BNTX Soars On COVID-19 Alliance, DBVT Plunges, OPGN Jumps 101%, ACRX Buys TTPH

pharma 010919 16mar20 lt

Today's Daily Dose brings you news about Moderna's progress in COVID-19 vaccine development, cancelation of FDA Panel meeting to review DBV Technologies' peanut allergy product, District Court ruling on Mallinckrodt's base date AMP for Acthar Gel and AcelRx Pharma's acquisition of Tetraphase Pharma, among others.

Read on…

AcelRx Pharmaceuticals Inc. (ACRX) is all set to acquire Tetraphase Pharmaceuticals Inc. (TTPH) in a stock for stock deal, valued at approximately $14.4 million as of the close of trading on March 13, 2020, plus a contingent value right (CVR).

As part of the deal, Tetraphase shareholders will receive 14.6% of AcelRx fully diluted shares outstanding in the transaction. The CVR would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA net sales milestones starting in 2021.

XERAVA is Tetraphase's approved antibiotic indicated for the treatment of complicated intra-abdominal infections.

Tetraphase and AcelRx have also entered into a co-promotion agreement to market and promote XERAVA and DSUVIA. As previously mentioned, XERAVA is Tetraphase's approved antibiotic indicated for the treatment of complicated intra-abdominal infections while DSUVIA, developed by AcelRx, is indicated for the management of acute pain in adults in medically supervised healthcare settings.

The transaction is expected to close in the second quarter of 2020.

ACRX closed Monday's trading at $0.83, down 18.46%. In after-hours, the stock was up 21.44% at $1.02.

Shares of BioNTech SE (BNTX) touched an all-time high of $52.80 in intraday trading on Monday, following a strategic development and commercialization collaboration with China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Under the terms of the agreement, the two companies will work jointly on the development of BioNTech's mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections. BNT162 is expected to enter into clinical testing in late April 2020.

BioNTech is in advanced discussions with its existing collaborator Pfizer regarding the development of the BNT162 vaccine outside China.

BNTX closed Monday's trading at $40, up 29.32%. in after-hours, the stock gained another 7.50% to $43.

Shares of DBV Technologies S.A. (DBVT) plunged more than 57 percent in after-hours trading on Monday, following the cancelation of the FDA Panel meeting, scheduled for May 15, 2020, to review Viaskin Peanut.

Viaskin Peanut is the Company's investigational product designed as a patch that leverages the skin to activate the immune system and induce desensitization in peanut-allergic children.

The decision to put off the panel meeting was taken by the FDA after the U.S. regulatory agency identified questions regarding Viaskin Peanut's efficacy, including the impact of patch-site adhesion.

The final decision on Viaskin Peanut is expected by August 5, 2020.

Meanwhile, Aimmune Therapeutics Inc. (AIMT), whose peanut allergy drug Palforzia received FDA approval in January of this year, was up more than 17 percent in after-hours today.

DBVT closed Monday's trading at $5.26, down 10.70%. In after-hours, the stock fell another 57.22% to $2.25.

Shares of Mallinckrodt Public Limited Co. (MNK) plummeted over 40%, following a disappointing ruling by the District Court in the Company's case against the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services (CMS).

The dispute involves the base date AMP under the Medicaid Drug Rebate Program for Acthar Gel, the Company's main revenue generator. A drug's "base date AMP" is used to calculate the Medicaid rebate amount payable by the drug's manufacturer to state Medicaid agencies when the drug is prescribed to Medicaid beneficiaries.

In May 2019, CMS indicated that if Mallinckrodt failed to revert to use of the original base date AMP in its calculation of Acthar Medicaid rebates, CMS would identify the Company as being out of compliance with its Medicaid Drug Rebate Program reporting requirements, among other potential actions, triggering certain negative consequences. That same month, Mallinckrodt had challenged the decision of CMS.

But now with the District Court rendering a ruling against the Company, retroactive payment of approximately $650 million for the period from January 1, 2013, to present, will have to be made by Mallinckrodt, and this will be reflected as a non-GAAP adjustment in the first-quarter results.

Based on current Medicaid patient volume, Mallinckrodt estimates the annualized prospective change to the Medicaid rebate calculation will reduce Acthar Gel net sales by roughly $90 million to $100 million.

MNK closed Monday's trading at $1.80, down 40.79%.

Moderna Inc. (MRNA) announced that the first participant has been dosed in a phase I study of its mRNA vaccine, mRNA-1273, against the novel coronavirus.

The phase I study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.

A total of 45 healthy adults will be enrolled in the study who will be randomized to receive three dose levels of mRNA-1273 (25, 100, 250 µg) administered on a two-dose vaccination schedule, given 28 days apart.

Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.

The Company noted that it is actively preparing for a potential phase II study of mRNA-1273 under its own IND.

MRNA closed Monday's trading at $26.49, up 24.37%. In after-hours, the stock gained another 9.85% to $29.10.

OpGen Inc. (OPGN), on Monday, announced that Curetis has started offering a CE-IVD certified real-time PCR test kit for SARS-CoV2, the coronavirus causing Covid-19.

The test kit, developed and manufactured by Curetis' strategic partner BGI (Shenzhen, China), was cleared by Chinese authorities in January 2020, and was CE-IVD certified by European regulators on February 28, 2020.

The BGI 2019-nCoV RT-qPCR Kit enables diagnostic laboratories to perform SARS-CoV2 testing of nasopharyngeal swabs and bronchoalveolar lavage fluid of patients suspected to suffer from Covid-19.

OpGen and Germany-based Curetis entered into a definitive agreement to combine businesses on September 4, 2019. The transaction has not closed yet, and is subject to a number of conditions. Until the closing occurs, each of OpGen and Curetis are operating as stand-alone businesses.

OPGN jumped 101% on Monday to close the day's trading at $4.04. In after-hours, the stock was up 0.25% at $4.05.

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