The Daily Biotech Pulse: FDA Nod For Bristol-Myers Squibb, Xencor Licenses Tech To Vir For COVID-19 Treatment, Delay In Pfizer's Upjohn-Mylan Merger

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs March 25.)

• Ra Pharmaceuticals Inc RARX

Down In The Dumps

(Biotech stocks that hit 52-week lows March 25.)

• Anixa Biosciences Inc ANIX
• IMMUTEP LTD/S ADR IMMP (reacted to breast cancer trial readout)
• PLx Pharma Inc PLXP
• Taro Pharmaceutical Industries Ltd. TARO

Stocks In Focus

Quidel COVID-19 Detection Assay Obtains Expanded EUA, CE Mark Approval

Quidel Corporation QDEL said its Lyra SARS-CoV-2 Assay has received expanded Emergency Use Authorization from the FDA to allow testing with three additional thermocyclers, namely Applied Biosystems' 7500, Roche Holdings AG's RHHBY LightCycler 480 and Qiagen NV's QGEN Rotor Gene Q.

Quidel said the initial EUA awarded allowed qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19. The expanded authorization includes nasal and nasal turbinate swabs.

Quidel also said it received the CE-Mark on March 25, which will allow it market and sell the Lyra SARS-CoV-2 Assay in Europe as well as other countries that accept CE Mark.

Alector Out-Licenses China Rights of AL008 In Oncology To Innovent Biologics

Alector Inc ALEC and Hong Kong-listed biopharma Innovent Biologics said they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody AL008 for the treatment of oncology indications in China.

The companies did not disclose the financial terms of the deal. The agreement gives Innovent the responsibility of leading development and commercialization of the investigational compound in China, while Alector is in charge of developmental activities outside of China.

See also: The Week Ahead In Biotech: Bristol-Myers, Rockwell Medical Await FDA Decisions, COVID-19 Updates In Focus

Bristol-Myers Squibb Receives FDA Nod For Celgene's Multiple Sclerosis Drug

Bristol-Myers Squibb Co BMY announced FDA approval for ozanimod 0.92 mg as a treatment option for patients with relapsing forms of multiple sclerosis.

In premarket trading Thursday, Bristol-Myers Squibb shares were adding 1.52% to $50.10.

Cerecor To Test Role Of Inflammatory Cytokinin In COVID-19-Induced Acute Respiratory Distress

Cerecor Inc CERC said it plans to explore the role of an inflammatory cytokine — LIGHT — in patients with COVID-19-induced acute respiratory distress. It said it will use its proprietary free LIGHT assay as well as multiple assay to determine if there are differences in LIGHT levels and other inflammatory markers, including IL-18 and IFN-g, in patients with mild-to-moderate vs. severe disease with Acute Lung Injury or Acute Respiratory Distress Syndrome.

Grifols To Develop Hyperimmune Globulin For COVID-19

Grifols SA - ADR GRFS said it has entered a formal collaboration agreement with the U.S. BARDA, the FDA and other federal public health agencies to collect plasma from convalescent COVID-19 patients and process this specific plasma into a hyperimmune globulin.

The company also said it will support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can be used to treat COVID-19 disease.

In Spain, Grifols is working on a clinical trial with inactivated plasma from recovered patients through a collaboration with select donation centers and public hospitals.

The company also said it has accelerated the development and validation of a proprietary technology transcription-mediated amplification–based diagnostic procedure to detect the virus, with a sensitivity equivalent or even superior to that of PCR test.

The stock was rising 10.47% to $19.63 in premarket trading.

Pfizer, Mylan Announce Delay In Merger Of Generic Businesses

Pfizer Inc. PFE and Mylan NV MYL announced the proposed merger between Mylan and Pfizer's generic unit Upjohn will now close in the second half of 2020 due to the unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process. The companies initially had a closing deadline of mid-2020.

Biopharmx Gets Delisting Notice From NYSE American

Specialty pharma company Biopharmx Corp BPMX said it received a notification from NYSE American LLC on March 24 regarding its determination to delist the company's shares from the exchange. The decision is due to the company's non-compliance with certain continued listing standards.

Biopharmx said it will appeal the delisting notice. The shares, according to the company, will continue to trade on the exchange during the appeal period.

The company also clarified that the delisting does not affect its business operations, its intention to merge with Timber Pharma announced Jan. 28 or its SEC reporting requirements,

The stock was down 2.83% at 28 cents at the time of publication.

Xencor, Vir Agree To License Technology To Extend Half-Life Of COVID-19 Treatment Candidates

Xencor Inc XNCR said it entered into a technology license agreement with Vir Biotechnology Inc VIR that provides Vir non-exclusive access to Xencor's Xtend Fc technology to extend the half-life of novel antibodies Vir is investigating as a  potential treatment for COVID-19.

"Xtend Fc technology has demonstrated, in multiple antibodies and through numerous human clinical trials, the ability to extend antibody drug half-life and reduce dosing frequency in patients, an important feature in anti-viral therapy for pandemic use," Xencor CEO Bassil Dahiyat said in a statement. 

The companies did not disclose the financial terms of the deal.

Vir shares were trading 3.22% higher at $31.74 in Thursday's premarket session.

Earnings

Biocept Inc's BIOC fourth-quarter revenue climbed 108% year-over-year to $1.8 million. The net loss narrowed significantly from $1.43 per share to 20 cents per share. Analysts estimated a loss of 10 cents per share.

The stock was trading 8.57% higher at 38 cents at the time of publication. 

On The Radar

PDUFA Dates

IntelGenx Technologies Corp.'s IGXT NDA for rizaport versafilm for the treatment of acute migraine is pending before the FDA, with the target action day fixed for Thursday. The company had faced three rejections for the investigational drug in the past.

Earnings

• Celsion Corporation CLSN (before the market open)
• Entera Bio Ltd ENTX (before the market open)
• TFF Pharmaceuticals Inc TFFP (before the market open)
• IGM Biosciences Inc IGMS (after the close)
• NovaBay Pharmaceuticals, Inc. NBY (after the close)
• Vermillion, Inc. VRML (after the close)
• aTyr Pharma Inc LIFE (after the close)

Related Link: Hoth Therapeutics Shares Jump On COVID-19 Vaccine Development Plans