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ABBV Seeks Expanded Approval Of Rinvoq, APTX Cheered By PTSD Data, ENDP Snaps Up BSTC, LQDA On Watch

biotech oct20 lt

Today's Daily Dose brings you news about AbbVie seeking expanded approval of RINVOQ in atopic dermatitis, Aptinyx's positive results in post-traumatic stress disorder trial, Endo International acquiring BioSpecifics Technologies, the merger agreement between Cleveland BioLabs and privately-held Cytocom, and the licensing agreement offer of Liquidia.

Read on…

1. AbbVie Seeks Expanded approval of RINVOQ In Atopic Dermatitis

AbbVie (ABBV) has sought approval in the U.S. and EU to expand the use of RINVOQ for the treatment of moderate to severe atopic dermatitis in adults and adolescents.

Atopic dermatitis, also known as eczema, is a chronic, inflammatory skin disease affecting an estimated 10 percent of adults and 25 percent of adolescents.

RINVOQ, a selective and reversible JAK inhibitor, received FDA approval in August 2019 for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, and European Commission's approval in December 2019 for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

ABBV closed Monday's trading at $84.31, up 2.27%.

2. Aptinyx Gets a Lift from Soothing Outcomes in PTSD Trial

Shares of Aptinyx Inc. (APTX) were up over 85% in extended trading Monday, following positive results from the company's first phase II study of NYX-783 in patients with post-traumatic stress disorder.

In the phase II study, which involved 153 patients with post-traumatic stress disorder, NYX-783 demonstrated statistically significant and clinically meaningful efficacy results and a favorable adverse event and tolerability profile.

It is estimated that roughly eight and a half million people in the United States suffer from post-traumatic stress disorder (PTSD).

PTSD can result from various forms of trauma, including combat exposure, car accidents, sexual or other physical assault, abuse, natural disasters, and others. This disorder is characterized by intrusive symptoms, avoidance, negative alteration in cognition and mood, hyperarousal, and/or arousal alterations following the experience of trauma.

Based on the encouraging phase II results, the company expects to initiate a pivotal study of NYX-783 in 2021.

APTX closed Monday's trading at $3.66, down 1.88%. In after-hours, the stock was up 85.11% at $6.77.

3. BioSpecifics Snapped Up By Endo

BioSpecifics Technologies Corp. (BSTC) has agreed to be acquired by Endo International plc (ENDP) for roughly $658 million, or $88.50 per share in cash.

The acquisition adds BioSpecifics' XIAFLEX and Qwo to Endo's portfolio. XIAFLEX is approved for the treatment of Dupuytren's contracture in adults and Peyronie's disease in adult men while Qwo is approved for the treatment of cellulite.

The transaction is scheduled to close in the fourth quarter of 2020.

BSTC touched a new high of $88.69 in intraday trading Monday before closing at $88.69, up 45.35%.

4. Cleveland BioLabs, Cytocom to Combine Business

Cleveland BioLabs Inc. (CBLI) and privately-held Cytocom Inc. have entered into a definitive merger agreement to combine their businesses in an all-stock transaction.

As per the deal, Cytocom shareholders will have a majority position in the newly combined entity. The combined business will operate as "Cytocom Inc." and will continue to be listed on the Nasdaq. The transaction is expected to close during the first quarter of 2021.

The combined company is expected to create near-term commercial opportunities in numerous areas of significant unmet medical needs including acute radiation injury, oncology, infectious disease, inflammation, and autoimmune-mediated conditions, with multiple commercial, regulatory, and clinical milestones expected over the next 12 to 18 months.

CBLI closed Monday's trading at $2.17, down 4.82%. In after-hours, the stock was up 43.78% at $3.12.

5. Liquidia Technologies: Licensing or Acquisition?

Shares of Liquidia Technologies Inc. (LQDA) jumped over 19% on Monday, following the receipt of an unsolicited offer to enter into a license agreement for the company's LIQ861 product candidate. No further details about the offer have been provided.

Liquidia's LIQ861, proposed for the treatment of pulmonary arterial hypertension, is under FDA review, with a decision expected on November 24, 2020.

The offer is conditioned upon Liquidia terminating its merger agreement with RareGen LLC that was signed on June 29, 2020.

In June of this year, Liquidia had entered into a definitive agreement to acquire RareGen LLC, a portfolio company of PBM Capital, through an all-stock merger. As per the deal, it was planned that Liquidia and RareGen will consolidate under a new holding company, to be named Liquidia Corporation, which is expected to trade on the Nasdaq Capital Market under the ticker symbol "LQDA," as the successor to Liquidia Technologies.

Now with the new offer in hand, the Liquidia Board of Directors is evaluating the proposal and will provide additional disclosure upon the conclusion of its review.

LQDA closed Monday's trading at $3.41, up 19.23%.

6. OraSure's OMNIgene ORAL Collection Device Gets FDA's Emergency Use Approval

OraSure Technologies Inc.'s (OSUR) OMNIgene ORAL Collection Device has received FDA Emergency Use Authorization for COVID-19 testing.

OMNIgene ORAL, developed by DNA Genotek, a subsidiary of OraSure Technologies, can be used for the self-collection, transport, and laboratory testing of saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA). The device also has the CE Mark for in vitro diagnostic use, including for COVID-19 testing, in the European Union.

OSUR closed Monday's trading at $15.94, up 15.42%.

7. Stocks That Touched New Highs/Lows

STAAR Surgical Company (STAA) closed Monday's trading at a new high of $67.63, up 11.97%.

Athira Pharma Inc. (ATHA) closed Monday's trading at a new high of $20.86, up 13.93%.

Kymera Therapeutics, Inc. (KYMR) closed Monday's trading at a new high of $39.24, up 2.24%.

ProQR Therapeutics N.V. (PRQR) closed Monday's trading at a new low of $4.13, down 6.35%.

Aerie Pharmaceuticals, Inc. (AERI) closed Monday's trading at a new low of $9.92, down 14.78%.

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