chief Executive Sonny Bal. The stock’s rally comes as futures ES00, 1.33% for the S&P 500 SPX, 0.52% rose 0.9% ahead of the open.
https://www.marketwatch.com/story/sintxs-stock-skyrockets-after-upbeat-data-on-its-silicon-nitride-powders-effect-on-covid-19-virus-2020-06-22

Barclays bails on Biogen after court ruling

The West Virginia court decision on Tecfidera threatens perhaps one-third Biogen’s (NASDAQ:BIIB) free cash flow, says analyst Carter Gould, downgrading to Equalweight from Overweight. He slashes his price target to $280 from $370. The stock closed at $271 on Friday.

While Biogen will surely appeal the West Virginia ruling, Gould says last week’s decision raises the odds of another unfavorable ruling in a pending Delaware case.

Gould then turns to Alzheimer’s treatment aducanumab: “Our conviction on aducanumab has waned in the wake of delays, a lack of clarity around points of discussion with FDA, and a seemingly less confident stance on aducanumab.”

https://seekingalpha.com/news/3584866-barclays-bails-on-biogen-after-court-ruling

Biocept’s COVID-19 testing kit now available for physician ordering

Biocept (NASDAQ:BIOC) announces the availability of 10,000 nasopharyngeal specimen collection kits for RT-PCR testing for COVID-19 for physician ordering.

Collected specimens will be shipped overnight to Biocept’s CLIA-certified and BSL-2 safety level laboratory in San Diego with results returned in an estimated 24 to 48 hours.

Biocept-developed RT-PCR COVID-19 kits are expected to be available in Q3.

https://seekingalpha.com/news/3584868-biocepts-covidminus-19-testing-kit-now-available-for-physician-ordering

FDA accepts Allergan application for expanded use of Botox

The FDA has accepted for review a supplemental marketing application from AbbVie (NYSE:ABBV) unit Allergan seeking approval to use Botox (onabotulinumtoxinA) to treat the signs and symptoms of detrusor (bladder muscle) overactivity associated with an underlying neurologic condition (e.g., spina bifida, spinal cord injuries) in pediatric patients (5 -17 years of age) who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication.

The agency’s action date will be in Q1.

https://seekingalpha.com/news/3584880-fda-accepts-allergan-application-for-expanded-use-of-botox